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Enhanced control in a single-use injector.1-3 The UltraSert™ Delivery System is designed to optimize implantation of the AcrySof® IQ IOL. Combining the control of a manual injector with the sterility and convenience of a pre-loaded system, the UltraSert™ System provides: ™ • Smooth Injection. The TensionGlide plunger provides smooth, one-handed plunger advancement.*,1,2
• Preserved Incisions. The depth guard nozzle is designed to minimize wound stretch.
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• Consistent Delivery. The plunger tip is designed to ensure correct haptic configuration and precise IOL placement.2,3
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©2015 Novartis 7/15 ACR15012FCV-EU *Out of 42 cataract surgeons who tried UltraSert™ System prototypes in an artificial setting, the majority spontaneously used “smooth” to describe the advancement of the plunger. 1. UltraSert™ Delivery System Prototype Human Factor Testing, February 2015. 2. AcrySof® IQ Aspheric IOL with the UltraSert™ Pre-loaded Delivery System Directions for Use. 3. Comparative Assessment of IOL Delivery Systems. Alcon internal technical report: TDOC-0018957. Effective Date 19 May 2015.
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P.36 Publisher Carol Fitzpatrick Executive Editor Colin Kerr Editors Sean Henahan Paul McGinn Managing Editor Caroline Brick Production Editor Conor Ward
CONTENTS
A EUROPEAN OUTLOOK ON THE WORLD OF OPHTHALMOLOGY
Senior Designer Janice Robb Designer Lara Fitzgibbon Circulation Manager Angela Morrissey Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin
COVER STORY 4 The challenge of
taking toric IOLs to the next level
NEWSMAKER INTERVIEW 8 European editor of the
JCRS Thomas Kohnen gives his advice on how to get published
Contributors Maryalicia Post Leigh Spielberg Pippa Wysong Gearóid Tuohy Priscilla Lynch Soosan Jacob
SPECIAL FOCUS
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CATARACT & REFRACTIVE
Advertising Sales Amy Bartlett ESCRS Tel: 353 1 209 1100 email: amy.bartlett@escrs.org Published by the European Society of Cataract and Refractive Surgeons, Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance. ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes. ISSN 1393-8983
9 Routinely adding CXL to LASIK surgery – benefits and risks
10 Arcuate keratotomy
performed with femtosecond laser shows promise
11 Topical antibiotics:
restricting their use in cataract surgery
12 ‘Study shows no
evidence that cataract surgery increases risk of progression to late AMD’
14 Wide adoption of
intracameral antibiotics for endophthalmitis prophylaxis
17 Cost of laser refractive
surgery in France varies from one centre to another
18 Pseudophakic patients – good candidates for presbyLASIK?
20 Not enough young
ophthalmologists joining the profession, French survey shows
23 Using image-guided As certified by ABC, the EuroTimes average net circulation for the 10 issues distributed between 01 January 2014 and 31 December 2014 is 42,957.
system for toric lenses – potential advantages
24 ‘New drug delivery
technologies poised to replace eye drops’
25 ‘Still plenty of room
45 Increasing dietary zinc
26 Phaco in myopes:
47 Supplementation
FEATURES
48 Management of exudative
CORNEA
50 Influential leader in anti-
for improvement in IOL design’
better surgery helps preserve retinal integrity in long eyes
28 CXL with therapeutic
refractive laser surgery for keratoconus
29 Patient recruitment
commences in major corneal graft study
30 DSEK follow-up: data show ongoing vision recovery
31 Amniotic membrane transplantation – a variety of useful applications
32 Innovations with pre-cut and pre-loaded lenticules
GLAUCOMA 35 ‘There is no current role for use of cannabis in treating glaucoma’
intake to decrease risk of late stage AMD
with macular pigment carotenoids for Alzheimer’s disease patients AMD – pilot trial findings
geniogenic therapy looks beyond VEGF
52 AIDS and AMD –
study shows increased prevalence of disease
53 Retinal haemorrhage risk: antiplatelet/anticoagulant drug therapy examined
55 ‘PDT useful for treatment of central serous chorioretinopathy’
56 Splitting clinical trial
endpoints into the functional and anatomic
58 Major population-based study investigates epidemiology of macular holes
OCULAR
36 Alternatives to
61 ‘Basic’ visual treatment
37 Trabecular bypass
REGULARS
trabeculectomy – new tools may improve outcomes
procedures: viable treatment for certain patients and scenarios
RETINA 39 Anti-VEGF treatment of
DME: patients receiving very few injections per year
41 Promising results for oral retinoid therapy
42 Vitrectomy for macular hole and epiretinal membrane
options for acquired brain injury patients
62 Travel 66 EBO Glaucoma Exam 67 EU-EYE Launch 68 Innovation 70 Book Reviews 71 Ophthalmologica Update 72 Resident’s Diary 74 Research 76 Review 78 JCRS Highlights 79 Industry News 80 Calendar EUROTIMES | SEPTEMBER 2015
2
EDITORIAL A WORD FROM JOSÉ GÜELL MD
A FANTASTIC EVENT
The ESCRS is holding its XXXIII Congress in Barcelona, Spain, and also welcomes delegates to the other congresses taking place in the same week
O
n behalf of the ESCRS and EuroTimes I am once And don’t forget, while you are here, to sample the feast again honoured and delighted to welcome friends for the senses that is Barcelona - a lively city, rich in art, and colleagues to Barcelona on this occasion of architecture and music, and delicious cuisine. We have the XXXIII Congress of the ESCRS. a warm and unique climate and as it is September we I am also delighted to welcome delegates will be expecting good weather. to the EuCornea and the World Society of I would also heartily encourage Although several ESCRS Paediatric Ophthalmology and Strabismus congresses. participants to stay on for an As in previous ESCRS congresses, there will also be a extra day or two because, in meetings have been held series of Glaucoma Day symposia, organised by the addition to the many attractions in Barcelona, this year European Glaucoma Society. this beautiful city provides at all we have a new venue, In addition, this year for the first time the times, September 11, the Friday the Fira Gran Via. It is International Congress on Ocular Infections will following the meeting, is the be held before the ESCRS congress. It has become National Day of Catalonia. a new congress centre standard to hold the annual ESCRS congress jointly It commemorates the region’s where many important with meetings of other ophthalmological societies. loss of autonomy in September international meetings This is of obvious advantage to both the industry and 1714 following the siege of have already been held attendees because it allows a wide variety of significant Barcelona. It was established as topics to be covered in a single meeting. a national holiday as the first act with great success And although, obviously, for some participants of the government of Catalonia there will be some clash of activities, we still think that upon regaining its autonomy in this is a fantastic, incredible event for attendees to be able to 1979 and is marked by numerous celebratory and cultural participate in all these activities in the same week. Although events. So enjoy our congresses, sample the delights of our several ESCRS meetings have been held in Barcelona, this year beautiful city, and look forward to meeting old friends and we have a new venue, the Fira Gran Via. It is a new congress making new acquaintances. centre where many important international meetings have already been held with great success. This year’s meeting also brings EuCornea full circle and to the beginning of a new era. EuCornea was introduced and launched at the ESCRS congress in Barcelona in 2009. The first four presidents were the society’s founders, and during their time in office the society has expanded and improved and now it is moving into a more established and mature stage of its existence. This year’s ESCRS congress will also see a continuation of the society’s dedication to young ophthalmologists that we have had in recent years, not only in our meeting programme but also in * José Güell is a medical editor of EuroTimes and past president a significant number of courses and activities during the year. of both ESCRS and EuCornea
MEDICAL EDITORS
Emanuel Rosen Chief Medical Editor
José Güell
Ioannis Pallikaris
Clive Peckar
Paul Rosen
INTERNATIONAL EDITORIAL BOARD Noel Alpins (Australia), Bekir Aslan (Turkey), Peter Barry (Ireland), Roberto Bellucci (Italy), Béatrice Cochener (France), Hiroko Bissen-Miyajima (Japan), John Chang (China), Alaa El Danasoury (Saudi Arabia), Oliver Findl (Austria), I Howard Fine (USA), Jack Holladay (USA) , Vikentia Katsanevaki (Greece), Thomas Kohnen (Germany), Anastasios Konstas (Greece), Dennis Lam (Hong Kong), Boris Malyugin (Russia), Marguerite McDonald (USA), Cyres Mehta (India), Thomas Neuhann (Germany), Rudy Nuijts (The Netherlands), Gisbert Richard (Germany), Robert Stegmann (South Africa), Ulf Stenevi (Sweden), Emrullah Tasindi (Turkey), Marie-Jose Tassignon (Belgium), Manfred Tetz (Germany), Carlo Enrico Traverso (Italy), Roberto Zaldivar (Argentina), Oliver Zeitz (Germany)
EUROTIMES | SEPTEMBER 2015
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4
COVER STORY: TORIC IOLS
OPTIMISING TORIC IOL OUTCOMES How can ophthalmologists take toric IOLs to the next level?
T
oric intraocular lenses (IOLs) have come a long way since Kimiya Shimizu implanted the first three-piece PMMA toric IOL through a 5.7mm incision in 1991. While those firstgeneration lenses delivered respectable distance visual acuity of 20/25 or better in 77 per cent of eyes, the data was less impressive for rotation, with about 20 per cent of the IOLs rotating 30 degrees or more and almost half more than 10 degrees off axis. Almost 25 years later, improvements in IOL material and design, and refinements in surgical technique have greatly enhanced postoperative rotational stability and, as a result, improved visual outcomes. Before toric IOLs entered the picture, patients with pre-existing astigmatism were either left uncorrected or required corneal curvature-altering procedures to correct this condition. The number of patients affected made the need to find a viable treatment even more pressing: some 40 per cent of patients presenting for cataract surgery have EUROTIMES | SEPTEMBER 2015
Dermot McGrath reports corneal astigmatism of 1.0D or higher and more than 20 per cent have 1.50D or higher. Fortunately, today’s cataract surgeons have no shortage of choice when it comes to treatment options for their astigmatic patients, with at least 10 monofocal toric IOL models and four multifocal toric lenses currently available.
SCOPE FOR IMPROVEMENT But greater choice and increasing demand for toric lenses does not necessarily mean that the scope for further improvement has been exhausted. “Toric lenses are still the way to go if we want to treat the one-third of our patients in the cataract population with moderate to high astigmatism,” Oliver Findl MD, PhD, Vienna Institute for Research in Ocular Surgery, Austria, told EuroTimes. “A lot of toric lenses are now available and most of them are rotationally very stable, and that has been shown in numerous studies. However, the results are far from being perfect and there is still a lot of inaccuracy, particularly when we are dealing with low astigmatism,” he said. This inaccuracy was borne out by a study carried out by Dr Findl et al looking
at toric IOL implantation in 250 eyes of 200 patients, which found that the most unpredictable outcomes were found in patients with low astigmatism. “The problem we have here is that we do not really have a good definition of low astigmatism. What is clear is that below 0.75D of astigmatism, especially when measured on the cornea, the measurements are so noisy and so variable from method to method and device to device that it is difficult to assess the magnitude and orientation of the astigmatism,” he said. The reasons for poor astigmatic reduction with toric IOLs typically stem from factors such as inaccurate preoperative calculations of IOL power and posterior surface of the cornea, as well as intraoperative issues such as mislabelling of the IOL, surgically-induced astigmatism and IOL misalignment. Of these factors, preoperative measurement errors, with large interdevice variability within and between different keratometric measurements and topographic measurements, represent the main source of error, said Dr Findl. Add in diurnal changes in corneal measurements over the course of the day and differences in postoperative refraction measures
COVER STORY: TORIC IOLS
REVOLUTION While preoperative diagnostic tools have certainly improved in recent years, the progress has been arguably even more impressive in the array of devices now available to deliver intraoperative guidance for surgical steps such as corneal marking, toric IOL alignment and centration, among others. As well as intraoperative aberrometers such as ORA (WaveTec Vision) and HOLOS IntraOp (Clarity Medical Systems), surgical guidance tools such as TrueGuide (TrueVision 3D Surgical), CALLISTO eye (Carl Zeiss Meditec) and VERION Image Guided System (Alcon Laboratories) all aim to reduce errors, increase accuracy and deliver better refractive outcomes by automating key aspects of the surgery.
T
N T
N “These new tools certainly help us to tighten up our refractive outcomes with toric IOLs,” said Stephen Slade MD, in private practice in Houston, USA. After years of performing arcuate corneal incisions and manually marking the eye, Dr Slade has made the transition to using both the ORA Verisyse and the VERION systems, and he believes the clinical outcomes justify the investment. “The reason I like the VERION is that it is a different sort of system which works more as a digital marker – it is not really reading the astigmatism but gives excellent precision for toric IOL alignment," he said. Dr Slade also uses the ORA device and the new HOLOS device and considers them useful because they give both a phakic and an aphakic reading. "The VERION is faster than the aberrometers though and a little more robust, but there are times when it is useful to have them both,” he added. Dr Slade explained that the VERION works by capturing a preoperative highresolution reference image of a patient’s eye in order to determine the radii and corneal curvature of steep and flat axes, limbal position and diameter, pupil position and diameter, and corneal reflex position. “I use it systematically now for every patient that has astigmatism and the results have been excellent. I can’t think of even
Toric lenses are still the way to go if we want to treat the one-third of our patients in the cataract population with moderate to high astigmatism Oliver Findl MD, PhD
Predicting post-op tilt and misalignment using swept-source OCT for biometry (IOLMaster 700, Carl Zeiss Meditec AG)
one patient where we have had to make a lens adjustment postoperatively because the VERION got the axis alignment wrong. It just hasn’t happened. We have even used it to reposition toric lenses that were implanted elsewhere and where the alignment was off – it is just so precise compared to any other tools we had and this is reflected in patient satisfaction,” he said.
PATIENT SATISFACTION Patient satisfaction, of course, remains the perennial dynamo driving development in all IOLs, toric lenses included. While rigorous surgical technique, precise measurements and quality implants are key to delivering the best possible refractive outcome, the importance of chair time should not be underestimated in ensuring the subjective happiness of patients after surgery. The tried-and-trusted formula of underpromising and over-delivering applies to toric IOLs too, Dr Slade told EuroTimes. “The main thing is to make sure that patients’ expectations are appropriate, but otherwise it is fairly easy to explain that they have astigmatism and that a toric lens will address that problem and give them very good postoperative vision. It’s a lot easier to explain than presbyopia, for instance, which requires more chair time to explain the compromises involved,” he said. Nevertheless, deciding which patients will benefit from a toric lens is not always based solely on the extent of their preoperative astigmatism – economic factors and the patient's willingness to pay for a premium IOL may also come into play, points out Jesper Hjortdal MD, PhD, Aarhus University Hospital, Denmark. EUROTIMES | SEPTEMBER 2015
Courtesy of Oliver Findl MD, PhD
and it is easy to see why there is so much variability correcting low-level astigmatism, he said. Yet Dr Findl is optimistic that some of the current deficiencies may be overcome in the near future thanks to advances in diagnostic technology, and in particular swept-source optical coherence tomography (OCT). “Our accuracy in measuring low astigmatism should improve with sweptsource OCT such as the Casia (Tomey) or the IOLMaster 700 (Carl Zeiss Meditec). Once we get this type of technology into our hands for routine patients we should become better at predicting the real corneal astigmatism and that will hopefully make things a lot better with our toric IOL outcomes,” he said. The scan speed in swept-source instruments is twice that of SD-OCT devices and enables the user to image structures that were previously unattainable. The IOLMaster 700, for instance, gives a longitudinal cut through the entire eye, allowing surgeons to screen for macular disease, verify fixation and check irregular eye geometries, which is particularly useful in trying to predict IOL tilt, said Dr Findl. “With the swept-source OCT we can simulate how a toric IOL will perform after implantation and adapt our calculations based on predicted tilt. While we still need a lot more data to confirm this, predicting lens tilt may actually enhance the function and the optical performance of IOLs, especially toric lenses and aspheric lenses, in patients who had a tilted crystalline lens to start with,” he said.
5
COVER STORY: TORIC IOLS
6
L Gobin, M-J Tassignon et al; JCRS 2011, 37, 1015-1019
ONE-SIDED TORIC IOL: MORE POWER WHEN FACING THE CORNEA
Surgically induced astigmatism after BIL
Courtesy of Marie-José Tassignon MD, PhD, FEBO
“In the Danish public health system we can offer free toric IOLs to patients with more than 2.0 dioptres of corneal astigmatism. While patients with more than 0.75D astigmatism may possibly benefit, this is a trade-off considering best value for money within a fixed budget,” he said. Dr Hjortdal said that he uses a variety of toric IOLs, with alignment based on preoperative keratometry and manual marking of the patient’s cornea in the upright position. In terms of improving outcomes from toric IOLs, Dr Hjortdal said that his clinic is planning to purchase a perioperative alignment system in the near future. “Perioperative keratometry, or even better perioperative evaluation of the refractive properties of the anterior and posterior surface, with a direct coupling of overlay video in the microscope, should be useful and help to improve our results,” he said. For exclusion criteria, the Danish guidelines for cataract surgery are helpful
in selecting which patients may not benefit from a toric lens, said Dr Hjortdal. “Patients who may not derive benefit from a toric lens include those who have not used correction for astigmatism in spectacles. Some degree of multifocality can be achieved by some patients with regular astigmatism, which may reduce the need for reading glasses. Furthermore, patients who wish to continue to use spectacles for distance vision after surgery or those who cannot expect good central vision postoperatively are usually not good choices for a toric lens,” he said. While toric lenses offer a high degree of predictability in patients with regular astigmatism, the picture becomes more complicated in cases of irregular astigmatism and ocular co-morbidities. One possible solution for such complex eyes is a spherotoric bag-in-the-lens (BIL) IOL (Morcher GmbH), which allows surgeon-controlled IOL centration along the patient’s line of sight.
Marie-José Tassignon MD, PhD, FEBO, of the University of Antwerp, Belgium, the inventor of the BIL technique, said that a toric version was a logical evolution given that the original lens has shown excellent long-term protection against posterior capsule opacification and very good rotational stability. The toric lens used by Prof Tassignon has the cylindrical correction located on the anterior side of the lens optic and the calculation method has been adapted for one-sided implantation anteriorly. The IOL is centred based on the patient’s pupillary entrance using Purkinje reflexes of the surgical microscope light. A recent prospective study of 52 eyes with corneal astigmatism ranging from 0.90 to 6.19 dioptres found that the lens delivered excellent refractive outcomes with minimal rotation of the lens six months after surgery. “Implantation of the spherotoric IOL using the BIL technique gave excellent clinical results and was beneficial in eyes with up to 15 degrees of irregular astigmatism,” said Prof Tassignon, noting that 5.2 per cent of eyes in the study had irregular astigmatism of that degree. “Implantation of the BIL IOL in eyes with irregular corneal astigmatism up to 10 degrees gave excellent results, but patients with a higher degree of astigmatism irregularity should be informed that the outcomes may be less predictable. However, the BIL IOL can be easily rotated in a secondary surgery without the surgeon having to deal with haptics embedded in fibrotic proliferative capsule tissue,” she added.
INNOVATIONS AHEAD While much progress has been made in recent years in IOL design and materials, Dr Findl sees further developments in the pipeline that will help to improve toric outcomes even more. “To come in the future, we will see corneal back-surface curvature measurements which is especially relevant for toric lenses. Also predicting IOL position according to the lens shape is something we are working on, because this may help us much more than the current central scan with two peaks. If we know the entire shape of the crystalline lens that may give a better estimate of where the equator is and where the IOL will be positioned. Finally, we will see our diagnostic devices incorporating ray tracing to enable us to get away from all these power calculation formulae that are based on old-generation ultrasound techniques,” he said. Oliver Findl: oliver@findl.at Jesper Hjortdal: jesper.hjortdal@clin.au.dk Stephen Slade: sgs@visiontexas.com Marie-José Tassignon: marie-jose.tassignon@uza.be
Toric BIL IOL: clinical results
EUROTIMES | SEPTEMBER 2015
See also: Eye Contact video with Dr Noel Alpins at www.eurotimes.org
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8
NEWSMAKER
HIGH STANDARDS European editor of the Journal of Cataract & Refractive Surgery Thomas Kohnen says only the best articles will get published Prof Dr Thomas Kohnen of Frankfurt, Germany and Dr Nick Mamalis of Salt Lake City, USA have assumed the roles of co-editors for the Journal of Cataract & Refractive Surgery. This continues the tradition of co-editorship, with one editor from Europe and one from the USA. Here Prof Kohnen looks back on the early days of the journal and discusses future plans with EuroTimes editor Sean Henahan.
T
he story begins in 1981 with the creation of the American Intra-Ocular Implant Society Journal, with Dr Stephen Obstbaum as the founding editor. This became the Journal of Cataract & Refractive Surgery in 1986, with Dr Obstbaum retaining his role as editor. During this same period Dr Emanuel Rosen and colleagues were creating a journal for the European Intraocular Implant Club, which would become the European Society of Cataract and Refractive Surgery. Emanuel had the idea to sit down with Steve Obstbaum and discuss a merger of the two journals. They brainstormed the idea of consolidating their journals, with two editors from each side of the Atlantic. They decided to keep the name JCRS in order to maintain the journal’s impact factor, launching the current form of the JCRS in 1996. Emanuel and Steve became the original co-editors, while Doug Koch and Julian Stevens, very quickly followed by myself, became the first associate editors. At the same time we consolidated editorial boards from each society. We have to remember that at this time refractive surgery was still viewed with suspicion by the establishment. It was considered something of a cowboy procedure. Therefore, considerable effort was expended to develop the journal as a credible source of scientific research. Over the years we have done many things with our US colleagues in terms both of popularising and bringing academic rigour to the field of refractive surgery.
NEW ASSOCIATE EDITOR
S
athish Srinivasan is the new European associate editor of the Journal of Cataract & Refractive Surgery. Dr Srinivasan is currently a Sathish Srinivasan consultant corneal surgeon and Joint Clinical Director at University Hospital Ayr, Scotland. His interests are in lamellar corneal surgery, micro-incision cataract surgery and anterior segment reconstruction. He has published over 85 papers in peer-reviewed journals and has over 60 scientific presentations to his credit in national and international meetings. He is the recipient of the Achievement Award and the International Scholar Award from the American Academy of Ophthalmology.
EUROTIMES | SEPTEMBER 2015
In more recent years we have also expanded our board to include members outside of Europe and the USA. The board now includes more than 30 members from the USA, Europe, Asia, Latin America, Australia and New Zealand. In the past 19 years, under the stewardship of Emanuel and Steve we have become a truly international journal, run by both societies. In the early days the JCRS provided a much needed place to publish peer-reviewed research on topics that might not appear in other journals. The JCRS early on gained a reputation as a place to read about interesting innovative research. We have built on this reputation of maintaining the highest academic standards and intend to keep it going. In addition to our peerreviewed research articles, we also include a lot of practical material that is of great use for our readers. By this I mean our sections on surgical techniques, consultations and case studies. We also provide editorials, comprehensive review articles, as well as information on more basic science through our laboratory science section. This blend of content distinguishes us from other journals in the field. The JCRS receives more than 1,200 manuscripts for review every year. We only have space for approximately 300 articles. This equals a rejection rate of 75 per cent, and it means we can really pick among the very best articles for acceptance in the journal. For those who are interested in submitting an article, I have several suggestions to improve your chances. First of all, you need a hot topic. You might have a perfect study of induced astigmatism following 3.0mm clear corneal incisions, but that has been done 15 years ago. Second, you need to follow the instructions to authors. You need to compose it in the suggested format in good English, carefully proofread. When my residents want to publish with me they get upset at the number of times I ask them to revise the manuscript. You have to spend a lot of time and effort on your manuscript. Moreover, if you want to publish in the JCRS you have to start early, at the idea stage. You have to plan how you structure your research, design the protocols, how you go through the ethical committee, and have a clear purpose for the study. The best advice I could give would be to read the journal, study the format, then impress us with a brand new idea and an influential topic.
You have to plan how you structure your research, design the protocols, how you go through the ethical committee... Thomas Kohnen MD, PhD
Finally, I would like to reiterate our gratitude to Emanuel Rosen and Steve Obstbaum. They are really the co-fathers of what has become an excellent source of the latest research in cataract and refractive surgery. In recognition of this, next year we will initiate two new awards in the names of the founding editors. These will be presented at each of our annual meetings, one each for best technical paper and for best original research paper.
SPECIAL FOCUS: CATARACT & REFRACTIVE
LASIK + CXL? Routine crosslinking may prevent ectasia, but long-term risks unknown. Howard Larkin reports
R
ecent research suggests that routinely adding corneal crosslinking (CXL) to LASIK surgery may offer benefits, including improving the refractive outcome’s predictability and stability, and potentially reducing the risk of ectasia. However, the practice may also pose risks that have not been fully evaluated, possibly including more infections, corneal haze and complicating future procedures, debaters told Refractive Surgery Day at the 2014 American Academy of Ophthalmology annual meeting in Chicago, USA. Arguing the pro side, Vance Thompson MD asserted that adding CXL addresses a known LASIK drawback – that it undermines the cornea’s structural integrity. “We know that LASIK can weaken the cornea. We know that crosslinking stiffens the cornea. What we need to know is whether combining the two is safe, provides predictable refractive outcomes, and improves corneal stability. Recent research suggests the answer to all three questions is yes," said Dr Thompson, Sioux Falls, South Dakota, USA.
ENERGY DOSAGE Dr Thompson, a consultant for Avedro, noted that CXL has been shown to stiffen the cornea, and the effect is dose-dependent. The CXL used in conjunction with LASIK uses only 2.7J/cm2 of energy, while CXL for traditional keratoconus treatment uses 5.4J/cm2, double the energy dosage. CXL with LASIK is also safe, Dr Thompson said. Several studies have found that it does not increase adverse events when used with refractive surgery (Kanellopoulos AJ et al. Clin Ophthalmol. 2012; 6: 1125-30. Tomita M et al. J Cataract Refract Surg. 2014; 40 (6): 981-90). As for predictability, finite element analysis at the Cleveland Clinic Cole Eye Centre found that CXL + LASIK that increased anterior residual stromal stiffness 50 per cent added less than 0.25 dioptre of hyperopic effect (Roy SI et al. ARVO 2014), Dr Thompson said. A study by Minoru Tomita MD and colleagues found adding CXL did not reduce LASIK refractive predictability at one year (JCRS 2014 40 (6)). In fact, in a study of highly myopic patients conducted by Jerry Tan MD, LASIK Xtra significantly improved refractive predictability relative to LASIK alone. LASIK Xtra has also been shown to reduce refractive drift, and is especially effective
in stabilising hyperopic LASIK treatment (Kanellopoulos AJ. Clin Opthalmol. 2012). “LASIK Xtra deserves more study and I am very excited about it. If I was undergoing LASIK this is how I would like to have it performed,” Dr Thompson said. Taking the opposing side, George Kymionis MD, PhD, University of Crete, Greece, noted that his own research indicates that combining CXL and laser corneal surgery is effective for treating progressive keratoconus. But that doesn’t mean it is useful or even safe for routine use in refractive cases, he said.
LONG-TERM EFFECT CXL, with the dosage used for the treatment of keratoconus, can have a continuous, long-term effect, with progressive corneal flattening of as much as 15 dioptres. “For keratoconus patients this is a positive side effect, but for a refractive patient it would be a huge problem,” he said. Many other risks of adding CXL to LASIK have not been studied, Dr Kymionis added. These include the possibility of higher infection rates due to longer surgical exposure, and increased corneal scarring, infiltrates and diffuse lamellar keratitis. CXL also kills keratocytes, raising questions about how repopulation of the stroma after surgery may affect refractive outcomes. Retreatment is also a question; CXL could interfere with raising the flap. Also, it is unknown whether crosslinked tissue ablates at the same rate as untreated stroma, Dr Kymionis said. Exposing the crystalline lens to UV radiation could complicate future intraocular lens (IOL) power calculations, Dr Kymionis added. It may also kill corneal and conjunctival stem cells, and may damage endothelial cells. CXL also decreases corneal permeability for fluoroquinolones and voriconazole. Also, prophylactic CXL has not been shown to prevent iatrogenic ectasia, Dr Kymionis noted. With an incidence of about one in 5,000 cases, it would take a study of thousands of patients over many years to confirm efficacy. For “high risk” corneas, instead consider photorefractive keratectomy (PRK), phakic IOLs or simply aborting the refractive procedure, Dr Kymionis advised. Vance Thompson: vance.thompson@vancethompsonvision.com George Kymionis: kymionis@med.uoc.gr EUROTIMES | SEPTEMBER 2015
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SPECIAL FOCUS: CATARACT & REFRACTIVE
ARCUATE INCISIONS Femtosecond laser shows promise in astigmatism correction.
A
Roibeard O’hEineachain reports
rcuate keratotomy performed with a femtosecond laser at the time of cataract surgery can produce results approaching those achieved with toric intraocular lenses (IOLs), and the accuracy of the technique is likely to improve as experience increases with this steadily advancing new technology, said Roberto Bellucci MD, Hospital and University of Verona, Italy. “I definitely think this is the future of our cataract surgery in our astigmatic patients in whom we decide not to implant a toric lens,” Dr Bellucci told the 19th ESCRS Winter Meeting in Istanbul, Turkey. Dr Bellucci noted that delegates responding to a survey conducted by the ESCRS at its meeting last year in London stated that they thought that, with modern cataract surgery, postoperative astigmatism should be no greater than 0.5D. He added that in his own experience, toric IOLs can achieve that result fairly reliably. For example, in a study he and his associates conducted, astigmatic patients implanted with toric IOLs had a mean residual astigmatism of only 0.42D. However, toric IOLs have a few disadvantages. For example, they have to be ordered in advance, which in a few instances might mean that surgery needs to be delayed. In addition, they may not be available for extremes of high myopia or high hyperopia. The lenses also require precise alignment and can rotate in the postoperative period, and even a small rotation will lead to a great loss in anti-astigmatic effect. “Incisional approaches also have problems. They are not perfectly centred and in the case of cataract surgery we don't exactly know if the existing refractive astigmatism is perfectly matching the topographic corneal astigmatism,” Dr Bellucci said.
SD-OCT GUIDED ARCUATE INCISIONS
FEMTO MAY IMPROVE PRECISION Dr Bellucci noted that the steady evolution of femtosecond laser technology and its increasing diffusion through ophthalmic practices appears likely to bring the efficacy and predictability of femtosecond laser incisional surgery into parity with that of toric IOLs before too long. He presented the results of a study in which 23 eyes of 16 cataract patients with a mean age of 69 years underwent femtosecond laser arcuate incision procedures to correct 1.5D to 5.5D of congenital corneal astigmatism. Dr Bellucci performed the arcuate corneal incisions at the time of surgery prior to performing the phaco incisions. In all eyes he used the Victus femtosecond laser (Bausch & Lomb) and he calculated the length of the incisions using the Bascom Palmer protocol. “That is quite an old protocol and useful for manual cuts, but so far there is no protocol for femtosecond laser incision. Hopefully the diffusion of femtosecond laser cataract surgery will lead us to a new protocol in a short time. However, this is the protocol that we decided to start with,” Dr Bellucci said. After six months the mean astigmatism was reduced from almost three dioptres to 0.7D. However, that was still a little bit above 0.5D, which is the level of astigmatism that surgeons today consider acceptable after cataract surgery. “We could be more precise with the cut angle and we could also take account of discrepancies between the corneal astigmatism and the refractive astigmatism in our treatment planning, by careful study of the cornea with the Scheimpflug camera in the preoperative assessment stage,” Dr Bellucci said. One advantage femtosecond laser-created incisions have over manually created incisions is that they may be performed EUROTIMES | SEPTEMBER 2015
SD-OCT to improve precision in planning and executing femtosecond-laser corneal incisions
intrastromally, Dr Bellucci noted. He cited a study by Gunther Grabner’s group in Salzburg, Austria, in which 16 eyes of 16 patients underwent intrastromal incisions with a fixed protocol in which all eyes received incisions with the same arc length and the same 7.5mm optical zone. “On average, the results were very satisfactory, although there was a standard deviation of 0.7D, indicating that probably the different corneas responded in different ways to the same surgical treatment,” Dr Bellucci said. Dr Bellucci noted that precision with the technique is likely to improve with the introduction of new nomograms based on empirical data and designed specifically for incisions created with the femtosecond laser. Other developments that may improve the predictability of outcomes are the use of curved interfaces that induce much less applanation, the incorporation of accurate posterior cornea measurements, and the preoperative planning and intraoperative visualisation of incision creation by optical coherence tomography (OCT) imaging. “The latest generation of femtosecond laser allows us to design our laser incisions directly on the OCT image and it tells us the exact pachymetry so we can adjust the cut depth accordingly, and do it intrastromally. This is the most important advancement with the femtosecond laser,” Dr Bellucci added. Roberto Bellucci: robbell@tin.it
Courtesy of Roberto Bellucci MD
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SPECIAL FOCUS: CATARACT & REFRACTIVE
TOPICAL ANTIBIOTICS Use in cataract surgery should be restricted to short regimens.
Tired of seeing those unhappy patients?
Roibeard O’hEineachain reports
S
urgeons who use topical antibiotics as a prophylaxis against endophthalmitis following cataract surgery should restrict their use to less than a day before surgery and to no more than a week after surgery, in order to prevent the proliferation of antibiotic-resistant organisms, said Yonca Aydin Akova MD, FEBO, Bayindir Hospital, Ankara, Turkey. “Cataract surgery is the most commonly performed surgical procedure in ophthalmology. Fortunately the advances in technology have transformed the outcomes in cataract surgery tremendously, but postoperative endophthalmitis remains a significant concern,” Dr Akova told the 19th ESCRS Winter Meeting in Istanbul, Turkey. She noted that the ESCRS Endophthalmitis Study demonstrated that the use of intracameral antibiotics can reduce the incidence of endophthalmitis several-folds after cataract surgery. As a result many surgeons, particularly in Europe, have adopted that practice. However, many surgeons remain reluctant to switch from the topical antibiotics regimens they currently use. Moreover, it is not clear whether topical antibiotics, applied before or after surgery, can provide an additional prophylactic effect when used in addition to intracameral antibiotics. She noted that a 2014 survey of ASCRS members showed that, although half of respondents were using intracameral antibiotics, 96 per cent were also using topical antibiotics. The efficacy of topical antibiotics for endophthalmitis prophylaxis after cataract surgery has yet to be demonstrated in a randomised controlled study. However, the findings of a casecontrol study carried out in Canada provide some evidence in favour of this practice. The study involved 23 cases of endophthalmitis cases among 75,000 eyes that had undergone cataract extraction by 26 different surgeons. A multivariate analysis indicated that postoperative topical second- and fourth-generation fluoroquinolones applied postoperatively had a statistically significant prophylactic effect. “Mainly, we use topical antibiotics not because of the microorganisms going into the eye during the surgery, but because of those going in after surgery. That is why it might be wise to use topical antibiotics until the epithelium is healed, after three days to seven days, and we should not taper antibiotics due to the risk of developing antibiotic-resistant bacteria,” Dr Akova added. There is less evidence in support of the use of preoperative antibiotics. The current standard for sterilising the ocular surface preoperatively is povidone iodine solution applied to the conjunctiva for at least Yonca Aydin Akova three minutes prior to cataract surgery. Some advocate the use of fourth-generation fluoroquinolones applied for a day or more before surgery. Research shows that topical moxifloxacin can reach therapeutic concentrations in the aqueous humour. The downside of that is that it can increase the number of fluoroquinolone-resistant bacteria in the eye.
CH T I W S ! NOW
Yonca Aydin Akova: yoncaakova@yahoo.com EUROTIMES | SEPTEMBER 2015
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SPECIAL FOCUS: CATARACT & REFRACTIVE
ADVANCED AMD Analyses in AREDS2 show no evidence that cataract surgery increases risk of progression to late AMD. Cheryl Guttman Krader reports
T
he Age-Related Eye Disease Study 2 (AREDS2) provides no evidence that cataract surgery increases the risk of progression to late age-related macular degeneration (AMD) in eyes at high risk, reported Emily Y Chew MD at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. “Understanding if cataract surgery affects the risk of progression to advanced AMD is important for us to move forward with our clinical recommendations for patients with AMD, and the data from AREDS2 are reassuring,” said Dr Chew, chair of AREDS2, and Deputy Director, Division of Epidemiology and Clinical Applications and Deputy Clinical Director, National Eye Institute, Bethesda, Maryland, USA. “Still, patients who are at risk for developing advanced AMD must be warned about their risk for progression regardless of cataract surgery. The opportunity for vision improvement with anti-VEGF therapy for neovascular AMD makes it compelling for us to watch these patients very carefully after cataract surgery,” she said. The AREDS2 analyses included only eyes that were phakic and without late AMD at baseline. In addition, cases (eyes that underwent cataract surgery) had to be free of late AMD at the time of surgery and have at least two years of follow-up after surgery. The controls were eyes that never had cataract surgery during the study. Three different approaches were used for the analyses – matched pair, Cox proportional hazard models with timedependent covariates, and logistic regression using general estimating equations. For each type of analysis, four different outcomes were investigated – progression to any late AMD, neovascular AMD, central geographic atrophy, or any geographic atrophy. In addition, the Cox proportional hazards regression model looked separately at right and left eyes. The matched pair analysis included 912 cases matched to the same number of controls based on multiple criteria: age group at time of surgery, smoking status, gender, race, AREDS assignment to lutein/zeaxanthin, AMD status at baseline and severity at surgery (cases only), neovascular AMD status in the fellow eye before cataract surgery, and length of follow-up after surgery. The results of the matched pair analysis were consistent in showing no harmful effect of cataract surgery. For all four
The opportunity for vision improvement with anti-VEGF therapy for neovascular AMD makes it compelling for us to watch these patients very carefully after cataract surgery Emily Y Chew MD EUROTIMES | SEPTEMBER 2015
outcomes, there were far fewer eyes with progression among the cases compared to the controls. In all of the other analyses as well, no statistically significant differences emerged that would suggest cataract surgery adversely affected the risk of progression to late AMD or any of its components, Dr Chew reported.
REVIEWING THE LITERATURE Previous studies examining whether cataract surgery affects the risk of progression to late AMD provided conflicting results. Population-based epidemiologic studies, including the Beaver Dam Eye Study, Blue Mountains Eye Study, Baltimore Eye Survey, Rotterdam Eye Study, and others, suggested that cataract surgery was a risk factor. In contrast, Dr Chew and colleagues found no strong evidence that cataract surgery increased the risk of progression to late AMD when analysing data from the AREDS using almost the same statistical approaches employed in the AREDS2 analyses. “In AREDS, the totality of the evidence suggested there was no major deleterious effect of cataract surgery on the risk of progression to late AMD,” she said. The Australian Cataract Surgery and Age-related Macular Degeneration Study also found no harmful effect of cataract surgery on progression to advanced AMD. It was a prospective study designed to specifically address the question of whether cataract surgery increased risk of progression to advanced AMD and used a paired eye comparison, including patients who had cataract surgery in one eye and remained phakic in the fellow eye for at least two years.
RESOLVING THE CONFLICTS Dr Chew offered several possible explanations for why the AREDS2 results differ from the findings in the population-based research. She noted the potential for unadjusted confounding in the latter studies and differences in their pool of “cases”. Cases in some of the epidemiologic studies were eyes with a history of cataract surgery at enrolment, and in the epidemiologic studies that looked at eyes with incident cataract surgery, it is presumed the recommendation for cataract surgery was made by a general ophthalmologist. “In AREDS2, patients were examined by a retina specialist who may have not recommended cataract surgery for a patient whose vision loss was thought to be related to retinal disease,” Dr Chew explained. Cataract surgery and intraocular lens (IOL) technology have also changed over the years. “Clearly, in AREDS2 we were in a different age in terms of better cataract surgery techniques, and patients in AREDS2 are also more likely to have been implanted with a UVB-blocking IOL, which may have an effect on AMD progression,” Dr Chew said. As another difference, the participants in AREDS2 are healthy volunteers. “The AREDS2 population may be different than the participants in a population-based study, and perhaps a limitation of AREDS2 is that it is not a population-based cohort,” Dr Chew said. Regardless of the results of the studies, such patients are at high risk for developing advanced AMD and should be followed vigilantly following cataract surgery. Emily Y Chew: echew@nei.nih.gov
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SPECIAL FOCUS: CATARACT & REFRACTIVE
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Courte s and L y of Jose A uis ug Hospit Cordoves usto Abreu M al Univ MD, P hD ersitari D, o de C anaria s
1 Image
s 1 an d 2: cefuro Intracamera xime in l jection
4 Image s posto 3 and 4: Hy perati ve end popyon - a c ophth almitis ute
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ENDOPHTHALMITIS PROPHYLAXIS Intracameral antibiotics for endophthalmitis prophylaxis now widely adopted worldwide. Roibeard O’hEineachain reports
A
n increasing number of cataract surgeons around the world, particularly in Europe, are now using intracameral antibiotics for endophthalmitis prophylaxis, reported Luis Cordoves MD, Hospital Universitario de Canarias, Spain, at the 19th ESCRS Winter Meeting in Istanbul, Turkey. Dr Cordoves noted that it was Gholam Peyman MD who first introduced the use EUROTIMES | SEPTEMBER 2015
of intracameral injections of antibiotics after cataract surgery in 1977 when he described their use in India Eye camps. Per Montan MD in Sweden picked up on the idea in 1996 and data from the Swedish Register showed that the rate of endophthalmitis fell from 0.35 per cent to 0.048 per cent following the almost universal adoption in the country of intracameral antibiotics. Wide adoption of the practice across Europe followed the publication of the randomised controlled ESCRS
Endophthalmitis Study, which yielded almost identical results to those of the Swedish Cataract Register. A European Observatory of Cataract Surgery survey carried out in 2014, and involving 490 surgeons from nine European countries, indicated that in many European countries the use of intracameral cefuroxime is almost universal. Overall, 71 per cent of respondents said that they use intracameral antibiotics in all cases, and of those, 67 per cent use Aprokam® (Théa),
SPECIAL FOCUS: CATARACT & REFRACTIVE a single dose preparation of cefuroxime for intracameral use, and 26 per cent used generic cefuroxime.
WHICH ANTIBIOTIC IS BEST? Among proponents of intracameral antibiotics, there is still considerable debate about which agent is most ideal for endophthalmitis prophylaxis. The contentious issues include whether a newer broader spectrum antibiotic like moxifloxacin might provide a significant improvement in safety, and whether cefuroxime’s efficacy may vary by geographical location, since the causative organisms vary throughout the world. Regarding moxifloxacin, he noted that in a survey by the International Society of Bilateral Cataract Surgeons in 2011, the rate of endophthalmitis was only 0.003 per cent among patients receiving intracameral moxifloxacin by injection compared to 0.01 per cent among patients receiving intracameral cefuroxime. A study by Dr Montan using data from the Swedish database showed that the rates of endophthalmitis with the use of cefuroxime and moxifloxacin are more similar, 0.025 per cent and 0.030 per cent respectively, Dr Cordoves said.
COMING AROUND TO IDEA Tat Keong Chan MD noted that there has also been a slow but sure narrowing of the
transatlantic divide regarding the antibiotic prophylaxis of endophthalmitis following cataract surgery since the publication of the ESCRS Endophthalmitis Study. “ASCRS practice surveys show that more US surgeons are routinely administering an intracameral antibiotic now than were in 2007, and the majority are now giving it by a direct bolus injection,” said Dr Chan, Singapore National Eye Centre, Singapore. He noted that, in a survey of ASCRS members carried out in 2007, only 30 per cent of respondents said that they used intracameral antibiotics for endophthalmitis prophylaxis in their cataract surgeries, and of those, only half used a bolus injection at the end of surgery. The remaining respondents used antibiotics in their infusion bottle. Nonetheless, 82 per cent said that they would use intracameral injections if there was a commercially available product at a reasonable cost. Despite some initial resistance, by 2011 the AAO had acknowledged the efficacy of the approach, stating that “there is mounting evidence that injecting intracameral antibiotics as a bolus at the conclusion of surgery is an efficacious method of endophthalmitis prophylaxis”, and in the same year the ASCRS Cataract Clinical Committee published a white paper stating that “of the various methods of antibiotic prophylaxis, the strongest evidence supports a direct intracameral bolus at the conclusion of surgery”, Dr Chan noted.
And if more evidence was needed, it was provided by a study by Neil Shorestein MD and his associates in California, and published in the January 2013 issue of the Journal of Cataract and Refractive Surgery, in which there was a 22-fold reduction in the endophthalmitis rate with no adverse reactions to the injections, Dr Chan noted. Because of these and other factors, when ASCRS members were again surveyed in 2014, the proportion of those using intracameral antibiotics had risen from 30 per cent to 50 per cent, and of those, 84 per cent administered the agent through direct injection. The antibiotics used were moxifloxacin, by 33 per cent, vancomycin by 37 per cent, and cefuroxime by 26 per cent. As for Aprokam, 21 per cent of respondents without access to the product said they would use it if it were available and another 48 per cent said they would use it if the cost were right. “Most US surgeons are now in favour of the intracameral strategy in cataract surgery and there are key opinion leaders in the US who are calling for the FDA to quickly approve a commercially available antibiotic for intracameral injections. However, because of regulatory and legal issues, your guess is as good as mine when one will be approved,” Dr Chan added. Luis Cordoves: luis.cordoves@hotmail.es Tat Keong Chan: tatkeongchan@gmail.com
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EUROTIMES | SEPTEMBER 2015
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10–14 September
2016
XXXIV Congress of the ESCRS Bella Center, Denmark
Instructional Course Abstract Submission Deadline 31 October 2015 www.escrs.org
SPECIAL FOCUS: CATARACT & REFRACTIVE
THE COST OF LASIK Wide variety in refractive surgery prices in France.
THE
Dermot McGrath reports
T
he price of laser refractive surgery in France varies from one centre to another. Addressing delegates at the annual meeting of the French Implant and Refractive Surgery Association (SAFIR) in Paris, Dan A Lebuisson MD, past president of SAFIR, in private practice in Paris, said that the current system of elective laser surgery is unregulated in terms of price, with differing centres offering a wide variety of tariffs and modalities of payment to potential customers. “Very few French surgeons have a clear and concise economic model in refractive surgery and it is these colleagues who usually find themselves at the mercy of laser manufacturers and health insurance companies,” said Dr Lebuisson. Looking at the price of LASIK surgery over the past decade, Dr Lebuisson noted that the prices quoted have remained stable despite the fact that costs have invariably risen. The average price (bilateral surgery) for photorefractive keratectomy (PRK) is €2,000, €2,400 for conventional LASIK, and €2,750 for femtosecond LASIK. Comparing this with data from the USA, Dr Lebuisson said that in 2013 the average cost overall for laser vision correction was $2,073 per eye. About half of the refractive surgeons in the USA survey said they quote a single price for laserbased procedures, while the other half quote different prices depending on the technology used and/or the amount of vision correction required by the patient. There is also considerable variation in the reimbursement rates practised by private health insurance providers in France, said Dr Lebuisson. Refractive surgery is not expensive in France. In a survey of 15 patients operated in Paris for myopic LASIK in the first quarter of 2015, for one eye one had no reimbursement, six received between €150 and €300, five between €300 and €500 and three patients received more than €500. The impact of group purchasing sites on the internet such as Groupon was not at all helping to drive down prices for LASIK, said Dr Lebuisson. He also cited the initiative of Santeclair, an alliance of health insurers and associated partners, whose professed goal is to “democratise” LASIK by directing patients to one of 60 different refractive surgery centres at a set price of €1,500 for both eyes. However, the impact is poor because money is not the main argument for most customers who consider safety and technology as key points. The wide disparity in prices offered from one refractive laser centre to another was shown by a recent survey in which two LASIK candidates contacted 30 different clinics in France, 13 in Paris and the surrounding region, and 17 in the provinces. Dr Lebuisson said that 22 out of the 30 centres (public and private) proposed a reduction of between 10 per cent and 30 per cent on the initial quoted price. For two of the clinics the reduction was contingent on payment in cash and others were prepared to accept staggered payments over three-four months. The variation in price was striking, remarked Dr Lebuisson, with the lowest price quoted at €900 and the highest in the range of €5,000 to €6,000.
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Dan A Lebuisson: dalebuisson@gmail.com EUROTIMES | SEPTEMBER 2015
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SPECIAL FOCUS: CATARACT & REFRACTIVE
PSEUDOPHAKIA Studies suggest five-seven per cent or more of those undergoing presbyLASIK lose two or more lines of best corrected distance vision. Howard Larkin reports
P
seudophakic patients might seem good candidates for presbyLASIK, which creates a multifocal cornea to restore near vision. However, eyes with monofocal intraocular lenses (IOLs) may require more near vision add than corneal ablation can provide, particularly since pupils in elderly patients may be too small for a multi-zone multifocal cornea to properly function, Thomas Kohnen MD, PhD told Refractive Surgery Day at the 2014 American Academy of Ophthalmology annual meeting in Chicago. “Therefore we think it is questionable to treat pseudophakic patients with presbyLASIK, even though the problems of presbyopia progression and future IOL calculation no longer occur,” said Prof Kohnen, of Goethe University, Frankfurt, Germany. Also, very little data on presbyLASIK in pseudophakic patients is available, though a few cases have been performed, he added. Indeed, some studies suggest that five-seven per cent or more of patients undergoing presbyLASIK lose two or more lines of best corrected distance vision, raising safety questions for any population, Prof Kohnen noted. However, the procedure is still developing and appears to be improving as treatment algorithms are adjusted.
MULTIFOCAL APPROACH Prof Kohnen defines presbyLASIK as multifocal corneal surgery, as opposed to monovision, which combines monofocal corneal surgery of different power in each eye. PresbyLASIK always uses monocular multifocality and thus simultaneous imaging of two or more foci on the retina. Early theoretical studies showed a central corneal add zone increases visual acuity at shorter distances, Prof Kohnen said. It also increases spherical aberration, resulting in more light reaching the retina at a point (Ortiz D et al. J Refract Surg. 2007;23:39-44). More recent research also suggests induced corneal wavefront aberrations from PresbyMAX treatment with the Schwind Amaris laser also increases both uncorrected and distance corrected monocular near vision. Multifocal corneas can be Thomas Kohnen MD, PhD shaped with a central near
Systems including the PresbyMAX now make it possible to surgically reverse the central add
add with peripheral distance focus, or vice versa, and both have been tried using various modalities, Prof Kohnen said. Lab science suggests a central steep island producing a near add is most effective. However, it is highly dependent on centration. Systems including the PresbyMAX now make it possible to surgically reverse the central add, Prof Kohnen noted. “But we have to look at this critically. When we have this cornea there is nothing we can do with correcting it with glasses postoperatively,” he said. In reviewing presbyLASIK for use in Germany, Prof Kohnen and colleagues found several articles showing an improvement in uncorrected near and distance vision. However, a closer look also often revealed loss of distance corrected visual acuity. Prof Kohnen’s ongoing unpublished research on phakic patients undergoing PresbyMAX, with -0.75 micro monovision in the nondominant eye, shows a similar pattern. Six-month results from the first 15 patients show increases in uncorrected near vision, with 60 per cent of dominant eyes and 87 per cent of non-dominant eyes at 20/25 or better at 40cm after surgery, up from seven per cent and zero per cent before surgery. Three-quarters of dominant and 80 per cent of non-dominant eyes gained three or more lines. However, uncorrected distance visual acuity was worse than corrected visual acuity after surgery, with 100 per cent at 20/25 corrected before and 50 per cent 20/25 uncorrected afterwards. Even more concerning, 46 per cent lost one or more line of best corrected distance vision, with 20 per cent losing two or more lines in the dominant eye, and 26 per cent one line and 20 per cent two lines in the non-dominant eye. “Basically we are losing vision here,” Prof Kohnen said. On the other hand, vision improved over time with patients more satisfied at six months than one month after surgery. Refractive astigmatism also increased after surgery in some cases. This may be due to irregularities in ablation in the central zone as noted on topography. All these procedures are evolving so this can be changed in the future, Prof Kohnen said. On a scale of one to six, with one best, patients rated distance vision worse, in the three to four range for activities such as watching TV and night driving, but in the two to 2.5 range for near tasks such as cooking and reading newspapers. Overall, 80 per cent said they would have the surgery again and would recommend it to a friend. Regarding use of presbyopia in pseudophakic patients, Prof Kohnen noted no reports in the literature and is using it himself only on phakic patients. Patients with monofocal IOLs need a full add of up to 2.5 dioptres, and this might be difficult to achieve using corneal ablation given the small pupils of many older patients. Thomas Kohnen: kohnen@em.uni-frankfurt.de
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SPECIAL FOCUS: CATARACT & REFRACTIVE
FRENCH SURVEY Age profile of the country’s ophthalmologists still a cause for concern. Dermot McGrath reports
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he growing popularity of the femtosecond laser, a marked trend towards higher-volume cataract surgery to cater for an increasingly older population and a significant increase in the use of toric intraocular lenses (IOLs) are some of the more pertinent findings of the latest survey of French ophthalmologists conducted by Richard Gold MD. In the 18th annual survey of French practices in ophthalmic surgery, Dr Gold, in private practice in Le Raincy, France, collected 547 responses to an anonymous questionnaire sent to 2,996 French ophthalmologists. The response rate of 18.32 per cent was a significant improvement on last year’s all-time low of 12.55 per cent, but is still the second lowest response rate since the study was initiated, said Dr Gold. The proportion of French ophthalmologists with a low volume of cataract surgery continues to decline, with about six per cent performing fewer than 100 cataract surgeries per year, down from 22 per cent in 1998 and 10 per cent in 2007. The most striking trend has been the proportion of surgeons performing higher-volume cataract surgery. While only 16 per cent performed between 500 and 999 procedures annually in 2004, that figure has risen to almost 27 per cent in 2014. “This is not surprising given the reduced number of ophthalmologists in France and the fact that the population is getting older,” said Dr Gold. Reflecting the wider global trend, the size of the incisions used by French ophthalmic surgeons for cataract surgery has steadily Richard Gold decreased in recent years, with the percentage of microincisions of less than 1.8mm being performed stabilising between five per cent and six per cent in the past few years. The number of surgeons using an incision size between 1.8mm and 2.2mm has climbed steadily from 25 per cent in 2009 to over 58 per cent in 2014. Oblique incisions also became the preferred choice (32 per cent) ahead of temporal incisions (29 per cent) for the first time since the survey began. Looking at premium IOL usage, Dr Gold noted that while growth has been relatively linear for multifocal and add-on IOLs in recent years, toric lenses have become increasingly popular, with over 45 per cent of respondents in 2014 implanting toric lenses compared to 13 per cent in 2008. The use of intracameral antibiotics in cataract surgery is now almost universally applied in France, having been made obligatory by the national health authority in 2011. Aprokam cefuroxime is the antibiotic of choice in 82 per cent of cases, and reconstituted cefuroxime in 17.5 per cent. An increasing proportion of French surgeons now use refractive surgery for the treatment of presbyopia. Finally, Dr Gold noted that the age profile of France’s ophthalmologists continues to cause concern, with not enough young ophthalmologists joining the ranks of the profession, which raises serious concerns for the ocular health of the population in the years to come. Richard Gold: rg@ophtalmo.net
EUROTIMES | SEPTEMBER 2015
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SPECIAL FOCUS: CATARACT & REFRACTIVE
TORIC IOL ALIGNMENT Potential advantages using imageguided system for toric lenses. Dermot McGrath reports
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specialised image-guided axis reference system offers surgeons an effective and efficient means of accurately aligning toric intraocular lenses (IOLs) and has some advantages compared to traditional ink marking methods, according to Gilles Lesieur MD, speaking at the French Implant and Refractive Surgery Association (SAFIR) annual meeting in Paris. “While our prospective study showed that precision is not increased for an experienced surgeon who is used to dealing with the limitations of traditional toric lens markings, there are other advantages using software for toric lens alignment,” said Dr Lesieur. “The ease and speed of using an automated image marker significantly improves the flow of patients through the operating room, saving an average of three minutes per patient. There is also a benefit for the patient in terms of less manipulation,” he added. Dr Lesieur’s study included 45 eyes implanted using traditional ink marking methods on the cornea for toric IOL alignment and 51 eyes without ink marking using the Callisto Eye system (Carl Zeiss Meditec). All eyes implanted with a toric IOL were followed with the Goniotrans 1.1 software application, which Gilles Lesieur is available free for download and runs on Microsoft Windows PC and iOS devices. The Goniotrans software uses a virtual protractor superimposed over the image of the eye to analyse the toric IOL alignment, said Dr Lesieur.
360-DEGREE ROTATION The implant selected in all patients was the AT TORBI 709M/ MP toric IOL (Carl Zeiss Meditec), a 25 per cent hydrophilic acrylic lens with a hydrophobic surface, which is very stable in the capsular bag with minimal rotation or decentration, said Dr Lesieur. Unlike some other toric lenses, which only allow clockwise rotation, the AT TORBI has been designed to enable 360-degree rotation in either direction, making it easier to align and fine-tune on the target axis. Turning to the results, Dr Lesieur said that there was no statistically significant difference between the two marking methods in terms of the final assessed rotational stability of the lens. “Using traditional marking methods, 91 per cent of the lenses had less than 10 degrees rotation, compared to 90.5 per cent for image-guided,” said Dr Lesieur. Summing up, Dr Lesieur said that while traditional toric marking did not pose a problem for an experienced surgeon, the ease of use of the image-guided system and its comfort for patients were two compelling arguments for its adoption. Furthermore, the device can be used for other applications such as capsulorhexis projection, keratoscopy and limbal arciform incisions, concluded Dr Lesieur. Gilles Lesieur: g.lesieur@centre-iridis.fr
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SPECIAL FOCUS: CATARACT & REFRACTIVE
The OCULUS Pentacam® AXL Always an Axial Length Ahead
DROPLESS DRUGS New technologies poised to revolutionise topical medication delivery. Howard Larkin reports
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p to 90 per cent of glaucoma patients do not take their eye drops as prescribed, with many quitting after six months. More than half of chronic users develop ocular surface disease symptoms. Many older and disabled patients lack the manual dexterity needed to administer eye drops. Even when drops make it into the eye, penetration is uncertain and drug concentrations peak and trough. All that may soon change. Several new drug delivery technologies that replace or greatly reduce the need for eye drops are available or nearing approval, Eric D Donnenfeld MD, New York University, told Glaucoma Day at the 2015 ASCRS•ASOA Symposium & Congress in San Diego, USA.
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Intracameral antibiotics for preventing endophthalmitis after cataract surgery are one eye drop substitute already available. Since the landmark ESCRS Endophthalmitis Study that found a five-fold reduction in endophthalmitis risk for intracameral cefuroxime compared with topical antibiotics (Barry P et al. JCRS 2006; 32:407-410), several very large studies have demonstrated similar results with intracameral moxifloxacin in Japan (Matsuura K et al. JCRS 2013; 39:1702–1706) and various antibiotics in the USA (Shorstein N et al. JCRS 2013; 39:8-14). “This is an idea whose time has come. A lot of thanks go to Peter Barry and the ESCRS,” Dr Donnenfeld said. Omidria (Omeros), a 4.0ml solution of phenylephrine 1.0 per cent and ketorolac 0.3 per cent added to 500ml standard irrigation solution, is another new approach. The solution prevented miosis during cataract surgery in more than 97 per cent of patients compared with about 73 per cent receiving standard preoperative topical mydriatics and anaesthetics alone in phase III FDA clinical trials (Omeros Corp data. Lindstrom R et al. Clin Opthalmol 2014; 8:17351744), Dr Donnenfeld said. The combination, recently approved by the FDA, also worked better than injecting phenylephrine alone. Perioperative eye drops can be greatly reduced with intravitreal injection of 0.2cc of triamcinolone with moxifloxacin and/or vancomycin (Imprimis Pharmaceuticals), Dr Donnenfeld said. “To my great surprise patients have embraced this. They have really liked this technology that removes drops or reduces drops,” he added. Drug-eluting bioabsorbable hydrogel plugs placed in the canaliculus (Ocular Therapeutix) have reduced flare cells with dexamethasone for 30 days in a phase III trial, and lowered intraocular pressure (IOP) for 30 days with travoprost as much as a timolol in a phase I trial. “The future of ophthalmic pharmaceuticals is clearly drug delivery. It may be nanotechnology drops, sustained delivery, external inserts, punctal plugs, or intracameral or intravitreal delivery, but I can promise you this will be disruptive and it will happen very quickly,” Dr Donnenfeld said. Eric Donnenfeld: ericdonnenfeld@gmail.com
EUROTIMES | SEPTEMBER 2015
SPECIAL FOCUS: CATARACT & REFRACTIVE
t 01 sa A t u th si oo Vi S b CR ES
IMPROVING IOLS Accommodation and dysphotopsias remain challenges. Howard Larkin reports
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ith high-quality central optics, square edges that retard posterior capsular opacification (PCO), reasonable pseudoaccommodative designs and toric optics, today’s intraocular lenses (IOLs) meet most patient needs. But there is still plenty of room for improvement in IOL design, Douglas D Koch MD, Baylor College of Medicine, Houston, told the 2015 ASCRS•ASOA Symposium & Congress in San Diego, USA. Lenses of silicone or hydrophobic acrylic with square edges inhibit lens growth on the posterior capsule (PC) better than other materials and designs, Dr Koch noted. But studies still find PCO in three to four per cent of square-edged lenses within three years of implantation, and rates go up with time. Dr Koch has seen PCO in seven per cent of patients within 40 months with one square-edge design, and four per cent at 15 months with another. “You see these rates rise to 75 per cent or higher if you follow patients long enough… I think this is a much bigger problem than we appreciate,” he said. Square-edge lenses also produce dysphotopsias in many patients. Early designs with polished edges produced light reflections, or positive dysphotopsias. Frosting lens edges have greatly reduced reflections, but shadows, or negative dysphotopsias, remain common. Studies suggest dysphotopsias occur in 1.6 to 7.8 per cent of patients at three weeks, Dr Koch said. But when asked, many more patients may acknowledge them. “As often as I see it in my practice, it feels to me like a bit of an epidemic,” said Dr Koch. Subtle IOL movement, which can be detected at the slit lamp by observing the fourth Purkinje image, complicates the problem by preventing neuroadaptation to a stationary shadow. “When I see that I know that dysphotopsia will not go away until the lens stabilises,” said Dr Koch. Samuel Masket MD has designed an IOL intended to eliminate dysphotopsias (Morcher). It features a groove around the optic into which the anterior capsulotomy edge fits like a tyre on a rim. “Hopefully these kinds of advances will reduce dysphotopsias. Their greater stability might also improve lens power predictability and further reduce PCO,” said Dr Koch.
SAFETY AND DURABILITY To date, only one accommodating lens is available in the USA, though several are marketed in Europe and elsewhere, and more are in development. But some don’t appear to work at all and others are untested over the long haul, Dr Koch noted. “Do we need to look at completely new approaches and think entirely out of the box? Ultimately this is where we are probably going to go for the best solutions,” said Dr Koch. Drug-eluting lenses are also desirable for controlling postoperative inflammation and infection, Dr Koch noted. “Why are we still either prescribing eye drops or injecting drugs through the zonules or even the pars plana? There must be better ways to do that,” he said. Overall, though, the quality of current IOLs is excellent, Dr Koch said. Barriers to further improvement include technology, cost of development and regulatory requirements, he concluded.
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Douglas D Koch: dkoch@bcm.edu EUROTIMES | SEPTEMBER 2015
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SPECIAL FOCUS: CATARACT & REFRACTIVE
PHACO IN MYOPES Better surgery helps preserve retinal integrity in long eyes.
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n patients with moderate to high myopia undergoing cataract surgery, steps taken to avoid intraoperative complications can help reduce the risk of postoperative complications as well, said Oliver Findl MD, Vienna Institute for Research in Ocular Surgery, Hanusch Hospital, Vienna, Austria. “In these patients we not only have the problem of retinal detachments after surgery being much higher, but we also have a higher rate of intraoperative complications, especially among those in the younger age group, patients in their 50s, who have high myopia,” Dr Findl told a Young Ophthalmologists symposium at the 19th ESCRS Winter Meeting in Istanbul, Turkey. Dr Findl cited a retrospective review involving 1,793 eyes of 1,547 patients which showed that the risk of rhegmatogenous retinal detachment by the 10th postoperative year was 4.9 times higher in eyes with an axial length of 24mm or greater than it was in shorter eyes. “Posterior vitreous detachment (PVD) is the predisposing event to the development of a break and then a retinal detachment. Approximately 10 per cent of patients with a symptomatic PVD have retinal breaks or retinal detachments requiring immediate treatment," Dr Findl said. The older the patient, the more likely they are to already have had a PVD, which reduces the risk of postoperative retinal detachment. But research suggests that over a third of younger patients will develop a PVD within the first three postoperative years after cataract surgery. Similarly, those with high myopia have a higher incidence of developing a PVD after cataract surgery. Recent research has shown that another risk factor for retinal detachment is the presence of an adhesion of the anterior vitreous face to the posterior lens capsule around the ligament. During cataract surgery the risk of posterior rupture and vitreous loss is approximately twofold among myopic eyes with an axial length greater than 26mm than it is in normal eyes. That in turn can set the rhegmatogenous retinal detachment process in motion, Dr Findl noted. “If you have capsule rupture during surgery, you will typically induce a PVD. And obviously if you have vitreoretinal adhesions, these will then cause breaks leading ultimately to retinal detachments. We know that the retinal detachment rate in eyes that have had a capsule rupture and vitreous loss during surgery is about 12 to EUROTIMES | SEPTEMBER 2015
Roibeard O’hEineachain reports
Relieving lens-iris diaphragm retropulsion syndrome in myopic eye using spatula, as seen with intra-op OCT. Deep AC during irrigation (top), lifting of iris with spatula (middle, asterisk), normal AC (lower). Arrow indicates rhexis edge
15 fold higher than in it is in eyes that do not have this complication,” Dr Findl said. The particularly difficult nature of cataract surgery in highly myopic eyes is an important factor in their higher rate of intraoperative complications. One problem commonly contributing to that difficulty is lens-iris diaphragm retropulsion syndrome. That occurs when the anterior chamber infusion displaces the lens-iris diaphragm posteriorly, because of the thin and stretched zonules and underdeveloped ciliary body common in myopic eyes. That in turn causes reverse pupillary block with a marked deepening of the anterior chamber, and a posterior bowing of the iris. “If the pupillary block is not relieved in some way, the surgeon will have a very steep axis in which to work, and on a nucleus which, in a long eye, is already far back eye to start with,” he said. In such cases, Dr Findl relieves the block by lifting the iris with a spatula, thereby creating some space between the iris and capsule and allowing the lens to come forward. He noted that myopic patients often need some additional anaesthesia because of the greater discomfort the surgery causes
them. Studies show that intracameral anaesthesia may be effective in that regard. A sub-Tenons block is another alternative and can be safely performed by placing the sub-Tenons cannula through a small opening in the conjunctiva, eliminating any risk of perforating the eye.
PREOPERATIVE CHECKLIST Dr Findl said that he has a preoperative checklist that he uses in all his myopic cataract patients. First, he insures that the patient is thoroughly informed and cognisant of the risk of retinal detachment. Second on the list is to decide on the planned refraction, which is not always emmetropia because some patients will want to continue reading without glasses. Dr Findl said that he will compare the lens powers indicated by different formulas, usually the SRK T, Haigis, and the Holladay formulas, and try to find a good mix. If it is the second eye in which the patient is to undergo cataract surgery, the power of the IOL should be adjusted in accordance with any refractive surprise in the first eye. Oliver Findl: oliver@findl.at
Courtesy of Oliver Findl MD
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The flattening of the anterior corneal curvature after a crosslinking procedure follows a Gaussian distribution curve. Whereas most patients show an average flattening, the extremes may lead to treatment failure (three per cent of cases) or extreme flattening (0.5 per cent)
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Courtesy of Farhad Hafezi MD, PhD
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EUROTIMES | SEPTEMBER 2015
rosslinking combined with therapeutic refractive laser surgery in eyes with keratoconus should be performed sequentially, with crosslinking first, instead of simultaneously, in order to ensure the stability of the visual outcome, said Farhad Hafezi MD, PhD, ELZA Institute, Switzerland, and Department of Ophthalmology, USC, Los Angeles, USA. “It’s all about the sequence of treatment. If I had a patient in whom I wanted to combine refractive laser surgery with crosslinking, I would first stabilise the disease and then wait a year to see if progression has truly stopped and then look after the visual aspects,” Prof Hafezi told the 19th ESCRS Winter Meeting in Istanbul. Performing crosslinking previous to, rather than simultaneously with, therapeutic refractive laser surgery makes sense on a number of grounds, he said. Crosslinking itself reduces the anterior corneal curvature by an average of about 2.7D in the first year. In addition, the flattening can continue several more years after the crosslinking procedure. If a patient were treated with a simultaneous approach, this average flattening might be taken into consideration to calculate the final postoperative refraction. “If I assume that I have an average patient, it doesn’t really matter that much to me if I do it simultaneously or sequentially because I can depend on a two-dioptre change. But it's not about the average patient, it's about the outliers,” he said. Even when using the widely recognised epithelium-off Dresden protocol,
crosslinking procedures may produce two extreme results: no effect = treatment failure, or too much effect = massive flattening. • Treatment failure: In about three per cent of patients the initial treatment fails, indicating that these corneas may show a very particular biomechanical behaviour. Is it really wise to ablate additional tissue using an excimer laser in such a biomechanically altered cornea? • Too much effect: In 0.5 per cent of cases, there will be an extreme flattening of the cornea of up to 11D. In the view of these extremes, it is better to follow a patient for 12 months after a crosslinking procedure, and assess whether the corneal reaction is average, extreme or absent. Then, the appropriate measures might be taken. In addition, when performing PRK, the ablation rate must be adjusted to compensate for the reduced amount of tissue ablated per laser pulse after crosslinking. Prof Hafezi cited research carried out by Prof Theo Seiler’s group and by his own group, both in Switzerland, involving two different excimer laser platforms – which showed that, at any given ablation rate, the lasers achieved nine per cent to 12 per cent less tissue ablation in crosslinked corneas than in virgin cornea. Future excimer laser software will implement these findings to generate nomograms that allow for greater accuracy when treating keratoconus patients that had undergone previous crosslinking. Farhad Hafezi: info@elza-institute.com * References available on request
CORNEA
CORNEAL GRAFT STUDY Recruitment commences in major new corneal graft study. Priscilla Lynch reports
Conor Murphy: conorcmurphy@rcsi.ie
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atient recruitment has commenced for VISICORT, a major new European study that aims to improve corneal graft outcomes. More than 100,000 corneal transplants are carried out annually worldwide. Immunological rejection remains the most important cause of corneal graft failure, with failure rates of up to 60 per cent at five years in high-risk situations, such as in patients with prior graft failure or herpes keratitis. VISICORT is a multi-disciplinary research project involving 12 partners from across the EU with expertise in corneal transplantation, cell therapy, immunology, bio-sampling, systems biology/immune profiling and bioinformatics. The project will complete the first ever systematic immune profiling of human corneal transplant recipients. Clinical data and biospecimens will be collected from over 700 corneal transplant recipients at five leading transplant centres, including the Royal Victoria Eye and Ear Hospital (RVEEH) and the Royal College of Surgeons in Ireland (RCSI), Dublin, Ireland; Aarhus University Hospital, Denmark; Charité University Eye Clinic, Berlin, Germany; University of Bristol and Bristol Eye Hospital, UK; and Nantes University Hospital, France. The samples will be centrally collated and distributed to cutting-edge laboratories in Edinburgh, UK and Nantes, France for multi-platform profiling and integrated bioinformatics analyses. Profiling data will generate a better understanding of corneal transplant rejection and failure. This knowledge will be used to develop novel biomarker-based surveillance strategies and, coupled with SME-based expertise in cell product development, will also inform the design and initiation Conor Murphy of a clinical trial of stromal stem cell therapy in high-risk human corneal transplant recipients. The VISICORT project is co-ordinated by Prof Matthew Griffin, Professor of Transplant Biology at NUI Galway, Ireland. Benefiting from a €6million award from the European Commission FP7 programme, the VISICORT project launched in May 2014 and patient recruitment has now opened following the development phase of the project. “The study is progressing well. We have recruited over 40 patients to the study at RVEEH in the past four months and over 100 patients across all clinical sites,” Conor Murphy PhD, FRCSI (Ophth), Professor of Ophthalmology at RCSI, told EuroTimes. “It is a strong consortium with an ideal mix of expertise that will enable us to have a real impact on the outcomes of corneal transplantation in the future by improving our understanding of the mechanisms causing transplant failure, identifying biomarkers predicting long-term outcomes and by evaluating a cell based therapy for patients with a poor prognosis for transplant survival,” he said.
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* For more information visit: www.visicort.eu EUROTIMES | SEPTEMBER 2015
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CORNEA
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EUROTIMES | SEPTEMBER 2015
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Serial data show ongoing improvement in visual acuity. Cheryl Guttman Krader reports
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DSEK: VISION RECOVERY prospective follow-up after Descemet stripping endothelial keratoplasty (DSEK) for Fuchs dystrophy shows there is improvement in visual acuity (VA) and corneal remodelling for at least five years, reported Sanjay V Patel MD, FRCOphth at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. Mark Terry and co-workers published their findings showing that VA after DSEK continues to improve during follow-up to three years (Li JY et al, Ophthalmology. 2012;119:126-9), but that is a retrospective analysis of non-standardised vision data, said Dr Patel, Professor and Chair, Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota, USA. “Our series is smaller, but it is prospective, and it has followup to five years with best corrected visual acuity (BCVA) measured by the electronic Early Treatment of Diabetic Retinopathy Study protocol,” said Dr Patel. The Mayo Clinic series included 49 eyes, of which 44 eyes were seen at 12 months and 34 at five years. All eyes were ideal candidates for DSEK – they had no other ocular co-morbidity affecting Sanjay V Patel vision, and if not already pseudophakic, they underwent phacoemulsification and implantation of a posterior chamber intraocular lens (IOL) at the time of DSEK surgery. Mean BCVA was about 20/30 at one year. At five years, mean BCVA improved to about 20/24, 55 per cent of eyes were seeing 20/25 or better, and about 20 per cent achieved BCVA of 20/20 or better. The results were similar in analyses including only eyes with complete follow-up through five years. Total corneal thickness and graft thickness were very stable between one and five years, averaging about 665 microns and 155 microns, respectively, as measured by confocal microscopy. “There is an ongoing debate about the effect of DSEK graft thickness on BCVA outcomes. We have found no correlation between graft thickness and BCVA at one, two or five years,” added Dr Patel. Anterior corneal haze, which was measured as corneal reflectivity with confocal microscopy, was high at one month after DSEK, improved significantly by six months, and also improved significantly between one and five years. “The continued reduction in haze between one and five years suggests there is ongoing remodelling and repair of the stroma,” he said. Dr Patel noted that abnormal subepithelial cells, presumably fibroblasts, are seen in most corneas with Fuchs dystrophy requiring DSEK, and persisted in a number of eyes at five years. Most endothelial cell loss occurred early, with the loss being 24 per cent at one month and 55 per cent at five years. There were five graft failures in the series. Four of these were iatrogenic and occurred in eyes operated on early during the DSEK learning curve. Sanjay V Patel: patel.sanjay@mayo.edu
7/22/15 8:43 AM
CORNEA
ADVICE ON AMT A useful tool but not a “cure all”. Priscilla Lynch reports
SAFETY AND STORAGE With increased Caesarean section rates has come increased availability
Preoperative ocular surface neoplasia
Courtesy of Damian Lake FRCOphth
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mniotic membrane transplantation (AMT) has a variety of useful ophthalmic applications and is now being used more due to increased Caesarean birth rates and improved preservation techniques, Damian Lake FRCOphth, The Queen Victoria Hospital, East Grinstead, UK, told the Joint Irish/UKISCRS Refractive Surgery Meeting in Dublin, Ireland. Clinically AMT has many long-established uses including treatment of persistent epithelial defects, reconstructions post tumour resection, neurotrophic ulceration, post-herpetic ulcerations, for PRK haze, following excision of conjunctivochalasis or pterygium, in patients with superior limbic keratoconjunctivitis after Tenon layer resection, and after ocular surface burns from chemicals or heat, Dr Lake explained. The two main surgical techniques using amniotic membrane are inlay AMT to act as a replacement basement membrane or to fill deep ulcerations, and onlay AMT to act as a bandage to promote epithelial healing, he added. “The AMT may be multilayered, and we prefer the stroma side down. We use nylon sutures in a running style, as they are quicker to use and less inflammatory than Vicryl,” he stated. AMT has many modes of action including inhibiting angiogenesis, antimicrobial and anti-fibroblastic. It does not produce an immunological response and it becomes incorporated within the host stroma. There is some evidence that the AMT contains some pluripotent stem cells, but the evidence on growth factors and anti-inflammatory molecules is often contradictory, Dr Lake noted. He advised that surgeons seek out clinical studies on AMT for definitive data, as mainstream media coverage and advertisements tend to exaggerate the benefits and potential of AMT.
Postoperative excision and amniotic membrane
of amniotic membrane in the Western world. The screening process when collecting amniotic membranes is exhaustive so as to exclude any possibility of transmissible diseases such as hepatitis or HIV, Dr Lake reassured the meeting. The storage process has commonly been through cryopreservation but increasingly freeze-dried tissue is now available with the advantage of easier storage in operating facilities. Despite its many uses, however, Dr Lake cautioned that AMT is not a robust material. “It is soft and should not be used for patching or glaucoma drainage tube erosion as it is unlikely to be successful,” he said. Summarising, Dr Lake said AMT is a useful tool but is not a “cure all”. The procedure may need to be repeated, particularly in burns, and surgeons must be vigilant regarding infections and continue to use antibiotics, he concluded. Damian Lake: lakedamian@hotmail.com
We use nylon sutures in a running style, as they are quicker to use and less inflammatory than Vicryl Damian Lake FRCOphth EUROTIMES | SEPTEMBER 2015
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CORNEA
EYEBANK INNOVATION Pre-cut and pre-loaded lenticules simplify endothelial keratoplasty procedures. Roibeard O’hEineachain reports
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new technique developed by Italian eye bank researchers provides a means of preparing posterior lenticules, precut and pre-loaded in a glide for use in endothelial keratoplasty procedures. “A few years ago surgeons asked us if we could provide them with just the posterior lenticules to help them in the surgical theatre. We tried to figure out if it was possible and the answer was, yes, it is possible,” said Alessandro Ruzza, Eye Bank Specialist, Veneto Eye Bank Foundation, Venice, Italy, at the 19th ESCRS Winter Meeting in Istanbul, Turkey. The new technique, born from the partnership between the Eye Bank and Dr Massimo Busin, involves the use of a modified (Busin-type) glide with a lid that contains the trephined posterior lenticule. The device is placed in a container of tissue culture medium and is delivered from the eye bank to the surgeon, ready for use in endothelial keratoplasty procedures. Preparing the lenticule in this way overcomes the portability issues that had previously made the use of pre-cut posterior lenticules less feasible on a wider scale. In addition, the use of the device reduces the number of steps necessary for graft preparation in the surgical theatre, making the endothelial keratoplasty procedure much easier to perform and potentially safer too. Mr Ruzza noted that in their laboratory evaluation of the technique, using a 3D printed prototype, there was an endothelial cell loss of only four per cent in 17 pre-cut and pre-loaded lenticules after storage for seven days. In a clinical validation study, surgeons from Italy and different parts of Europe implanted a total of 16 pre-cut and pre-loaded lenticules for DSAEK and ultrathin DSAEK. They reported that there was no significant difference between the clinical outcomes achieved with the preloaded lenticules and those they achieved with the more conventional pre-cut tissues. EUROTIMES | SEPTEMBER 2015
However, the surgeons also reported that the pre-loaded lenticules greatly simplified and sped up the procedures by an average of around 20 minutes. Mr Ruzza said that in the course of their experiments they found that the very thin lenticules were very difficult to handle. They therefore developed two different scaffolding approaches, one involves the use of the anterior lenticule and the other used a contact lens. In both approaches, the scaffolding is detached from the lenticule and removed from the glide just prior to surgery. He noted that when using the anterior lenticule scaffolding approach, the posterior graft tissues increased in thickness by a mean of only 20 per cent, but were somewhat adherent to their anterior lenticule scaffolding. The lenticules were much less adherent to the contact lens, but they increased in thickness by a mean of 40 per cent when using that approach.
FROM EYE BANK TO THEATRE Mr Ruzza explained that the preparation of the lenticule involves separating a standard pre-cut posterior lenticule from the anterior lenticule and placing it on the contact lens, then performing a punch trephination to the desired diameter (from 8 to 9mm). The still mutually adherent lenticule and contact lens are then placed in the new glide device, the lid is locked and the device is placed in a container of tissue culture medium for storage and delivery. Preparation of the graft in the surgical theatre involves lifting the device from its container using its special handle and then draining the liquid out of it, to better distinguish between the lenticule and the contact lens. The surgeon then engages the lenticule with a 23-gauge forceps and separates it from the contact lens, which is then removed from the glide and the endothelial keratoplasty
Three-dimensional software files and printed prototype. A and B: different stages of the glide development; C: the 3D printed prototype with the “F”-marked posterior lenticule inside (asterisk); D: sectioned image of the glide inside of the container
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Pre-stripped membrane procedure for DMEK surgery. A: Descemet incisions by the calibrated punch; B: cleavage of the peripheral membrane; C: stripping procedure by sectors; D: stromal rim marking to identify the position of the peripheral membrane hinge; E: a pre-stripped membrane ready to be delivered
procedure is performed in the same manner as with a Busin glide. “Right now we are in the production phase and very soon we’re going to final validation study,” added Mr Ruzza.
Mr Ruzza noted that he and his associates are also working on a means of providing pre-stripped and pre-loaded Descemet’s membrane lenticules for DMEK procedures. He added that they currently use a stripping technique rather than pneumatic technique to cleave Descemet’s membrane from the stroma. To simplify the incision into Descemet’s membrane, they use a special pre-calibrated punch with a maximum cut depth of 150µm. Deeper cuts make the cleavage plane between the membrane and the stroma harder to see. They then strip the
All images courtesy of the Veneto Eye Bank Foundation
PRE-STRIPPED DMEK
membrane by sectors but leave it attached to the corneal button by a small hinge, and mark the scleral rim with a skin marker. They then place it in a container of tissue culture medium for storage and delivery. Alessandro Ruzza: alessandro.ruzza@fbov.it
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9–10 September Bella Center, Copenhagen, Denmark
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CANNABIS FOR IOP? he growing “medicalization” of cannabis, by legalising its use on a doctor’s order, pressures physicians to prescribe marijuana and its derivatives – despite limited evidence of its effectiveness. However, the safety and effectiveness evidence that does exist suggests that marijuana is a poor choice for glaucoma treatment, Marc F Lieberman MD told Glaucoma Day at the 2014 American Academy of Ophthalmology annual meeting in Chicago, USA. He currently serves as Director of Glaucoma Services at California Pacific Medical Centre, and Clinical Professor of Ophthalmology at the University of California San Francisco, USA. The benefits simply do not justify the risks, particularly since many safer and more effective treatments are readily available, he said. While early studies show marijuana lowers intraocular pressure (IOP) in many eyes, the effect was modest at best, lasting but a few hours. But marijuana’s potential risks, both medical and social, can be substantial and potentially life-long, Dr Lieberman said. Chronic use beginning in adolescence can lead to irreversibly impaired cognitive capacities – and marijuana’s illegality places users at risk for the stigma of criminal conduct and incarceration. Yet compared to other, widely available ‘recreational’ agents, marijuana is fortunately not lethal. (See Table 1) As such, marijuana as glaucoma therapy violates the Hippocratic dictum to first do no harm, Dr Lieberman said. “In my personal practice I educate patients about the risks, advocate evidence-based regimens, and refrain from prescribing,” he added.
MYTH BECOMES PUBLIC POLICY Despite dozens of recent US state and local statutes permitting its medical or recreational use, US federal law still classifies marijuana as a “Schedule I” agent, incorrectly equating marijuana as having the same high potential for addiction and absence of medical value, as cocaine and heroin. Dating from the 1930s, these prohibitions were politically driven - with racist and xenophobic overtones and without a shred of scientific substantiation, Dr Lieberman said. Yet many adults with direct experience relate recreational marijuana use to that of alcohol and tobacco. In the past 50 years over 20 million Americans have been arrested, and over $US100 billion spent on prohibition. The American government’s hysterical demonization of marijuana’s risks, plus mass incarceration of minor marijuana offenders, have shredded the credibility of medical-legal authorities, Dr Lieberman said. Its illegal status has also prevented necessary research.
THE EVIDENCE Marijuana’s available potency is on an upward trajectory: from four per cent THC-concentration in 1995 to nearly 20 per cent in 2014, Dr Lieberman said. More powerful delivery systems by vapourization (“dabbing”) of oils and waxes of potent marijuana concentrates are readily available. That the plant
In my personal practice I educate patients about the risks, advocate evidence-based regimens, and refrain from prescribing
Courtesy of Marc F Lieberman MD
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Big risks and uncertain benefits make it poor choice for treating glaucoma. Howard Larkin reports
Table 1: Non-lethality of marijuana usage compared to other ‘recreational’ agents
contains many poorly understood active chemicals, and that its IOP-lowering mechanisms remain unknown, further complicate the challenges of medical studies and recommendations. And despite public perception, chronic marijuana use is not benign, Dr Lieberman said. About nine per cent of users develop long-term dependency. “At the end of 2014 we have unanimous consensus among many ophthalmological societies that there is no current role for the use of cannabis agents in the management of glaucoma,” Dr Lieberman said. Marc F Lieberman: sfdrmarc@gmail.com
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Marc F Lieberman MD EUROTIMES | SEPTEMBER 2015
GLAUCOMA
NEW DETAILS ON OUTFLOW
Courtesy of Barbara A Smit MD, PhD
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iStent inject devices inserted in the trabecular meshwork
MORE OPTIONS New developments may improve outcomes in Schlemm’s canal surgery. Howard Larkin reports
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ecent research that challenges assumptions about aqueous outflow could increase the effectiveness of Schlemm’s canal surgery enough to make it a viable – and safer – alternative to trabeculectomy for lowering intraocular pressure (IOP) in glaucoma patients, Barbara A Smit MD, PhD told the 2015 ASCRS•ASOA Symposium & Congress in San Diego, USA. Traditional filtering surgery is highly effective in lowering IOP, because it shunts fluid to the subconjunctival space, bypassing the natural outflow system and any resistance it entails, noted Dr Smit, Glaucoma Consultant, Spokane Eye Clinic, Spokane, Washington, US, who delivered the Stephen A Obstbaum MD Honoured Lecture. But it also exposes patients to long-term risk of complications including hypotony, scarring and bleb failure, and possibly endophthalmitis. Filtration surgery is also technically complex and requires a lot of follow-up, making it impractical for many surgeons, particularly given the rising incidence of glaucoma as the population ages, said Dr Smit. “We really need some procedures that require less follow-up, have fewer complications and are technically accessible for the anterior segment surgeon,” she added. EUROTIMES | SEPTEMBER 2015
This is where microinvasive glaucoma surgery, or MIGS, comes in. Many of these procedures are what Dr Smit refers to as Schlemm’s canal surgery, including canaloplasty, viscocanalostomy and trabecular meshwork bypass stents. Their goal is to restore access to the eye’s natural distal outflow system, which is presumably blocked by a damaged or clogged trabecular meshwork. The problem is these techniques don’t always work. And when they do work they usually produce IOPs in the midteens, much higher than the 8.0mmHg that might be expected if episcleral venous pressure were the limiting factor, Dr Smit said. New research offers clues as to why, Dr Smit said. It also suggests that many common assumptions about aqueous outflow may not be correct – and developing a better understanding of outflow mechanisms might result in better surgical outcomes.
One old idea is that 75 per cent of outflow resistance comes from the trabecular meshwork, and many procedures focus on removing or bypassing it. But research using aqueous angiography shows that significant resistance to outflow resides distal to the trabecular meshwork, in collector channels and the deep scleral plexus. “The location of resistance may vary among patients, and resistance also may vary with time and healing,” Dr Smit said. Similarly, research shows that collector channels are unevenly distributed and outflow only occurs in some, contradicting conventional wisdom that outflow occurs through 360 degrees, Dr Smit noted. This means placement of devices or incisions is critical. One way to test whether the distal outflow system is functioning at a particular location is to look for retrograde blood flow into the collector channels and Schlemm’s canal when anterior chamber pressure is lowered. This suggests the outflow mechanism may be intact, and marks a good position for a trabecular meshwork bypass stent. Outflow also has been thought static, depending solely on pressure differential. But OCT imaging suggests that outflow may be dynamic and regulated, showing evidence for pumping mechanism, valves and variable resistance, Dr Smit said. These observations are buttressed by molecular research by James Tan MD, PhD, suggesting collector channels and the intrascleral plexus are all lined with contractile tissue. Evidence also suggests that the trabecular meshwork stiffens as glaucoma progresses, which may inhibit any pumping action, Dr Smit noted. OCT images also suggest that high IOP may push the trabecular meshwork into Schlemm’s canal, effectively closing it off. It’s not known if this effect is temporary or causes permanent damage. These insights, and the tools that provide them, are likely to reshape Schlemm’s canal surgery, Dr Smit concluded. “Clinical tools like OCT and outflow angiography may help us not only to understand the system better, but eventually help us select surgical candidates for the best surgical techniques for them. Current surgical approaches to outflow via Schlemm’s canal will pave the way for more elegant and effective surgeries tomorrow,” she said. Barbara A Smit: bsmit@spokaneeye.com
The location of resistance may vary among patients, and resistance also may vary with time and healing Barbara A Smit MD, PhD
GLAUCOMA
TRABECULAR BYPASS Viable first-line treatment for select patients and scenarios. Howard Larkin reports
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rabecular bypass procedures, including trabeculotomy and stents, are gaining ground as safer alternatives to trabeculectomy and tubes for treating glaucoma. However, they should be carefully matched to the patient, the clinical scenario and the type of glaucoma treated, Oluwatosin U Smith MD, Dallas, told a session of the 2015 ASCRS•ASOA Symposium & Congress in San Diego, USA. Trabecular bypass procedures enhance aqueous outflow by removing or bypassing obstructions related to the trabecular meshwork (TM) and Schlemm’s canal. Therefore, a good collector system distal to the TM is required for success, Dr Smith noted. She reviewed four bypass technologies with potential as first-line glaucoma treatments. Trabectome (NeoMedix) is a high frequency electrocautery device inserted through a corneal incision into the angle guided by gonioscopy to un-roof 90 to 120 degrees of Schlemm’s canal, exposing the posterior canal wall and collector channels. It is often combined with cataract surgery in mild to moderate open-angle glaucoma. An early study saw a mean 41 per cent reduction in intraocular pressure (IOP) at 18 months with few complications. Gonioscopy-assisted transluminal trabeculotomy (GATT) is an ab interno procedure performed with a suture or illuminated catheter inserted into Schlemm’s canal up to 360 degrees. The TM is torn off with the suture or catheter, leaving the posterior wall of Schlemm's canal and collector channels exposed. It is useful in several different types of glaucoma in adults and children, and in patients with prior surgery, Dr Smith said. Studies show GATT reduces mean IOP by 33 to 55 per cent, and medications from three before surgery to about one after 18 months. Complication rates are low, but at 24 months failure rates run as high as 60 per cent in patients with prior cataract extraction. iStent (Glaukos) is a TM bypass device indicated for use with cataract surgery in adults with mild to moderate openangle glaucoma treated with medication. It is inserted into Schlemm’s canal during cataract surgery, allowing fluid to flow directly to collector channels. At 24 months, in a study with one shunt implanted, it lowers IOP more than cataract surgery alone, with 53 per cent reduced 20 per cent or more compared with 44 per cent for cataract surgery alone. Complication rates are low, but its IOP reduction effect fades over time. Hydrus (Ivantis) is a microstent in phase 3 clinical trials. It is inserted into Schlemm’s canal, scaffolding and dilating the canal for three clock hours. At 24 months it lowers IOP by 20 per cent or more in 86 per cent of patients, compared with 45 per cent with cataract extraction alone. Complication rates are low, and IOP reduction effect does not appear to fade as much as some other approaches. “Angle surgery is here to stay, so overcome the learning curve and get comfortable in the angle,” Dr Smith concluded. Oluwatosin U Smith: Tsmith@glaucomaassociates.com To view surgical video go to: https://vimeo.com/133328258 EUROTIMES | SEPTEMBER 2015
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8–11 September 2016
COPENHAGEN 16th EURETINA Congress
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RETINA
ANTI-VEGF TREATMENT Patients in the real world receive very few injections for DME. Sean Henahan reports
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hile the evidence from clinical studies supporting the therapeutic value of antiVEGF agents for the treatment of diabetic macular oedema (DME) continues to mount, it seems patients in the real world are not receiving nearly the number of injections as patients in randomised clinical trials, nor are they experiencing the visual acuity improvement seen in those studies. Speaking at the 2014 annual meeting of the American Society of Retinal Specialists in San Diego, USA, Nancy M Holekamp MD presented a “real-world” study indicating that patients receiving fewer anti-VEGF injections for DME have a corresponding lack of visual acuity improvement compared to what has been reported in randomised clinical trials. “If you look at large electronic claims databases such as Medicare, it shows that patients with DME only receive between two and three anti-VEGF injection Nancy M Holekamp treatments in the first year of therapy. This is far below the monthly injections of ranibizumab seen in the RISE and RIDE trials, and is even less than the average of nine bevacizumab injections patients received in the BOLT study,” noted Dr Holekamp, Professor of Clinical Ophthalmology and Visual Sciences at the Washington University School of Medicine in St Louis, Missouri, USA. She and her colleagues examined data from the Geisinger Health System to determine if fewer anti-VEGF injections resulted in less visual acuity improvement. Her study included all patients who had received anti-VEGF for DME for whom 12-month follow-up was available. Some 94 eyes with a mean visual acuity of 20/80 at baseline met the inclusion criteria. At the 12-month mark the average number of injections was 2.6. Approximately 40 per cent of patients received only one injection, 19 per cent two injections, and 15 per cent three injections. Overall, 75 per cent of patients received three or fewer injections over the 12-month period. At the six-month mark the researchers noted a mean increase in visual acuity of four letters, which fell to 3.7 at 12 months. By comparison, patients in the RISE and RIDE clinical trials gained more than 10 letters of visual acuity at month 12. According to Dr Holekamp, if one looks across all studies of anti-VEGF injections for DME, there is a linear association between the number of injections and the improvement in vision: the more injections, the better the vision. “We already knew that patients in the real world were being undertreated. What this study shows for the first time is that they are also experiencing less visual acuity improvement. It may be hard to change this because the diabetic population has other health burdens. In patients with DME it may be useful to have treatments with longer duration of action, so patients can obtain better visual acuity improvement with fewer treatments,” she said.
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RETINA
ORAL RETINOID THERAPY Results encouraging for treatment of retinal degenerative disease. Cheryl Guttman Krader reports
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epeated treatments with oral 9-cis-retinyl acetate (QLT091001 developed by QLT Inc.) in patients with Leber congenital amaurosis (LCA) and/or retinitis pigmentosa (RP) due to RPE65 or LRAT mutations had an acceptable safety profile and led to sustained visual improvements, reported Hendrik P Scholl MD, MA, at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. He presented results from an international, multicentre Phase 1b study that enrolled patients who were treated in an earlier study with a single seven-day course of 9-cis-retinyl acetate at doses of 10 or 40mg/m2. In the second retreatment trial, patients received up to three seven-day courses of the synthetic cis-retinoid at doses of 10, 40 or 60mg/m2. The study defined a responder as a patient showing an increase in at least one eye and at least two consecutive visits within six months from the start of any treatment course of ≥20 per cent in the functional retina area of the primary isopter determined from the Goldmann visual field. Some 86 per cent of RP patients and 54 per cent of LCA patients met those criteria. About two-thirds of RP patients and about half of LCA patients were responders using the same criteria, except with a more stringent 40 per cent threshold for improvement. Approximately two-thirds of RP patients and three-quarters of LCA patients achieved a visual acuity (VA) response, defined as having a ≥ 5 ETDRS letter increase in at least one eye and at least two consecutive visits within six months from the start of any treatment course. The mean duration of the VA response exceeded five months in the RP patients and was almost 10 months in the LCA subcohort, reported Dr Scholl, the Dr Frieda Derdeyn Bambas Professor of Ophthalmology, Wilmer Eye Institute, Johns Hopkins University, Baltimore, US. “We must be cautious because this is not a placebocontrolled study. However, these are diseases where patients decline over time and never get better. So to see improvement of this magnitude is quite unlikely,” he said.
ADVERSE EVENTS Most adverse events were mild (78 per cent) or moderate (18 per cent) in intensity, consistent with the retinoid class, and were transient and/or reversible. In addition, their incidence did not increase with successive treatment courses or appear to be dose-related. Headache and fatigue were the most common treatment-related adverse events. There was one serious adverse event – a case of pseudotumor cerebri – that resolved without complications. Oral 9-cis-retinyl acetate represents a pharmacological retinoid replacement therapy in patients with LRAT and RPE65 mutations, restoring function to their defective visual cycle to allow regeneration of the visual pigment. Dr Scholl noted that the sustained benefit noted in the study is explained by the systemic route of administration. Preclinical and clinical data suggest that the systemic route of administration may lead to storage of the active compound in tissue depots from where they may be slowly released. Hendrik P Scholl: hscholl1@jhmi.edu EUROTIMES | SEPTEMBER 2015
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EUROTIMES | SEPTEMBER 2015
itrectomy for macular hole and epiretinal membrane (ERM) is a safe procedure with excellent five-year visual results in elderly patients, according to the results of a new Irish study presented at the 2015 Irish College of Ophthalmologists annual conference in Westport, Ireland. Vitrectomy for macular hole and ERM accounts for approximately 20 per cent of all vitreoretinal surgery, according to UK data. However, some recent studies have demonstrated a negative long-term impact of inner limiting membrane peeling in macular hole surgery, while other studies have shown a continued improving benefit in ERM surgery over five years, noted Sinead Connolly MD, Mater Hospital, Dublin, Ireland. The Irish study looked at the long-term visual and anatomic results following vitrectomy for macular hole and ERM in a single Irish centre under a single surgeon (2007-2010). The study assessed the results of 75 eyes in 64 patients. Some 46 eyes were treated for macular hole, 26 for ERM and three for vitreomacular traction. Seven patients underwent combined phaco and vitrectomy. Of the 63 phakic patients, 10 underwent combined phacoemulsification, lens implantation and pars plana vitrectomy (PPV), and a further 35 underwent subsequent cataract surgery during the five-year follow up.
VISUAL ACUITY A total of 69 per cent of eyes with macular hole, 68 per cent of eyes with ERM and 100 per cent of eyes that underwent vitrectomy had improved visual acuity from baseline. “The visual acuity improvement was significant, with 60 per cent of the macular hole patients achieving a visual acuity of 6/12 at five years out. These patients were in their late 70s and 80s and this meant that they were still able to meet driving criteria and go to the shops,� Dr Connolly told the meeting. Meanwhile, she reported that the macular hole primary closure rate was 93.1 per cent (41 out of 44 eyes). Of the three eyes that did not attain primary closure after the first surgery, two of them were large holes; >600 microns.
NO COMPLICATIONS The vast majority (88 per cent) of patients experienced no complications and recovered well, she said. The most common complication was iatrogenic retinal breaks, in eight eyes (10.67 per cent). One patient was treated for a retinal detachment 10 months post surgery, but had been classed as an at-risk patient, she noted. Dr Connolly said the Irish study results were very positive and in line with similar international studies. The Irish study now hopes to collaborate with the Amsterdam Medical Centre to increase the study numbers in order to publish the results. Sinead Connolly: connolsi@tcd.ie
Geographic Atrophy:
THE NEXT FRONTIER IN AMD 15th EURETINA Congress Calliope room, Acropolis, Nice, France 13:00–14:00, Friday 18 September 2015 Please join our experts in their discussion of the evolving field of geographic atrophy and its impact on clinical practice Chaired by Jean-François Korobelnik
Welcome and introduction Jean-François Korobelnik
Geographic atrophy: Leading with the science Frank Holz
Geographic atrophy: From the science to the clinic Neil Bressler
Geographic atrophy: What now for patients? Eric Souied
Q&A
Job code: NP/LAMP/1506/0024k Date of preparation: July 2015
15th ESASO Retina Academy 2015 22 – 24 October 2015, Palau de Congressos, Barcelona /Spain The 15th ESASO Retina Academy, is a first-rate forum on diagnosis and treatment of retinal diseases. Internationally renowned specialists and their colleagues from all continents will share and discuss the latest scientific insights and technical advances in the field of ophthalmology. Our scientific highlights 2015 are a Live Surgery session at the Instituto de Microcirugía Ocular (IMO) with direct transmission to the Palau de Congressos on 22 October, and ESASO style roundtable discussions. Scientific highlights
Scientific Committee
Session formats including prestigious Lectio Magistralis key note lectures, plenary talks and expert debates, ESASOspecific style debates and roundtable discussions, MasterClasses, and poster presentations by participants. • Retinal detachment • VMA/VMT/MH • AMD • DME • RVO • PM • Retinal non-perfusion • Geographic Atrophy • Central Serous Chorioretinopathy • Uveitis • Tumours • Dystrophy • Rehabilitation • Artificial Vision • and other topics of Retina and General Topics. • 2 hours of ESASO Live Surgeries presented by Instituto de Microcirugía Ocular (IMO)
Chair: Francesco Bandello, Italy
CME Accreditation ESASO has applied for international EACCME credits with UEMS and is contacting the Spanish body to provide national CME credits
Registration and fees Special rate for Spanish delegates € 500
Online registration
Co-Chairs: Neil Bressler, USA Borja Corcóstegui, Spain José María Ruiz-Moreno, Spain José García-Arumí, Spain Coordinators: Bruno Falcomatà, Italy Maurizio Battaglia Parodi, Italy
Faculty James Bainbridge, UK; Francesco Bandello, Italy Maurizio Battaglia Parodi, Italy; Camiel Boon, Netherlands Rupert Bourne, UK; Neil Bressler, USA Susan Bressler, USA; Anniken Burés, Spain Itay Chowers, Israel; Borja Corcóstegui, Spain José Cunha-Vaz, Portugal; Fabiana D‘Esposito, Italy Claus Eckardt, Germany; Theo Empeslides, UK Bruno Falcomatà, Italy; Thomas Friberg, USA José García-Arumí, Spain; Alain Gaudric, France Michaella Goldstein, Israel Giuseppe Guarnaccia, Switzerland Yan Guex-Crosier, Switzerland; Pearse Keane, UK Adrian Koh, Singapore; Paolo Lanzetta, Italy Phuc Lehoang, France; Anat Loewenstein, Israel Carlos Mateo, Spain; Jordi Monés, Spain Rafael Navarro, Spain; José María Ruiz-Moreno, Spain Ann Schalenbourg, Switzerland Ursula Schmidt-Erfurth, Austria Sobha Sivaprasad, UK; Gianni Virgili, Italy Leonidas Zografos, Switzerland
www.jointogethergroup.com/meetingpoint/ESASO2015/
For further information Contact the congress secretariat at congress@esaso.org
www.esaso.org
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ZINC-GENETICS INTERACTION Data suggest higher dietary zinc intake benefits those at high risk. Cheryl Guttman Krader reports
I
ncreasing dietary zinc intake appears to decrease the risk of late stage age-related macular degeneration (AMD), but only among persons with a high genetic risk, according to analyses of data from Europeanderived population-based cohorts. The research was presented by Paul R Healey MD, PhD at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. The effect of genetic risk on the relationship between dietary zinc intake and incident late stage AMD was investigated using data from the Blue Mountains Eye Study and the Rotterdam Study. The pooled population included 5,246 subjects who were categorised into four genotype groups based on numbers (0, 1, 2) of Compliment Factor H (C) and Age-Related Maculopathy Susceptibility 2 (A) risk alleles: Group 1 (C01, A0), Group 2 (C2, A0), Group 3 (C01, A12), Group 4 (C2, A12). Genotype distribution was similar in the two populations, with the highest frequencies (53 per cent to 55 per cent) in Group 1, the lowest AMD risk group, and only about a five per cent frequency in Group 4, the highest risk group. The 15-year cumulative incidence of late stage AMD was five per cent in the overall population, 2.7 per cent in Group 1, 8.2 per cent in Group 2, 6.2 per cent in Group 3, and 19.7 per cent in Group 4. In a regression analysis adjusting for age, smoking and zinc intake, the risk of developing AMD was nearly 12-fold higher in Group 4 than in Group 1.
DIETARY INTAKE When each genotype group was divided into quartiles based on daily dietary zinc intake, a relationship between dietary zinc intake and late stage AMD risk was seen only in Group 4, and it showed a reasonably strong dose-response effect. Compared with persons having the lowest interquartile zinc intake (7.5mg/day), those with the highest intake (15.3mg/day) had a very substantial 80 per cent lower risk of developing late stage AMD, reported Dr Healey, Clinical Associate Professor of Ophthalmology, University of Sydney, Australia. “Further study is needed to determine whether we should be encouraging people to change their diet to increase their zinc intake. While we found there was no harm associated with higher zinc intake in Paul R Healey terms of mortality or AMD risk, a very small risk that may not be evident in smaller studies may be amplified in a large population,” he said. Dr Healey also pointed out that the genotype distribution in the two population-based studies differs substantially from what was seen in AREDS. “The majority of cases of late stage AMD occur in the low risk genotypes, and that is important when thinking about genetic screening or specific treatment,” he said. Paul R Healey: phealey@glaucoma.net.au
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RETINA
CAROTENOIDS IN ALZHEIMER’S Patients are deficient in macular pigment, supplementation could help. Roibeard O’hEineachain reports
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upplementation with macular pigment carotenoids can restore pigment to the macula and bring about a significant improvement in the contrast sensitivity of Alzheimer’s disease patients, a recent study suggests. “What we found in our interventional supplement trial was that we were able to rebuild the pigment in these patients, and the implication of that in a six-month period is that we were able to improve patients' vision,” lead investigator John Nolan PhD, Macular Pigment Research Group, Vision Research Centre, Waterford Institute of Technology, Ireland, told EuroTimes in an interview. The randomised, double-blind trial involved 31 Alzheimer's disease patients and 31 age-controlled patients of a similar age who received six months of supplementation with either Macushield, consisting of 10.0mg meso-zeaxanthin, 10.0mg lutein and 2.0mg zeaxanthin, or sunflower oil as a placebo. At the end of the trial, both the Alzheimer’s disease and control patients receiving the supplement had significant increases in serum concentration of the three supplemented carotenoids, significant increases in central macular pigment, and significant improvements in contrast sensitivity. (Nolan et al, Journal of Alzheimer’s Disease 44 (2015) 1157–1169)
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SIGNIFICANT RESULTS Specifically regarding the improvements in contrast sensitivity, among those receiving the active supplement, paired sample t-tests from five spatial frequencies tested showed significant results for four spatial frequencies in the Alzheimer’s disease group, and for two spatial frequencies in the control group. The improvement in the Alzheimer’s disease patients was equivalent to a gain of one line on the Pelli-Robson chart. Dr Nolan noted that the rationale of the trial was the findings of a previous study he and his associates conducted. It showed that in 36 patients with moderate Alzheimer’s disease the central macular pigment and macular pigment volume were significantly lower than in 33 control patients (p<0.001 for both). The Alzheimer’s disease patients also John Nolan had lower best corrected visual acuity (BCVA), contrast sensitivity, and lower serum concentrations lutein and zeaxanthin than the control patients (p<0.05, for all). (Nolan et al, Journal of Alzheimer’s Disease 42 (2014) 1191–1202) The findings of the two studies add to a growing body of evidence suggesting that deficiency of macular pigment carotenoids in the central nervous systems may play a role in the cognitive decline of Alzheimer’s disease patients, Dr Nolan said. However, neither of the groups receiving the active supplement had any cognitive improvements, suggesting that the carotenoids may have a protective rather than a restorative effect regarding Alzheimer’s disease pathology, he added. New clinical trials are currently under way testing the impact of the supplements in patients with mild cognitive impairment.
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John Nolan: jmnolan@wit.ie EUROTIMES | SEPTEMBER 2015
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MANAGEMENT OF AMD Pilot trial finds combination therapy lowers injection burden. Cheryl Guttman Krader reports
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dexamethasone intravitreal implant (Ozurdex, Allergan, Inc.) may be a useful adjuvant for decreasing the treatment burden in patients with neovascular age-related macular degeneration (nAMD) persisting or recurring after initial anti-VEGF therapy. Speaking at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA, Sandra Rezar MD presented the results of a pilot study conducted by the Vienna Study Centre at the Medical University of Vienna, Austria. The study enrolled 40 consecutive patients presenting with subretinal and/or intraretinal fluid on optical coherence tomography (OCT) after receiving at least three monthly consecutive injections of ranibizumab (Lucentis, Genentech/Novartis). They were randomised to receive a dexamethasone implant in combination with ranibizumab or continue anti-VEGF monotherapy and followed monthly. Repeat Sandra Rezar treatment was based on OCT and visual acuity criteria, and a second dexamethasone implant was allowed no sooner than six months. During the 12-month study, both groups had stable mean visual acuity and macular sensitivity along with a significant reduction in central retinal thickness. There were no significant differences between groups at 12 months in any of those parameters. However, time to first retreatment was significantly delayed in the combination group compared with eyes continuing on monotherapy. The difference corresponded to higher rates of complete resolution of macular oedema with the combination therapy. “We know that persistent and recurrent choroidal neovascularisation is common in eyes with nAMD and that persistent exudation leads to reduced visual acuity outcomes,” said Dr Rezar. As nAMD is a multifactorial disease, monotherapy that focuses selectively on inhibiting angiogenesis may not be optimal. Combination therapy with a corticosteroid addresses the inflammatory component and may help limit VEGF upregulation, she explained. The mean duration of anti-VEGF treatment prior to enrolment was about 12 months in both groups. The mean number of anti-VEGF injections administered during that period was 5.6 in the eyes randomised to monotherapy and 6.7 in the combination group. Safety review showed that significant progression of lens opacity occurred in four eyes in the combination group and one eye treated with monotherapy. “This pilot study showed that combination therapy with dexamethasone and ranibizumab resulted in delay in retreatment while functional parameter could be maintained. Further investigation is needed in order to identify those patients showing greatest benefit from adding corticosteroids to anti-VEGF,” added Dr Rezar. Correspondence – Stefan Sacu: stefan.sacu@meduniwien.ac.at Sandra Rezar: sandra.rezar@meduniwien.ac.at
EUROTIMES | SEPTEMBER 2015
Alcon in Barcelona September 5-9, 2015
SAVE THE DATE FOR THESE SYMPOSIA DURING THE XXXIII ESCRS CONGRESS IN BARCELONA A Glaucoma Journey from New Medication to Surgery Friday, September 4, 2015 From 12:45 pm to 1:45 pm Fira Gran Via / Room 9 Moderated by Prof. Gandolfi
Novel Therapies for Improving Cataract Surgery Outcomes Sunday, September 6, 2015 From 1:00 pm to 2:00 pm Fira Gran Via / Room 11 Moderated by Prof. Kohnen
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Precision in Refractive & Cataract Surgery with New Innovative Solutions Monday, September 7, 2015 From 1:00 pm to 2:00 pm Fira Gran Via / Room 16 Moderated by Prof. Kohnen
These events are for healthcare professionals only. Please present your ESCRS congress badge for entry into these symposia. For Medical information about the Alcon products discussed in these programs, please visit the Alcon Booth #D13. © 2015 Novartis
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FUTURE AMD TREATMENT Pioneering leader in development of anti-angiogenic therapy now looking beyond VEGF. Cheryl Guttman Krader reports
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nti-VEGF therapy is rightly regarded as a breakthrough in the management of age-related macular degeneration (AMD), and investigation in this area is continuing. Still, there is room for improvement. Researchers are now focusing on understanding the mechanisms of AMD pathogenesis and retinal cell death and applying that knowledge to develop new therapies that could have a greater benefit for reducing disease-related vision loss. Delivering the Weisenfeld Award Lecture at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA, Joan W Miller MD discussed why it is necessary to look beyond VEGF and offered her perspectives about the directions where future treatment should be headed. “With anti-VEGF therapy, more than 90 per cent of patients avoid moderate vision loss and one-third achieve 20/40 or better vision. However, data from longer-term studies show that one-fourth to one-third of patients end up with 20/200 or worse vision. When we look anatomically with imaging, we see macular atrophy in up to 98 per cent of eyes,” said Dr Miller, Chief of Ophthalmology, Mass Eye and Ear and Mass General Hospital, Henry Willard Williams Professor of Ophthalmology and Chair, Department of Ophthalmology, Harvard Medical School, Boston, USA.
ATROPHIC CHANGES Postulating that control of neovascularisation with anti-VEGF therapy unveils a degenerative process and hence EUROTIMES | SEPTEMBER 2015
Courtesy of Alexander Coster Scott
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Illustration showing age-related changes in the development of AMD: lipid and lipoprotein metabolism and transport, inflammation and immunity, extracellular matrix and cell adhesion, angiogenesis, and cellular stress and toxicity leading to cell death
atrophic changes, Dr Miller proposed intervening with neuroprotection. “Neuroprotection may provide a broadbased treatment approach to a variety of retinal diseases, including AMD, and it could be conceived of as an adjuvant treatment with anti-VEGF therapy. However, it might also be initiated sooner, to treat early and intermediate AMD,” said Dr Miller. In the interest of developing neuroprotective treatments for AMD, Dr Miller and colleagues undertook studies to identify the pathways leading to photoreceptor and retinal pigment epithelium (RPE) cell death. Their findings
suggest that a strategy targeting inhibition of both caspase to prevent apoptosis and receptor interacting protein kinase to prevent necrosis may be effective. Dr Miller reviewed research from various animal models showing that photoreceptor cell death was mediated primarily by apoptosis and RPE cell death primarily by necrosis. However, when the primary pathway was blocked, photoreceptors died by necrosis and apoptosis took over as a compensatory mechanism leading to RPE cell death. Dual inhibition of apoptosis and necrosis supported survival of both cell types.
Even if introduced early, neuroprotection does not address the underlying cause of AMD. Therefore, early treatment would ideally interfere with a key pathway in AMD pathogenesis to limit disease development and progression. “It is worth remembering that our success in treating neovascular AMD is based on a treatment targeted to a key pathway. Development of targeted therapies for early AMD will require better understanding of AMD pathogenesis,” Dr Miller said. Dr Miller cited six pathways for the development of AMD: ageing, lipid and lipoprotein metabolism and transport, inflammation and immunity, extracellular matrix and cell adhesion, angiogenesis, and cellular stress and toxicity leading to cell death. Noting that neuroprotection would address the last pathway, she proposed the development of future biologically-based treatments should focus on lipids and inflammation. She explained that inflammation is an attractive target because it seems to have an early central role in the development of AMD, but also in progression to the intermediate and advanced stages. “Targeting inflammation, the complement pathway, and inflammasomes seems to be a worthy area of therapeutic development. There are many clinical trials under way in this space, and so we will be learning if it is effective,” said Dr Miller.
Courtesy of © Association for Research in Vision and Ophthalmology 2015
RETINA
Dr Miller receiving the Weisenfeld Award from outgoing ARVO president Dr William Mieler
A treatment that targets lipids has been explored in the form of studies looking at oral statins, which also affect inflammation. Research investigating the effects of statins on AMD has generated mixed results, which Dr Miller said may be explained by disease heterogeneity, variability in the drugs and doses studied, and the widespread use of statins in the population.
DRUSEN REGRESSION However, she mentioned encouraging findings that were achieved in a pilot study investigating high-dose atorvastatin, which was initiated by Dr Miller’s colleague Demetrios Vavvas MD, PhD. The study was undertaken based on
earlier positive experience in a single patient. It enrolled 26 patients aged more than 50 years who had soft confluent drusen, no to minimal geographic atrophy, and no neovascular disease. Among 23 patients who completed follow-up of at least 12 months, drusen regression was observed in 10, and it was nearly complete in eight patients. Among the 10 responders, visual acuity improved by an average of three letters. Importantly, the changes occurred without any development of atrophy or neovascularisation. “When we have seen drusen regression previously, it has been accompanied by atrophy and vision loss. While this is a pilot study, high-dose atorvastatin is tantalising, and I hope it can be pursued.” Recognising that the heterogeneity of AMD creates challenges to developing effective treatments for early and intermediate disease, Dr Miller also proposed that future progress in therapy will benefit from improvements in phenotyping and classification. “We need to use our findings from imaging and dark adaptation and perhaps combine that with metabolomics and genotyping in order to tease out subgroups within this heterogeneous patient population,” she added. Joan W Miller: joan_miller@meei.harvard.edu
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EUROTIMES | SEPTEMBER 2015
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RETINA
AIDS AND AMD STUDY
Holland DALK SCISSORS
Research finds AIDS patients have higher prevalence of disease.
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ompared with their uninfected, similarly aged counterparts, persons with HIV infection have higher rates of various agerelated diseases, including cardiovascular disease, osteoporosis, diabetes and neurocognitive decline. Now, intermediate-stage age-related macular degeneration (AMD) can be added to the list, according to an analysis of baseline data collected in the Longitudinal Study of the Ocular Complications of AIDS (LSOCA). The research was recently published (Jabs DA et al. Am J Ophthalmol. 2015;159:1115-1122) and was presented by Douglas A Jabs MD, MBA at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. The analysis included data from 1,825 patients with AIDS who had no ocular opportunistic infection(s). The participants ranged in age from 13 to 73 years with a mean age of 43.4 years. Overall, 9.9 per cent of the participants were identified as having intermediate-stage AMD as determined by grading of baseline wide-field retinal photographs performed at the University of Wisconsin-Madison reading centre. Multiple regression analysis found age was a strong risk factor for intermediate-stage AMD, with the risk increasing nearly twofold for every decade of age, and the prevalence rate reaching 16.8 per cent and 24.3 per cent in subgroups aged 50-59 and ≥60 years, respectively.
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Published data from the Beaver Dam Offspring Study was used for comparing the prevalence rate of intermediate-stage AMD in the LSOCA population to a non-HIV infected cohort, since retinal photographs in the two studies were graded at the same institution with similar methods. The results showed the AIDS patients had a four-fold higher age-adjusted prevalence of intermediate-stage AMD. “Although the underlying mechanism leading to this increase in intermediate-stage AMD in persons with AIDS is not yet known, it may relate to the state of chronic immune activation and systemic inflammation seen in these patients,” said Dr Jabs, Professor of Ophthalmology and Medicine, Icahn School of Medicine at Mount Sinai, New York, USA. Consistent with that idea, the multiple regression analysis also found that AIDS patients who acquired HIV infection through injection drug use had a significantly increased risk of having intermediate-stage AMD compared with their counterparts acquiring disease by male-to-male sexual contact. The investigators noted that injection drug use itself is associated with immune activation and inflammation. Accelerated immunosenescence, which also occurs in the setting of HIV disease, might also be contributing to the development of intermediate-stage AMD in AIDS patients. Dr Jabs and colleagues note that HIV-infected persons have immunologic changes similar to those seen in HIV-uninfected persons over 70 years of age. Douglas A Jabs: douglas.jabs@mssm.edu
EUROTIMES | SEPTEMBER 2015
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RETINAL HAEMORRHAGE Analyses detect no safety signals with antiplatelet/anticoagulant drugs. Cheryl Guttman Krader reports
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ntiplatelet or anticoagulant drug therapy does not appear to be related to the presence or size of retinal haemorrhage in patients with neovascular age-related macular degeneration (nAMD), new analyses of data collected in the Comparisons of AMD Treatment Trials (CATT) suggest. Speaking on behalf of the CATT Research Group, GuiShuang Ying PhD told a session of the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA, that patients with nAMD should continue taking antiplatelet/anticoagulant drugs as indicated for systemic medical conditions. “Antiplatelet and anticoagulant drugs are commonly used in older persons to manage cardiovascular disease, and their use is associated with an increased risk of bleeding. Several studies have evaluated the association between antiplatelet/ anticoagulant drugs and ocular haemorrhage, but their results are conflicting and inconclusive,” said Dr Ying, Associate Professor of Ophthalmology, and Senior Biostatistician, Centre for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, USA.
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LARGEST STUDY Now, with data analysed for 1,165 patients, CATT is the largest study to evaluate the association of antiplatelet/anticoagulant drug use with retinal haemorrhage. Patients who were eligible for CATT had untreated, active nAMD on optical coherence tomography (OCT), leakage on fluorescein angiography, and no vitreous haemorrhage or diabetic retinopathy that might require intervention during two years of follow-up. Retinal haemorrhage associated with the choroidal neovascular (CNV) lesion was identified in the participants’ study eye by masked, certified readers using standardised grading of colour fundus photographs taken at baseline and after one and two years. Retinal haemorrhage included intraretinal, subretinal or sub-RPE bleeding, and was graded both for presence and size using four categories (none, ≤1, 1−2, and >2 disc areas). At baseline, 608 patients (52 per cent) were using antiplatelet and/or anticoagulant drugs, and 724 patients (62 per cent) had a retinal haemorrhage. Rates of retinal haemorrhage were not significantly different among users of antiplatelet/anticoagulant drugs and non-users (64.5 per cent vs 59.6 per cent, p=0.09) or when comparisons were made between users and non-users considering only anticoagulants, only antiplatelets, or specific drugs. In a logistic regression analysis adjusting for age, gender, smoking status, diabetes, cardiovascular disease and CNV bilaterality, there was no association between antiplatelet/ anticoagulant drug use and retinal haemorrhage (odds ratio = 1.18, p=0.21). Medication dose or duration of use also did not matter – there were no associations between antiplatelet/anticoagulant drug use and retinal haemorrhage even among patients who took higher doses or had more than 10 years of use.
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Gui-Shuang Ying: gsying@mail.med.upenn.edu EUROTIMES | SEPTEMBER 2015
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RETINA
PDT USEFUL FOR CSC Eyes with CSC show an excellent response to half-fluence PDT on OCT imaging. Priscilla Lynch reports
H
alf-fluence verteporfin photodynamic therapy (PDT) is a useful treatment option for the treatment of central serous chorioretinopathy (CSC), the 2015 Irish College of Ophthalmologists annual conference in Westport, Ireland heard. Christine Goodchild MD, University Hospital Galway, Ireland, reported positive results on optical coherence tomography (OCT) imaging following the procedure from a small-scale Irish study. She explained that CSC is characterised by neurosensory detachment and choriocapillaris leakage through the retinal pigment epithelium (RPE). While it usually resolves spontaneously, some patients experience persistent or recurrent leakage, so treatment is considered, usually after three months of acute CSC, she said. “What you find with CSC is that these eyes have a very characteristic appearance in OCT and fundus fluorescein angiography (FFA) – you get this neurosensory retinal detachment on OCT and this smoke stack appearance, ink blot, or diffuse leakage on FFA,” said Dr Goodchild. Dr Goodchild and colleagues carried out a study to determine the outcomes of patients who underwent half-fluence PDT treatment for CSC in University Hospital Galway over a four-year period. Eleven patients (11 eyes) with chronic (unresponsive to other treatment) or Christine Goodchild persistent CSC after three months were involved in the study. The patients, with a mean age of 57 years, underwent a visual acuity check, a dilated fundal examination, OCT and FFA assessment at baseline, three months and six months follow-up. Investigators set out to determine if intraretinal and subretinal fluid resolved in the majority of cases, and if visual acuity was maintained, following half-fluence PDT treatment. Patients were treated with half-fluence verteporfin PDT. Intravenous verteporfin was given at a dose of 3mg/m2 over 10 minutes and the delivered laser energy was half of the standard dose (half-fluence PDT), ie 25mj/cm2 over 83 seconds. The study outcome measures were best corrected visual acuity (BCVA), subretinal fluid thickness and central macular thickness. The baseline mean BCVA was LogMAR 0.4+/-0.21 (range 0.1-0.8) and at three months post-treatment was LogMAR 0.31+/-0.26 (range 0.1-1.7). Mean pre-PDT subretinal fluid thickness was 114+/-57µm, and post-PDT the mean was 41+/-57µm. Final visual acuity improved in seven cases, stabilised in two cases, and worsened in two cases. There was one post-PDT choroidal neovascular membrane (CNVM), a rare complication. In all cases there was either resolution or improvement in subretinal fluid thickness. Dr Goodchild concluded that the study results were encouraging and, including the postPDT CNVM, were in line with the published results to date internationally of using of half-fluence PDT for the treatment of active CSC.
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Christine Goodchild: christine_siew88@yahoo.com EUROTIMES | SEPTEMBER 2015
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CLINICAL
TRIALS FUNCTIONAL
ANATOMIC
TRIAL ENDPOINTS Established retinal endpoints used in clinical trials can be split into the functional and anatomic. Gearoid Tuohy reports
T
he US FDA classifies clinical trial endpoints as “results, conditions or events associated with individual study patients that are used to assess study treatments”. However, clinical trial endpoints must primarily support the intended hypothesis of the trial and therefore the features of a disease and how it might be altered with particular treatments need to be addressed for a drug to get approved, said Prof Aniz Girach, Chief Medical Officer at NightstaRx, and Honorary Professor of Ophthalmology at Wills Eye Hospital, Philadelphia, USA, in his lecture to delegates at the 5th EURETINA Winter Meeting at Merton College Oxford, UK. In short, a drug seeking regulatory approval should ideally improve either survival, or improve patients’ functional outcomes or prevent a disease from progressing, and therefore a clinical trial endpoint must serve one or more of these purposes for the endpoint to be ultimately usable and validated from a regulatory point of view. In terms of retinal disease endpoints, Prof Girach explained that such measurements need to be clinically relevant, “true or hard endpoints”, and in the ophthalmic world visual acuity (VA) is probably the most common measurement in regular use today.
Prof Girach explained that endpoints differ depending on the phase of the trial. For example, in phase 1, safety and tolerability evaluations are the main objective and much effort is focused on these measures, consequently there are few if any efficacy endpoints. While an efficacy signal is always welcomed in phase 1 studies, such early stage assessments are rarely powered for such detection. As treatments move into phase 2, a better picture of efficacy begins to build and more elaborate endpoints are included, both primary and secondary, running parallel to the background of safety and tolerability. Finally, as a drug progresses into phase 3 the focus shifts to efficacy, as ultimately this is what drives the indication for which approval is received. The secondary endpoints will provide additional data that may also end up on the labelling, however it is the primary endpoint that is key and fundamental in the phase 3 stage. As such, significant time and effort is generally invested in designing, validating and negotiating such endpoints with the regulatory agencies. Established retinal endpoints used in clinical trials can be split into the functional and anatomic endpoints, with VA as the functional endpoint that is used most frequently. “Any element of visual function testing is accepted by the regulators as an established endpoint, as long as you can show a statistical
Any element of visual function testing is accepted by the regulators as an established endpoint... Prof Aniz Girach EUROTIMES | SEPTEMBER 2015
and clinical relevance in that parameter of visual function at more than one time point,” according to Prof Girach. Although VA is one of the key parameters, there are different ways to measure VA. Some trials use mean VA – detecting a mean VA difference from baseline on ETDRS scores between treatment and control groups, and the mean difference between the groups is the critical measure that the regulators look for. Anything beyond a mean difference of five or more letters is generally accepted as being clinically significant. Categorical analysis for VA is also a common measurement, so for example, “two or three line gain/loss in VA on the ETDRS Chart” has been accepted in a number of publications to provide a clinically meaningful change and the regulators are becoming increasingly attuned to such a VA measurement. In terms of anatomic retinal endpoints, the progression of non-proliferative diabetic retinopathy via a three-step or more progression on the ETDRS retinopathy grading scale has now being established for some time. Usually the duration of such diabetesrelated trials must be three years, primarily due to the DCCT data (Diabetes Control and Complications Trial) which showed that glycaemic control influences the switch over occurring at the 18-month stage of outcomes in terms of retinopathy progression. However, more recently the FDA has become more flexible in allowing shorter duration trials that look at the same endpoints, provided that one can show that the glycaemic control has not been altered. The most recent example of anatomic endpoint approvals in the retinal field was with Jetrea (ocriplasmin), which was achieved by a team led by Prof Girach himself. Aniz Girach: a.girach@nightstarx.com
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MACULAR HOLE STUDY Researchers use insurance claims database as a rich resource for elucidating risk factors and clues to pathophysiology. Cheryl Guttman Krader reports
T
he largest population-based study ever conducted to investigate the epidemiology of macular holes has identified risk factors that relate to age, gender, race and phakic status, reported Ferhina S Ali MD, MPH at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. Dr Ali, in collaboration with Jay Stewart MD of the University of California, San Francisco and Joshua Stein MD, MS of the University of Michigan, will follow up these findings with further analyses that may improve understanding of macular hole pathophysiology and prevention. The retrospective longitudinal cohort analysis drew on insurance claims data from a large United States-managed care network for the years 2001 through to 2011. It identified nearly 2.5 million patients who met the inclusion/exclusion criteria. Eligible patients were at least 40 years old and had at least one visit to an eye provider while being enrolled in the plan for at least three years. Patients with diabetes, uveitis or prior diagnosis or vitrectomy were excluded. During a mean follow-up of 2.6 years, 1,130 (0.05 per cent) patients developed a macular hole that required vitrectomy within 90 days of diagnosis. Multivariable analysis adjusting for sociodemographic factors and ocular and systemic comorbidities identified a 50 per cent increased risk of macular holes among women compared to men. In an age and gender interaction model, the risk of macular holes increased four per cent with each year of age among men, whereas among women it increased 53 per cent. Asians had a 50 per cent increased risk of developing a macular hole compared with non-Hispanic whites, and individuals who were pseudophakic or aphakic had a two-fold higher risk than their phakic counterparts. The risk associated with a history of ocular trauma approached, but did not reach, statistical significance. “We know that vitreomacular adhesion and vitreomacular traction (VMT) play a role in macular hole development. Now, as we move toward pharmacotherapeutics for VMT, it is important that we revisit our understanding of macular hole incidence and risk factors,” said Dr Ferhina S Ali MD, MPH
..it is important that we revisit our understanding of macular hole incidence and risk factors
Ali, resident, Department of Ophthalmology, University of California, San Francisco, USA. “Previous epidemiologic data in this area, from single institution and single region studies, have revealed our current understanding of macular hole incidence and risk factors. Our data, from a diverse group of patients throughout the United States, are consistent with earlier findings on macular hole incidence, and in showing a significantly increased risk of macular hole in women compared with men, and particularly among women in their perimenopausal years,” she added. Commenting on the study methods, Dr Ali noted that the managed care network database used in the study afforded a large sample - it encompassed nearly 16 million patients who received any form of eye care - and it allows longitudinal follow-up. “Our colleagues have previously validated use of these claims data to accurately estimate incident cases of other ocular pathologies, including nonexudative age-related macular degeneration and nonproliferative diabetic retinopathy,” she said. “The consistency of our findings on macular holes with those of smaller studies lends reliability to use of these claims data for future investigation of questions relating to macular holes and to look for exposures that might modify risk.”
FUTURE DIRECTIONS Dr Ali stated that previous studies attempting to understand the underlying aetiology for the increased incidence of macular holes in perimenopausal women have focused on a role of oestrogens, and how oestrogen might affect vitreoretinal dynamics. “Now our group is planning to use the information from the managed care network database to investigate whether exposure to hormone replacement therapy may modify the risk of macular holes in older women,” she said. Dr Ali acknowledged the potential for misclassification and miscoding of claims data, but she noted the requirement for macular holes to be linked to vitrectomy attempted to mitigate such errors. “The vitrectomy criterion also narrows our cases of macular holes to those that were more likely to be visually significant,” she said. Dr Ali also pointed out that, despite the strengths of the study’s population, its findings cannot necessarily be generalised to persons outside the health system examined or to the uninsured. In addition, she observed that refractive error data could not be extracted, which would have been of interest to see if it might explain the increased risk noted among Asians. Ferhina S Ali: alif@vision.ucsf.edu
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OCULAR
ACQUIRED BRAIN INJURY
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There are a number of “basic” visual treatment options. Priscilla Lynch reports
I
nformed consent, full consideration of temporary and non-invasive treatments as well as a ‘wait and see’ approach are key components of the optimal treatment of ocular issues caused by acquired brain injuries, according to Ian Marsh MD, Consultant Ophthalmic Surgeon, Aintree University Hospital NHS Foundation Trust, UK, who spoke at the 2015 Irish College of Ophthalmologists annual conference in Westport, Ireland. Common acquired brain injury ocular issues include diplopia, nerve palsies, as well as acuity and visual field loss, he said, adding that occult perforation or retinal detachment may occur in some traumatic injuries. However, penetrating ocular injuries are not as common now from road traffic accidents due to the use of seatbelts and shatter-proof windscreens, he explained. Dr Marsh recommended a multidisciplinary approach to assessing acquired brain injury patients, with a full assessment of visual apparatus as well as determination of the patient’s mental capacity. “Because the discussion you are going to be having about any type of intervention you are going to do is going to be at a very complex level, and if they don’t have the mental capacity to take that in, that can be very difficult for you,” he said. There are a number of “basic” visual treatment options, some short-term or reversible for acquired brain injury patients, as some ocular problems will recover in time or will need surgery later on, Dr Marsh explained. Basic treatment includes prisms, and occlusion using contacts, intraocular lenses (IOLs) and patches. However, he cautioned against using IOLs for occlusion in diabetic patients because of the need to be able to monitor the retina.
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REALISTIC EXPECTATIONS Botox injections also have significant therapeutic and diagnostic uses in these patients, Dr Marsh told the conference, particularly in the treatment of the various nerve palsies, and in pre-surgical simulation and postoperative diplopia testing. “For example, in a patient with third nerve palsy who asks for an operation, using Botox you can simulate surgically what you are going to do and say: ‘that is what you are likely to have after I have done any intervention, do you want it or not?’, which also helps with informed consent,” he commented. In sixth nerve palsy, spontaneous recovery is quite common. “In diabetics for example, about 80 per cent of them will recover spontaneously without any intervention,” Dr Marsh added. Dr Marsh stressed the need for realistic expectations about surgical outcomes, in both doctors themselves and patients, and for informed consent. Specifically, he said patients with an ocular paresis do better than those with actual palsies.
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Ian Marsh: Ian.marsh2001@gmail.com EUROTIMES | SEPTEMBER 2015
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TRAVEL
ATHENS
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TO NOTE...
ATHENS
FEBRUARY TEMPERATURE: AVERAGES 7/13°C TIME: GMT +3 AIRPORT TO CITY: flat fare of €35 (€50 after midnight) ERMOU STREET
Take a stroll down Ermou Street, the one and a half kilometre avenue that starts at Syntagma Square. It’s said to be the 10th most expensive retail street in the world (but the sales are on in February). In about 15 minutes you reach the Byzantine Church of Panaghia Kapnikarea, an 11th Century structure. The oldest Greek Orthodox church in Athens, it was built over an earlier temple. Go inside to enjoy the magnificent mosaics and the very special atmosphere. Kapnikarea Church is open from 8.00-13.00 on Monday, Wednesday and Saturday; 8.00-13.00 plus 16.00-20.00 on Tuesday, Thursday and Friday; 8.00-11.30 Sunday. To visit the church without the walk, take the metro to Monastiraki station.
ARTS FOUNDATION The Arts Foundation (TAF) is a five-minute walk away from the Monastiraki metro station. Go west on Ermou and turn left on the first side street (Normanou). The graffiti-framed doorway is a few meters in, to your left. It is hard to spot but worth the effort – you’ll be surprised by the lively interior spaces built around an open-roofed atrium. TAF is popular with young Athenians who come for cultural programmes, modern art exhibitions, lectures and theatre productions. The bar serves reasonably priced drinks, wine and sandwiches. TAF is open to all, every day; visit: http://theartfoundation.metamatic.gr
FLEA MARKET The Monastiraki Flea Market is just outside the Monastiraki metro station. Open every day of the week, it is at its best on Sundays when local merchants join the permanent stall holders – clothing shops, antiques, used books, vintage record stores, restaurants and cafes. Crowded with tourists, it naturally appeals to pickpockets too, so be careful. If this is too much of a hassle continue into Psiri and look for the shop of Stavros Melissonos, the Poet Sandal-maker at No 2 Ag Theklas Street. Here you can either buy a pair of sandals (as did Jackie Onassis and the Beatles) or an autographed copy of his book on the joys of drinking wine.
EUROTIMES | SEPTEMBER 2015
Byzantine Church
TAKE TIME IN ATHENS
Delegates to the 20th ESCRS Winter Meeting can get a feel for this exciting city. Maryalicia Post reports SIGHTSEEING
DINING
The iconic Parthenon crowns the Acropolis and draws the eye from vantage points all over Athens. Floodlit, moonlit or dazzling in the sun, it is the image of the city you take away with you. The Acropolis museum opened in 2009 in Makrygianni, just a 400-metre walk from the Parthenon (the museum is also reached easily from the Acropolis Metro stop). A handsome building in itself, its exhibits enhance the understanding of the Parthenon and its history. Purchase tickets online from the museum website: www.theacropolismuseum.gr/en For a complete contrast to the bustle of Athens, lose yourself on the northeastern slope of the Acropolis; the nameless lanes of Anafiotika are lined with tiny vine-draped houses built in the 1800s. Part of the historic neighbourhood of Plaka, they were once the homes of workers from the island of Anafi, who were employed in the refurbishment of King Otto’s palace. The feel of a Greek Island community remains to this day.
For two-star Michelin dining in Athens, choose between Spondi, serving French food in a picturesque Hellenic setting, and Funky Gourmet for Greek cuisine ‘molecular gastronomy’ style. Varoulko Seaside, a one- star Michelin restaurant in Pireaus, is a top recommendation for seafood (at the water’s edge on Mikrolimano Marina, a 15-minute taxi ride from central Athens). Reserve a table on their respective websites: funkygourmet.com; spondi.gr; varoulka.gr You can also combine a walking tour of downtown Athens with an introduction to popular Greek cuisine. The five-hour Culinary Backstreet tour departs from Monday to Saturday at 9.30am. In a group of two to six persons, you visit an oldfashioned dairy bar, sample loukoumades, souvlaki and kebabs, stop at seafood eateries and taste fine cheeses and honey. Book at: www.culinarybacktours.com
SHOPPING Byzantino is mentioned in nearly every guide book – and with good reason. Almost a museum with its brilliant selection of 22-carat gold jewellery, the shop is the life’s work of two brothers, Kostas and Georgio. Their first collection, in 1987, consisted of faithful replicas of ancient Hellenic jewels. Since then they have developed several other themes: Byzantine, Greek key and Modern. Their shop is in the Plaka at 120, Adrianou Street; visit: www.byzantino.com Plaka is full of souvenir shops. Take an evening stroll here and pick up some mati - these blue glass charms are said to ward off the evil eye.
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66
EUROPEAN BOARD OF OPHTHALMOLOGY
EBO EXAM EBO takes first steps to accredit ophthalmic subspecialties. Dermot McGrath reports
T
he European Board of Ophthalmology (EBO) and the European Glaucoma Society (EGS) are inviting ophthalmologists to sit the second EBO Glaucoma Subspecialty Exam in Paris in May 2016. Applications will open on the EBO and the EGS websites in November 2015. This year, for the first time, the EBO in collaboration with the EGS organised an EBO Glaucoma Subspecialty Exam which took place in Paris in May alongside the traditional EBO Diploma examination in general ophthalmology. Eleven candidates sat the examination, with successful candidates awarded the FEBOS-Glaucoma Diploma (Fellow of the EBO Subspecialty Glaucoma Diploma). “I think it has been a very successful debut, and the EGS is very satisfied about the process and the feedback,” said Prof Carlo Traverso, president of the EGS. The initial inspiration for the subspecialty examination came from Prof Wagih Aclimandos, who was president of the EBO in 2011-2012. “It was one of my goals as president of the EBO to advance this project. It’s very gratifying to see it come to fruition thanks to the efforts of the EGS, and we hope that this will be the start of an ongoing process and other subspecialties will soon follow suit,” said Prof Aclimandos. Dr Gordana Sunaric Mégevand, president-elect of the EBO who also serves on the executive committee of the EGS, did an enormous amount of work to help move the project forward and make it a reality, said Prof Traverso. “When Dr Sunaric Mégevand brought the idea to our executive committee we were enthusiastic, because we thought it was a good idea for specialists to be aware of where they are in terms of their knowledge, and to set quality standards. There is a need to provide official recognition and validation of the level of knowledge attained by glaucoma specialists at a European level,” said Prof Traverso. In the academic culture of Europe subspecialty training in
ophthalmology has not developed as far as formally recognised qualifications, he said. “There are high-quality subspecialty programmes in some countries, but the practice differs from country to country and it is clearly desirable to have some benchmark of knowledge which is recognised everywhere and which will help to raise standards across Europe,” he added. The diploma is also a useful way to instil the concept of lifelong learning in ophthalmologists just starting out in their careers, said Prof Traverso. “It is very good for the younger generation of physicians to appreciate that this is not just a diploma to hang on the wall or a generic hope to enhance their job prospects, but a means to develop the mentality of self-assessment and peer review,” he said. As neither the EBO nor the EGS can interfere with national legislation and health structures, the diploma cannot be regarded as a method to obtain a better work position, but only demonstrates official proof of knowledge to a recognised standard.
CHALLENGING BUT FAIR A lot of work went into designing an examination that would be challenging but fair, said Prof Traverso. “We were very clear in explaining to the candidates what was expected from them, the baseline being an in-depth knowledge of the EGS guidelines, a widely-used practical reference for the diagnosis and management of glaucoma.” The vive voce oral part of the exam also gave candidates a real chance to show the true breadth of their knowledge, he said. “We try to test their knowledge and clinical judgement and in certain surgical cases we discuss techniques and strategies to deal with specific situations. We try to be fair even if their suggested approach is not necessarily the one that the examiners would have chosen. It is about the strategy they would adopt and have them make a clinically sound, evidence-based and reasoned argument,” said Prof Traverso. * See also: www.ebo-online.org/newsite/ home.asp; www.eugs.org
There are high-quality subspecialty programmes in some countries, but the practice differs from country to country... Prof Carlo Traverso EUROTIMES | SEPTEMBER 2015
EUEYE
EU-EYE IS LAUNCHED
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15 R1S0,‘Hall 7 C ES G Vis
Boo
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Multi-society alliance aims to increase vision research funding. Roibeard O’hEineachain reports
T
he European Alliance for Vision Research and Ophthalmology (EU-EYE), a nonprofit pan-European advocacy organisation with representatives from eight of Europe’s ophthalmology societies, is being officially launched at the XXXIII Congress of the ESCRS in Barcelona. Their main objectives are to raise political and public awareness of ophthalmology and to increase funding for vision research at EU level. “We decided to pool our efforts in order to increase visibility and performance and to focus on broader issues rather than on specific eye diseases, in order to complement the specific similar activities of some member groups like the EGS, ESCRS and EURETINA,” EU-EYE president Thierry Zeyen MD told EuroTimes in an interview. The participating societies are the Eye Complications Study Group of the European Association for the Study of Diabetes (EASDec), the European Eye Bank Association (EEBA), the European Glaucoma Society (EGS), the European Society of Retina Specialists (EURETINA), the European Paediatric Ophthalmological Society (EPOS), the European Society of Cataract and Refractive Surgeons (ESCRS), the European Society of Cornea and Ocular Surface Disease Specialists (EuCORNEA), and the European Association for Vision and Eye Research (EVER). The EU-EYE board includes one or two members from each society, appointed by their individual boards. The larger societies, such as the ESCRS and EURETINA, can appoint two members, but will still have only one vote. The EU-EYE executive committee consists of Thierry Zeyen from the EGS, as president; Einar Stefánsson from EURETINA, as vice-president; Jesper Hjortdal from the EEBA, as secretary; Peter Barry from the ESCRS, as treasurer; and Leopold Schmetterer from EVER. EU-EYE has appointed Agenda Communications in Dublin, Ireland to act as their secretariat, and appointed Burson-Marsteller to be their external advocacy advisor in Brussels. Prof Zeyen noted that EU-EYE has a number of short- and long-term goals. Their first goal is to try to increase funding and ensure representation of ophthalmology in the EU’s health-related policymaking decisions. “We would like to ensure representation of ophthalmology in advisory and decisionmaking EU panels, eg in the European Research Council. We also want to try to simplify funding application so that more researchers can access EU funding,” he said.
We decided to pool our efforts in order to increase visibility and performance and to focus on broader issues... Thierry Zeyen MD
Thierry Zeyen: thierry.zeyen@telenet.be
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EUROTIMES | SEPTEMBER 2015
67
INNOVATION
ADVANCED IMAGING Low-cost mobile alternative to the slit lamp brings benefits of greater convenience and broader utility. Cheryl Guttman Krader reports
A
compact, computational solid-state system being developed as a tool for examining and imaging the anterior segment offers many advantages and advanced capabilities compared to the ophthalmic slit lamp, according to Shantanu Sinha BS, who presented the technology at the 2015 annual meeting of the Association for Research in Vision and Ophthalmology in Denver, USA. “Our platform is a less expensive, low-complexity, portable system and can be operated by less skilled technicians. Its features make it attractive for use in settings where cost and access to medical care are issues, and to the best of our knowledge, it is the only portable system that can generate a complete 3D model of the anterior segment,” said Mr Sinha, speaking on behalf of his colleagues in the Camera Culture Group, MIT Media Lab, Massachusetts Institute of Technology, Cambridge, Massachusetts, USA. The system is comprised of a pico projector, which outputs a computationally generated slit of light, simplified optics that collimate and focus the slit onto the eye, and a 60fps RGB camera fitted with a beam splitter that images the anterior chamber in high definition. The examination is completed in less than five
Courtesy of MIT Media Lab
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Proof-of-concept prototype on optical breadboard being tested on a bovine eye
seconds, and the image is transferred to a computer, where it can be reviewed later by an ophthalmologist. The prototype device measures 120mm long x 60mm wide. Like a conventional slit lamp, it has an 80° field of view. However, because it is under computational control, the system can project any pattern of light on to the eye, generate a 3D model of the anterior segment, and provide quantitative metrics and topographical maps.
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Therefore, Mr Sinha and colleagues envision that the system has great utility for not only imaging external, corneal and anterior segment pathologies, but also for generating quantitative information to guide management. For example, it could measure the distance between the apex of a pterygium and the central visual axis and quantify irregular astigmatism associated with the lesion. By quantifying light scatter, it could grade cataract opacity. Topographic imaging capabilities would allow its use for identifying and characterising corneal ectatic disorders and facilitating complicated contact lens fittings. In addition, it is capable of measuring corneal thickness and posterior corneal surface radius of curvature at an infinite number of locations. The Camera Culture Group is collaborating with the LV Prasad Eye Institute, Hyderabad, India, to develop, validate, and eventually deploy this technology. They hope to initiate clinical trials with their prototype in 2015, and by mid-2016, to have a clinic-ready device suitable for seeking regulatory approvals.
Our platform is a less expensive, low-complexity, portable system and can be operated by less skilled technicians Shantanu Sinha BS
EUROTIMES | SEPTEMBER 2015
Shantanu Sinha: sssinha@mit.edu
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YEAR-ROUND EDUCATION Annual meetings, clinical reports, and the ASCRS MediaCenter (surgical videos, symposia, and paper sessions)
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Femto cataract clinical update Evolution of laser cataract surgery — P. 44 Femtosecond cataract laser upgrades — P. 46 Experiences around the world — P. 48 Forgoing the femto laser — P. 50 Embracing the technology — P. 52
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Vol. 41 No. 5 • May 2015
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Explanted, spontaneously dislocated IOL–capsular bag complexes (see page 929) pages 909–1128
Corneal changes with accommodation Prediction of refractive outcome with toric IOLs Pseudoexfoliation and in-the-bag IOL dislocation Wavefront analysis of aspheric and spherical IOLs Prediction of accommodative response using ultrasound biomicroscopy
Elsevier
Table of contents P. 4, 6 ELSEVIER ISSN 0886-3350
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The honey bee colony: A model for practice success
Two cases of TASS caused by an oily substance in the anterior chamber
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Tribute to Robert Sinskey, MD — P. 16 The latest on mydriatic agents — P. 26 Pearls for MIGS success — P. 42
At a certain point in an ophthalmologist’s career, he or she hopefully develops the feeling that the diagnostics aspect of clinical care is relatively secure – that with a good ophthalmic exam and the necessary imaging and laboratory examinations, a diagnosis can be reached. PUBLICATION But what about the treatment OPTHALMIC DIAGNOSIS & TREATMENT aspect? Have we all memorised AUTHOR each of the potential therapeutic DR MYRON YANOFF options for the rarer diseases? And in case the patient needs PUBLISHED BY JAYPEE to be referred to a subspecialist, have we performed a sufficiently complete exam, covering each of the investigative steps required for a particular condition, so as to simplify the referral and provide the best possible transfer of care? Ophthalmic Diagnosis & Treatment (Jaypee), by Dr Myron Yanoff, aims to provide this information within a single view. The left page covers the diagnostics, including a concise definition, signs, symptoms, suggested investigations with their respective expected results, differential diagnosis, and classification if relevant. The right page deals with the treatment, including pharmacological and nonpharmacological means, treatment aims, prognosis and follow-up. More complicated conditions are supplied with a bibliography of relevant literature for further study. Ophthalmic Diagnosis & Treatment is a purely clinical handbook, to be used during patient care for quick reference. A useful feature that I have never previously seen in such a handbook is the number classification from The International Classification of Diseases (ICD), which allows physicians to “organise their patients’ medical records and to facilitate the timely reimbursement of their services”. This book is appropriate for ophthalmologists at every stage of their career, from training to retirement.
Articles, books and presentations about femto-phaco techniques have been popping up like wildflowers over the past few years, and Dr Lucio Buratto and Dr Stephen F Brint have been responsible for many of these teaching modalities. For their latest work, Cataract Surgery with Phaco and Femtophaco Techniques (Slack Incorporated), they have teamed up with Dr Rosalia Sorce to provide an updated overview of femtosecond laser cataract surgery. The text is illustrated with detailed drawings and informative surgical photographs of a femtolaser procedure. Particularly interesting for those, like me, who have never performed a femtolaser procedure, are the descriptions of the initial steps of the surgery phase. For example, how are the nucleus fragments separated into four quadrants? Answer: A so-called “prechopper” is used. This book is most interesting for late-stage residents, phaco fellows, and ophthalmologists considering making the leap from traditional to femto surgery. LEIGH SPIELBERG Books Editor
If you have a book you would like to have reviewed please send it to: EuroTimes, Temple House, Temple Road, Blackrock, Co Dublin, Ireland
EUROTIMES | SEPTEMBER 2015
OPHTHALMOLOGICA
OPHTHALMOLOGICA VOL: 234 ISSUE: 1
EXPERT CONSENSUS ON RVO A Canadian expert consensus statement on the optimal treatment of retinal vein occlusion (RVO) summarises the discussions of 11 expert retinal specialists at a day-long meeting in 2014. Among their conclusions was that laser remains the therapy of choice for treating neovascularisation secondary to RVO. Adjunctive anti-VEGF may be considered in RVO cases with vitreous haemorrhage and for those with symptomatic visual loss associated with central macular oedema. Options for those poorly responsive to anti-VEGF treatment include grid laser, in those with branch RVO, and intravitreal steroids, in those with central RVO. A R Berger et al, “Optimal treatment of retinal vein occlusion: Canadian expert consensus”, Ophthalmologica 2015; Volume 234, Issue 1.
DEXAMTHASONE IMPLANT CAN REDUCE NEED FOR ANTI-VEGF TREATMENT A dexamethasone implant can reduce the need for adjunctive ranibizumab treatment and shows acceptable tolerability in patients with neovascular age-related macular degeneration (AMD), according to the findings of a multicentre randomised study. The 240 patients in the study received two intravitreal ranibizumab injections and either a dexamethasone implant (Ozurdex) or a sham procedure. The investigators found that, compared to the sham procedure, the dexamethasone implant increased the injection-free interval from 29 to 34 days, in the 50th percentile, and from 56 to 85 days, in the 75th percentile (p = 0.016). However, there were no significant differences between the groups in terms of visual acuity or retinal thickness. Conjunctival haemorrhage and intraocular pressure elevation were significantly more common among those with the dexamethasone implant. B D Kuppermann et al, “Dexamethasone Intravitreal Implant as Adjunctive Therapy to Ranibizumab in Neovascular Age-Related Macular Degeneration: A Multicenter Randomized Controlled Trial”, Ophthalmologica 2015; Volume 234, Issue 1.
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REAL-WORLD RESULTS WITH RANIBIZUMAB A two-year follow-up study of patients with age-related macular degeneration (AMD) treated at a university hospital indicates that intravitreal ranibizumab will stabilise or improve the visual acuity in around two-thirds of patients. The study’s authors found that, by the final follow-up, 46.4 per cent of eyes achieved visual acuity stabilisation, 21.7 per cent of eyes gained 15 or more ETDRS letters and 31.9 per cent lost 15 or more letters. The authors noted that those with lower baseline visual acuity scores had on average a greater gain of letters (p < 0.001) and that early diagnosis appears to be the key to achieving optimal outcomes. A Cazet-Supervielle et al, “Intravitreal Ranibizumab in Daily Clinical Practice for Age-Related Macular Degeneration: Treatment of Exudative Age-Related Macular Degeneration in Real Life”, Ophthalmologica 2015; Volume 234, Issue 1.
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EUROTIMES | SEPTEMBER 2015
71
RESIDENT’S DIARY
COOL NERVES
Continuing from the last Resident’s Diary, Leigh Spielberg recalls his first unsupervised cataract surgery sessions
D
espite the absurd, of the procedure. Like the surrealistic rapper Tupac Shakur said: dreams I had had “All eyes on me.” There was the night before, a palpable sense of respect chaotic dreams towards me, something that I of disappearing had rarely experienced. patients and overflowing “Doctor, shall we go ahead toilets, I arrived in the and open the material? hospital with cool nerves and Doctor, let us know if there’s a clear head. anything we can do for you.” “Dr Spielberg! Welcome This privilege, this respect, back to the phaco suite!” comes with the responsibility said two nurses as I entered of getting it done. No one the locker rooms where we in the room could help out change into our operating if the operation went awry. clothes. Due to a lack of both I could always call for Dr space and prudishness, the Manzulli to come assist me, Dutch have unisex changing but that would be a lastrooms. I thought back to resort option. As the patient three years ago, the first time was wheeled into “my” OR, I entered the changing room I thought to myself: ‘Am I and saw the same nurses really ready for this?’ undressing. Being unaware But as I settled into the of this Dutch custom, I surgeon’s seat, one usually apologised profusely, closed occupied by my surgical the door, turned around and mentors, with the patient bumped right into Niels, before me and an experienced my resident buddy and key nurse at my side, it all felt right. to all things Dutch. “Dude! There was no panic. There Welcome to Holland.” was no feeling of an absence I had gotten used to it of knowledge or skill. Rather, since then. “Who are you there was an eye to be operated operating with today?” and the instruments to be used. asked one of the nurses. I got right to work. ...there was an eye to be operated “Dr Manzulli already has a I thought of what Joyce and the instruments to be used. resident assisting him. Was Jansen, a young vitreoretinal there a change of schedule?” surgeon, had once said to I got right to work. “Nope, I’m on my own me: “Cataract surgery... so today,” I said, as a wave of much more stressful than VR panic washed away my thin veneer of pride. I tried to keep cool. surgery... every single step can go fabulously wrong and make the “Who’s my assistant?” rest of the procedure almost impossible to complete.” I changed into my operating scrubs and proceeded to the OR. I With that in mind, I operated conservatively and took my time hadn’t been in the phaco suite for about a year, so I was no longer with every movement. There was no rush. There was no need to familiar with the workflow, with the standard procedures. Who strive for perfection - that eternal enemy of good outcomes - as I decided when to proceed? Who fetched the patient? Who, I asked had done while my mentors were watching over my shoulders. I myself, was really in charge here? completed one step at a time, while always thinking one step ahead. As though on cue, my question was answered. An OR nurse All the operations went reasonably well, but each procedure poked her head through the door and asked: “Doctor, have you had a step or two that made me stop and think. How much had your coffee yet? And if so, would you like us to fetch your first do I have to enlarge the primary incision to accommodate patient from the prep room?” the larger cartridge required to insert a 27-dioptre intraocular As a younger resident, I had spent most of my time shadowing lens (IOL)? How do I remove the capsulorhexis flap that has the attending surgeon in the OR. The emphasis here is on the somehow gotten stuck to the corneal endothelium? What do word shadow, simply being present and more or less silent in the I do with this mushy lens that doesn’t have a single properly background. Even when I was operating, the nurses’ attention was cracked quadrant? focused squarely on the staff surgeon, who was really running the Each eye introduced an element of complexity and the potential show. A resident is politely tolerated, but is not really listened to. for a complication that I hadn’t really anticipated. But no complications occurred. Each patient left the OR with an intact capsule, an IOL in the bag and, I imagine, a genuine feeling of ALL EYES ON ME relief at least as authentic as my own. For the first time in my The dynamic is totally different when you’re the primary surgeon, residency, I had the feeling that all would be well in my career as when you’re the one responsible for the successful completion an ophthalmologist. Courtesy of Eoin Coveney
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EUROTIMES | SEPTEMBER 2015
RESEARCH
Church of Santo Tomé, Toledo
74
The Burial of the Count of Orgaz
THE EL GRECO ENIGMA
Could keratoconus account for aspects of the Greek painter’s highly individual style? Ioannis Pallikaris MD, PhD reports
T
he painter Doménikos Theotokópoulos, better known by his Spanish name El Greco (“The Greek”), is widely acknowledged as being one of the greatest painters in the history of European art. Records indicate that he was born in Crete in 1541, into a wealthy and socially prominent family. Early in his career he received training in the Byzantine style of painting. This style is concerned with religious expression and more specifically the impersonal presentation of church theology in artistic terms. At the age of 27, El Greco travelled to Italy where he continued his artistic training. Among his teachers were Titian,
EUROTIMES | SEPTEMBER 2015
one of his greatest contemporaries. Through his influence, El Greco adopted the Venetian features of bright colours, movement, and dramatic light in his work. For a short period of time, El Greco lived in Rome where he saw the works of Michelangelo, Raphael and Parmigianino. These artists practised the style of Mannerism, which valued the portrayal of the nude in complex and artificial poses. The figures often have elongated limbs, small heads and stylised facial features, which can be seen in exaggerated form in El Greco’s later works. El Greco left for Spain in 1577 and despite the lack of royal commission his work was very popular. In 1579, El Greco completed the first of two works that
were commissioned for the church of Santo Domingo el Antigua in Toledo and established a local reputation that would sustain him for the rest of his life. At about the same time, the most recognisable feature of El Greco’s style emerged – the elongation of figures. “The Burial of the Count of Orgaz” (1586-88; Santo Tomé, Toledo) is universally recognised as El Greco’s masterpiece. This vision is fabricated by an astonishing handling of brilliant colour and radiant light. El Greco’s Mannerist method is nowhere more clearly expressed than here. As his career progressed, the elongation of human figures in El Greco’s work became more pronounced. This can be seen in his classic “Saint Martin and the Beggar”.
RESEARCH
It has been suggested that El Greco suffered from astigmatism. This suggestion is based on the unidirectional elongation in the perception of objects that astigmatism characteristically induces and the observation that viewing one of El Greco’s paintings through a cylindrical lens with the proper power and orientation eliminates the distortions. However, there are several arguments against this theory. Firstly, El Greco’s tendency for elongation may be simply stylistic and traceable back to both the Byzantine and Mannerist eras. Secondly, El Greco’s elongated distortions did not simply occur in one direction as would be expected with astigmatism. Thirdly, in “The Burial of the Count of Orgaz” (see left), the vertical distortions are not uniform; there are normally proportioned figures as well as distorted ones. Fourthly, El Greco’s distortions progressed over his career. However, astigmatism does not normally increase in severity with age. Fifthly, while the axis of astigmatism normally changes with age from the vertical axis (with-the-rule astigmatism) to the horizontal axis (against-the-rule astigmatism), there was no indication of this change in El Greco’s work. Lastly, and perhaps most conclusively, X-ray analyses of some of El Greco’s works reveal that
THE KERATOCONUS THEORY
National Gallery of Art, Washington, Widener Collection
IS EL GRECO’S UNIQUE STYLE EXPLAINED BY ASTIGMATISM?
Saint Martin and the Beggar
the underlying figures were painted in normal proportions. On those grounds it might be more reasonable to conclude that the artist’s distorted tendencies should be attributed to a purposeful style rather than astigmatism. Yet it may also be that there is an alternative optical defect at work.
The elongations of the figures and the Manneristic approach in his paintings first begin to appear in those works he did at around 30 years of age, immediately after his arrival in Italy. This style becomes prominent in the depiction of the burial of the Count of Orgaz, where the figures of the angels are stressed, that is, in figures which come from his fantasy rather than from living models. The elongation of the figures is demonstrated more obviously in his later works. These elements are consistent with keratoconus, a progressive corneal disorder, which has a very high prevalence among Eastern Mediterranean populations. Patients with keratoconus first notice its effects when they are around 30. If there is no acute progression causing a substantial decrease in vision during the first two to three years, keratoconus has a slow progression and continues until the age of 40-50 years. The landmark of this period is the appearance of the so-called “irregular astigmatism”, which elongates and distorts the objects, but in an irregular way. Εl Greco’s “evolutionary Mannerism”, as I would call it, perfectly fits the profile of chronic, progressive, subclinical keratoconus. Unfortunately, only topographies and resolution of El Greco’s corneal and optical system’s wavefront aberrations could resolve this enigma.
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DIRECT CHOPPING Everything you ever wanted to know about horizontal and vertical chopping. Dr Soosan Jacob reports
D
irect chopping techniques are essential for the cataract surgeon to know, as they help in performing surgery in difficult situations such as small pupil, zonulodialysis and mature cataracts. Chopping techniques utilise manual forces to crack the nucleus with phaco power being utilised only to obtain a purchase on the nucleus. They utilise natural planes within the crystalline lenses to create lines of cleavage. In essence, the nucleus is grasped with the phaco tip and a chopping movement is used to crack the nucleus into two planes. It consists of the vertical and horizontal chops.
chopper is mainly used for vertical chopping and has the advantage of being able to pass through a 26-gauge side port.
HORIZONTAL OR NAGAHARA CHOPPING First described in 1993 by Nagahara, it is so-called as the instruments move towards each other in the horizontal plane. The horizontal chopper in the nondominant hand slides under the rhexis rim and epinucleus, around the equator of the nucleus to hook it. The tip should pass under the rim and not above where it can tear the rhexis or get caught in
the zonules and cause a zonulodialysis. Therefore, it should be made sure that the chopper touches the endonucleus before sliding it outwards under the epinuclear shell. An anterior capsule that has been stained with Trypan blue also helps in ascertaining the subcapsular position of the chopper. The phaco probe is then used to engage the nucleus close to the proximal edge of the capsular opening. Burst mode phaco is applied angling downwards to obtain a deep purchase of the nucleus. The nucleus is then held using high vacuum, while simultaneously the chopper is moved towards the phaco probe and
TECHNIQUE An adequately sized rhexis, thorough hydrodissection, hydrodelineation and nuclear rotation are necessary before attempting to chop. Anterior cortex and epinucleus within the rhexis rim is aspirated to expose the nucleus. There are various choppers available. Horizontal choppers have a blunt tip and are long enough to reach the equator. They may have an inner cutting edge but this is not a must. The Lieberman microfinger is a bent 1.5mm-long microfinger that follows the curve of the equator of the bag and is a very good instrument for horizontal chop. It can safely be used for rotation and for tumbling the quadrants out of the capsular bag. The Chang combo chopper, which has a modified Lieberman microfinger on one side and a sharp vertical tip on the other side, is also a good option. Other choppers available are the Nagahara karate chopper, which has a sharp spear tip with internal cutting edge, and the Agarwal chopper for moderately dense nuclei. The Agarwal EUROTIMES | SEPTEMBER 2015
Horizontal chopping (A and B) - the blunt tipped horizontal chopper engages the equatorial nucleus and the phaco tip embeds the nucleus proximally (A); the chopper moves towards the phaco tip and then sideways to cleave the nucleus (B). Vertical chopping (C and D) - the phaco tip is embedded deeply into the proximal nucleus and used to stabilise the nucleus upwards (C); the sharp tipped vertical chopper presses downwards next to the phaco tip and cleaves the nucleus into two (D)
REVIEW then horizontally in the form of a laterally reversed “L” to cleave the nucleus into two halves. The nucleus is rotated and the same manoeuvre repeated to chop it further into smaller fragments, which are then emulsified to create more working space in the bag for the remaining pieces.
VERTICAL CHOPPING It is so-called as the movement between the two hands is in a vertical plane. A good purchase on the nucleus is much more important here than in horizontal chopping. In the latter, the nucleus is compressed between the two instruments moving towards each other, whereas in vertical chopping, forces act against each other as the phaco tip holds the nucleus up and the chopper depresses downwards into the nucleus to cleave it. While embedding, it should be made sure that the phaco tip is completely occluded by the nucleus. This can be attained using traditional ultrasound with burst mode and high vacuum levels. A sharp chopper should be used to prevent a break of occlusion of the phaco tip. In dense nuclei the crack may not propagate throughout and the nucleus needs to be rotated 180 degrees to repeat the chop from the other side. Each hemi-nucleus is then similarly chopped into smaller pieces. In hard brown cataracts, the posterior leathery plate has to be separated before the quadrants
can be lifted out of the capsular bag. Vertical chopping is completed and the pieces are then lifted out one-by-one to be emulsified in the anterior chamber.
DISADVANTAGES Vertical chopping is not suitable for soft cataracts where the chopper can cheese wire through the soft nucleus without splitting it into two. It is however highly suited to brown cataracts. Similarly, horizontal chopping should be performed carefully in mature cataracts as the chopper passes very close to the capsule.
ADVANTAGES Both horizontal and vertical chop techniques decrease the amount of phaco energy used within the anterior chamber as well as time taken for nuclear division while being more zonule friendly. As compared to divide and conquer, chopping decreases stress on zonules that is caused by sculpting. However, during vertical chopping in hard nuclei, the tendency by beginner surgeons to push downwards and outwards to crack the nucleus should be avoided. Instead, the nucleus should be held firmly with an upward pull with the phaco tip using high vacuum while the second instrument is used to cleave the nucleus. In comparison to phaco flip or tilt and tumble, chopping avoids the need for the entire nucleus to be prolapsed out of the capsular bag. It is therefore advantageous in harder cataracts and when the rhexis is not large enough to allow nucleus prolapse. Chopping is especially advantageous in small pupils where sculpting is difficult to perform and may result in damage. Vertical chopping needs only the central portion of the nucleus exposed. Chopping may also be used in subluxated cataracts for nuclear disassembly.
CONCLUSION As for all techniques, chopping techniques too have a learning curve, however they are an essential armament of every cataract surgeon and should be learnt in order to be prepared for difficult cases. * Dr Soosan Jacob is Director and Chief of Dr Agarwal’s Refractive and Cornea Foundation at Dr Agarwal’s Eye Hospital, Chennai, India, and can be reached at: dr_soosanj@hotmail.com
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LATE IOL DISLOCATION
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Late in-the-bag intraocular lens (IOL) dislocation is a serious complication of cataract surgery that usually requires surgical management. Previous studies have identified pseudoexfoliation as one of the main risk factors for zonular weakness and, as a consequence, spontaneous in-the-bag IOL dislocation. Other risk factors are believed to include uveitis, previous vitreoretinal surgery, increased axial length (AL), age, certain connective tissue disorders, retinitis pigmentosa, and zonular dehiscence during cataract surgery. With concern growing that the number of surgeries for late IOL dislocations has increased in recent years, Swedish researchers reviewed 21 years of surgical records in an attempt to identify the incidence and risk factors for this problem. The annual incidence varied between 0.00 per cent and 0.08 per cent. The cumulative risk five, 10, 15 and 20 years after cataract extraction was 0.09 per cent, 0.55 per cent, 1.00 per cent and 1.00 per cent, respectively, and was significantly higher (P < .001) in eyes that had cataract surgery between 2002 and 2012 than in those operated earlier. The calendar time (date) of dislocation was positively correlated with the duration of preceding pseudophakia. Phacoemulsification time was longer in eyes with dislocation than in control eyes (P < .001). Other identified risk factors were pseudoexfoliation, zonular dehiscence, pseudophacodonesis, and increased AL. The study did not include refractive lens extraction (RLE) cases, as these are rarely performed in public healthcare, although the number of middle-aged patients having RLE is increasing worldwide. K Dabrowska-Kloda et al, JCRS, “Incidence and risk factors of late in-the-bag intraocular lens dislocation: Evaluation of 140 eyes between 1992 and 2012”, In Press, June 2015.
MANAGING REFRACTIVE ERROR FOLLOWING CATARACT SURGERY Surgeons seeking to manage refractive error following cataract surgery have many options, but which is best? A new comprehensive literature review looked at existing options such as LASIK, photorefractive keratectomy (PRK), arcuate keratotomy, intraocular lens (IOL) exchange, piggyback IOLs and lightadjustable IOLs. The reviewers had several recommendations. First, they suggest that all patients be counselled in advance that uncorrected distance acuity may fall short of 20/20. Piggyback IOLs appear to be an effective approach for large spherical errors with or without astigmatism. For small spherical errors with or without astigmatism, both LASIK and PRK are safer, more effective and more predictable than intraocular approaches. The same is true for astigmatism. Laser vision correction is also useful after ametropia following implantation of a multifocal IOL. Wavefrontguided treatments do not appear to be superior to conventional treatments in these cases. Finally, the researchers note that the light-adjustable IOL does look very promising for preventing dreaded refractive surprises in postrefractive-surgery patients. CS Sales et al, JCRS, “Managing residual refractive error after cataract surgery”, In Press, June 2015.
THOMAS KOHNEN European editor of JCRS
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