EuroTimes Vol. 21 - Issue 6 by EUROTIMES

SPECIAL FOCUS GLAUCOMA INNOVATION

PRESBYOPIA: FEMTOSECOND LASER PIONEER ENCOURAGED BY RECENT DEVELOPMENTS June 2016 | Vol 21 Issue 6

GLAUCOMA

WHAT’S NEXT?

EYE ON TECHNOLOGY

SMALL INCISION LENTICULE EXTRACTION: THE TECHNIQUE AND ITS ADVANTAGES

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Publisher Carol Fitzpatrick Executive Editor Colin Kerr Editors Sean Henahan Paul McGinn Managing Editor Caroline Brick Production Editor Conor Ward Senior Designer Janice Robb Designer Lara Fitzgibbon Circulation Manager Angela Morrissey Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin Contributors Maryalicia Post Leigh Spielberg Pippa Wysong Gearóid Tuohy Priscilla Lynch Soosan Jacob Colour and Print W&G Baird Printers 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

CONTENTS

A EUROPEAN OUTLOOK ON THE WORLD OF OPHTHALMOLOGY

SPECIAL FOCUS GLAUCOMA 4 Cover Story: Where will

glaucoma management find itself in the future?

8 The evolving nature

of therapies for optic neuropathies

10 OHTS: Landmark study

funded for a third phase, extending follow-up period to 20 years

11 FDA provides new

guidelines for MIGS trials

FEATURES CATARACT & REFRACTIVE 13 High myopia –

challenges in choosing from surgical solutions

14 FLACS: Review finds early

RCT data favourable, but more evidence needed

16 New variables to make

EUREQUO an even more powerful research tool

17 New tablet-based

device shows high repeatability in quantifying glare disability

As certified by ABC, the EuroTimes average net circulation for the 10 issues distributed between 01 January 2015 and 31 December 2015 is 46,515.

CORNEA

P.40

23 EuCornea takes big step

forward with launch of online journal dedicated to corneal research

25 Endothelial dysfunction:

results encouraging for cell injection therapy

RETINA 26 Frustration with gene

therapy results gives way to hope

30 ‘New surgical system

can significantly improve accuracy in retinal procedures’

31 Scleral haptic fixation for secure positioning of a replacement IOL

PAEDIATRIC OPHTHALMOLOGY

REGULARS 36 Book Reviews 38 Innovation 39 ESCRS News 40 Hospital Diary 41 Industry News

32 Reducing the myopia

burden – research aims to identify targets for intervention

35 ‘BIL IOL pushes back

boundaries for primary lens implantation’

42 JCRS Highlights 43 ESASO Update 45 Travel 46 Eye on Technology 48 Calendar

P.14 EuroTimes & JCRS 1996–2016

EUROTIMES | JUNE 2016

EDITORIAL A WORD FROM CARLO E TRAVERSO MD, PhD

ESCRS GLAUCOMA DAY We have made great strides in the management of glaucoma, we still have a long way to go

am delighted to contribute this month’s editorial for EuroTimes. The issue has a special focus on glaucoma, and it is to be the point for announcing our Glaucoma Day later this year in Copenhagen at the ESCRS. Five years ago, in September 2011, the ESCRS held its inaugural Glaucoma Day in Vienna, in partnership with the European Glaucoma Society (EGS). This activity was born from the recognition of a common goal by both the EGS and ESCRS: to improve education and research, and suggest clinical solutions to the challenges that face ophthalmologists every day. In the strive for better outcomes, it is necessary to focus on what is relevant for our patients. One goal is to improve surgical skills, whereas another is to develop new drugs that will help patients’ quality of life.

update on glaucoma research, as well as practical advice on the clinical management of glaucoma. The EGS is to be commended for compiling what promises to be another stimulating and informative programme, while both the EGS and the ESCRS are to be thanked for having the vision to organise this event. I would also urge all attendees to give us with their feedback. This will help us to develop an even more exciting programme at the XXXV Congress of the ESCRS next year in Lisbon, Portugal. It is an exciting time to be a glaucoma specialist. Major advances have been made in optical coherence tomography imaging for glaucoma, and new algorithms are being developed to refine patient follow-up. Although new glaucoma drugs haven’t recently been made available, new delivery methods such as slow-release intraocular depots are in the pipeline. Novel glaucoma surgery ALLOWING DISCUSSION This meeting is now firmly is adding a potentially powerful Reading the latest research findings in peer-reviewed established as one of the new weapon to our arsenal. journals and news magazines such as EuroTimes is Glaucoma drainage tubes have highlights of the ESCRS helpful, but there is no substitute for educational become the first choice surgical meetings. The development of new diagnostic Congress and we can look option in some large centres, techniques, advances in medicines and improvements forward to another excellent displacing trabeculectomy. in surgical techniques go hand-in-hand towards programme in Copenhagen And much has been learned such goals. from previous studies of Glaucoma Day is aimed at delivering such an update, neuroprotection, which will allow but also, most importantly, at allowing discussion better studies to be designed going forward. We spoke with among speakers and with the audience. Drs Hans Lemij, Ingeborg Stalmans and Francesca Cordeiro to The 2016 Glaucoma Day will be held on Friday, 9 September, gain the insights of key opinion leaders for this month’s cover immediately preceding the XXXIV Congress of the ESCRS, story on the future of glaucoma. and will cover a wide range of topics related to glaucoma that will be of broad general interest to practitioners. This meeting is now firmly established as one of the highlights of the ESCRS Congress and we can look forward to another excellent programme in Copenhagen. Key topics will include imaging, visual function, neuroprotection, intraocular pressure measurement, and various aspects of surgery. We anticipate that the programme will be stimulating and will provide attendees with a useful

Professor Carlo E Traverso is the immediate past president of the European Glaucoma Society

MEDICAL EDITORS

Emanuel Rosen Chief Medical Editor

José Güell

Thomas Kohnen

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) , Soosan Jacob (India), Vikentia Katsanevaki (Greece), 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), Leigh Spielberg (The Netherlands), Sathish Srinivasan (UK), 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 | JUNE 2016

YOUR SAFEST LENS BEGINS AT BENZ 50 Million IOL Blanks Sold, Zero Recalls

Benz Quality. Benz Innovation. benzrd.com

COVER STORY: GLAUCOMA

REDEFINING GLAUCOMA What’s next for diagnosis, treatment and management? Leigh Spielberg MD reports

he past decade has seen great strides made in the management of glaucoma. From the refinement of optical coherence tomography (OCT) imaging of the optic disc and retinal nerve fibre layer (RNFL) to the development of preservative-free prostaglandin analogs and the introduction of minimally invasive glaucoma surgery (MIGS), glaucoma treatment has changed for the better. However, we still have a long way to go. Several promising drug classes have not lived up to the hype they had generated, and all the new medications recently released on to the market have EUROTIMES | JUNE 2016

been variations or combinations of older molecules. Neuroprotection has not yet entered the general clinics and stem cell therapy is still in the realm of science fiction. So where will glaucoma management find itself 10 years from now?

DIAGNOSTICS “Although major advances have been made in OCT imaging, there are still a lot of issues to work out. Image quality remains a problem, particularly the signal-to-noise ratio in advanced disease,” explained Hans Lemij MD, PhD, of The Rotterdam Eye Hospital, The Netherlands. Because the thin tissue of interest left over in advanced disease is more difficult

to detect, the signals tend to get obscured by the noise inherent to the current technology. “As such, the monitoring of advanced glaucomatous damage is in need of something else, something more precise, because measurement variability becomes too large, both in imaging and in functional testing,” observed Dr Lemij. Would that be more advanced OCT, or another modality entirely? “I don’t know. I’ve been thinking about it for years now, but I haven’t come up with the answer, nor do I know of anyone else who has.” He is, however, actively investigating. “It turns out that with advanced glaucomatous damage, the RNFL tissue not only thins, but it also becomes more

COVER STORY: GLAUCOMA transparent,” he said, describing the decreased attenuation coefficient that characterises the tissue. Dr Lemij’s team has developed a new algorithm that combines the tissue’s transparency measurements with those of the tissue’s thickness, allowing the technology to highlight the characteristic wedgeshaped defects seen in glaucoma. “This might shed more light on the pathogenesis of the disease.” What about the future of diagnostics? “I doubt anything will replace OCT in the near future,” predicts Dr Lemij. “It’s here to stay for at least 10 more years, especially for early and intermediate disease. A possible advance in follow-up might be found in visual field testing with other stimuli, other backgrounds or other algorithms,” he added.

Courtesy of Ingeborg Stalmans MD, PhD and Allergan

XEN® gel implant placement

NEUROPROTECTION “Maintaining low intraocular pressure (IOP) is still the best neuroprotective strategy that we’ve come up with, but unfortunately it’s impossible in some patients and insufficient in others,” says Francesca Cordeiro MD, PhD, UCL and Imperial College London, UK. “Both retinal ganglion cell loss and optic nerve atrophy can independently occur with IOP at normal levels.” How might this be prevented? “Pharmacologic goals are to counteract oxidative stress and prevent apoptosis,” said Dr Cordeiro. There are medications known to do this, but whether this applies to the loss encountered in glaucoma remains to be seen. Neuroprotection has not made the same type of headway into the day-to-day clinics as IOP-lowering strategies. This might have something to do with the difficulty of study design. Early trials were too complex, too long and too expensive, with too many patients and vague endpoints, explained Dr Cordeiro. “But we have learned that neuroprotection research should start with a proof-of-concept study in order to obtain data within a reasonable time frame. This can be done by studying patients with rapidly progressing disease. For example, pseudoexfoliative glaucoma can progress by 1.6 decibels per year. If the endpoint is a 50 per cent reduction in that progression as compared to historical controls, then 50 to 60 patients followed over 12 months are all we would need for a proof-of-concept trial,” she added.

Maintaining low intraocular pressure (IOP) is still the best neuroprotective strategy that we’ve come up with... Francesca Cordeiro MD, PhD

This is a great advantage over the 10 years previously thought to be necessary for a study into neuroprotection, she stressed. As for actual molecules of interest, these include neurotrophic factors, NMDA receptor antagonists, anti-apoptotic agents, and antioxidants.

MEDICAL THERAPEUTICS “I expect new pharmacologic advances will make breakthroughs within five years. Injectable anterior chamber depots with slow release of prostaglandins are being evaluated by several companies. These would provide slow release over a threemonth period, despite containing the same tiny amount of medication as is contained in a single drop of traditional topical treatment,” says Dr Lemij. These are currently being tested in patients and might counter the well-known problems of local irritation and variable medical compliance in glaucoma. Ingeborg Stalmans MD, PhD, of University Hospitals Leuven (UZ Leuven), Belgium, is equally enthusiastic about this modality.

Although major advances have been made in OCT imaging, there are still a lot of issues to work out Hans Lemij MD, PhD

“Fortunately, we haven’t yet seen any of the theoretical problems that one might expect from a foreign body in the anterior chamber, such as inflammation, endothelial damage or injury to the trabecular meshwork. Goniophotographic monitoring in the study settings has not shown any damage to the angle, and the injection needle, custom-designed for the anterior chamber, makes the administration quite safe,” she told EuroTimes. Dr Lemij is also confident that further advances will be made to develop preservative-free topical medications. “Considering the growing literature about how counterproductive preservatives can be, pharmaceutical companies have certainly taken notice. They’ll find ways of storing and administering these new preservative-free medications. The only drawback will be the price tag,” he noted. Dr Stalmans reminds us, however, that not all topical medications can be manufactured without preservatives. “Molecules like carbonic anhydrase inhibitors are unstable as solutions when formulated at a physiological pH. If they are manufactured as a suspension, a more neutral pH can be maintained, improving comfort over more acidic formulations, but suspensions must contain preservatives to remain stable. It’s a delicate balance between the irritation of a low pH and the stability of a preserved suspension.” EUROTIMES | JUNE 2016

COVER STORY: GLAUCOMA

SURGICAL THERAPEUTICS Once medical treatment has been maximised and further lowering of the IOP is necessary, what’s next? Dr Lemij is very hopeful when it comes to the advances in surgical treatment of glaucoma. MIGS (also referred to as microinvasive glaucoma surgery), which includes various types of micro-stents that bypass the trabecular meshwork, can cause a 20-30 per cent decrease in IOP. They can be implanted independently or concurrently with cataract surgery. The implants are currently considered by many to be an acceptable option prior to trabeculectomy or glaucoma tube, since these can still be performed if the MIGS implant fails. “What I’ve seen so far are cleverly made shunts and tubes. They are all very sophisticated in design and manufacturing, made of either titaniumbased alloys or collagen. There are several caveats, however. Follow-up is still quite short at this point, around three years. They occasionally scar down and grow over. Further, they are quite costly,” said Dr Lemij. Dr Lemij finds them to be useful primarily for moderate decreases in IOP, but for more dramatic and long-lasting IOP control, the more traditional procedures like glaucoma tube implantation or trabeculectomy are more appropriate. “Ideally, MIGS procedures would be less invasive and as efficacious as the traditional techniques. All the studies have shown that they have a good safety profile, but their efficacy is clearly inferior to the gold standard of trabeculectomy,” notes Dr Stalmans. Most of the MIGS were studied in trials which compared cataract surgery alone against cataract surgery plus MIGS implantation. “Both procedures decrease the IOP, but the difference with or without MIGS is not very large. It’s in the realm of approximately 1.0mmHg, albeit with fewer IOP-lowering medications. Now, one can claim that every millimetre of mercury counts, but how much is 1.0mm really worth in financial terms? The implants cost between €500 and €1,000 apiece!”

SOME EXCEPTIONS There may be some exceptions, however. “The available one-year data from an ongoing phase IV trial suggest that the XEN® implant from Allergan seems to

The XEN® gel implant in-situ

Courtesy of Ingeborg Stalmans MD, PhD and Allergan

generate a more significant decrease in IOP,” says Dr Stalmans. The transcleral XEN® gel implant is a minimally invasive ab interno glaucoma device that creates a fistula between anterior chamber and subconjunctival space. But why might there be a difference between the various MIGS implants? “Each MIGS implant shunts aqueous to a specific intraocular or periocular space. Some target Schlemm’s canal, while others drain to the suprachoroidal space. The XEN® drains subconjunctivally. Maybe this is the ideal location to which to drain aqueous: there’s plenty of space and very low resistance, as we have known for a long time with trabs and glaucoma tubes,” explained Dr Stalmans. What might be a problem with Schlemm’s canal or the suprachoroidal space? Dr Stalmans emphasised that there are currently no data to explain the differences in effect between the various implants, but that the following hypothesis might be sound: “In patients with glaucoma, the trabeculum has not been properly working for years. This can lead to a collapse of Schlemm’s canal. If you plug in a stent, why would it reopen? Moreover, scarring is an issue for all types of glaucoma surgery. Despite it’s off-label status for ocular use in Europe, mitomycine C is widely used for glaucoma surgery because of its reported beneficial effects on surgical outcome.” Clearly, we can’t inject mitomycin C into the eye. It can, however, be used under the conjunctiva.

I’m not fond of the tube-first strategy, as I feel like one option, the trabeculectomy, has been passed over Ingeborg Stalmans MD, PhD EUROTIMES | JUNE 2016

TO TUBE OR TO TRAB? There are big differences of preference and opinion regarding surgical treatment. “In patients with primary glaucoma, I still prefer to first perform trabeculectomy and keep drainage tubes as an option of last resort. I’m not fond of the tube-first strategy, as I feel like one option, the trabeculectomy, has been passed over,” Dr Stalmans explained. “Various trials show that in the long run, large glaucoma tubes like the Baerveldt perform better than trabeculectomy, in terms of complication rates, notably in the early postoperative phase, although trabs show somewhat lower IOPs,” counters Dr Lemij. “We almost completely abandoned trabeculectomies many years ago, primarily due to the early postoperative complications. We currently perform about 95 per cent glaucoma tubes and only about five per cent trabeculectomies.” The jury is clearly still out on this question. Key opinion leaders’ research interests often point the way to the future. “Are glaucoma tubes’ anterior chamber tubes harmful to the corneal endothelium? The reports have been mixed, so we’re running a trial to investigate that question,” said Dr Lemij. Dr Cordeiro is interested in initiating a pan-European trial that compares the optic neuroprotective effects of several different molecules in a systemic fashion. And Dr Stalmans will continue her investigations into the ideal combination of drugs to decrease the fibrotic reactions which can complicate a perfectly good glaucoma procedure. Hans Lemij: h.lemij@oogziekenhuis.nl Francesca Cordeiro: m.cordeiro@ucl.ac.uk Ingeborg Stalmans: ingeborg.stalmans@mac.com

Yo ur Yo vo ur ic e. Yo sp ur ec Yo ia fu lt ur tu y. ti r e m . e to jo in .

Belong to something personal. Join us.

www.escrs.org

SPECIAL FOCUS: GLAUCOMA

CHANGING TIMES In a new series of articles sponsored by ISOPT Clinical, Barrett Katz MD, MBA looks at the evolving nature of therapies for optic neuropathies

t was not so long ago that glaucomatologists and neuroophthalmologists lived in different worlds. As our understanding of glaucoma has migrated to appreciate it as, first and foremost, an optic neuropathy, these disparate worlds – and associated treatment interventions – have begun to merge. Nowhere is this more compelling than in the world of neuroprotection. For decades clinicians caring for those with glaucoma have directed their intervention at lowering the major risk factor of the disease’s progression – pressure. Understandably, this was recognised as treating not the disease, but a proxy of the disease. Yet this tradition and approach has been so widespread that we lost sight of our ultimate goal, saving the integrity of the retinal ganglion cells and their axons. As our thinking has evolved, we recognised that it is damage to the axons of the retinal nerve fibre that is the final common pathway for glaucomatous damage; from this insight emerged the idea of protecting those axons with an additional methodology to simply lowering intraocular pressure. What is neuroprotection? It is the strategy of targeting those very retinal ganglion cells and their axons – card carrying members of the central nervous system – to shield these cells from insult, injury, or degeneration. The objective of neuroprotection is to limit physiologic dysfunction and death of these cells of the central nervous

True innovation comes from sharing knowledge.

Clinical Research Awards 2017 Call for Proposals ESCRS has made available funding of €750,000 over three years for clinical research projects in the field of cataract and refractive surgery

system, slow their progressive damage in disease and attempt to maintain the integrity of anatomy and physiology of cells and their interactions in the eye. This initiative – still in its infancy and not yet bearing fruit – makes use of multiple possible interventions. Strategies examined in the past have included those which inhibit apoptosis, decrease oxidative stress, alter mitochondrial dysfunction, boost free radical scavengers, alter excitatory modulators, promote active neurotrophic factors, modulate ion channel actions, and chelation of metal ions. Thoughts of active gene therapies and stem cell interventions are newer, still. Both oxidative stress and excitotoxicity are thought to initiate neuron cell death, and when conjoined, seem to have synergistic effects that cause even more degradation than either on their own. Restricting excitotoxicity and oxidative stress are an important aspect of neuroprotection and this should be equally true in glaucoma as in any other optic neuropathy. Much of the efforts of neuroprotection have included glutamate antagonists and antioxidants, each of which strives to limit excitotoxicity and oxidative stress respectively. The good news is that researchers are thinking about this avenue. The bad news is that they have not yet hit upon a successful and commercially viable product. The import of these initiatives is much wider than just ophthalmology and optic neuropathies, for any intervention that successfully retards neuronal cell loss will have immediate and obvious relevance to other neurologic diseases, be they acute or chronic. When we can actively protect those retinal ganglion cells in glaucoma, we may be able to generalise that protection and apply it to more classic neurologic disorders such as Alzheimer's disease, spinal cord trauma, stroke, multiple sclerosis, amyotrophic lateral sclerosis, Parkinson’s disease, and conceivably even the effects of aging. The eye is arguably the best tissue to explore such neuroprotection in, and glaucoma perhaps the best disease model for induced effects of cellular protection and anatomic integrity. Both the tissue’s anatomic integrity and physiologic function can be directly seen and measured with optical coherence tomography and formal perimetry, and our success of protecting retinal ganglion cells awaits the success of neuroprotection-ists. Stay tuned!

The eye is arguably the best tissue to explore such neuroprotection in... Barrett Katz MD, MBA

Deadline for expressions of interest: 27 June 2016

www.escrs.org EUROTIMES | JUNE 2016

Prof Barrett Katz is the head of the neuro-ophthalmology and glaucoma sections at ISOPT Clinical Barrett Katz: bkatz@montefiore.org

Glaucoma Day 2016 ESCRS

Friday 9 September

ation & r t s i g e R ings k o o B l Hote

OPEN

Immediately preceding the XXXIV Congress of the ESCRS 10â&#x20AC;&#x201C;14 September

Scientific Programme organised by

www.escrs.org

SPECIAL FOCUS: GLAUCOMA

OHTS AT 20 YEARS Extending follow-up may help to better prevent and treat open-angle glaucoma. Howard Larkin reports

he landmark Ocular Hypertension Treatment Study (OHTS) has been funded for a third phase that extends the followup period to 20 years, Michael A Kass MD told a Glaucoma Day session of the American Academy of Ophthalmology annual meeting in Las Vegas, USA. The information gained will help patients and clinicians make better informed, evidence-based decisions about managing ocular hypertension (OHT) and early primary open-angle glaucoma (POAG), said Dr Kass in the American Glaucoma Society Lecture.

EVIDENCE NEEDED

OHT affects somewhere

between 4.8 million to 8.5 million

OHT affects somewhere between 4.8 million to 8.5 million people over the age of 40 in the US – a number that will grow as the population ages, Dr Kass said. “Managing over the age of these people is associated with substantial cost and effort for patients, clinicians and society,” he added. But while elevated intraocular pressure (IOP) has long been thought a leading risk factor for POAG, basic questions about managing it remained unanswered as late as the 1990s, Dr Kass noted. These include Michael A Kass MD how often patients should be tested, what tests should be performed, whether early treatment of OHT can prevent or delay and optic discs, were enrolled. Half received POAG; and if treatment works, which medication and half were observed without patients should be treated and when? treatment. Both groups received Humphrey “Many of us thought we knew some visual field tests every six months and of the answers, but there was no level 1 stereoscopic disc photos annually. At five evidence and no clear consensus,” years, visual field and optic disc changes said Dr Kass, who is were attributed to POAG by a Professor of Ophthalmology masked endpoint committee. and Visual Sciences at Overall, medication Washington University produced about a 20 per in St Louis, USA. cent reduction in IOP, Dr So in 1994, with support Kass reported in 2002. The from the US National five-year incidence of POAG Eye Institute, Dr Kass was also less than half in the and colleagues launched medicated group, at 4.4 per cent the OHTS. The prospective, compared with 9.5 per cent in the randomised controlled trial observation group. “OHTS Phase 1 Michael A Kass evaluated the safety and efficacy provided proof of concept: medication of topical ocular hypertensive medications reduces the incidence of POAG,” he said. in delaying or preventing POAG. Baseline demographics and clinical factors were WHO TO TREAT? identified that predict which patients are However, Phase 1 did not test when more likely to develop POAG, Dr Kass said. medication should begin, if all OHT More than 1,600 participants of ages patients should receive early medication, of 40 through to 80 years with IOP of if there is a penalty for delaying medication 24-32mmHg in one eye and 21-32mmHg in OHT, Dr Kass said. OHTS Phase 2 was in the fellow eye, with normal visual fields designed to answer these questions.

EUROTIMES | JUNE 2016

in the

Beginning in 2002, 672 patients left in the observation group began topical IOP treatment, while 694 patients in the medication group continued treatment. This created a group in which medication was delayed a median of 7.5 years followed by 5.5 years of treatment and a group treated continuously for 13 years. During OHTS Phase 2 there was no difference in incidence in POAG between the delayed medication and early medication groups, Dr Kass reported in 2010. However, over OHTS Phase 1 and 2, the early medication group had a lower incidence of POAG. The absolute effect was greatest in patients with the highest risk as determined by a prediction model developed and validated using OHTS data. It incorporates age, IOP, central corneal thickness, cupto-disc ratio and field pattern standard deviation as significant risk factors. The risk calculator is available at: http://ohts. wustl.edu/risk Conversely, Phase 2 found little benefit to early treatment for low-risk patients. Phase 1 and 2 demonstrate that the risk of developing POAG continues over at least 15 years, and there are safe and effective treatment options for most OHT patients, Dr Kass added.

REFINING THE PREDICTIVE MODEL The third phase will re-examine all living participants in the original OHTS cohort. The overall goal is to better understand how treating OHT and early POAG affect later loss of vision and quality of life – and what can be done to reduce the long-term risks, Dr Kass said. Specific aims include determining the 20-year incidence of POAG, and developing 20-year models for stratifying POAG risk and predicting vision loss rates. Frequency and severity of self-reported limitations from POAG will be correlated with clinical findings to clarify the causal relationship of POAG to disability. “The true goal of managing patients with OHT is to prevent the development of functional limitations from POAG,” Dr Kass said. A 20-year model will be particularly helpful because it approaches the life expectancy of patients diagnosed in their 60s and 70s, and half the life expectancy of those diagnosed in their 40s and 50s, he added. Michael A Kass: kass@vision.wustl.edu

SPECIAL FOCUS: GLAUCOMA

LEAP FROG GUIDANCE FDA provides new guidelines for MIGS trials.

he US FDA, with public input from the American Glaucoma Society and other stakeholders, has devised recommendations to help speed the development of new minimally-invasive glaucoma drainage devices (MIGS), said Malvina B Eydelman MD, who is Director of the FDA’s Division of Ophthalmic and Ear, Nose and Throat Devices. “The leap frog guidance for MIGS devices is a mechanism by which we can share our initial thoughts regarding the content of pre-market submissions for emerging technologies and speed development and approval of future submissions,” she said in a keynote lecture at a Glaucoma Day session at the XXXIII Congress of the ESCRS in Barcelona, Spain. Dr Eydelman noted that, although in recent years there has been an explosion of peerreviewed reports on MIGS in the literature, there has been a lack of consistency in clinical trials. Moreover, there remains some debate about the definition of MIGS as well as the indications for the surgery. Furthermore, there has been a lack of FDA guidance regarding the safety and efficacy endpoints to be used. To remedy that situation the FDA and the American Glaucoma Society held a meeting on 26 February 2014, where they discussed the best clinical trial designs for MIGS devices including appropriate patient population, safety and effectiveness. The definition they agreed upon for MIGS included those devices used to lower intraocular pressure (IOP) using an outflow mechanism with either an ab interno or ab externo approach, with little or no scleral dissection and minimal or no conjunctival manipulation. The leap frog guidance includes recommendations for non-clinical testing related to device biocompatibility, physical and mechanical attributes, sterility, packaging, shelf-life, and shipping. Final guidance was issued by the FDA on 15 December 2015 (http://www.fda. gov/downloads/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/UCM433165.pdf). The guidance also includes recommendations for clinical trial design. Subjects included in clinical trials for MIGS devices should have evidence of early or moderate open-angle (confirmed by gonioscopy) glaucoma with characteristic visual field and optic nerve changes. The recommendations in this guidance document do not apply to implants used to reduce IOP in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical or conventional surgical treatments have failed. It is strongly recommended that all subjects be followed for a minimum of 12 months prior to submission of any pre-market application. If the benefit-risk analysis raises concerns beyond 24 months after implantation, longer follow-up may be appropriate. The recommended primary effectiveness endpoint is the percentage of patients with a reduction of 20 per cent or more in mean diurnal IOP from baseline. The recommended secondary effectiveness endpoint is the mean diurnal IOP change from baseline, Dr Eydelman said.

HISTORY OF IMPROVEMENT Dr Eydelman noted that the MIGS leap frog guidance, potentially expediting availability of more treatment options for glaucoma patients, was made possible by a long history of improvement in the understanding of the association between IOP and vision loss with glaucoma, and the increasing accuracy of medical devices used for diagnosis and treatment of glaucoma. She pointed out that Hippocrates first described the visual changes associated with glaucoma in the fifth century BC, when he documented a condition he called hemianopsia. The first illustration of visual fields were done by Ulmus in 1602, followed by Mariotte’s identification of the physiological blind spot and its relationship to the location of the optic disc in 1668. Building on these discoveries, von Graefe published his report in 1856 on quantitative visual field measurements and also documented the visual fieldloss characteristics of glaucoma. That led in turn to development professional of several perimeters culminating organisations in the development by Heijl and (providers) colleagues of the Humphrey field analyser, which was cleared for marketing in the US in 1985. “Standardised quantitative measurement of visual fields is now a mainstay of clinical practice and trials,” she said. The observed association between IOP and glaucoma dates back na to the 10th century, when the Arabian lvi Ma f surgeon Al-Tabari reported an association o y rtes between glaucomatous visual loss and increased Cou ocular tension. In 1826, William Bowman recommended digital palpation as part of the routine eye examination and in 1863 von Graefe developed the first indentation tonometer. In 1885-1888 Imbert and Fick discovered a key principle in applanation tonometry. Based on that principle, Hans Goldmann developed the applanation tonometer in 1955. “Goldmann applanation tonometry began the era of truly accurate IOP measurement, revolutionising the field as can be seen in several landmark studies, which showed that reductions in elevated IOP delays or prevents glaucomatous damage,” Dr Eydelman said. Many ophthalmic devices now used took centuries to evolve. Novel approaches for evaluating emerging technology can improve the speed of innovation. The FDA collaborated with several professional organisations, with that goal in mind, to outline nonclinical and clinical recommendations in its leap frog guidance. However, measures of patient preferences to help inform benefitrisk decisions for MIGS devices still need to be developed. To consider these measures as valid scientific evidence, we must first advance the state of the science, Dr Eydelman said. The FDA is collaborating with academic centres and professional organisations to study patient-centric outcomes for MIGS devices which will lead to patient-centric device development, evaluation and delivery of innovations that benefit patients, she concluded.

Patients

lm a

industry

FDA

academic centres expediting migs innovation to benefit patients

Roibeard O’hEineachain reports

Malvina B Eydelman: malvina.eydelman@fda.hhs.gov EUROTIMES | JUNE 2016

FOUR EVENTS ONE VENUE Bella Center, Denmark

XXXIV Congress of the ESCRS

16th EURETINA Congress

7th EuCornea Congress

WSPOS Paediatric Subspecialty Day

10–14 September www.escrs.org

8–11 September www.euretina.org

9–10 September www.eucornea.org

9 September www.wspos.org

CATARACT & REFRACTIVE

LENS OR LASER? Age, vision defects and biometry guide refractive surgery for high myopia. Howard Larkin reports

DEFINING HIGH MYOPIA High myopia is generally defined as a refractive error of -6.0 dioptres or more, or an axial length of 26.0mm or more, noted Dr Tassignon. But the two measures do not always correlate well. In a study at Dr Tassignon’s clinic, axial lengths in patients with zero refractive error ranged from 21.50mm to 25.50mm. While no emmetropic patients were seen with axial lengths of 26.0mm or more, about three per cent of patients with -2.0D to -3.0D had axial length of ≥26.0mm. Also, only about one-quarter of patients with -6.0D to -7.0D refractions had axial lengths ≥26.0mm, rising to nearly twothirds at -8.0D and 86 per cent at -9.0D. “When we speak of myopia, what is your definition? How do you treat it at the corneal level or in a lenticular plane?” Dr Tassignon asked.

Courtesy of Sonia Yoo MD

igh myopia presents a variety of challenges in choosing among corneal and lenticular refractive surgical solutions. Beyond refractive error, patient age, corneal and retinal characteristics, cataract development, anterior segment anatomy and axial length are among factors to consider, according to an expert panel at the Ophthalmology Futures Forum Barcelona 2015, in Spain. Wide biometric variability and prevalence of anatomic anomalies among patients with long eyes and high myopic refractive errors complicate lens power calculations, noted panel moderator Marie-José Tassignon MD, PhD, FEBO, Professor and Head of the Department of Ophthalmology at University Hospital Antwerp, Belgium. Similarly, lack of biomechanical data can make corneal ablation uncertain. New instruments that measure features such as corneal stiffness and capsular bag volume may help improve refractive outcomes, she added.

Phakic posterior chamber IOL

The answer depends on the patient, said Michael Mrochen PhD, founder and CEO of IROC Science, Zurich, Switzerland. Some patients may not be suitable for corneal surgery at all, while it might be appropriate for a younger patient who still has accommodation, while an older patient without accommodation might be better off with a lens implant. “A treatment paradigm based only on the patient biometrics in my opinion is not really adequate, and might be misleading,” he said. At the Singapore National Eye Centre, most refractive procedures are LASIK or small incision lenticule extraction (SMILE), though she does not do refractive procedures herself, said Soon Phaik Chee FRCOphth. Long axial lengths are very common in Singapore, which is the most myopic city in the world, and therefore are not usually considered a contraindication for surgery, she added. “Whether a patient has a lens replacement or corneal refractive procedure does not depend on axial length, but on the absolute sphero-cylinder equivalent. My colleagues correct up to -15.0D provided the cornea is thick enough,” she said. However, very high corneal corrections can produce poor visual outcomes, noted Abhay Vasavada FRCS, founder of Raghudeep Eye Hospital, Ahmedabad, India. “Any time you have to do more than 100 micron removal the aberration profile is very high… in reality we don’t end up doing

When we speak of myopia, what is your definition? How do you treat it at the corneal level or in a lenticular plane? Marie-José Tassignon MD, PhD, FEBO

more than -8.0D on the cornea,” he said, generally preferring the Visian ICL phakic intraocular lenses (IOLs) for higher myopes. But phakic IOLs may accelerate cataract formation, narrowing the target population, said Sonia Yoo MD, Professor of Ophthalmology at Bascom Palmer Eye Institute, University of Miami, USA. She also avoids lens extraction for safety reasons. She prefers phakic lenses in patients aged 30 to 50 years. “While lens surgery is very very safe, there are some catastrophic things that can happen, particularly in high myopes, including retinal tears and detachments,” Dr Yoo said. By comparison, most complications with laser surgery are relatively easy to treat as long as reasonable treatment parameters are adhered to.

CHALLENGING Laser surgery is also more economical and better at hitting the refractive target, Dr Yoo added. Multifocal lenses are particularly challenging in myopes because they tend to have retinal issues that lower contrast sensitivity, or maculas that are displaced relative to multifocal image projection, Dr Tassignon said. Even extended-depth-of-focus lenses are problematic for myopic patients without cataracts, Dr Chee said. About 25 per cent are dissatisfied because of decreased contrast sensitivity even when refractive targets are achieved – which can be quite difficult in highly myopic patients. The question often comes down to what the cornea can withstand under laser surgery and still deliver good quality of vision. New technology that measures corneal elasticity may help determine in advance what the cornea will do, as will a better understanding of the relationship between the anterior and posterior corneal surfaces. “Besides biometric parameters we need more information about the biomechanics of the cornea. This is absolutely imperative but we do not have it yet… we hope such devices will come up in the near future,” said Dr Tassignon. Marie-José Tassignon: marie-jose.tassignon@uza.be Michael Mrochen: michael.mrochen@irocscience.com Soon Phaik Chee: chee.soon.phaik@singhealth.com.sg Abhay Vasavada: icirc@abhayvasavada.com Sonia Yoo: syoo@med.miami.edu EUROTIMES | JUNE 2016

CATARACT & REFRACTIVE

Below: The patient’s eye is docked to the laser to eliminate eye movements during laser procedure Right: Overview of the femtosecond-laser automated steps of cataract surgery (capsulotomy, lensfragmentation, corneal incisions, and arcuate incisions)

Courtesy of University Eye Clinic Maastricht

Left: Perfect circular capsulotomy created with the femtosecond-laser Above: A perfect circular rhexis created with the femtosecond-laser allows IOLs to clamp into the capsulorhexis, without risk for the lens to dislocate postoperatively

EVIDENCE FOR FLACS Review finds early RCT data favourable, but more evidence needed. Cheryl Guttman Krader reports

n evaluation of current high-level evidence shows that femtosecond laser-assisted cataract surgery (FLACS) provides some advantages compared with conventional phacoemulsification. However, it remains unclear whether the advantages translate into better patient satisfaction and/or quality of life, said Rudy MMA Nuijts MD, PhD. Speaking during the main symposium on FLACS at the XXXIII Congress of the ESCRS in Barcelona, Spain, Dr Nuijts presented findings from a review of published clinical randomised controlled trials (RCTs) comparing FLACS and conventional phacoemulsification cataract surgery. Using Forest plots to display individual study findings for various endpoints and the summary statistics from data pooling, Dr Nuijts reported statistically significant differences favouring FLACS over conventional phacoemulsification in analyses of capsulotomy circularity and intraocular lens(IOL)-capsule overlap; IOL tilt and decentration; phacoemulsification energy and effective phacoemulsification time (EPT); endothelial cell loss and early corneal thickness increase; refractive error; and corrected distance visual acuity (CDVA) at six to 12 months postoperatively. EUROTIMES | JUNE 2016

The two procedures did not differ significantly in uncorrected distance visual acuity (UDVA) up to one year postoperatively, increase in clear corneal thickness over time, or complication rates (anterior capsular tears, posterior capsular tears, macular oedema). None of the studies included in the review reported on patient satisfaction or quality of life. “A meta-analysis of randomised clinical trials comparing FLACS and conventional phacoemulsification published just prior to this meeting (Sci Rep. 2015 Aug 13;5:13123) echoed the results I shared today. Importantly, however, an adequately powered long-term outcome study is still needed to determine the impact of FLACS on patient outcomes and quality of life after cataract surgery,” said Dr Nuijts, Professor of Ophthalmology, Maastricht University Medical Center+, The Netherlands. Although the first FLACS case was performed almost seven years earlier, a search of literature published through to June 2015 identified only nine RCTs comparing FLACS and conventional phacoemulsification. Together with his colleagues Valentijn SC Webers MD, and Laura HP Wielders MD, Dr Nuijts extracted data from the papers to answer four key questions: 1) Does FLACS improve intraoperative parameters?; 2) What is the impact of

CATARACT & REFRACTIVE FLACS on visual and refractive outcomes?; 3) How does FLACS affect the complication rate?; and 4) Does FLACS improve patient satisfaction and quality of life?

INTRAOPERATIVE PARAMETERS The evaluation of intraoperative parameters considered endpoints related to clear corneal incisions, capsulotomy, and nuclear fragmentation. Only one trial included data on clear corneal incisions morphology, and they showed a significant lower percentage of endothelial gaping and misalignment in the FLACS group compared to conventional phacoemulsification. Three trials evaluated capsulotomy circularity and two reported on IOL-capsule overlap, and their results consistently favoured FLACS. Data from two RCTs showed statistically significantly less IOL decentration and tilt (vertical and horizontal) when the femtosecond laser was used to create the capsulotomy. Data on nuclear fragmentation were available from three RCTs for phacoemulsification energy and for EPT from four RCTs. FLACS had a benefit in the pooled analysis for both endpoints. There were also data to suggest that more efficient nucleus fragmentation translated into less corneal trauma, as assessed by changes in central corneal thickness early after surgery and endothelial cell counts.

POSTOPERATIVE OUTCOMES Three RCTs included data on UDVA, and the pooled analysis found no significant differences between FLACS and conventional phacoemulsification at any follow-up interval through one year after surgery. Four RCTs reported on CDVA, and collectively their results showed a slightly better outcome with FLACS at one week and six months after surgery, but not at intermediate time points (one to three months). Only two studies analysed refractive outcomes, and their results showed the mean absolute error was significantly smaller in the FLACS group at one to three months after surgery than in eyes that underwent conventional phacoemulsification.

Safety analyses focused on capsular tears and macular oedema. Dr Nuijts noted that authors of a comparative cohort case series (Ophthalmology. 2014;121:17-24) suggested that postage-stamp perforations and additional femtosecond laser aberrant pulses could lead to a higher rate of anterior capsule tears after FLACS compared with conventional phacoemulsification. In a follow-up report (J Cataract Refract Surg. 2015;41:47-52), the same authors reported a higher rate of anterior capsular tears using FLACS versus conventional phacoemulsification, however no significant difference in posterior capsule tear rates were found between groups. In the review conducted by Dr Nuijts and colleagues, only two RCTs reported on anterior capsule tears, and the data showed that the rate with FLACS was low and not significantly different compared with conventional phacoemulsification. Posterior capsule tears were mentioned in two studies, but there were no cases of this complication in either trial. Two randomised trials also included macular thickness measurements from evaluations through followup to six months, and the data showed no significant difference between the two surgical groups.

CAVEATS TO CONSIDER Although the review focused on randomised clinical trials, Dr Nuijts noted some potential limitations and weaknesses that leave the conclusions of the research open to discussion. “The power calculations in some studies are not very realistic in describing expected differences, and most of the published studies are performed by consultants for the laser companies. In addition, technology evolves rapidly, and the initial results of these studies may be outdated by the introduction of updated technology. Therefore, in order to determine the impact of FLACS on quality of life and cataract surgery, adequately powered long-term outcome studies are needed,” added Dr Nuijts. Rudy MMA Nuijts: rudy.nuijts@mumc.nl Valentijn SC Webers: valentijn.webers@mumc.nl Laura HP Wielders: laura.wielders@mumc.nl

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CATARACT & REFRACTIVE

EUREQUO UPGRADE Over two million cataract cases, expanded data sets enhance registry. Howard Larkin reports

ith more than two million cataract cases (two million passed on 17 March 2016) recorded since its 2008 launch, the European Registry of Quality Outcomes for Cataract and Refractive Surgery (EUREQUO) is shedding new light on ocular surgery practices and outcomes. New variables added this spring – including data on cases lost to follow-up and questions specific to femtosecond laser-assisted cataract surgery (FLACS) – will make EUREQUO an even more useful and powerful research tool, explained Mats Lundström MD, PhD, who is clinical director of EUREQUO. “In some countries patients may go to an optometrist instead of the clinic for follow-up, and this makes it very difficult for surgeons and clinics to deliver follow-up data,” Dr Lundström said. The flexibility to enter cases without follow-up, or to complete cases by adding follow-up data later, will enable the registry to capture information on preoperative indications and surgical complications for a large number of procedures excluded under previous data entry rules, he added. To better track outcomes and complications for femto-cataract surgery, EUREQUO can now collect data on laser use for corneal incisions, capsulotomy, nuclear fragmentation and astigmatism treatment. Laser-specific complications, including docking failures and laser issues such as skips, may also be recorded. “There are a pretty large number of new variables for those,” said Dr Lundström, of Lund University, Sweden.

NEW CATEGORY On the refractive side, new variables include use of mitomycin C in corneal refractive surgery, the type of intraocular lens used in refractive lens exchange, intended monovision, and information on the small incision lenticule extraction (SMILE) procedure. EUREQUO has also built an automated data interface with Memira AB (which operates 45 refractive surgery units in Scandinavia), which Dr Lundström believes will yield about 25,000 new records annually to the refractive database. This now includes about 40,000 cases.

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Discussions are under way to build similar data interfaces with other large refractive surgery chains, he added. A new category has been added for surgeons in training. This will allow ocular surgery residents to track and more easily compare their outcomes with other trainees, Dr Lundström said. Later this year, patient-reported outcomes will be added for the first time, Dr Lundström said. Initially, these will include information regarding vision-related limitations on activities of daily living and quality of life, such as reading newspapers, driving, watching television and recognising faces - both for cataract and refractive surgery.

BIG DATA INSIGHTS Mining the two million EUREQUO cataract cases collected from centres in 18 countries is already yielding important clinical insights, particularly for rare complications and unusual combinations of risk factors, Dr Lundström noted. For example, analysis of “refractive surprise” cases, in which visual outcome was 2.0 dioptres to 6.0 off target, identified several significant risk factors. These are poor preop visual acuity (VA), younger age, myopic target refraction, ocular comorbidities and surgical difficulties such as previous corneal refractive surgery or corneal opacities. Moreover, adding risk factors multiplies the risk. Among patients with the three risk factors of pre-op VA of 20/200 or worse, age below 70 years, and target refraction of -2.0D, 9.5 per cent experienced refractive surprise. Adding glaucoma to the three raised the rate to 13.3 per cent, while adding amblyopia to the three raised it to 17.9 per cent. Adding corneal opacities increased it to 28.6 per cent. Without a large number of cases it would be difficult to detect how these unusual combinations affect outcomes, Dr Lundström said. Examining registry outcomes also complements randomised controlled trial results by recording outcomes among patients with conditions excluded in controlled studies, Dr Lundström said. “Using the registry like this you will find out what works in real life.” Patient-reported outcomes will yield information valuable for counselling patients on the trade-offs of various surgical options, Dr Lundström added. “With a multifocal lens, you may have more optical symptoms but have a nice convenience because you are spectacle free.” Eventually, EUREQUO will expand to include data on other conditions, such as corneal transplant surgery (an agreement with the EU has recently been signed) and maybe paediatric cataract surgery, Dr Lundström said. Other plans involve to use EUREQUO as a case report form in a clinical study about toric intraocular lenses (similar to the FLACS study).

In some countries patients may go to an optometrist instead of the clinic for follow-up... Mats Lundström MD, PhD

EUROTIMES | JUNE 2016

Mats Lundström, clinical director of EUREQUO: mats.lundstrom@ karlskrona.mail.telia.com

CATARACT & REFRACTIVE

NEW TABLET HALOMETER

New OCULUS Smartfield

Device shows high repeatability in quantifying glare disability. Roibeard O’hEineachain reports

new tablet-based device, the Aston Halometer, provides a sensitive, repeatable and objective quantification of disabling glare, according to James S Wolffsohn OD, PhD, of Aston University, Birmingham, UK. The new halometer is designed to measure aspects of dysphotopsia commonly encountered with multifocal intraocular lenses, Prof Wolffsohn told the XXXIII Congress of the ESCRS in Barcelona, Spain. “Some people are more prone to report dysphotopsia than others. And we need to be able to support people when we feel that they have these symptoms,” he commented. The Aston Halometer consists of a bright light-emittingdiode (LED) glare source in the centre of a modern iPad tablet computer (Apple) placed at 2.0m from the patient. When undergoing halometry with the device, patients identify letters subtending 0.21° on the iPad screen as they move centrifugally from the LED in 0.05° steps, in orientation separated by 45° for each change in the level of contrast. An iPhone is used to control the eccentricity and the randomisation of the letters. “This halometer is very simple. You can detect light scatter and it also has what we call face validity. Patients are used to describing glare for example around car headlights so this test minics this effect,” Prof Wolffsohn said. He noted that in a validation study involving 20 patients with a mean age of 27.7 years, halo size as measured with the Aston Halometer increased with the different target contrasts (F=29.564, p<0.001) ranging from 1,000 to 25 Weber contrast units (Cw), as expected, and in a similar pattern to stray light measures (F=80.655, p<0.001).

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BEST COMPROMISE Courtesy of James S Wolffsohn OD, PhD

He added that lower contrast letters showed better sensitivity to glare effects, but larger glare-obscured areas resulted in ceiling effects due to the screen’s fieldof-view, with 500 Weber contrast units being the best compromise. Intra-observer and inter-observer repeatability of the Aston Halometer The Aston Halometer device, with was good, at 0.84-0.93 and 0.53-0.73, the iPad that is positioned at 2m, and the iPhone used to control the respectively, at 500Cw, and were similar eccentricity and randomise the letters to the stray light measurements with the CQuant (OCULUS). Moreover, unlike the CQuant, the new halometer differentiates between the glare effects of monofocal, concentric diffractive multifocals and segmented multifocal lenses. The findings of the Aston team were published in the November 2015 issue of the Journal of Cataract & Refractive Surgery. Prof Wolffsohn added that he and his associates are in the process of commercialising their new device. “The Aston Halometer provides a sensitive, repeatable way of objectively quantifying subjectively reported glare discomfort,” Prof Wolffsohn added.

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James S Wolffsohn: j.s.w.wolffsohn@aston.ac.uk EUROTIMES | JUNE 2016

10–14 September

2016

XXXIV Congress of the ESCRS

Main Symposia n

Modern Corneal Transplantation

Cataract, AMD and Beyond

Astigmatism Management in Cataract Surgery

Femtosecond Laser Ophthalmic Surgery

Management of the Ocular Surface before and after Refractive Surgery

Better Outcomes in Glaucoma

Ridley Medal Lecture José Güell SPAIN 30 Years of ‘Iris Claw’ IOLs

Presbyopia Day Tuesday 13 September n n

Presbyopia Workshop Main Symposium: Management of the Ocular Surface before and after Refractive Surgery

Free Paper Sessions

Instructional Courses

Young Ophthalmologists Programme Poster Village 122 Instructional Courses 65 Surgical Skills Courses

www.escrs.org /ESCRS @ESCRSOfficial ESCRS

XXXIV

Congress of the ESCRS

10–14 September 2016

O P E N H A G E N

Saturday 10 September

Sunday 11 September

Lunchtime Symposia

13.00 – 14.00

Ziemer Satellite Meeting

Pentacam® AXL and Corvis® ST: New Approaches for Combining Tomography with Biometry and Biomechanics

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Mini WELL, the Progressive EDOF IOL: One Year Later Moderator: G. Auﬀarth GERMANY D. Pinero SPAIN New preclinical optical assessments G. Savini ITALY Final results of multicentric study G. Auﬀarth GERMANY Preliminary results of a prospective trial Sponsored by

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Sunday 11 September

Monday 12 September

Lunchtime Symposia

13.00 – 14.00

Boxed Lunch Included

Complex Cataract Cases, The Simple Truths Moderator R. Osher USA R. Osher USA Diﬃcult cases rescued by the new Malyugin Ring B. Malyugin RUSSIA Small pupil and FLACS S. Masket USA Little instruments can help big problems Sponsored by

Near Live Surgery: A World of Choice Innovative Procedures Across All Patient Ages Moderator: T. Neuhann GERMANY Sponsored by

Ellex ABiC Symposium Sponsored by

New Technology for Improved Refractive Outcomes with the LENSTAR Sponsored by

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Sunday 11 September

Evening Symposium 18.00

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Monday 12 September

Lunchtime Symposia Boxed Lunch Included

13.00 – 14.00 Alcon Satellite Meeting

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Abbott Satellite Meeting Supported by an unrestricted educational grant from

A New Era of Trifocality by PhysIOL Moderator: K.G. Gundersen NORWAY

S. Marcos SPAIN Chromatic aberration in patients implanted with hydrophylic and hydrophobic PhysIOL IOLs O. Findl AUSTRIA Clinical outcomes of the double C-loop platform with G-free raw material D. Gatinel FRANCE A new era of trifocality: clinically relevant optical properties P. Stodulka CZECH REPUBLIC A new era of trifocality: ﬁrst clinical outcomes

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Paediatric Cataract. Challenges and Successes in Developing Countries Moderator: R. Walters UK Sponsored by

C O P E N H A G E N

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CORNEA

CORNEA RESEARCH EuCornea launch open access peer-reviewed online journal.

Dermot McGrath reports

uCornea has taken another major step forward in its development with the launch of a new online journal dedicated to the field of corneal research. The broad goal of JEuCornea, as the new journal has been called, is to promote the study and learning of the science and practice of all matters related to the health and management of diseases of the cornea, ocular surface, tears and associated tissues of the eye. “We want to achieve this through the timely publication of highquality manuscripts from across the globe, complemented by expert reviews, commentaries and editorials with free access to all readers,” explained Prof Harminder Dua, editor-in-chief of JEuCornea. The journal will include articles related to the cornea and ocular surface, covering aspects of structure, function, biomechanics, refraction, imaging, diseases and their investigation, treatment and management. Instrumentation, interventions, innovations and aspects of delivery of care and its regulation will also be covered. Prof Dua told EuroTimes that the journal will be very specialtyfocused and also publish major reviews on current topics solicited from experts. “We will cover innovations in eye care delivery and novel innovations, including instrumentation and in particular eye-banking issues. Europe has been the source of numerous innovations in aspects of cornea and ocular surface. JEuCornea, whilst retaining a global perspective, is likely to have a European flavour,” he said. All publications will be online and in English, but translations into other languages of full articles or their abstracts may be considered. While some may question the wisdom of launching another scientific journal in an already crowded field, Prof Dua and the board of EuCornea believe that JEuCornea has a real contribution to make. “The field is packed but globally the number of researchers submitting papers is increasing and the acceptance rate of the mainstream journals is low or decreasing. As a consequence, many good papers from good researchers are struggling to get published,” he said. Prof Dua said that the proliferation of “dot com” journals has not necessarily led to improved quality. “A new journal seems to appear almost every other day, and authors are confused as the credibility of many of these journals is unknown. Some are no doubt good journals but others are very difficult to assess. We hope that, with the backing of an organisation like EuCornea and a publisher like Elsevier, we will be able to provide a platform that can be trusted and provide reassurance to authors and readers,” he added. The fact that JEuCornea is open access is another key advantage and sets it apart from many other mainstream journals, believes Prof Dua. “We hope to expand our readership and contributors in this manner and also provide a service to specialists in the field across the world, especially in countries where individuals and libraries often cannot afford to purchase access to all papers,” he said.

JEuCornea JEuCornea Journal of the European Society of Cornea and Ocular Surface Disease Specialists

“Finally, authors are welcome to communicate with me, as editor-inchief, or any member of the editorial board for questions or advice in relation to a proposed or submitted manuscript,” he said. While any new venture is fraught with difficulty and runs the risk of EuCornea failure, Prof Dua remains optimistic that JEuCornea will ultimately achieve its objectives. EuCornea “When EuCornea as a society was started seven years ago there was concern and scepticism. Today it is flourishing, with an ever-increasing membership and attendance at the annual conference. JEuCornea is being presented with the same questions and concerns. Time will tell, but the board of EuCornea and the editorial board of JEuCornea are confident and motivated to see this through,” he concluded. Journal of the European Society of Cornea and Ocular Surface Disease Specialists

J J

Journal of the European Society of Cornea and Ocular Surface Disease Specialists

Harminder Dua, editor-in-chief of JEuCornea: harminder.dua@nottingham.ac.uk To access the JEuCornea online journal, go to: www.journals.elsevier.com/journal-of-eucornea

CONSTRUCTIVE COMMENTS Prof Dua said that would-be authors should not hesitate to put JEuCornea at the top of their list of potential journals for submission. “We will provide a very rapid turnaround and decision, with constructive comments for revision and improvement where needed. I would also advise authors to read the instructions for submission provided on the website and not to be afraid to submit work that has been rejected elsewhere, as all material received will be given a complete and fair assessment.

aegean

summer school in Visual Optics

EUROTIMES | JUNE 2016

7th EuCornea Congress

OPENHAGEN2016 9–10 September

Bella Center, Denmark

2 Days. 4 Symposia. 8 Focus Sessions.

4 Courses. 6 Free Paper Sessions.

EuCornea Medal Lecture Friday 9 September

16.00 – 17.00 (At the Opening Ceremony) Cultivated Stem-cells for Ocular Surface Disorders: Current Application and Future Perspectives

Corn

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C o r n

European Society of Cornea and Ocular Surface Disease Specialists

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Friday 9 September | 13.00 – 14.00 Théa Satellite Meeting Sponsored by

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CORNEA

ENDOTHELIAL DYSFUNCTION Preclinical and clinical results encouraging for cell injection therapy. Cheryl Guttman Krader reports

he development of cultured endothelial cell therapy for eyes with bullous keratopathy is a work-in-progress for Shigeru Kinoshita MD, PhD, and colleagues. Speaking at the 6th EuCornea Congress in Barcelona, Spain, Dr Kinoshita gave a brief history of the project that began in 2003 and entered a clinical research phase in 2013. So far, there are promising results in a limited number of eyes injected with cultured human corneal endothelial cells (cHCECs). More work needs to be done, however, before this “advanced cell therapy” can move into a larger clinical trial. The ultimate goal of corneal transplantation for endothelial dysfunction is to obtain a cornea with a high endothelial cell density and long-lasting, good physiological function, said Dr Kinoshita, Professor and Chairman of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. “Endothelial transplantation with cHCECs has several possible advantages compared with grafting tissue from donor eyes. Using a single young donor cornea, we could obtain master cells with good longevity and physiological function and conceptually treat many patients, perhaps more than 100 or 1000, in a procedure that is minimally invasive,” he said. The work began in a monkey model with cultivation and transfer of a corneal Shigeru Kinoshita endothelial cell sheet. Achieving only partial success, that approach was abandoned in favour of a technique based on injecting a suspension of cultured cells, and corneal endothelial recovery was achieved in rabbit and monkey models. Culturing of HCECs suitable for transplantation in human eyes proved more difficult, but Dr Kinoshita and colleagues developed a successful protocol that incorporates a rhokinase inhibitor, mesenchymal stem cell-derived conditioned medium, and TGF-beta signalling inhibition. Having found that the cHCECs represent heterogenous subpopulations, they have also characterised markers to identify the welldifferentiated cells that are desired for injection. Dr Kinoshita presented a case of a 58-year-old patient injected with cHCECs for treatment of Fuchs’ corneal dystrophy. After five months, the patient’s central corneal thickness had decreased from 725 microns to 543 microns and best corrected visual acuity improved from 0.06 to 1.0. In preparation for a larger clinical trial, ongoing work is focusing on quality-control issues to assure the cultivated product is safe and stable. With safety in mind, another recent study investigated whether injected cells exiting the eye into the peripheral circulation might accumulate or proliferate ectopically. Assessments of tissue from numerous organ systems in monkeys undergoing anterior chamber cHCEC injection showed no abnormalities by histological evaluation or evidence of human DNA using polymerase chain reaction assays.

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RETINA

GENE THERAPY UPDATE Frustration with gene therapy results gives way to hope. Roibeard O’hEineachain reports

n improved improvement,” said Dr understanding of Fischer, who delivered his the dose response Ophthalmologica lecture at characteristics of gene the Young European Retinal therapy for hereditary Specialist Group (YOURetina) retinal disease may session at the 15th EURETINA lead to better outcomes with Congress in Nice, France. future treatments, according to Underdosing might also Dominik Fischer MD, Centre for explain why the older patients Ophthalmology, University of had the most pronounced and Tübingen, Germany. sustained improvements in the Dr Fischer noted that the UCL study. Generally, older landmark gene therapy studies patients have more advanced by James Bainbridge MD, PhD disease and therefore less and his associates at University tissue to treat. This results in a College London (UCL), UK, higher dose per RPE cell being and Albert Maguire MD and transduced with the RPE65 gene. colleagues at University of Another explanation might be Pennsylvania, USA, showed that the patients received the that in a small series of patients treatment at too late a stage of with Leber congenital amaurosis their disease to stop the ongoing (LCA) there was a functional degenerative process. improvement in the areas of Despite some of the the visual field corresponding shortcomings of the early gene to areas of the retinal pigment therapy trials, they did establish epithelium (RPE) injected with with certainty that it is possible modified adeno-associated virus to deliver billions of AAV (AAV) carrying the RPE65 gene. particles into the subretinal Schematic of viral gene therapy using an adeno-associated virus (AAV). A therapeutic AAV is a commonly found space safely. The studies also gene sequence is packaged into the capsid and the full AAV binds to the cell membrane and carries the gene sequence to the nucleus. The genetic sequence then allows the microorganism among the showed that it is possible to cell to make the therapeutic gene product healthy population, which is not administer gene therapy in known to cause a disease by itself. the second eye without any In addition, functional magnetic resonance imaging datasets of clinically relevant complications, such as an immune reaction. the treated eyes showed a fairly stable increase of activity in the Medical scientists around the world are showing no signs of matching side of the visual cortex data upon visual stimulation discouragement as research into gene therapy for retinal disease of the retina, but showed a decrease on the side of the cortex continues apace. Dr Fischer noted that the Centre for Ophthalmology matching the untreated fellow eye. in Tübingen (Directors: Karl Ulrich Bartz-Schmidt and Marius Ueffing) has received regulatory approval to go ahead with what will in fact be the first ocular gene therapy trial in Germany. FADING EFFECT The condition they will be treating is achromatopsia, a rare He noted that the replacement of the mutated genetic information condition due to mutations in the CNGA3 gene. Patients with in the treated RPE cells should, in theory, lead to long-term achromatopsia have a complete loss of cone function, resulting beneficial effect. However, some of the improvements in vision in low visual acuity with poor contrast sensitivity and no colour faded over time in several patients, with loss of visual function vision. The study is funded by the Kerstan Foundation and was becoming apparent in one to four years. developed by the RD-CURE consortium, which is coordinated One possible explanation for the loss of effect over time may be by Drs Bernd Wissinger and Martin Biel and consists of scientists that the patients did not receive an adequate dose of the virus. In from Tübingen, Munich and New York. the dog model, while all dogs showed behavioural changes, only The molecule which the CNGA3 gene codes for is part of a cation the animals treated with much higher doses showed improvements channel, without which the cone photoreceptors cannot function. also in electroretinography (ERG). Experiments with the knockout mouse model have shown proof “This fits nicely with what was found in the clinical setting. of efficacy and proof of principle in gene therapy for the condition. Patients were able to navigate more effectively under scotopic Patients in the phase I study will be divided into three dosage conditions, even when there was no proof of electrophysiological groups. To target the cone photoreceptors, Dr Fischer and his associates will create a retinotomy, temporarily detaching the fovea, injecting the therapeutic vector carrying the gene and then returning the fovea to its original position. Toxicology studies in non-human primates indicate that the approach is safe without relevant clinical inflammation or damage to the fovea and with acceptable bio-distribution. Courtesy of Dominik Fischer MD

Patients were able to navigate more effectively under scotopic conditions... Dominik Fischer MD

EUROTIMES | JUNE 2016

Dominik Fischer: dominik.fischer@med.uni-tuebingen.de

8–11 September 2016

COPENHAGEN 16th EURETINA Congress

Bella Center, Denmark

10 Main Sessions 20 International Society Symposia 30 Free Paper Sessions 45 Instructional Courses 4 Surgical Skills Courses

EURETINA Lecture Keynote Speaker: José Cunha-Vaz PORTUGAL The Blood-Retinal Barrier in Retinal Disease Management

Inaugural Richard Lecture Keynote Speaker: Gisbert Richard GERMANY Restoration of Sight: Prospects and Limitations of Artiﬁcial Vision and Stem Cell Therapy

Kreissig Lecture Keynote Speaker: Emily Chew USA Nutrition, Genes and Age-Related Macular Degeneration: What Have We Learned from the Trials?

/EURETINA

@EURETINA

EURETINA

www.euretina.org

EURETINA CONGRESS

8–11 September 2016

O P E N H A G E N

Thursday 8 September

Friday 9 September

Lunchtime Symposium

Lunchtime Symposia

13.00 – 14.00

Boxed Lunch Included

Allergan Satellite Meeting

Boxed Lunch Included

Bayer Symposium II Sponsored by

Sponsored by

Friday 9 September

Morning Symposia 10.00 – 11.00 Bayer Symposium I Sponsored by

ZEISS Satellite Symposium Sponsored by

Novartis Satellite Meeting Sponsored by

Heidelberg Engineering Satellite Meeting Sponsored by

Topcon Satellite Meeting Sponsored by

Optos Satellite Meeting

Boxed Lunch Included

Geographic Atrophy: The Patient Perspective Moderator: F. Holz GERMANY F. Holz GERMANY Welcome and introduction N. Bressler USA Beyond visual acuity: patientcentred outcome measures for GA U. Chakravarthy UK Functional impact of GA: insights into the natural history of GA from electronic care records G. Staurenghi ITALY Assessment of disease severity in GA F. Holz GERMANY Pathophysiology and progression of GA F. Holz GERMANY Concluding remarks Sponsored by

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Alimera Satellite Meeting

Nidek Satellite Meeting

Sponsored by

C O P Saturday 10 September

Morning Symposia 10.00 – 11.00

Alcon Satellite Meeting

Saturday 10 September

Lunchtime Symposia

13.00 – 14.00

Boxed Lunch Included

Novartis Satellite Meeting

Topcon Satellite Meeting

Sponsored by

Allergan Satellite Meeting

Bayer Symposium III

Sponsored by

The Future of Retina Technology is Approaching

Sponsored by

Moderator: Y. Le Mer FRANCE

Spark Therapeutics Satellite Meeting Sponsored by

DORC Satellite Meeting

Sponsored by

Second Sight Medical Products Satellite Meeting Sponsored by

Théa Satellite Meeting Sponsored by

Quantel Medical Satellite Meeting Sponsored by

Oertli Satellite Meeting Sponsored by

E N H A G E N

RETINA

The PRECEYES Surgical System

THE BIONIC SURGEON New robotics technology can enhance skill in retinal surgery.

he new PRECEYES Surgical System can significantly improve the accuracy and precision in the performance of retinal procedures, according to Marc de Smet MD, PhD, Lausanne, Switzerland. “For us as surgeons, robotics are best used as an assistant type of device. It is not meant to replace us, but rather to assist in carrying out precision tasks that are difficult or novel, or which go beyond our human capabilities,” he told the 15th EURETINA Congress in Nice, France. The robotics system uses the point of insertion into the eye as the point of reference for the motions of the instruments. The device has a pen-like interface through which the surgeon controls the robotic manipulator that controls the instruments inside the eye with up to 10.0µm precision. “One of the nice features is that, as you manipulate the interface, the tip of the pen translates exactly to the tip of the instrument inside the eye. When you are peeling a membrane you can define your plane so you don’t end up hitting the surface below,” explained Prof de Smet, who is Chief Medical Officer for the Preceyes company. Moreover, the PRECEYES Surgical System further facilitates retinal surgery by keeping track of the precise position within the eye where the surgery is EUROTIMES | JUNE 2016

Roibeard O’hEineachain reports

For us as surgeons, robotics are best used as an assistant type of device. It is not meant to replace us, but rather to assist... Marc de Smet MD, PhD taking place. Therefore, when exchanging instruments the surgeon can quickly return to the site of surgery, he said. “For a robotic system to be efficient it should be intuitive. In other words, you shouldn't have to spend your time remembering the sequence of events programmed to occur with the device,” he added.

IMPROVED PERFORMANCE He noted that in a study comparing surgeons with and without the PRECEYES Surgical System, performing procedures with automated assistance increased surgeons’ accuracy in all three major axes, but most notably so in depth. Improvements were up to 68-fold in accuracy and 12.5-fold in precision in a fully automated mode, and up to 3.5fold in an assisted mode. The maximum deviations were also significantly reduced when using the robotic system. In addition, the PRECEYES Surgical System doesn’t take up much space. It

can therefore be easily and conveniently combined with non-robotic surgery, without the need to move the patient mid-procedure. Some of the future challenges include the development of more advanced and automated functionalities. Developing new manoeuvres using the surgical robot involves the translation of surgical manoeuvres into independent engineering steps, which then can be computerised. “The new functionalities will be adaptable to surgeons’ preferences. And since you can record the motions you make during surgery, it can help you find the best way to do a procedure, optimising your surgical skills or developing new ones,” Prof de Smet added. Marc de Smet: marcdesmet@preceyes.nl

For more information on the system visit: www.preceyes.nl

Courtesy of Preceyes B.V.

RETINA

SECURE IOL POSITIONING Scleral haptic fixation effective for patients requiring lens exchange. Roibeard O’hEineachain reports

cleral haptic fixation can provide a secure positioning of a replacement intraocular lens (IOL) in patients who require IOL exchange due to late subluxation of the lens and capsular bag, according to Gábor B Scharioth MD, PhD, Augenzentrum Recklinghausen, Germany, and University of Szeged, Hungary. “This is a real sutureless technique and that means that we are not depending on the stability of the suture material. Prolene sutures, as are used in most cases, have a tendency to break after eight to 12 years, making refixation necessary,” Dr Scharioth told the 15th EURETINA Congress in Nice, France. He noted that the incidence of late IOL and capsular bag subluxation – generally occurring many years after IOL implantation – has increased markedly over the past decade. A study carried out in Sweden showed that the trend began there with patients who underwent cataract surgery after 1992. “Before 2000 most of the IOLs were not implanted into the capsular bag and therefore dislocation occurred mainly in the early postoperative phase. That is different from the situation we are faced with today,” Dr Scharioth said. Dr Scharioth noted that he opts for Gábor B Scharioth re-centration of a decentred intracpasular IOL only if the capsular bag is intact and the zonules are quite strong. In most such cases he uses, after reopening of the capsular bag, a capsular tension ring to improve centration. In most eyes with weak zonules the capsular bag is filled with excessive secondary cataract. Furthermore, often Nd:YAG laser capsulotomy was already performed and often laser pitts are present in the IOL optic. Dr Scharioth added that IOL re-fixation in eyes where there is a dislocated capsular bag can result in posterior capsular opacification material falling into the vitreous during the surgery. He noted that pars plana infusion will reduce that occurrence during explantation of a subluxated capsular bag-IOL-complex. When there is subluxation of the entire capsular bag and IOL complex, he opts for explantation of the lens and implantation of a replacement IOL using the scleral fixation technique he introduced 10 years ago. The scleral fixation technique involves first creating two ciliary sulcus sclerotomies 1.0mm to 2.0mm behind the limbus and exactly 180° apart, then using the scleral incisions to prepare a limbus-parallel intrascleral tunnel. That is followed by implantation of the IOL with a handshake manoeuvre, passing the haptic from one hand to the other with two special endo forceps. The haptics are then drawn into position and fixated into the limbal scleral tunnel without any suture. “So far we have not found any contraindication to this technique. It is a standardised technique that can be used with standard IOLs with predictable refractive outcome, low complication rate and excellent long-term stability,” Dr Scharioth added. Gábor B Scharioth: gabor.scharioth@augenzentrum.org EUROTIMES | JUNE 2016

PAEDIATRIC OPHTHALMOLOGY

MYOPIA BURDEN

Research on mechanisms for development aims to identify targets for intervention. Cheryl Guttman Krader reports yopia is currently considered to be an environmentally driven condition which develops in genetically susceptible individuals. As discussed by speakers at the 3rd World Congress of Paediatric Ophthalmology and Strabismus in Barcelona, Spain, research designed to identify the contributing genetic and environmental factors and how they interact will hopefully lead to effective strategies for myopia prevention or control. “Nowadays one of the main goals in genetics research is the identification of possibly modifiable factors and the translation ‘from bench to bedside’. This is especially important for myopia considering its prevalence and importance as a cause of EUROTIMES | JUNE 2016

low vision,” said Fabiana D’Esposito MD, PhD, University of Naples Federico II, Italy. “The real answers in complex traits such as myopia, however, probably lie in epigenetic mechanisms. Research in this way aims at understanding the effects of external stimuli in eyes genetically predisposed to develop myopia,” she added. Dr D’Esposito noted that findings from familial and twin studies provide strong evidence that isolated (non-syndromic) myopia can be inherited. However, it is a genetically complex trait with more than 20 associated genetic loci identified so far. The genes in those loci are involved in many different biological processes, including neurotransmission, ion channel function, extracellular matrix formation and stabilisation, retinoic acid metabolism, and ocular development. As suggested by authors of a study

demonstrating that an individual’s genetic risk of developing myopia was influenced by educational level, individual genes may be differentially affected by different environmental factors. “Speculating that not all classes of myopia-related genes contribute to the geneeducation interaction, the investigators of this study hypothesised that neurotransmissionrelated genes that are expressed in the outer retina may be particularly vulnerable to the effect of retinal defocus,” Dr D’Esposito said. “To make the scenario even more complicated, we need to consider that education means a large use of vision from near, which is more correlated to lifestyle. There are also studies associating intelligence and myopia, but there too it is not easy to make an objective evaluation of intelligence levels, as those can be interconnected with educational levels.”

PAEDIATRIC OPHTHALMOLOGY

THE OUTDOORS CONNECTION Discussing environmental factors, Kathryn Rose PhD, University of Technology Sydney, Australia, said that aside from education, time spent outdoors is the only other major variable that has been consistently reported to affect myopia risk. “Other reported environmental factors associated with myopia include urban dwelling and higher levels of intelligence, socio-economic status, and hours spent in near work and/or reading. However, these factors are likely to be intertwined with education and time spent outdoors, and whether they have an independent role remains to be teased out,” Dr Rose said. The first evidence that time spent outdoors may affect the development of myopia rather than time spent in near work came from the Sydney Myopia Study (SMS). Examining the relationship between near work, outdoor activities and myopia prevalence, the SMS found that children having a low level of outdoor activity and high level of near work had the highest odds ratio for myopia, whereas children doing a high level of near work who had a high level of outdoor activity were relatively protected. Subsequently, analyses of longitudinal data from the Sydney Adolescent Vascular and Eye Study (SAVES) generated similar findings. Findings from the Orinda Longitudinal Study of Myopia suggested that heritable myopia is not necessarily inevitable. In that study, the risk of a child becoming myopic decreased with increasing time spent playing sports, irrespective of the number of myopic parents. The evidence from epidemiological studies on time spent outdoors and myopia risk led to controlled interventional trials which demonstrated increased outdoor time reduced incident myopia. In the Guangzhou Outdoor Activity Longitudinal Study,

...environmental factors associated with myopia include urban dwelling and higher levels of intelligence... Kathryn Rose PhD schools were randomly allocated to add 45 minutes of outdoor activity class at the end of each day or to follow their normal activities. After three years, the cumulative incidence of myopia was significantly less in the intervention arm. In a study in Taiwan, increasing outdoor time by 80 minutes per school day through recess outside the classroom significantly reduced the rate of new onset myopia after just one year. Dr Rose noted that physical activity alone does not appear to account for the protective effect of increased time spent outdoors. Rather, being outdoors is what seems to matter, and the mechanism may involve exposure to higher intensity light stimulating retinal release of dopamine that inhibits axial

elongation. Findings from animal studies are consistent with this hypothesis. Dr Rose concluded her presentation by discussing a number of other factors which have been speculated to affect myopia risk. She said that many of them, including full correction of myopia, time spent watching television, vitamin D, and diet, can be dismissed either due to a lack of temporal association with the rise in myopia prevalence or lack of supporting evidence. “However, body posture for reading and viewing distance are two issues that warrant further investigation,” Dr Rose added. Fabiana D’Esposito: fdesposito@alice.it Kathryn Rose: kathryn.rose@uts.edu.au

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PAEDIATRIC OPHTHALMOLOGY

WHICH IOL FOR A CHILD? BIL IOL pushes back boundaries for primary lens implantation. Cheryl Guttman Krader reports

rimary intraocular lens (IOL) implantation is not always possible in paediatric cataract surgery, but when it is, the bag-in-the-lens IOL (BIL, Morcher) is the only implant that can be used in every case, said Marie-José Tassignon MD, PhD, FEBO. Dr Tassignon was speaking at a joint session of the 3rd World Congress of Paediatric Ophthalmology and Strabismus and the XXXIII Congress of the ESCRS in Barcelona, Spain. Reviewing the ranges of age (one to 119 months), axial length (16.71-28.40mm), and corneal curvature (36.0054.25D) from her series of paediatric eyes implanted with the BIL IOL, Dr Tassignon noted that no traditional one-piece or thee-piece IOL could be used in all of those cases. “With a total length of 7.5-8.0mm, the BIL implant can fit even the smallest eye. Moreover, the long-term results are beautiful,” said Dr Tassignon, Professor of Ophthalmology, Antwerp University, Belgium. The BIL implant is designed to prevent posterior capsular opacification (PCO). Published long-term results show it performs Marie-José Tassignon well. Among 46 paediatric eyes having at least five years of follow-up, 42 (91 per cent) maintained a clear visual axis (J Cataract Refract Surg. 2015;41(8):1685-1692). The BIL IOL prevents PCO by trapping lens epithelial cells within the capsule. Dr Tassignon suggested that this principle of the BIL IOL also explains the very low rate of glaucoma that has occurred in her paediatric cataract series. Implantation of the BIL IOL requires making identically and specifically sized anterior and posterior capsulorhexes. The capsule becomes sealed through apposition of the anterior and posterior capsulorhexis rims, which are placed into the implant’s circumferential interhaptic groove.

POSTERIOR LIP Dr Tassignon said that the posterior lip of the BIL haptic lies in Berger’s space. After objectification of the space by Jan Worst MD, Dr Tassignon developed the idea of using it to accommodate the BIL haptic. “We are not just putting the lens somewhere, we are putting it into an existing space,” she said. Dr Tassignon noted finding anomalies at the anterior vitreolenticular interface in a high proportion of paediatric eyes with congenital cataract (46 per cent). By presenting videos of surgeries in eyes with posterior capsule plaque and anterior persistent foetal vasculature, she demonstrated that it is still possible to implant the BIL IOL in such cases. In addition, with the use of bean-shaped rings as auxiliary support devices, the BIL IOL can also be used in eyes without good capsular and zonular integrity. The rings are placed into the sulcus and fit into the BIL IOL interhaptic groove.

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Marie-José Tassignon: marie-jose.tassignon@uza.be EUROTIMES | JUNE 2016

BOOK REVIEWS

RAPID REVIEW

Save the Date!

There are no secrets in ophthalmology, at least not regarding information known by some doctors and unavailable to others. That is the beauty of medicine: discoveries are eagerly shared, and the discoverers are rewarded for their efforts. Nevertheless, the PUBLICATION Ophthalmology Secrets OPHTHALMOLOGY SECRETS (Elsevier) series, now in EDITORS its fourth edition, has JANICE A GAULT & JAMES F VANDER made a name for itself as a go-to study guide for PUBLISHED BY ELSEVIER trainee ophthalmologists who are preparing for exams. The question-and-answer format (“How is Coats’ disease managed?”, for example) lends itself perfectly to collaborative study, with answers given in concise prose. As opposed to bullet-style lists, prose is likely to improve retention. Prose also allows the reader to prepare practice replies for oral examination or quizzing in the clinic. Edited by Janice A Gault and James F Vander, each of the 52 chapters was written by subspecialists. The chapters average 30 or so questions, progressing from the very simple (“What is proptosis?”) early in the chapter, to the complex later in the chapter, interspersed with the rather obscure (“Can posterior polymorphous membrane dystrophy recur in a corneal graft?”). Chapter headings include clinical presentations, such as “The Red Eye”; specific pathologies, such as “Retinopathy of Prematurity”; and clusters, such as “Miscellaneous Optic Neuropathies and Neurological Disturbances”. The book can be used not only for exam prep, but also for refreshing one’s memory of the management of less frequently encountered entities, and for rapidly reviewing a particular topic prior to attending a lecture. Medical students, trainees and general ophthalmologists can all benefit. Just make sure to hide it from your three-to-five-year-old daughter, as the pink accents on the cover will make her want to own it.

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PRESBYOPIA THERAPIES Presbyopia: Therapies and Further Prospects (self-published by Alain N Gilg) is a comprehensive review of presbyopia, from the biological etiology to the past, current and future treatment options. Starting with accommodation, that which is lost in presbyopia, Dr Gilg discusses the mechanism in depth, preparing the reader for the logic behind the many solutions that have been proposed throughout time. Optical compensations, such as spectacles, contact lenses, orthokeratology, laser refractive surgeries, phakic intraocular lenses (IOLs), intracorneal rings and inlays receive their own chapter. However, Dr Gilg is most interested in true accommodative restoration, such as accommodative IOLs, lenticular refilling and his own, patented invention, the cilio zonular tension ring (CZTR). A reader could do worse than start here for a detailed look at presbyopia. 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 | JUNE 2016

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INNOVATION

PRESBYOPIA ADVANCES Pioneer of femtosecond laser approach encouraged by recent developments. Cheryl Guttman Krader reports

he concept of treating the crystalline lens with an ultra short-pulse laser as a novel method of correcting presbyopia was first proposed by Ronald R Krueger MD, and Raymond I Myers OD, in 1998. Now, because of increased industry interest and advances in technology, this vision may be coming closer to reality. Speaking at the WOC 2016 in Guadalajara, Mexico, Dr Krueger, of Cleveland, USA, discussed the past, present, and future of this non-invasive procedure that aims to soften and increase the flexibility of the crystalline lens. Summarising evidence from research conducted so far, Dr Krueger said that reliable and significant accommodation restoration is theoretically possible and clinically promising with femtosecond laser lens treatment. In addition, no significant safety issues have emerged with the techniques used so far, and results are promising from initial clinical evaluations performed using a commercially available femtosecond laser rather than a prototype system. Furthermore, subsequent to corporate restructuring, there is a renewed focus on developing femtosecond laser crystalline lens treatment for presbyopia correction at LENSAR, the company co-founded by Dr Krueger for the purpose of developing a laser for accommodation restoration, and this application is also being pursued

by a second company, ROWIAK, Hannover, Germany. “Alpheon, which recently acquired LENSAR, has placed the necessary resources and commitment toward the commercial development of laser accommodation restoration. Now, if we can resolve the variability in the results of this procedure to get more consistent outcomes, I believe we will have a technique that might become a commercial product in the future,” Dr Krueger said. Following proof-of-concept research in human cadaver eyes, safety studies were undertaken to investigate cataractogenesis. “From these studies, we concluded that localised photodisruption of the lens with the femtosecond laser causes a local cataract, if you consider cataract as any micro opacity, but the cataracts are not visually significant or progressive. We also learned from these studies, however, that the treatment should probably avoid the centre of the lens,” Dr Krueger said.

VARIABLE OUTCOMES Assessments of efficacy among patients treated with a prototype laser, including measurement of objective accommodation and best distance-corrected near visual acuity (BDCNVA), showed variable outcomes. Average changes were modest, but some outliers demonstrated more dramatic benefit. “The device that is in commercial use for cataract surgery is significantly different to the prototype system used in the first

...I believe we will have a technique that might become a commercial product in the future Ronald R Krueger MD

clinical trial. It has a shorter pulse width, reduced pulse energy that should limit collateral effects, sophisticated lens and anterior segment diagnostic capabilities, and a fluid interface that minimises laser light scatter,” Dr Krueger said. He reported that in 2014, Sunil Shah MD, in Birmingham, UK, used the commercial laser to treat 20 eyes of patients ages 40 to 55 years. The best results were achieved in eyes that were emmetropic, which comprised about half of the series. Whereas none of the emmetropes had 20/40 or better BDCNVA at 40cm prior to treatment, all achieved that level of vision at one month postoperatively. In addition, the preferred viewing distance decreased from an average of 45.83cm to 37.17cm. Among the nonemmetropes, the proportion with 20/40 or better BDCNVA increased from 7.7 per cent pretreatment to 38.5 per cent at one month, and the average preferred viewing distance decreased by 4cm, from 50.3cm to 46.3cm. “Although the results were not quite as good in the non-emmetropes, they were still promising enough to support further study,” Dr Krueger said. After a pilot trial, ROWIAK sponsored a two-centre study including 30 eyes of patients aged 50 to 65 years. Results from optical coherence tomography and wavefront imaging showed that the treatment resulted in increased thickening of the crystalline lens during accommodation, which was accompanied by increases in refractive power and spherical aberration. Dr Krueger said that research now under way is trying to determine whether treatment performed closer to the centre can achieve greater lens flexibility and with acceptable safety. He also suggested the idea of obtaining synergistic benefit from combining the lens procedure with a scleral treatment. Ronald R Krueger: krueger@ccf.org

Türkiye TURKISH LANGUAGE EDITION ONLINE Visit: www.eurotimesturkey.org EUROTIMES | JUNE 2016

ESCRS NEWS

EU-EYE board members at its 2015 launch in Barcelona

...watch the video

ESCRS

NEWS

NEW EU-EYE WEBSITE EU-EYE, which was officially launched during the XXXIII Congress of the ESCRS in Barcelona, Spain, now has a new website: www.eueye.org EU-EYE was established after nine European subspecialty ophthalmology societies decided to join forces in order to raise political and public awareness of ophthalmology and secure increased funding for vision research. The members are ESCRS, EURETINA, EGS, EVER, EEBA, EPOS, EuCornea, EASDec and EVI. “We decided to pool our efforts in order to have better visibility and better performance, and also to focus on broader issues rather than focus on specific eye diseases,” said EU-EYE founding president Prof Thierry Zeyen, of the EGS. Prof Einar Stefánsson, EURETINA, is the current EU-EYE president. EU-EYE is working around three main themes: firstly, increasing and sustaining political awareness for ophthalmic subspecialties; secondly, raising the profile of ophthalmology within EU research funding; and thirdly, gathering and disseminating information among stakeholders in the field and at political level. Since its launch, EU-EYE has liaised with stakeholders to identify possible partners already active in Brussels. More details are available on the website at: www.eueye.org

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ESCRS VIDEO OF THE MONTH DISCUSSES FLACS In the ESCRS Video of the Month for May, Dr Brian Little, UK, discussed the video ‘Complex cases made simpler: FLACS in difficult and challenging cases’, by Armando Crema and Aileen Walsh, Brazil. The Video of the Month is an educational initiative from the ESCRS,

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EUROTIMES | JUNE 2016

HOSPITAL DIARY

READY TO START?

Seeking your first job as a vitreoretinal surgeon is a nerve-wracking experience. Dr Leigh Spielberg reports

here will you be working n e x t year?” a s k e d Prof Jan van Meurs, my vitreoretinal fellowship director, on the first morning of my fellowship, just before we entered the operating room. I felt an unpleasant wave of stress flow through my body. I hadn’t yet figured out my next step, despite my training hospital’s unwritten rule that a fellow will not be trained unless she or he already has a position waiting thereafter. “I haven’t made a decision yet,” I replied. “But I’m working on it.” Which I was. I had the advantage of having been trained in a well-known centre where an ambitious and focused resident can graduate with 300 solo phacos, 100 nights in the hospital on call and at least six months of subspecialty training even before starting a fellowship. So I figured there was legitimate demand for what I had to offer.

Applying for work as a doctor is unlike most other job searches. A new colleague might remain for the rest of his or her career. Thirty-plus years! Once they’ve said ‘Yes’ to you, once you’ve signed a contract, you might be there forever, for better or worse. This makes them very interested in personality and interpersonal interactions, maybe even more so than ophthalmology skills. I had heard someone say: “Any well-trained ophthalmologist will continue to improve as a physician, but an irritating colleague will be annoying for 30 years!” So, those who interviewed me tended to take me out to lunch or dinner, to spend time with me. “What are your interests? Hobbies? What do you do in your free time? Are you married? Do you have children? Have you done any interesting travelling?” they frequently asked. At first I thought these questions were intended to screen out applicants who might be away from the clinic too often, but I soon realised that they were I felt an unpleasant wave of stress flow instead intended to gauge the through my body. I hadn’t yet figured applicants’ well-rounded, sociable nature. out my next step... Occasionally a question or BECOMING AN EXPERT comment would throw me for a loop. “You look quite a bit like the But what did I want? How does one decide? What was I looking young doctor who writes for EuroTimes,” said the chief of a very for? And, maybe just as importantly, what was I trying to avoid? nice clinic in Belgium. “Have you ever read any of his articles? He My colleague ophthalmology resident, Niels Hoevenaars, had writes all about his experiences as a resident in training.” done some good research. Umm… was he kidding? Was this a funny little test to see how “There are 10 general ophthalmology positions within 10 I’d react to an unexpected question? An issue of EuroTimes was kilometres of Rotterdam,” he said one day. “It’s as though every lying on his desk, between him and me. A young colleague of his Dutch ophthalmologist is retiring this year. It’s incredible!” leaned in to inform him that the writer and the person he was That was great news for many of my colleagues, but this was not interviewing were one and the same. the case for retinal surgery. There were a few vacancies, but the He looked at me and we had a good laugh. I was very interested location was either too far away, or I would be working solo. I was in working with him, but I would be the only vitreoretinal not yet interested in simply practising VR surgery independently surgeon. Other interesting possibilities included a big-city solo without first further sharpening my skills under the guidance of practice that I had been offered to take over and transform into a master. Even after a full year of intense vitreoretinal surgery a private vitreoretinal clinic; joining a well-organised 10-doctor training, I felt I owed it to my future patients to try to become a group in southwestern Netherlands; and various other part-time real expert in the field, not just someone who had taken only the positions that would allow me to perform a great deal of elective necessary steps. macular surgery. I was ready to do this, but not willing. At least not yet. Not at INTERPERSONAL INTERACTIONS this stage in my career. I still had too much to learn from other, So I made a few phone calls to friends, acquaintances and more experienced colleagues. But no offers from established ex-colleagues, all to get a feel for what was on offer. I responded groups were forthcoming, until I received a call back from… to a few online advertisements and sent out several applications. Many practices were interested in adding vitreoretinal surgery to ...To be continued in a future issue of EuroTimes their portfolio, but there were no vitreoretinal surgery practices Dr Leigh Spielberg is a vitreoretinal and cataract surgeon actively trying to enlarge their group. EUROTIMES | JUNE 2016

Illustration by Eoin Coveney

INDUSTRY NEWS

NEWS IN BRIEF

Rayner’s new state-of-the-art Ridley Innovation Centre

PRECISION IN CATARACT SURGERY Leica Microsystems, in partnership with TrueVision Systems Inc, has launched the IOLcompass Pro. “IOLcompass Pro is a software-based guidance system for preoperative planning and intraoperative positioning of premium IOLs,” said a company spokeswoman. “With traditional IOL guidance systems, surgeons can experience several inconveniences, which may affect precision. IOLcompass Pro is flexible and responsive with seamless interfacing, allowing surgeons to perform astigmatism corrections with the highest level of accuracy,” added the spokeswoman. www.leica-microsystems.com

INDUSTRY

NEWS

NEW CENTRE SHOWS AMBITION Rayner has officially opened The Ridley Innovation Centre, a new £20million R&D, training and production facility in Worthing, West Sussex, UK. The state-of-the-art, dedicated intraocular lens (IOL) production facility has the capability of manufacturing three million IOLs each year. In addition, a new Enterprise Resource Planning (ERP) quality system enables the company to trace every lens from source materials to a patient’s eye. “The opening of The Ridley Innovation Centre marks a significant step in what we plan - an exciting, transformative period of growth ahead of Rayner. This major investment will treble our manufacturing capacity and put us in the best position to support the company’s ambitious business expansion,” said Rayner CEO Tim Clover. The new centre has also been designed to enable training, education and research. Featuring a wetlab, library, training facilities and a museum on the history of the IOL, the company also plans to engage and partner surgeons and academics in new product development, with a product pipeline of 11 new products in three years. www.rayner.com

SUPPLY AGREEMENT Quantel Medical has announced that it has been awarded and delivered a €3million competitive tender for ophthalmic laser equipment. Under the terms of a supply agreement signed by the Directorate General of Armed Forces Medical Services of the Indian Ministry of Defence, Quantel Medical will provide 61 photocoagulator lasers (532nm Supra with Suprascan) for use in 53 military hospitals across India. www.quantel-medical.com

EXTENDED RANGE Dr Alex Huang at work

RESEARCH AWARD WINNER Dr Alex Huang is the winner of the Heidelberg Engineering Xtreme Research Award 2016 for his research on aqueous angiography and optical coherence tomography structural analysis of outflow pathways. He received the award in a ceremony during ARVO’s annual meeting in Seattle, USA. Dr Huang, who is a glaucoma clinician scientist at the Doheny Eye Institute and at the Department of Ophthalmology of the David Geffen School of Medicine at UCLA, presented the highlights of his current research. www.heidelbergengineering.com

NEW TOMOGRAPHIC KERATOCONUS CLASSIFICATION A new tomographic keratoconus classification/staging display is currently available on the OCULUS Pentacam®. “The Belin ABCD Keratoconus Staging independently grades the anterior corneal surface, posterior corneal surface, and corneal thickness,” said a company spokeswoman. The new display is a free update for all Pentacam®/Pentacam® HR users, and works retrospectively for all previously taken exams. This helpful classification display is included in the topometric software of every new Pentacam®/ Pentacam® HR device. www. oculus.de

Gebauer Medizintechnik GmbH says it has further refined the single-use head, releasing an even finer range of single-use heads, adding 25μm steps for more precision ultrathin DSEAK lamella preparation. “Every cornea is unique, therefore using your standard technique and just one of our refined range of head sizes, you achieve better results than ever. More head sizes, more flexibility, more precision delivers better outcomes,” said a company spokeswoman. www.gebauermedical.com

WE WANT YOUR NEWS

If you want your company news considered for inclusion in this section, send your press releases and high resolution images to Colin Kerr, Executive Editor, EuroTimes. Email: colin@eurotimes.org

EUROTIMES | JUNE 2016

JCRS

JCRS HIGHLIGHTS

VOL: 42 ISSUE: 4 MONTH: APRIL 2016

MACULAR DISEASE DETECTION BEFORE CATARACT SURGERY

Our members aren’t just predicting the future of eye surgery and patient care, they’re creating it. Belong to something powerful. Join us. www.escrs.org

A biometry device featuring swept-source optical coherence tomography (SS-OCT) appears to be useful for detecting macular pathologies prior to cataract surgery, especially for intraretinal fluid and macular holes. The consecutive case series included 125 eyes of patients with or without macular disease. All patients were scanned using the new biometry device (IOLMaster 700), which allows a 1.0mm central retinal scan using SS-OCT technology. Also, all eyes were assessed using a dedicated retinal OCT device (RTVue) on the same day. Of the 125 eyes included, five were excluded from the analysis, 65 had a macular disease, and 55 were healthy. The sensitivity of the biometry device was moderate (between 42 per cent and 68 per cent), and the specificity was high (89 per cent to 98 per cent). While the OCT biometry device was beneficial in terms of detecting macular holes and intraretinal fluid, other macular pathologies, such as atrophy and epiretinal membranes, were missed in several cases. Therefore, conventional spectral-domain OCT is still necessary to refine the presumed diagnosis made based on scans from the biometry device. N Hirnschall et al, JCRS, “Macular disease detection with a swept-source optical coherence tomography-based biometry device in patients scheduled for cataract surgery”, Volume 42, Issue 4, 530-535.

3D TORIC IOL ALIGNMENT Accurate alignment of toric intraocular lenses (IOLs) at the intended meridian is crucial to achieve intended astigmatism correction. A single degree of off-axis rotation produces a loss of up to 3.3 per cent of intended cylinder correction. A novel 3D computer-guided system (TrueVision) showed good accuracy in guiding the alignment of toric IOLs in femtosecond laser-assisted cataract surgery (FLACS). The 3D system used the anterior keratometry values to create an optimised plan for the toric IOL alignment. Intrastromal marks were created by the femtosecond laser at the intended toric meridian, guided by manual ink marks placed at the 3 o'clock and 9 o'clock limbus with the patient sitting upright. Intraoperatively, the 3D system was used to align the IOL and measure the angular position of the femtosecond marks relative to the IOL meridian. The 3D system proved equal in accuracy to manual marking for IOL alignment. The new system is a step in evolution towards a system that fully automates the entire process, including measurement of the anterior and posterior cornea, provision of algorithms for the IOL selection, and intraoperative guidance of the IOL. Such an approach would save time and improve accuracy, but would also increase costs, the researchers conclude. I de Oca et al, JCRS, “Accuracy of toric intraocular lens axis alignment using a 3-dimensional computer-guided visualization system”, Volume 42, Issue 4, 550-555.

THOMAS KOHNEN European editor of JCRS

Become a member of ESCRS to receive a copy of EuroTimes and JCRS journal

EUROTIMES | JUNE 2016

ESASO

ESASO MEMBER NETWORK Join the growing ESASO Alumni and Member community

he European School for Advanced Studies in Ophthalmology (ESASO) has established itself as a talent hub and first-rate educational institution of international appeal and reputation. Since its foundation in 2008, ESASO has trained over 1,700 young ophthalmologists in advanced scientific and clinical skills for the benefit of their patients. Particularly well-appreciated and well-attended are the annual Retina Academies with their high-level intellectual and social spirit, world-class faculty and creative session formats. These recurrent educational conferences always cover the latest developments in eye science, diagnosis and treatment, in a particularly supportive and engaging learning environment. ESASO’s five-full-week modules are another highlight, from which 60 graduates with a postgraduate diploma of Specialist Superior in Ophthalmology (DiSSO) have emerged so far. Eight ESASO fellows have received financial, organisational and advisory support for one year, to develop their skills as a guest at prestigious academic and clinical institutions. ESASO wishes to further support the young talents who attended the academies, modules and advanced courses. We are thus strongly determined to promote the network of alumni and members. This evolving and expanding community will provide ever better chances for organised and self-organised connections in the ESASO spirit, for further exchanging with colleagues and leaders in the field by mail and in person. ESASO is now offering a membership to its network, to contribute as well as receive ideas, and to initiate activities as well as assist and support members’ initiatives. Opportunities include continuing medical education, congress participation, publications and research, as well as tools to support your professional career. These tools will address topics such as technical innovation, publication support, hospital management, presentation skills, patient reports, good clinical practice, compliance, among others. We encourage, support and organise activities of all kinds and formats, to benefit from all possible synergies. We offer face-to-face educational modules as well as moderated webcast training of the type “ESASO eMasterClass”, and will potentially organise a Young Ophthalmologists Forum during the annual Retina Academy congress. The ESASO global member network can potentially connect you with 7,500 colleagues, and will develop and grow as an integral part of the already flourishing international ESASO community and network, which includes over 180 leaders in ophthalmology and a multitude of renowned universities and clinics from across the world. “Enhancing and developing the member network to full bloom is the next step and level to fill ESASO’s vision of collaboration with life. We are ardently dedicated to developing the member network into an even more vibrant community with benefits for all, and lots of extra values,” says Giuseppe Guarnaccia, Global Executive Director of ESASO. For further information and membership forms, please visit: www.esaso.org EUROTIMES | JUNE 2016

EURETINA is delighted to announce the

5th Retina Race at the 16th EURETINA Congress in Copenhagen

Date: Saturday 10 September, 6.30am Registration Fee: Ă?30 in aid of Orbis Information to follow at www.euretina.org

TRAVEL

The Standard – an old ferry terminal, a new dining spot

COPENHAGEN

TO NOTE...

COPENHAGEN

TIPS: Not expected DINNER: Served from 17.00 to 21.00 DRESS CODE: Smart casual

Copenhagen’s famous hot dog stands – 'pølsevogne', literally meaning ‘sausage wagon’ – first appeared on the street in the early 1900s. A cross between a cart and a mobile kitchen, you’ll find them on busy corners in squares, in parks. Try the classic ristet hot dog med det hele - that’s a grilled sausage in a hot dog bun, topped with ketchup, mustard, sweet pickled sauce, fresh and roasted onions, and pickled cucumbers. The bright red hot dogs are called 'rødpølser'. Once they were dipped in red dye to make them look fresh, now the red dye is just tradition. These come with a small bun and a dab of mustard on a paper plate. For the full effect, order a chocolate milk drink, a ‘cocio’, to go with your hot dog. Torvehallerne is a food market that seems to have caught Copenhagen’s imagination. Since opening in 2011, it has become one of the city’s top spots for shopping, snacking, meeting friends, people watching or even just sitting in the sun enjoying a picnic at an outdoor table. Over 60 stands are set out in a pair of glass-walled buildings - inside you’ll find flowers,chocolates, exotic spices, sushi, pastries, coffee and much else including several takeaway restaurants. One side of Torvehallerne fronts on to Israels Plads, where a huge pink stone from the Holy Land stands. It is a gift from 'friends of Denmark in Israel’, and bears the inscription 'Night fell and morning came’. It is located on Frederiksborggade 21. Open: 10.00-20.00 daily. In the mood for Smørrebrød? Well there’s an app for that! ‘Smorresbrod in Copenhagen’ will guide you to the nearest table when the mood for one of Denmark's famous super sandwiches overcomes you. It lists 12 smørrebrød restaurants in the city, including Schønnemann’s, which is said to be where chef René Redzepi of Noma fame likes to lunch. Or combine a look at colourful Nyhavn with a meal at Cap Horn. An historic restaurant with 19th century decor, it is touristic but welcoming. The Smørrebrød app also offers a dictionary of terms and a section on ‘cold table’ etiquette. The app is free from iTunes.

COPENHAGEN DINING

Delegates to the ESCRS Congress should start making dinner plans now. Maryalicia Post reports By the time the ESCRS meets in Copenhagen in September, Noma, in partnership with chef Kristian Baumann, will have opened a new, more casual restaurant simply called 108 (that’s its address on Strandgade). “In preparation, we’ve started collaborations with various farmers, and salted, pickled, and preserved all the delicious berries, plants, and flowers that nature has to offer,” Baumann said. Reserve at: www.108.dk, or take your chances for a seat at a ‘walk in’ table. Noma holds two Michelin stars and still tops the must-try list of many gourmets. Each month this 40-seat restaurant receives some 20,000 reservation requests. Go online three months in advance to try your luck at booking: noma.dk. Choosing the option of a ‘shared table’ improves your chances. Noma will serve its last meal in the present location at 93 Standgade on New Year’s Eve 2016, after which it will reopen on its own vegetable farm in the Christiana area.

on the ground floor, and Verandah, a pan-Indian restaurant, upstairs. Only four months after opening in 2013, Studio was awarded a Michelin star, the first among many distinctions. Chef Torsten Vildgaard, who worked at Noma’s test kitchen for eight years, has introduced Japanese and French elements to his Nordic-based creations. Open: Tuesday and Wednesday, 19.00-24.00; Thursday, Friday and Saturday, 12.0015.00 and 19.00-24.00. Closed on Sunday and Monday. Retour-Steak is the place for a simple steak perfectly presented. Lobster is also on the menu. It’s best to book at this popular dinner-only restaurant at Trommeasalen 5, about a 15-minute drive from the Bella Center. Website: www.retoursteak.dk See more travel reviews at: www.maryaliciatravel.com Inside The Standard

INSPIRED BY NATURE This year, restaurant Geranium was awarded its third Michelin star, the first of only two Scandinavian restaurants to achieve this distinction (the other is in Sweden). Rasmus Kofoed, the multiaward-winning chef, presents a set meal of 20 tiny courses ‘inspired by nature’. The restaurant is on the eighth floor of a building at the edge of a park, and the views are also inspired. Bookings are open three months in advance at: geranium.dk

ON THE WATERFRONT On Copenhagen’s waterfront, The Standard, once a customs building, houses three restaurants: Studio and Almanak EUROTIMES | JUNE 2016

EYE ON TECHNOLOGY

SMILE PROCEDURE Techniques such as FLEx and SMILE offer patients greater variety of options. Dr Soosan Jacob reports

efractive surgery is at an exciting stage of evolution. With newer techniques such as femtosecond lenticule extraction (FLEx) and small incision lenticule extraction (SMILE), patients wanting spectacle independence have a wider variety of options available. Here I will look at these latest developments, especially SMILE, which is developing as an even safer option than LASIK.

TECHNIQUE: All femtosecond laser-based refractive surgery developed following extensive work by Walter Sekundo and Rupal Shah, and was first developed as the FLEx procedure. While femtosecond LASIK involves creating a femtosecond laser flap followed by excimer ablation for refractive correction, FLEx uses the femtosecond laser itself to carve an intrastromal lenticule under the flap. This is done by creating two intersecting lamellar cuts â&#x20AC;&#x201C; a posterior lenticule cut and an anterior flap/cap cut that correspond to the posterior and anterior surfaces of the intrastromal lenticule, respectively. The characteristics of this lenticule can be varied. Thickness varies according to the refractive error of the patient and the diameter of the lenticule determines the optic zone. Once the lenticule is created, the flap is lifted and the lenticule removed in order to achieve refractive correction. SMILE was the logical next step which made flapless treatment possible. Here, the flap side cut was shortened to allow only a small opening in the flap, thereby converting the flap into a cap. The lenticule is then dissected from under the cap and extracted through this small incision, the size of which can be varied and can be set to be as EUROTIMES | JUNE 2016

small as 2mm. Cap thickness can also be varied, however at present a thickness of 120 microns is most commonly preferred and used (see Figures A-B).

ADVANTAGES OF SMILE:

an inability to treat hyperopia and absence of correction for cyclotorsion. Nomogram adjustments may however be made to achieve satisfactory correction of astigmatism.

INTRAOPERATIVE COMPLICATIONS:

The presence of only a cap and no flap confers numerous advantages. The absence of any potentially displaceable flap makes the procedure safer in both the short-term as well as the long-term. SMILE is a minimally invasive procedure with incision size as small as 2mm. The absence of a flap and a very small incision together bring about a decrease in flap-related complications. This results in decreased risk of striae, flap dislodgement, epithelial ingrowth etc. The anterior corneal innervation is less disrupted as compared to a flap, resulting in faster recovery of dryness and corneal sensitivity as compared to LASIK. The retention of a nearly intact anterior stronger layer of the cornea allows better maintenance of biomechanical strength after SMILE as compared to LASIK. The entire procedure is completed with a single laser, thus decreasing surgical time and cost. These advantages, along with visual and refractive outcomes similar to LASIK, give SMILE a superior edge to LASIK. Disadvantages include

Decentration may occur because of poor centration by the surgeon or with a patient unable to fix on the fixation light. Good centration needs to be confirmed before laser application and is generally not difficult in a cooperative patient. Suction may not build up in case of insufficient applanation, or if the eyelashes/drape or any other extraneous material is present within the applanating interface. These should be removed and the cornea reapplanated. Intraoperative suction loss is managed by repair cuts applied according to stage of suction loss. Excessive opaque bubble layer may indicate more difficult dissection. Uncut spots are rare and among other causes, may also be due to debris on the applanating glass which, if present, should be meticulously cleaned/replaced if necessary prior to laser application. Small uncut areas are generally not problematic, however large uncut zones can potentially cause difficult dissection and irregular

Figure A: Dissection of the SMILE lenticule

Figure B: SMILE lenticule extracted

EYE ON TECHNOLOGY minimally invasive nature of the procedure. Enhancement after SMILE is possible either as a surface ablation, a thinner femto flap created on the SMILE cap, or by using the CIRCLE software that converts the existing cap into a flap.

OTHER USES OF SMILE LENTICULE:

Figure C: A torn but completely extracted lenticule

Figure D: Small innocuous cap tear

astigmatism. During dissection, anterior and posterior lamellar planes should be carefully identified to avoid difficult separation and misdissection. Low powers have correspondingly thinner lenticules and these should be dissected with extra care to avoid lenticule tears (see Figure C) and retained lenticular fragments. To facilitate dissection in low powers, the lenticule thickness can be increased by increasing minimum lenticule thickness by adding a refractive neutral base. The cap may tear during dissection either due to faulty technique or sudden patient movement (see Figure D). If seen, the cap should be replaced carefully and allowed to adhere well without striae formation and a bandage contact lens applied.

more difficult to separate and can result in cap tears. I have described this sign as a technique to differentiate anterior from posterior plane. The white ring seen intraoperatively is a light reflex from the lenticular side cut, and the instrument seen above this ring indicates anterior plane dissection. Conversely, when the shaft of the instrument lies below this ring, it indicates posterior plane dissection.

WHITE RING SIGN: The cap cut (anterior plane) should always be dissected prior to the lenticule cut (posterior plane). The reverse results in a lenticule adherent to the cap which is

POSTOPERATIVE COMPLICATIONS: Epithelial defects should be avoided. These and other predisposing factors such as bleeding from cut peri-limbal vasculature, sebaceous secretions and other foreign material in the interface, may lead to diffuse lamellar keratitis. Other postoperative complications are similar to LASIK and can include undercorrection, overcorrection, transient interface haze, striae, ectasia, infection etc. Some of these complications are generally expected to be less frequent than after LASIK because of the innate

The SMILE lenticule has been used to treat hyperopia in a recipient eye and to seal corneal defects. I have pioneered the PEARL (PrEsbyopic Allogenic Refractive Lenticule) corneal inlay which uses a 1mm SMILE lenticule for presbyopia correction. This has shown very promising results.

CONCLUSION: SMILE is the latest form of refractive surgery which has come into its own because of good predictability, safety and efficacy, along with relative ease of surgery. Complications are rare and generally resolve favourably with no long-lasting effect on the patient's vision. Visionthreatening complications are rare. Dr Soosan Jacob is Director and Chief at Dr Agarwal’s Refractive and Cornea Foundation, Dr Agarwal’s Eye Hospital, Chennai, India, and can be reached at: dr_soosanj@hotmail.com

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CALLING ALL MARKETING GURUS!

ESCRS

Practice Management

& Development 11–12 September 2016

Copenhagen, Denmark

ESCRS Practice Management and Development Marketing Case Study Competition

BUSINESS

Winner of a €1,000 bursary will be announced during the XXXIV Congress of the ESCRS in Copenhagen, Denmark

UTILISE BUSINESS

To enter email colin@eurotimes.org

INNOVATE UTILISE BUSINESS

Submission Deadline Monday 15 August 2016 LEADERSHIP INNOVATE UTILISE BUSINESS

Further details at www.escrs.org DEVELOPMENT LEADERSHIP INNOVATE UTILISE BUSINESS

EUROTIMES | JUNE 2016

CALENDAR

JULY

Aegean Cornea 2016

1–3 July Crete, Greece www.ivo.gr/en/aegean-cornea/ meeting.html

↙

XXXth Meeting of the Club Jules Gonin

LAST CALL

JUNE 2016

12th EGS Congress

19–22 June Prague, Czech Republic www.eugs.org

6–9 July Bordeaux, France www.clubjulesgonin.com

Barcelona

29th APACRS Annual Meeting 27–30 July Nusa Dua, Bali www.apacrs.org

SEPTEMBER

12th JOI (Journées d’Ophtalmologie Interactives)

AUGUST

Echography Teaching Services – International Annual Course and Workshop on Diagnostic Ultrasound in Ophthalmology 29 August–2 September Munich, Germany www.echography.com

SEPTEMBER

8–11 September Copenhagen, Denmark www.euretina.org

114th DOG Congress

NEW Joint Irish and UKISCRS Refractive Surgery Meeting

46th ECLSO Congress (European Contact Lens Society of Ophthalmologists)

9–10 September Copenhagen, Denmark www.eucornea.org

30 September–1 October Paris, France www.eclso.eu

1–3 December Rome, Italy www.isoptclinical.com

2 December Dublin, Ireland Email: hmurphy@materprivate.ie

FEBRUARY 2017

21st ESCRS Winter Meeting 10–12 February Maastricht, The Netherlands www.escrs.org

OCTOBER

The European Association for Vision and Eye Research (EVER) Congress 2016

↙

XXXIV Congress of the ESCRS

DECEMBER

ISOPT Clinical 2016

29 September–2 October Berlin, Germany http://dog2016.dog-kongress.de

7th EuCornea Congress

18–19 November Barcelona, Spain www.imo.es/glaucoma2016

42nd Annual EPOS Meeting

23–25 September Zurich, Switzerland www.epos-focus.org

16th EURETINA Congress

10–14 September Copenhagen, Denmark www.escrs.org

23–24 September Toulouse, France www.joi-asso.fr

NOVEMBER

IMO – Trends in Glaucoma: Surgical & Medical Meeting

5–8 October Nice, France www.ever.be

AAO 2016

15–18 October Chicago, USA www.aao.org

EYE CONTACT

STUDIO INTERVIEWS with leading ophthalmologists EXCLUSIVE TO EUROTIMES! COMPLICATIONS OF CXL

Dr Paul Rosen interviews Prof Theo Seiler Available at http://player.escrs.org/eurotimes-eye-contact and the EuroTimes App

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