Volume 15_Issue 11

VOLUME 15

ISSUE 11 NOVEMBER 2010

COVER STORY:

MICS

MICROINCISION CATARACT SURGERY

ESCRS

EUROTIMES

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november 2010 Volume 15 | Issue 11 This month...

Special Focus: MICS 4

Cover Story: Experts discuss their experiences with micro-incision cataract surgery

Cataract

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12

8

Studies highlight benefits of femtosecond laser capsulotomy

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Reducing errors in postoperative ACD and refraction

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IOL power calculations important for refractive outcomes

Refractive Lens 12 New lens concepts discussed 13

Study shows IOL performs well in high myopes

Refractive Laser 14

Femtosecond lasers and LASIK flap creation

Cornea Update 16

Cross-linking treatment time could be reduced with new procedure

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FALK is a viable alternative to conventional methods

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Caution needed when choosing treatments for ocular surface reconstruction

Glaucoma Update

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19

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Adherence vital to glaucoma therapy

21

GDx can help reduce unnecessary follow-up of glaucoma suspect cases

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Three OCT devices are put to the test

Retina Update 24

Understanding PVR will help in management of primary retinal detachment

Global Ophthalmology 26 ORBIS 2010 Medal Winner 27

Global initiative to reduce cataracts

News 28

MICS will ultimately benefit the patient

29

EUREQUO in The Netherlands

30 New EBO president discusses future plans

Features

37

27 editorial staff

ESCRS

EUROTIMES

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Published by The European Society of Cataract and Refractive Surgeons Publisher Carol Fitzpatrick

Managing Editor Caroline Brick

Executive Editor Colin Kerr

Production Editor Angela Sweetman

Editors Sean Henahan Paul McGinn

Senior Designer Paddy Dunne

31 Outlook on Industry

37

Industry News

34

38

Legal Matters

34, 36 Journal Watch

39

JCRS Highlights

35

Book Review

40

Calendar

36

Bio-Ophthalmology

Assistant Designer Janice Robb

Seamus Sweeney Gearóid Tuohy

Circulation Manager Angela Morrissey

Colour and Print Times Printers

Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin

Advertising Sales ESCRS, Temple House, Temple Road Blackrock, Co. Dublin, Ireland Tel: 353 1 209 1100 Fax: 353 1 209 1112 email: escrs@escrs.org

Contributors Devon Schuyler Eisele Stefanie Petrou-Binder Maryalicia Post

Practice Development

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.

Cover image courtesy of Jorge Alio MD

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.

As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2009 and 31 December 2009 is 29,298.

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EUROTIMES

Editorial

ESCRS

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EDITORIAL

Medical Editors

Volume 15 | Issue 11

José Güell

Ioannis Pallikaris

Clive Peckar

Paul Rosen

A creative process

MICS can lead to better and safer outcomes for cataract patients

by Roberto Bellucci MD

International Editorial Board

T

his month’s EuroTimes focuses on micro-incision cataract surgery (MICS). I am very happy to see such extensive coverage being given in the Cover Story to this important topic that is renovating cataract surgery once again.

Continuing improvements in micro-incision phacoemulsification technology are reducing the complications and improving the results of our surgery. My personal view is that the theoretical support for reduced intraocular trauma is very strong, and as the article points out, the results of numerous studies comparing MICS with standard incision surgery support the theory that microincision surgery induces less corneal astigmatism than conventional surgery. However, in my opinion the most important advancement involved with MICS has been the better understanding of fluidics with improved safety, and I welcomed the opportunity to present on this subject at the session devoted to MICS during the XXVIII Congress of the ESCRS in Paris.

Of course there are differing views on this topic and I am glad to see the opinions of my colleagues Charles Claoue, John Hunkeler, William Fishkind and Phillippe Sourdille are also represented in this article.

The reduced corneal incisions typical of MICS are also driving the development of MICS IOLs, an entirely new series of IOLs designed with specific features rather than reduced versions of larger models. In this regard some compromise has to be agreed at the moment: hydrophilic acrylic material is more suitable than hydrophobic for MICS IOLs, with the relevant advantages and drawbacks. I presented a study at the congress showing a high rate of YAG capsulotomy at three years’ follow-up in eyes implanted with the Akreos MICS IOL, although in part due to a more proactive approach to PCO. The study involved 20 eyes which had been implanted with the Akreos MICS lens following biaxial phacoemulsification. At three years of follow-up, six eyes had undergone YAG laser capsulotomy because of reduced visual acuity.

As I have said before, different surgeons have different views and approaches to MICS and I would welcome any comments from colleagues on the articles on this topic.

Learning curve Also on the MICS theme, I would draw your attention to an article in the Research section in this issue.

Jorge Alio MD points out that more effective pumps, control of the aspiration flow, pressurised infusion to implement inward fluidics, minimal use of phacoemulsification and an overall decrease in the aggressiveness by decreasing phaco time and phaco power are the main hallmarks of MICS as a different surgical technique for cataract removal.

He makes the important point that the learning curve of surgeons influences MICS outcomes, as in every new emerging technology, but it is Dr Alio’s opinion that in the hands of experienced surgeons, MICS is better than the standard phacoemulsification.

EUROTIMES | Volume 15 | Issue 11

Emanuel Rosen Chairman ESCRS Publications Committee

Noel Alpins australia Bekir Aslan TURKEY Bill Aylward UK Peter Barry IRELAND Roberto Bellucci ITALY Hiroko Bissen-Miyajima JAPAN “In summary, MICS is a concept that involves the leadership in the progress of cataract surgery towards minimising incisions.

This progress in cataract surgery is made possible thanks to the contribution of creative surgeons and industry in close cooperation. The final destination of this progress is the cataract patient, who will benefit, in the immediate future, from better and safer cataract surgery outcomes,” states Dr Alio.

This month’s EuroTimes also features reports from podium presentations from the major ophthalmological meetings on refractive lens, refractive laser, cataract surgery, retina, cornea and glaucoma.

The next major ESCRS meeting is the 15th Winter Meeting in Istanbul from 18-20 February 2011, so make sure you keep reading EuroTimes for regular updates and also visit the ESCRS website at www.escrs.org.

John Chang CHINA Joseph Colin FRANCE Alaa El Danasoury SAUDI ARABIA Oliver Findl AUSTRIA I Howard Fine USA Jack Holladay USA Vikentia Katsanevaki GREECE Thomas Kohnen GERMANY Anastasios Konstas GREECE Dennis Lam HONG KONG Boris Malyugin RUSSIA Marguerite McDonald USA Cyres Mehta INDIA Thomas Neuhann GERMANY Gisbert Richard GERMANY Robert Stegmann SOUTH AFRICA Ulf Stenevi SWEDEN Emrullah Tasindi TURKEY Marie-Jose Tassignon BELGIUM Manfred Tetz GERMANY Carlo Enrico Traverso ITALY

Roberto Bellucci MD is a member of the EuroTimes Editorial Board and secretary of the ESCRS

Roberto Zaldivar ARGENTINA Oliver Zeitz germany

™

ISTANBUL 15 th ESCRS Winter Meeting in conjunction with the Turkish Ophthalmological Society Cataract & Refractive Surgery Division

18 – 20 February 2011

Hilton Hotel, Istanbul, Turkey

www.escrs.org

European Society of Cataract and Refractive Surgeons

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Cover Story

MICS

Making smaller better

Continuing improvements in micro-incision phacoemulsification technology are driving the development of MICS IOLs

by Roibeard O’hEineachain

“

I have serious reservations about our trend into MICS. I think there is good evidence that MICS does not alter the amount of corneal astigmatism, but the problem is most corneas do have a degree of astigmatism Charles Claoue FRCS

“

MICS is safer than conventional because you have better fluidics, whether you have a Venturi pump or a peristaltic pump Roberto Bellucci MD

EUROTIMES | Volume 15 | Issue 11

F

rom the earliest days, the goal of cataract surgery has been to minimise trauma to the eye and provide good postoperative vision.

Daviel’s approach 250 years ago was an advance on the couching procedure, continued improvements over the centuries led ultimately to what is now the standard technique of phacoemulsification followed by implantation of IOLs through a 3.0mm incision.

While this approach has resulted in visual outcomes in cataract cases that would have been unimaginable just a few decades ago, it has still tended to leave patients with around half a dioptre of astigmatism.

Various authors, therefore, proposed that ultra-small or micro-incision cataract incision might reduce ocular trauma and postoperative astigmatism still further.

There are now a number of different modalities available for performing phacoemulsification through incisions less than 2.0mm and lenses are also becoming available which can be placed through the un-enlarged incisions.

Advocates of reducing the size of the incisions for cataract surgery currently fit mainly into two groups. First, there are those who favour a biaxial approach using a pair of sub-2.0mm incisions through which to place phacoemulsification instruments with separated vacuum and infusion.

And second, there are those who use a slightly modified coaxial approach which permits phacoemulsification and IOL implantation of a standard IOL through a 2.2mm incision.

Those in the biaxial camp tend to maintain that, in addition to inducing less astigmatism, their approach has the advantages of superior chamber stability and easier followability of nuclear fragments due to a lack of repulsion by the phaco tip. Moreover, there are several IOLs now available which can be implanted through un-enlarged 1.8mm incisions.

Proponents of coaxial micro-incision surgery for their part point out that it involves almost no learning curve and that a 2.2mm incision is essentially astigmatically neutral, and thanks to new injectors, many standard IOLs can be implanted through the 2.2mm incisions.

Furthermore, technology that allows coaxial phacoemulsification and IOL implantation through 1.8mm incisions is also available, allowing surgeons the best of both worlds.

However, the questions surgeons will always ask is do these new technologies deliver on their promise and are the advantages they provide enough to justify the trouble of switching to the new techniques?

Growing evidence and experience with micro-incision surgery The

results of numerous studies comparing micro-incision cataract surgery (MICS) with standard incision surgery support the theory that micro-incision surgery induces less corneal astigmatism than conventional surgery.

For example, in a randomised controlled study conducted by Jorge Alio MD and his associates there was significantly less induced astigmatism among 50 patients who underwent MICS biaxial surgery with 1.5mm incisions than there was among 50 patients who underwent coaxial surgery with standard incisions (0.43 D vs 1.20 D) (Ophthalmology 2005;112(11).

However, as pointed out by Charles Claoue FRCS, London, UK, at the recent XXVIII Congress of the ESCRS, induced astigmatism is not the same as postoperative astigmatism, since most patients have some astigmatism preoperatively.

“I have serious reservations about our trend into MICS. I think there is good evidence that MICS does not alter the amount of corneal astigmatism, but the problem is most corneas do have a degree

of astigmatism. And since you have to make an incision it really seems logical to make an incision that reduces the astigmatism if your aim is to reduce astigmatic induction

by MICS perhaps we should only really be using it in eyes with a preoperative corneal astigmatism of 0.25 D or less,” he said.

Dr Claoue is also a consultant to Rayner Intraocular Lenses Ltd. On the other hand, Dr Alio’s study, and others that have followed, also showed that the micro-incision surgery involved significantly less phaco time and phaco power than conventional surgery.

However, MICS did not appear to confer any significant benefit with regard to endothelial cell loss, and the results of subsequent studies have been equivocal in that regard.

Nonetheless, MICS proponent Roberto Bellucci MD, University Hospital, Verona, Italy, argues that the theoretical support for reduced intraocular trauma is still very strong, based on the altered fluidics.

“MICS is safer than conventional because you have better fluidics, whether you have a Venturi pump or a peristaltic pump. With the Venturi pump you have a reduction in flow and with a peristaltic pump you have a reduction in flow and a reduction in post-occlusion surge. So it’s always best to use MICS,” he said at a session devoted to MICS during the XXVIII Congress of the ESCRS in Paris.

Moreover, it is for those same reasons that micro-incision surgery is more ideal for difficult cases such as eyes with intraoperative floppy iris syndrome, said John D Hunkeler MD, University of Kansas School of Medicine, Kansas City, Kansas, in another presentation at the ESCRS Congress.

Dr Hunkeler said that the coaxial MICS technique using 1.8mm incisions with the Stellaris system provided extremely stable anterior chambers thanks to its sensitive control of phaco power and vacuum. As a result iris hooks and Malyugin rings are

less often necessary in IFIS cases, and there is less trauma to the iris.

“First off you have to have the incision water tight and do the surgery so that no fluid comes out. That also reduces the total amount of fluid you use during surgery so there is less fluid movement within the eye. Furthermore the iris can’t get into the incision,” he told EuroTimes in an interview.

Femto may be the future While all of the above systems have their supporters, the advent of femtosecond laser cataract surgery may herald a new era in which it will be possible to perform a large part of the procedure without any incisions at all and with extraordinary precision.

Three companies are designing femtosecond lasers for several different aspects of cataract surgery including capsulorrhexis creation and lens fragmentation. The companies are LenSx Lasers Inc. (Aliso Viejo, CA), LensAR Inc. (Winter Park, FL), and OptiMedica Corp.

(Santa Ana, CA).

The LenSx and OptiMedica Lasers use OCT to guide the laser energy within the eye and also to create corneal incisions with self-sealing tongue-and-groove architecture, similar to that used in penetrating keratoplasty procedures. The LensAR uses an innovative confocal structured illumination technique, essentially a super EUROTIMES | Volume 15 | Issue 11

Courtesy of Philippe Sourdille MD

Tooling up Surgeons transitioning to micro-incision coaxial or biaxial surgery need to acquire and familiarise themselves with a new set of tools. They include special surgical knives for making the incision, new forceps, phacoemulsification instrumentation, new IOL injectors, and new micro-incision IOLs. There are now several surgical knives available that are especially designed for performing the trapezoidal incisions which MICS surgeons tend to favour. They enable surgeons to easily create an incision which is wider on the outside than it is on the inside.

The aim of the incision style is to create a watertight wound that will not become distorted or stretched during surgery and will self-seal at the conclusion of surgery.

The new MICS incision knives include models produced by Katena, Bausch + Lomb, Rhein Medical, Oasis Medical and Physiol.

To facilitate the creation of trapezoidal incisions, all of the knives have blades that decrease in width distally along their length and have a triangular tip.

New capsulorrhexis forceps have also become available which are especially designed for use through MICS incisions.

They include several 23-gauge models such as the Alio MICS forceps (Katena), the Kelman forceps (Synergistics). In addition, for those opting for the biaxial approach there are now several types of irrigating choppers available, such as the Alio’s MICS irrigating Stinger (Katena) and the Fine/Olsen irrigating chopper (Storz, Bausch + Lomb).

Most of the major phacoemulsification platforms offer features designed to optimise their performance in coaxial or bi-axial MICS. For example, the Accurus (Alcon), the Infiniti (Alcon) and the Stellaris (Bausch + Lomb) and The Signature (AMO) systems all have advanced fluidics to prevent post-occlusion surge, and advanced delivery of phaco power to prevent wound burn when performing sleeveless phaco.

5

Miyake Apple views of the same capsular bag diameter modifications with different IOLs

scheinflug camera to perform similar functions.The new lasers may also be used for creating topographically matched limbal relaxing incisions to correct preoperative astigmatism.

Femtosecond lasers can create a variety of lens fragmentation patterns which can assist in lens removal with the use of little or no phaco energy, reducing the impact of ultrasound energy on ocular structures, said William Fishkind MD, Tuscon, Arizona, and clinical professor at the University of Utah.

He presented a study at the recent ESCRS Congress which compared three patterns of lens fragmentation using the LensAR femtosecond laser. The study involved 119 patients, 32 of whom underwent femtosecond capsulotomy alone and 87 of whom underwent femtosecond capsulotomy and lens fragmentation. The three patterns investigated were one which divided the lens into tiny cubes, another which divided it into spheres and another which sliced through the lens in a way similar to the lines of latitude and longitude on a globe.

They found that overall 25 per cent of the lenses fragmented with the femtosecond laser could be subsequently removed with the Alcon Infiniti system using vacuum alone and that, compared to eyes which had only undergone femtosecond laser capsulorrhexis. Additionally the cumulative dissipated energy in LOCS III and IV cataracts was 37 per cent lower among the eyes which had undergone femtosecond lens fragmentation.

“Using femtosecond laser for softer nuclei really frees us from using phaco energy and in the harder nuclei there were significant

decreases in the amount of energy being used,” Dr Fishkind said.

MICS IOLs

A critical shortcoming to coaxial and biaxial MICS in the early days was a lack of IOLs on the market which could be placed through the un-enlarged micro-incision. Industry has since addressed this problem in two ways, one of which is to develop IOLs that can be fit through the micro-incisions and the other is to develop new injectors which can insert standard IOLs through 2.2mm or even 1.8mm incisions.

The micro-incision lenses currently on the market in Europe include IOLs in the AcriTec family (Carl Zeiss Meditec), the plate haptic acrylate lenses include multifocal and toric designs and which can be injected though a 1.7mm incision using the Acri.

Shooter and the Acri.Smart injector system.

Other lenses available for use in Europe include the hydrophilic acrylic MicroSlim and SlimFlex IOLs from Physiol. The lenses are implantable through incisions of 1.5mm using Viscoject injector and Viscoglide Cartridge (Medicel). There is also the Akreos MI60 micro-incision lens (Bausch + Lomb) implantable through a 1.8mm incision.

Injectors for standard lenses include the new Rayner single use disposable injector “RaySert” for implantation of the Rayner C-flex lens through a sub-2mm incision, and the new preloaded AcrySert C system for injection of Alcon’s AcrySof IOLs. Among the challenges for microincision IOLs is that they must not only fit through the very small incisions but also fulfill the expected requirements of standard IOLs, such as stability within the

“

Using femtosecond laser for softer nuclei really frees us from using phaco energy and in the harder nuclei there were significant decreases in the amount of energy being used William Fishkind MD

Cover Story

mics

“The indication for YAG capsulotomy changed in our department.

We now prefer early capsulotomy, as soon as the patient complains of a decrease in vision which could be related to PCO”

Different Patterns used in the evaluation of Laser Lens Fragmentation

of YAG capsulotomy at three years’ followup in eyes implanted with the Akreos MICS IOL, due at least in part to a more proactive approach to PCO. The study involved 20 eyes which had undergone implantation with the Akreos MICS microincision lens following biaxial phacoemulsification. At three years of follow-up, six eyes had undergone YAG laser capsulotomy because of reduced visual acuity.

“The indication for YAG capsulotomy changed in our department. We now prefer early capsulotomy, as soon as the patient complains of a decrease in vision which could be related to PCO. The indications are changing so the figure I showed probably represents an exaggeration of YAG requirement,” Dr Bellucci added.

Courtesy of Roberto Bellucci MD

Roberto Bellucci MD

capsular bag to ensure refractive precision and stability. Miyake Apple views can demonstrate capsular bag enlargement, and potential consecutive IOL misalignment with different designs. Standard IOLs should also meet the criteria of lens material clarity and of whole capsular bag transparency, said Philippe Sourdille MD, Nantes, France. “Vacuoles and clarity of the IOL still represent a problem, and the refraction index which makes a thin lens possible, must not be too high, otherwise there will be a number of undesired optical effects. An interesting statistic coming from the Belgian Cataract Registry is a 46 per cent rate of YAG capsulotomies in 2008 and the numbers for 2009 are identical. The growing incidence of YAG capsulotomy seems to arise from two factors, multifocal IOLs with more demanding patients, and small incision IOLs with optic edges that are too thin to prevent the wave of epithelial cells, and this has been confirmed by different studies,” he told the recent ESCRS Congress.

Dr Bellucci presented a study at the congress which appeared to confirm Dr Sourdille’s assessment, showing a high rate

Charles Claoue – eyes@dbcg.co.uk Roberto Bellucci – roberto.bellucci@ospedaleuniverona.it John D Hunkeler – jhunkeler@hunkeler.com William Fishkind – wfishkind@earthlink.net Philippe Sourdille – philippe.sourdille@wanadoo.fr

Courtesy of William Fishkind MD

contacts

6

The small ports of MICS decrease the flow rate both with Venturi and with Peristaltic pump. In addition a nonlinear vacuum/low curve is obtained with Venturi, and surge is decreased with Peristaltic

The filter in the aspiration line of the Stellaris machine effectively reduces flow/vacuum ratio, increasing safety

17-21 SEPTEMBER REED MESSE VIENNA AUSTRIA

European Society of Cataract & Refractive Surgeons EUROTIMES | Volume 15 | Issue 11

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contacts

Update

cataract

Juan Batlle – carolina.garcia.dr@gmail.com Zoltan Nagy – nz@szem1.sote.hu

Femtosecond laser capsulotomy

A considerable advantage over the traditional manual approach

by Dermot McGrath in Paris

F

emtosecond laser capsulotomy provides a more accurate and repeatable capsular opening with a more regular shape compared to manual capsulorrhexis, according to a number of studies presented at the XXVIII Congress of the ESCRS. “I believe that this is one of those rare moments which will fundamentally change the way we perform cataract surgery in the very near future,” said Juan Batlle MD. “Our initial results show that the Catalys Precision Laser System (OptiMedica Corp.) provides significant improvements in reproducibility of capsulotomy size, shape and centration when compared to manual capsulorrhexis.”

Dr Batlle, a professor of ophthalmology in Santo Domingo, Dominican Republic, said that being able to create a reproducible and predictable capsulotomy gives femtosecond lasers a considerable advantage over the traditional manual approach. “This becomes particularly important today with the advent of new premium intraocular lenses whose performance depends significantly on a well-performed capsulorrhexis. I think this is definitely where the trend is going in the future,” he said.

Dr Batlle said that the OptiMedica system combines a femtosecond laser, integrated optical coherence tomography (OCT) imaging and pattern scanning technology.

“It’s a combination of different strategies. It uses a liquid-based docking system to avoid folding of the cornea, which is more comfortable for the patient, stabilises the eye for treatment and ensures high quality incisions.

The integral guidance system uses a proprietary Fourier domain OCT-3D visualisation system in real-time that is directly connected to the laser for more precise cutting.

It incorporates automated surface detection, safety zones and advanced treatment algorithms. The ultrafast 100 Khz femtosecond laser disrupts only microns of tissue and delivers greater precision,” he said.

As well as capsulotomies, the Catalys Precision Laser System can also be used for clear corneal incisions, paracenteses, limbal relaxing incisions (LRIs) as well as softening and disassembly of the nucleus, said Dr Batlle.

To compare the accuracy of capsulotomy results performed with a femtosecond laser and conventional manual methods, 44 capsulotomies were performed with the laser and 30 using the traditional continuous curvilinear capsulorrhexis approach.

Both methods included a target outcome of a perfectly circular capsular aperture 5.0mm in diameter. Capsular tissue was obtained intraoperatively, stained, and imaged using an inverted video microscope. The digital images were calibrated with a NIST-traceable reticule and analysed to determine the difference between predicted and obtained diameters, and deviation from a perfect circle. The edge quality of the reticules was evaluated with scanning electron microscopy.

Don’t miss Outlook on Industry, see page 31 EUROTIMES | Volume 15 | Issue 11

Courtesy of Juan Batlle MD

8

Capsulorhexis and Lens Segmentation with Optimedica Femtosecond

Manual Capsulorhexis

Dr Batlle said that the femtosecond laser produced a capsulotomy with a cleaner edge with less tags, radial tears, appendages, and irregularities than the capsulorrhexis performed by the manual technique. The manually performed capsulorrhexis was also found more likely to deviate from a perfect circle than those obtained by the femtosecond laser and the measured capsulotomy diameter was almost an order of magnitude more accurate for the laser group than the manual group, he said.

The femtosecond laser created capsules were 30 microns (± 24 microns) from intended target compared to 329 microns (± 250 microns) for the 30 manual capsulorrhexis reticules. For decentration, the mean deviation was 86 microns for the femtosecond compared to 1,000 microns for the manual created capsulorrhexis.

Dr Batlle said that the OptiMedica femtosecond laser produces a capsulotomy that is more predictably sized and shaped than those performed by the manual technique.

“This type of predictability may permit better phacoemulsification surgery with less likelihood of capsular compromise,” he concluded.

The virtues of the femtosecond laser in creating precise capsulotomies were also emphasised in a separate presentation by Zoltan Nagy MD. Dr Nagy, clinical professor at Semmelweis University, Budapest, Hungary, presented a prospective study comparing femtosecond laser assisted (LenSx Lasers Inc.) and manual capsulorrhexis during phacoemulsification. He said that he believed that the femtosecond laser would take cataract surgery to a higher level of precision and safety.

“Traditional phacoemulsification cataract surgery has not changed much over the past 20 years. It remains a

manual procedure that is highly dependent on surgeon skill and even skilled surgeons occasionally get inconsistent operative experience depending on the cascading effects of each surgical step. With the laser, however, OCT images are captured while the eye is fixed to the laser and the system is computer-guided with complete surgeon control to deliver laser-precise surgical incisions in a reproducible manner,” he said.

Dr Nagy’s study included 20 anterior capsulotomies with the LenSx and 20 manual capsulorrhexis eyes. The IOL centration was measured at one week, one month and one year postoperatively using retro-illumination photos with Adobe Photoshop.

All capsulotomies created with the laser had smooth, uniform edges, and there were no capsular tears or adverse events. There was significantly better IOL centration and a better anterior capsule-IOL overlap in the femtosecond laser group compared to the manual CCC control group.

“Decentration was associated with irregularity of the manual capsulorrhexis shape. With irregular capsulotomy, the asymmetric vector forces as the capsule contracts may well play a role in IOL decentration,” he said.

The study also found fewer higher order aberrations and an improved postoperative quality of vision with the LenSxtreated patients.

“In summary, the laser’s precise image-guided OCT provides complete surgeon control, a significantly improved IOL centration and anterior capsule-IOL overlap as well as fewer higher order aberrations and improved quality of vision. The LenSx procedure is efficient and accurate, and it increases safety for cataract procedures due largely to the use of real-time image guidance,” he said.

9

Update

cataract

IOL power prediction

Reducing errors in postoperative ACD and refraction

by Cheryl Guttman Krader in Paris

A

newer low coherence interferometer (Haag-Streit LS900) that provides high definition measurements of anterior segment anatomy shows promise for improving the accuracy of IOL power calculations, said Thomas Olsen, MD, at the XXVIII Congress of the ESCRS. In addition to its utility for providing accurate axial length and keratometry measurements, the newer device determines anterior chamber depth (ACD) and lens thickness with high precision. Availability of data for these four variables enables use of an IOL power calculation formula incorporating a multiple-variable postoperative ACD prediction algorithm (Olsen formula; PhacoOptics™ software, IOL Innovations).

This formula results in more accurate determination of the postoperative position of the pseudophakic IOL and improves the precision of IOL power calculation compared with other formulas using fewer variables for ACD prediction, explained Dr Olsen, professor of ophthalmology, University of Aarhus, Denmark.

“In contrast to other formulas for ACD prediction, my ‘thick-lens’ formula represents a better physical model of the pseudophakic eye allowing input of all distances and curvatures with correction of the principle planes of each optical element of the eye. In this way we have a realistic representation of the physical position of the IOL rather than a virtual ACD, which is used in conventional ‘thin-lens’ formulas. Better ACD prediction is the key to better IOL power calculation and in this regard preoperative anterior chamber depth and lens thickness has been demonstrated to play a significant role. Now with the Lenstar LS900, surgeons have access to an instrument that can generate these values with high accuracy,” he said.

In the past, inaccuracy in axial length measurement was the leading source of error in IOL power calculations when ultrasound was used for axial length determination.

More recently, its importance has decreased with the advent and increased use of partial optical coherence interferometry for biometry, and subsequently, incorrect prediction of postoperative ACD is now the bottleneck of IOL power calculation, Dr Olsen said.

“Personalisation of ‘fudge factors’ to determine an optimised surgeon factor and

EUROTIMES | Volume 15 | Issue 11

A-constant has been used as a method to fine-tune predictions of the effective lens plane (ELP) with conventional formulas.

However, this approach to formula personalisation helps to reduce the mean prediction error to 0 in the average case, but does not decrease the spread of the distribution”, he commented.

Dr Olsen reminded the audience, “The A-constant is not a constant!”

Results from a study including more than 3,000 eyes showed that adding data on axial length (optical biometry), corneal radius (conventional keratometry), preoperative ACD as well as lens thickness (by ultrasound) to estimate the effective ACD significantly improved the accuracy of predicting postoperative ACD as well as IOL power.

Compared with conventional formulas that use only one or two variables for ELP prediction (Holladay I, SRK/T, Haigis, SRK I, and SRK II), use of the more sophisticated, four-variable thick-lens formula also resulted in a significant improvement in IOL power prediction error, Dr Olsen reported.

Notably, the four-variable ACD formula had the lowest bias with axial length compared with the conventional formulas.

The higher accuracy of the Olsen formula was confirmed in another study of 507 consecutive eyes using the Lenstar for preoperative biometry of all intraocular distances. Performance of the formula was compared with that of the Holladay I, SRK II, SRK I, and SRK/T by determining the difference between the predicted and final refraction. Use of Dr Olsen’s multiple variable formula resulted in a mean absolute prediction error of 0.41 D, which was significantly lower than the values for any of the other formulas (SRK/T and Holladay I, 0.46 D; SRK II, 0.57 D; SRK I, 0.65 D).

Dr Olsen noted that the physical position of the IOL could be quite accurately predicted based on accurate data for the preoperative ACD and lens thickness only, without the need for keratometry data.

“As a result, by omitting the K-reading from the algorithm, use of the Lenstar may have benefit for improving IOL power prediction in post-LASIK cases where problems with inaccurate keratometry readings are an important source of error,” he said.

contact

Thomas Olsen – tkolsen@dadlnet.dk

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ASCRS Glaucoma Day 2011 Friday, March 25 www.ASCRSGlaucomaDay.org

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11

Update

cataract

Refractive outcomes Calculating IOL power is a very complex process

by Dermot McGrath in Paris

T

he chance of achieving predictable refractive outcomes after cataract surgery can be considerably enhanced if surgeons take a few straightforward measures to ensure the accuracy of their IOL power calculations, according to a study presented at the French Implant and Refractive Surgery Association (SAFIR) annual meeting.

“With advances in surgical techniques and technology, the refractive result is more and more considered to hold the key to success in cataract surgery, and this has become even more the case with the advent of diffractive implants,” said Laurent Gauthier-Fournet MD. He noted, however, that the high quality results expected from excellent surgery and the implantation of a premium IOL would inevitably be compromised by erroneous IOL powers calculated from low quality measurement data.

The past few years have seen an evolution from traditional manual Javal-Schiötz keratometers to the use of automated optical biometric devices such as the IOLMaster (Carl Zeiss Meditec), said Dr Gauthier-Fournet.

“In some respects the IOLMaster has become the standard device for IOL power calculation in modern practices because it provides an automated, easy-to-delegate, precise, all-in-one means of measuring K values, axial length and anterior chamber depth and then uses built-in formulae to calculate the correct IOL power,” he said.

Nevertheless, Dr Gauthier-Fournet said that some surgeons have occasionally expressed concern about the accuracy of the K measurements provided by IOLMaster and prefer to stick with conventional keratometry for their IOL power calculations.

Looking at the IOLMaster in more detail, Dr Gauthier-Fournet explained that its calculation is obtained by measuring the distance between the images of six luminous infrared marks projected onto the cornea.

Five internal individual measurements are taken for a single keratometer measurement within 0.5 seconds based on a central hexagonal zone of 2.3mm diameter.

Dr Gauthier-Fournet noted that all keratometers measure the radius of curvature, the value of which is then converted to corneal power values in dioptres using a suitable keratometer index. While most keratometers use an index of radius to power of 1.3375, some instruments on the

EUROTIMES | Volume 15 | Issue 11

market use different values such as 1.332.

This means that while a given patient should produce the same radii on all keratometers, they will nevertheless end up with K values that differ by up to 0.8 D after the conversion is made into dioptres, he said.

To look more closely at possible discrepancies in the measurements obtained by a conventional keratometer and an optical biometry device, Dr Gauthier-Fournier carried out a small study at his private practice in St Jean de Luz. He performed bilateral keratometry using the Topcon KR7000 and the IOLMaster 500 in 96 eyes of 48 cataract patients using the same index of refraction. The mean keratometric value was 43.34 with the Topcon and 43.55 with the IOLMaster, with a statistically significant mean difference of 0.21. Using the built-in SRKT formula, the different keratometric measurements would translate into an estimated difference of 0.18 D for IOL calculation, said Dr Gauthier-Fournet.

Looking at the individual variation between the two devices, the difference was less than 0.25 D in 64 per cent of cases measured, between 0.25 D and 0.5 D in 26 per cent, and greater than 0.5 D in 10 per cent. Interestingly, in the latter 10 per cent of cases where the difference was greater than 0.5 D, the minimal keratometry value was 43.84, suggesting that reproducible measurements may be more difficult with steeper corneas.

Dr Gauthier-Fournet emphasised that calculating IOL power is a very complex process, with a good deal of the complexity arising from the fact that the cornea is not a perfectly spherical surface.

“The IOLMaster measures just a very central zone of 2.3mm, while most other keratometers measure a 3.0mm central zone. Therefore the greater the asphericity of the cornea, the bigger the difference in the measurements made by different instruments. At the moment, there is no recognised gold standard in terms of keratometry,” he said.

As well as keratometry, other important factors to be taken into account in IOL power calculations include the measurement of axial length and anterior chamber depth and the A-constant used by the individual surgeon.

contact Laurent Gauthier-Fournet MD –Igauthier2@yahoo.fr

contacts

Update

Refractive Lens

Dimitra M Portaliou – mimi24279@gmail.com Detlev Breyer – d.breyer@zeitzbreyer.de

lens concepts add flexibility

Exchanging front optic or adding sulcus lens allows enhancements, easily reversible procedures

by Howard Larkin in Boston

I

Courtesy of Dimitra M Portaliou MD

12

Slit lamp photo of the patient that underwent enhancement surgery

Figure representing the base lens (in white) and the front lens (in purple) attached as a single unit

Don’t miss Practice Development, see page 34 EUROTIMES | Volume 15 | Issue 11

ntraocular lens concepts are emerging that offer a less-invasive alternative to a full lens exchange for patients requiring refractive enhancements or explants of multifocal optics. They include multi-component lenses designed to allow adjustment, as well as sulcus-fixated lenses that can adjust or correct a primary lens.

In an early test of a multicomponent lens (InfiniteVision Optics) at the University of Crete, the front optic of the multi-component intraocular lens was successfully replaced nine months after the initial cataract surgery, Dimitra M Portaliou MD told the American Society of Cataract and Refractive Surgery annual meeting. The patient’s spherical refraction improved from +2.25 D to +0.25, and 20/20 uncorrected distance vision.

The InfiniteVision Optics Lens is an acrylic foldable posterior chamber optical system consisting of two lenses. The base lens is a plate haptic design and corrects for sphere only. The front lens, which may include multifocal, toric and spherical elements, is injected after the base lens and fits into a capture bridge on the face of the base lens, positioned in front of the capsule. Because the total lens spherical power (e.g. 20 D) can be shared by both lens components, each lens thickness is quite small allowing injection through sub 1.8mm incision. Also, because the optics of the front lens and base lens are always optically aligned, significant optical aberrations due to decentration of two separate lenses, ie, sulcus combined with in the bag, are avoided.

In the short term, the design allows for enhancements that may be necessary to compensate for biometry errors or residual astigmatism, or to remove multifocal elements from patients who cannot tolerate them, Dr Portaliou said.

In the longer term, it allows for multifocal elements to be removed in the event a patient develops macular degeneration or another contraindication. It also allows for installation of new optic technology as it becomes available, she added.

“Enhancements are easy and safe and can be done without complications.”

“

Enhancements are easy and safe and can be done without complications Dimitra M Portaliou MD

The Sulcoflex (Rayner) provides similar capabilities when paired with a conventional IOL, according to Detlev Breyer MD, Dusseldorf, Germany. The lens can be inserted through a 1.6mm incision and is available in multifocal, spherical and toric versions.

In a 10-patient series, Dr Breyer reported that all 10 implanted with a multifocal Sulcoflex achieved spectacle independence for daily distance vision and reading headlines, eight achieved it for driving and reading newspapers. Seven said they would have the lens implanted again or recommend it to a friend while one had the lens explanted. “But it was so easy she really wasn’t angry with the surgeon,” Dr Breyer said.

While Dr Breyer said he would prefer a refractive model, he believes the addon lens is a good alternative to laser surgery for refractive patients needing an enhancement, particularly for surgeons without access to a laser. The add-on lens is also preferable for patients who may need a reversible procedure, such as children or adults who are uncertain about using a multifocal lens. The lens design also minimises the chance of cell ingrowth between the lens or the lens contacting the iris, which were sometimes problems with earlier designs. The small incision size also makes the lens more attractive than previous add-ons that required incisions of 3mm or more to accommodate their large optics.

“All in all it meets expectations. It is a nice alternative to laser enhancements or IOL exchange,” Dr Breyer said.

contact

Kunihiko Nakamura – up4k-nkmr@asahi-net.or.jp

Update

Refractive Lens

MIOLs for high myopes

“

With its simple optical design that distributes light equally for near and far, the Tecnis multifocal IOL provides good near vision

Study finds good visual function and high patient satisfaction, highlights issues of IOL power calculation and retinal complications

by Cheryl Guttman Krader in Paris

I

EUROTIMES | Volume 15 | Issue 11

Kunihiko Nakamura MD, PhD

Courtesy of Kunihiko Nakamura MD, PhD

mplantation of the ZM900 aspheric diffractive multifocal IOL (Tecnis multifocal, Abbott Medical Optics) offers favourable visual outcomes for high myopes that are comparable to those achieved among patients with lowto-moderate myopia. However, a potential for late retinal complications in eyes with long axial length is an issue that should be considered in this patient population, said Kunihiko Nakamura MD, PhD, at the XXVIII Congress of the ESCRS. “With its simple optical design that distributes light equally for near and far, the Tecnis multifocal IOL provides good near vision. This feature makes it particularly well suited for high myopic patients who often see well unaided at near preoperatively and so may have a high demand for good uncorrected near vision after cataract surgery,” said Dr Nakamura, assistant professor of ophthalmology, Tokyo Dental College Suidobashi Hospital, Japan.

“Results from visual acuity testing and patient satisfaction surveys are consistent with this concept. However, in selecting a multifocal IOL for high myopes, we believe it is important for ophthalmologists to consider that these eyes are at increased risk of pseudophakic retinal detachment and be aware of a recent paper [Am J Ophthalmol 2010;149:113-9] reporting a significantly late increase in this complication after four years post-op, because observing the peripheral retina and performing vitreoretinal surgery can be more difficult after implantation of a multifocal versus monofocal IOL.” Dr Nakamura reported retrospectively analysed outcomes from a series of 37 high myopic eyes of 26 patients implanted with the ZM900 IOL. The high myopic group was defined as eyes requiring an IOL power <10 D. Their results were compared with a control group comprised of 78 eyes of 46 patients with low-to-moderate myopia defined as requiring an IOL power >16 D. In all eyes, IOL power was calculated based on measurements obtained with laser interferometry (IOLMaster, Carl Zeiss Meditec).

All patients were operated on for cataracts.

The high myopes had an average age of 54.4 years, compared with the controls whose mean age was 66.1 years. Mean corneal astigmatism was higher in the high myopes than in the controls, 1.03 D vs. 0.61 D.

After follow-up ranging from nine months to four years, mean distance UCVA for the high myopes was 0.93 (range 0. to 1.5) and was not significantly different than the mean distance UCVA in the controls, 0.95 (range 0.4 to 1.5). Mean corrected distance VA in the high myopes was 1.26 (range 0.7 to 1.5) and similar to that in the controls (mean 1.29, range 1 to 2).

Results from near visual acuity testing showed outcomes for high myopes were comparable to those achieved in the low-to-

moderate myopes. Mean near UCVA was 0.65 (range 0.3 to 1) in the high myopes and 0.72 (range 0.5 to 1) for the controls. With distance correction, the high myopes achieved mean near VA of 0.94 (0.6 to 1.2) and the results were nearly identical in the controls, 0.94 (0.7 to 1.2).

The mean refractive error was also nearly identical in the high myopes and the controls, -0.08 D vs. -0.10 D, although there was a slightly greater range in the high myopes (-2.25 to 1.00 D) than in the controls (-2.00

to +0.75 D) and a larger standard deviation in the high myopes (0.65 D vs. 0.46 D).

However, the rate of refractive enhancements with LASIK was similar in the high myopes and controls, 10.8 per cent (four eyes) vs. 11.5 per cent (nine eyes). Among the high myopes, refractive enhancement was more likely to be performed to correct astigmatism than residual spherical error (three eyes vs. one eye), while the enhancements in the controls were for correction of astigmatism in five eyes and sphere in four eyes.

“IOL power calculation based on measurements with the IOLMaster may be less accurate in long eyes, which may explain the larger standard deviation for refractive error in the high myope group. However, because the residual refractive error has a greater effect on distance vision than on near, the high myopes, whose expectations for unaided vision are greatest for near, may have still have been satisfied with their distance vision,” observed Dr Nakamura.

Contrast sensitivity was evaluated using grating-based charts (CSV-1000, Vector Vision) with testing at spatial frequencies of 3, 6, 12, and 18 cpd. The results showed contrast sensitivity was significantly lower in the high myopes compared with the controls at 6 and 12 cpd.

“There is no apparent explanation for this difference, although possible differences between the two groups in pupil diameter or retinal function that were not recorded in our study may account for the finding,” Dr Nakamura said.

Rates of Nd:YAG laser capsulotomy were low in both the high myopes and controls, 2.7 per cent and 5.1 per cent.

Retinal complications consisting of retinal tear, macular degeneration, and epiretinal membrane, had occurred in 8.1 per cent of the high myopes, while one control eye (1.3 per cent) developed an epiretinal membrane.

Satisfaction was generally high in both groups. Whereas compared with the controls higher proportions of high myopes were unsatisfied (five per cent vs. two per cent) or partially unsatisfied (eight per cent vs. five per cent), the high myopes were also more likely than the low-to-moderate myopes to be completely satisfied (54 per cent vs. 35 per cent), Dr Nakamura reported.

13

14

Update

Refractive Laser

A new direction

Research on developing femtosecond laser-based refractive treatments is ongoing

by Cheryl Guttman Krader

F

emtosecond lasers currently being used for LASIK flap creation reflect an improved understanding of the physical principles underlying femtosecond laser-tissue interactions, said Michael Mrochen PhD, at the 1st EuCornea Congress. “Features of commercially available platforms are being optimised to maximise tissue cutting precision and workflow efficiency while minimising transmission of laser power and opaque bubble layer (OBL) formation. Targets for the future include integration of online imaging for real-time control of three-dimensional cutting, and perhaps the development of an all-femtosecond laser refractive procedure,” said Dr Mrochen, IROC, Institute for Refractive and Ophthalmic Surgery, Zurich, Switzerland.

The opportunity to reproducibly achieve precision cutting represents the key advantage for using femtosecond lasers for LASIK flap creation. However, there are potential strategies for optimising tissue cutting precision that include use of a lower pulse energy, higher numerical aperture, or shorter wavelength, said Dr Mrochen.

Tissue cutting with the ultrashort pulse duration femtosecond lasers is a result of a photodisruptive effect as cavitation bubbles and plasma are created when the energy per area (focal plane of a lens) exceeds the threshold for optical breakdown. As precision increases with decreasing cavitation bubble size, reducing cavitation bubble size by lowering the amount of energy per laser pulse represents one possibility for increasing tissue-cutting precision, he said.

However, in order to achieve photodisruption, each pulse must contain a certain minimal amount of energy within a specific volume. Therefore, increasing the numerical aperture (relation between beam diameter and focal length) of the femtosecond laser is a viable strategy for enabling the use of less energy because it results in beam focusing on a smaller spot size. The concept of a higher numerical aperture lens is found on the Femto LDV femtosecond laser (Ziemer Ophthalmic Systems Group), which uses much lower energies (in the nanoJoule range) compared with other systems, said Dr Mrochen. A down side of such a high numerical aperture is the technical difficulty to allow surgeons a direct view on the patient eye during the treatment. Other systems such as the WaveLight FS200 (Alcon) have follow the concept to have a compromise between a high quality direct view of the patient eye and high numerical aperture for focusing the laser beam.

Precision also depends on the reproducibility of focusing within the tissue that can be affected by the precision of mechanical components, such as the cornea-laser interface, as well as environmental conditions.

“Changes in temperature and humidity can affect the beam profile and reduce focusing quality to increase the amount of energy needed for inducing cavitation. In this regard, the performance of the Femto LDV and the WaveLight FS200 are less influenced by environmental factors than older femtosecond lasers,” said Dr Mrochen.

Use of shorter wavelengths represents another possible method for reducing energy since the shorter wavelengths EUROTIMES | Volume 15 | Issue 11

would use fewer photons for plasma induction. The currently available femtosecond lasers all use infrared wavelengths ~1000-nm, but ongoing research investigating the use of other laser technology with shorter wavelengths is generating some promising results, noted Dr Mrochen.

Although the laser is focused to create its photodisruptive effect at a particular corneal depth, a substantial amount of energy is transmitted to posterior-lying ocular tissues, including the iris, lens, and retina. Results of a study by Alfred Vogel et al. and Karsten Koenig et al. showed that depending on the numerical aperture and energy level, 30-50 per cent of the average laser power delivered to the cornea is transmitted to structures beneath the cornea where it can cause thermal damage or, with the use of very short pulses, induce free radicals that can incite inflammation. Minimising this transmission depends on good optical quality and a high quality focus, said Dr Mrochen.

“Paying attention to environmental factors is also important for minimising the amount of energy transmitted to the back of the eye because of their potential to affect beam focus size and increase energy needs,” said Dr Mrochen.

Another goal for optimising femtosecond laser technology has been to reduce OBL formation, as this turbid layer within the cornea can inhibit pupil visualisation and eyetracker performance. With its delivery of lower energy and very high repetition rate, the Femto LDV minimises gas creation and OBL formation. Another strategy for minimising the OBL is to create a channel that allows gas diffusion out of the cornea.

This technique is a feature of the WaveLight FS200 (Alcon).

Research is ongoing developing femtosecond laser-based refractive treatments. These include a procedure for treating myopia using the VisuMax laser to cut a stromal lenticule that is removed from the cornea and a no-flap technique for presbyopia treatment (IntraCor) using the Femtec laser (Technolas Perfect Vision) to disrupt the stromal structures and induce changes in corneal biomechanics and shape.

With its precise cutting ability, the femtosecond laser has enormous potential for use beyond creation of the LASIK flap. However, for applications involving three-dimensional tissue cutting and considering that corneal thickness distribution may be uneven beneath the applanation interface, it will be necessary to have online OCT or some other imaging system to provide guidance for achieving controlled depth of focusing, noted Dr Mrochen.

Within the clinical environment, an integrated femtosecond laser/excimer laser platform has advantages for improving patient flow and enabling customised procedures where the flap size and shape precisely matches the planned area of ablation. Systems combining both laser technologies are already available, including the iFS + S4 (Abbott Medical Optics), VisuMax + MEL 80 (Carl Zeiss Meditec), and FS200 + WaveLight ex500 (Alcon), while with its articulating arm, the Femto LDV can be used beneath several other excimer laser systems.

contact

Michael Mrochen – Michael.mrochen@iroc.ch

LONDON 2011 11 EURETINA CONGRESS TH

26–29 May 2011 QUEEN ELIZABETH II CONFERENCE CENTRE LONDON, UK

www.euretina.org

contact

16

Update

CORNEA

John Marshall – eye.marshall@googlemail.com

Cross-linking

New approach could shorten cross-linking treatment time

by Howard Larkin in Boston

A

new process known as focal corneal collagen cross-linking could reduce treatment times from one hour to just a few minutes while reducing the potential for endothelial damage due to prolonged UV exposure, said John Marshall PhD, Rayne Institute, St Thomas Hospital, London, UK, in his Innovators lecture at the American Society of Cataract and Refractive Surgery.

The new technology is being developed for possible use with the Keraflex KXL (Avedro, Waltham, Massachusetts, US) procedure, in which collagen cross-linking is used to lock in place corneal thermal remodelling induced by microwave keratoplasty to treat keratoconus and refractive errors. Clinical trials of the KXL procedure using the more traditional cross-linking approach are under way in Europe and the US. “Everyone is used to 30 minutes [riboflavin] soak and 30 minutes [UV]

exposure. We use a two-minute soak and a three-minute exposure so instead of an hour you are down to five minutes,” Prof Marshall said.

The shorter exposure is achieved by increasing the UV power. While this might seem to create a greater risk of UV exposure deep in the cornea and beyond, Prof Marshall’s research indicates otherwise.

Higher power and lower exposure time actually result in a greater proportion of UV energy absorbed by riboflavin and collagen fibres in the outer cornea with less total energy reaching the endothelium than with a longer, lower power exposure, he said.

To further enhance safety, the centre and periphery of the cornea are covered with masks during the UV exposure to prevent radiation from reaching the crystalline lens, retina and peripheral corneal stem cells.

Only the ring of tissue treated with the microwave device to flatten the cornea is

www.cxl-congress.org 6th International Congress of Corneal Cross-Linking January 21-22, 2011 / Milan, Italy

The CXL congress is an international forum for the most recent advances in corneal cross-linking

For more information please contact:

CBS Congress & Business Services, Technoparkstrasse 1, CH-8005 Zurich, Switzerland E-mail address: info@cbs-congress.ch Registration: www.cxl-congress.org EUROTIMES | Volume 15 | Issue 11

exposed, Prof Marshall said. “We are only trying to change the area where we induce corneal remodelling with microwaves.”

In early trials the focal cross-linking technique has greatly slowed the rate of regression in corneas flattened with microwave keratoplasty, Prof Marshall said.

“We are still playing around with how much of the cornea in terms of area we need to expose. But certainly the short exposure time is working and is safer.”

Prolonging thermal remodelling

Microwave keratoplasty and focal crosslinking are effective because they target the area of the cornea that is most important to its structural strength, Prof Marshall said.

The microwave remodels the cornea by delivering a “controlled insult” to stromal collagen fibres below the epithelium and Bowman’s layer, causing them to change shape without cutting them.

“It turned out that if you do a very superficial treatment in a small ring you will flatten the cornea and if you do a deeper treatment in a bigger ring you have the capacity to steepen the cornea.”

Leaving the collagen fibre intact preserves the strength of the cornea, which can be reduced by 30 per cent or more by LASIK and other incisional approaches.

“The moment you take a blade to the cornea and cut collagen fibres, there is some loss of structural integrity, and the depth of the cut determines how much tissue and strength is lost,” Prof Marshall noted.

Over the past two and a half years, research with the Avedro microwave device has established a relationship between dose and effect, making the treatment predictable. But because it is a thermal treatment it regresses significantly within the first three months.

Focal cross-linking may arrest this regression by stiffening the collagen fibres in the remodelled area, Prof Marshall said.

Corneal collagen naturally stiffens over time as sulphur-hydrogen thiol bonds convert to sulphur-sulfur disulfide bonds which are much more rigid.

Originally it was thought that this stiffening resulted from cross-linking between collagen fibres, but they are too far apart to achieve covalent bonding, Prof Marshall said. The next theory was that cross-linking tightened the tension within

“

The results are extremely impressive from the combination of microwaves and short duration cross-linking John Marshall PhD

collagen fibres, but x-ray diffraction studies do not support that. So the current concept is that cross-linking occurs between the collagen helix and amino glycans and other substances in corneal substrate, and “rather like a floppy stick of liquorice that you coat with sugar and then brittlize the sugar.”

Whatever the mechanism, UV radiation accelerates this stiffening with riboflavin serving to absorb the energy, creating reactive oxygen that changes the bonds in the tissue. After cross-linking the fibres achieve rigidity equivalent to 600 years of natural ageing. If fixed with glutaraldehyde, the stiffening effect is equivalent to about 1,000 years of ageing, he added.

Research also shows that the outer onethird of the cornea provides most of its structural strength. It is in this area that the microwave keratoplasty remodels fibres, and it is in this area that most of the energy of the short focal approach to UV radiation is absorbed, strengthening the areas that are most important while sparing potentially sensitive tissues, Prof Marshall said.

The Keraflex KCL procedure with focal cross-linking is particularly attractive for treating keratoconus, Prof Marshall added.

The microwaves flatten the cone, then the cross-linking makes the collagen fibres rigid, which strengthens the cornea rather than weakening it with an incision or ablation. The procedure is highly effective in flattening the cornea, though more research will be needed to address astigmatism, he said.

Still, the result is greatly improved uncorrected visual acuity in keratoconic patients, Dr Marshall said.

“The results are extremely impressive from the combination of microwaves and short duration cross-linking.”

17

EuroTimes

Update

CORNEA

9/10

FALK update

Good long-term results for femtosecond-assisted anterior lamellar keratoplasty

Anticipating every move.

Now thatâ&#x20AC;&#x2122;s smart.

by Dermot McGrath in Crete

F

emtosecond-assisted anterior lamellar keratoplasty (FALK) appears to be a viable alternative to conventional anterior lamellar keratoplasty (ALK) and penetrating keratoplasty (PK) in patients with anterior corneal scarring, a new long-term study suggests. â&#x20AC;&#x153;The overall results were very promising with patients who underwent sutureless FALK showing rapid and stable visual rehabilitation. There were no significant changes in refractive error after the procedure and there were no sightthreatening complications,â&#x20AC;? Sonia H Yoo MD told delegates attending the Aegean Cornea X meeting.

Dr Yoo, professor of ophthalmology at Bascom Palmer Eye Institute, University of Miami, explained that ALK is a partial thickness corneal transplantation used in eyes with pathology limited to the anterior layers. Indications for the procedure include superficial corneal scars after trauma, keratitis, and corneal epithelial or anterior stromal dystrophies. She noted that ALK offers several advantages over PK. â&#x20AC;&#x153;Anterior lamellar keratoplasty minimises potential intraoperative complications and allows for faster visual and refractive recovery. Furthermore, the fact that we are maintaining the recipient endothelial layer decreases the rate of graft rejection,â&#x20AC;? she said.

Dr Yoo said that the advancements in Descemetâ&#x20AC;&#x2122;s stripping endothelial keratoplasty (DSAEK), potentially may enable surgeons to perform multiple lamellar corneal transplantations from one donorâ&#x20AC;&#x2122;s cornea.

She noted that the traditional method of performing ALK had significant drawbacks. â&#x20AC;&#x153;For a start there was the technical challenge of performing manual dissections which was not always easy. There were also issues of induced astigmatism and late visual recovery due to the use of sutures,â&#x20AC;? she said.

Dr Yooâ&#x20AC;&#x2122;s study included 15 eyes of 15 patients aged 11 to 79 years with anterior corneal scarring resulting from corneal infections in 11 patients, granular dystrophy in two patients and trauma in the remaining two patients. Exclusion criteria included patients with severe corneal scars totally obscuring visualisation of anterior segment structures, corneal scarring leaving less than 250 microns of posterior residual corneal bed thickness and those patients with less than six months' follow-up.

EUROTIMES | Volume 15 | Issue 11

All procedures were performed under topical anaesthesia. Anterior segment OCT was used in all patients to estimate corneal scarring depth in the recipient cornea.

To prepare the donor graft, corneoscleral donor tissue was mounted on an artificial anterior chamber. When a whole donor globe was available, it was mounted directly under the laser. The epithelium was removed before the flap creation. The donor graft was created using the femtosecond laser (IntraLase, AMO) with a lenticule thickness of 160 to 270 microns. â&#x20AC;&#x153;The thickness of the lenticule was adjusted in relation to the depth of the lesions according to the anterior segment OCT findings,â&#x20AC;? said Dr Yoo. Depending on the donor tissue quality and edema, up to 20 per cent additional thickness was added to the donor lenticule to adjust for donor tissue swelling. The range of energy was also adjusted according to the severity of the corneal scar, with higher spiral energy, and lower tangent and radial spot separation for denser scars, she said.

The next step in the procedure was to use the femtosecond laser to create a recipient corneal lenticule. The same settings were used as for the donor graft except that the recipient corneal lenticule was set to be 0.1mm smaller in diameter than the donor graft diameter. The host corneal button was then removed and replaced with the donor lenticule on the recipient residual corneal stromal bed. A bandage contact lens was fitted over the cornea and patients were then placed on topical antibiotic and steroids for one week, with steroid drops slowly tapered over several months.

Putting the results in context, Dr Yoo said that the visual acuity results, with a mean postoperative follow-up time of 25 months (range six to 60 months), compared favourably with published studies of manual ALK and microkeratome-assisted lamellar keratoplasty. Visual rehabilitation, however, was faster with sutureless FALK compared to traditional methods.

Looking at intraoperative complications, Dr Yoo said that FALK has the edge in terms of technical ease and reproducibility.

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2nd EuCornea Congress 16â&#x20AC;&#x201C;17 September 2011 Vienna, Austria

Immediately preceding the XXIX Congress of the ESCRS

www.eucornea.org

contact

Sadeer Hannush – sbhannush@comcast.net

Update

19

CORNEA

Amniotic membrane

A thoughtful approach is needed

by Cheryl Guttman Krader in Venice

EUROTIMES | Volume 15 | Issue 11

“

Courtesy of Sadeer Hannush, MD

A

mniotic membrane transplantation (AMT) for ocular surface reconstruction has been increasing in popularity in recent years with about two dozen possible indications currently described.

However, the expanding use of AMT for some purported indications is occurring without adequate or at least evidence-based justification, said Sadeer Hannush, MD. Speaking at the 1st EuCornea Congress, Dr Hannush encouraged his colleagues to take a “thoughtful approach” to AMT, weighing its pros and cons with those of its alternatives. Based on such an analysis, Dr Hannush has categorised uses for AMT into three tiers considering whether: 1) no other treatment modality yields the same results, 2) other treatment modalities may yield similar results, or 3) other treatment modalities may yield superior results.

“AMT represents a true advance in ocular surface reconstruction for some indications, but for others it may be a viable, albeit not necessarily the preferred option; in some instances AMT may be inferior to established treatment modalities,” said Dr Hannush, attending surgeon, Cornea Service, Wills Eye Institute, Philadelphia, PA. Providing some examples, Dr Hannush said AMT represents the treatment of choice for ocular surface reconstruction after alkali burns or Stevens-Johnson Syndrome. In the acute stage, AMT has value for both promoting re-epithelialisation and for its anti-inflammatory properties, and, once the eye is quiet, it is the best option for reconstructing the scarred fornices.

However, while AMT also is very efficacious when surgical management is indicated to promote healing of a neurotrophic ulcer, tarsorrhaphy is equally effective. For this indication, the treatment decision may take into account the cosmetic advantage AMT offers the patient against its higher cost, said Dr Hannush.

Assuming there is adequate healthy conjunctiva for harvesting conjunctival auto-grafting at the time of pterygium excision is another situation where AMT represents an effective, but not necessarily preferred alternative. Dr Hannush noted that in his hands AMT and conjunctival auto-grafting work equally well in decreasing the incidence of pterygium

AMT represents a true advance in ocular surface reconstruction for some indications...

17-year-old boy after chemical injury

Sadeer Hannush, MD recurrence, although conjunctival autografting has a longer and proven track record. Conjunctival autografting also requires more technical expertise. Favouring AMT is its ease of use and a possibly better cosmetic result, noted Dr Hannush. AMT eyes look quieter more quickly than eyes receiving conjunctival autografts.

AMT is also gaining popularity for use in the setting of chronic ulceration in blind painful eyes. However, it may not be as effective as a total conjunctival flap (Gunderson), a technique recognised for decades as the standard of care for this indication.

Technical issues Amnion is available in two forms in the US: a cryopreserved product (AmnioGraft or ProKera from Bio-TissueTM) that must be kept at -80 deg C and a dehydrated version (AmbioDry2 from IOP, Inc.) that is stored at room temperature with a longer shelf life. From a convenience perspective the dehydrated amniotic membrane (AM) may be preferred, especially for facilities where there is a low volume of AMT use. However, Dr Hannush noted he favours the cryopreserved product because there is published data from Scheffer Tseng MD, PhD, describing its components and mechanisms of action whereas such information about the dehydrated form remains proprietary.

In choosing an AM fixation technique, Dr Hannush favours a tissue adhesive (Tisseel VH Fibrin Sealant) over suture. Relative to suturing, the tissue adhesive reduces surgical time as well as postoperative discomfort and it may offer some anti-inflammatory activity.

“Sutures carry a lower direct cost, but the ease of using fibrin sealant more than helps offset the difference by reducing surgical time,” Dr Hannush said.

Same patient (as above) after keratectomy, conjunctivoplasty and amniotic membrane transplantation

A 58-year-old patient immediately after ocular surface reconstruction with amniotic membrane transplantation

20

Update

Glaucoma

adherence aids

Adherence could be bettered by improving accessibility to healthcare

by Stefanie Petrou Binder MD in Berlin

A

LASIK safe in our hands, is a new website developed by the ESCRS to provide accurate and up-to-date information about LASIK for the European population.

The site has been produced in 2010, European Year of LASIK, the 20th anniversary of the first LASIK surgery.

It will be continually updated to ensure that it reflects the latest information and techniques.

Please visit:

www.europeanyearoflasik.com for further information

EUROTIMES | Volume 15 | Issue 11

dherence is the toughest aspect of glaucoma therapy and is likely to influence disease progression, so what keeps patients from taking their medication? Understanding patient motivation may provide a key to achieving adherence and developing strategies toward better therapeutic outcomes, according to researchers at the World Ophthalmology Congress (WOC).

“Qualitative examinations lend themselves well to determining adherence. We found through extensive patient interviewing that a multi-factorial, tailored, patient-centred approach was needed to understand patient behaviour, and improve adherence” said the session’s co-chair person, Jenny Lacey BSc, who worked on a qualitative study in the area of adherence to Glaucoma Medication alongside David Broadway, consultant ophthalmologist and Ms Heidi Cate, Glaucoma Research Unit Manager at the UK NHS Glaucoma Research Unit in Norwich, UK. To understand the motivation behind adherence, she used semi-structured interviews with 24 glaucoma patients to gain an in-depth understanding of their experiences. She found multiple complex barriers to and motivations for adherence.

One main barrier to therapy adherence was inadequate ‘initial education’.

Communication issues with doctors leave patients unsure and have a negative effect on adherence. However, when education was lacking, patients who self educated and took a personal interest in their disease, were more likely to show regimen adherence. She noted that knowledge about treatment success was a strong motivation, since adherence was seen when the patient perceived efficacy in the prescribed eye drops. Conversely, a lack of medication confidence had a negative effect.

Remembering to take drops was a barrier in itself, especially when the routine was broken because of a busy schedule or complex dosing-regimes, while easy routines, fixed schedules and memory aids had a positive effect.

Relevant insights into adherence strategies come from an investigation on adherence for ocular hypertensive therapy.

Miss Lacey highlighted some potential strategies, which included changes in doctorpatient communication and behavioural modification techniques.

Doctor-patient communication should involve in-depth discussions about the medication and the regime. The physician needs to acknowledge that taking the medication can be difficult and missing it is understandable. The patient has to comprehend that the treatment decision is based on adherence and that sharing information is vital. Only then should the physician discuss adherence directly.

Another strategy practitioners may use is the ask-tell-ask dialogue, another doctorpatient communication strategy, used in other chronic diseases to support adherence.

The practitioner first asks the patient to describe his understanding of the disorder and treatment. The patient then tells the doctor his perspective of the disease. The doctor then asks again what the patient truly understands about the information given, to give him the opportunity to explain any misconceptions in a way the patient understands.

The readiness to change the model, adapted from patients with substance misuse problems, observes that all people progress through a predictable series of five stages when changing behaviour eg, to become adherent: pre-contemplation (denial phase), contemplation (ambivalent about change), preparation (prepare to make a specific change), action (true desire for lifestyle change), and maintenance and relapse prevention. The practitioner can use this established model to help identify the current stage at which a person is in and target interventions to the psychology of that stage.

A final strategy which may enhance adherence is a motivational interview, where a trained interviewer may elicit behavioural change by helping patients explore and resolve ambivalence to therapy. The idea behind the interview is that change must be elicited from the patient, and direct persuasion and confrontation avoided.

No intervention is proven to work for every person, suggesting that a multifactorial tailored patient-centred approach may be the answer to understand and change behaviour, she stressed.

contact Jenny Lacey – jenny_lacey@hotmail.co.uk

contact

Simon Walker – simon-walker@talktalk.net

Update

Glaucoma

Measuring RNFL

Comprehensive exams of new glaucoma referrals with GDx examinations

by Roibeard O’hEineachain in Madrid

D

edicated glaucoma clinics which certainty in terms of both sensitivity and incorporate GDx measurements specificity, and that the efficiency of the (Carl Zeiss Meditec) in their diagnosis could be greatly enhanced through assessments can greatly improve the use of one-stop clinics, said Simon Walker the diagnosis and discharge of false FROphth who co-authored the study with positive referrals and can therefore reduce Raly Job MRCOphth MRCSEd, Leighton unnecessary follow-up of glaucoma suspect Hospital, Crewe, UK. cases, according to a study presented at the “The National Institute for Clinical Ninth Congress of the European Society of Excellence (NICE) glaucoma guidelines have Glaucoma. resulted in a big increase in the number of The study involved prospective audits of referrals, especially patients with borderline the diagnostic assessments of patients referred ocular hypertension. Opticians no longer have for possible glaucoma. Its findings indicated any discretion in the matter. The challenge is faros_245x150_EuroT_e 6.5.2010 Uhr out Seite 1 positive referrals as early that combining GDx with standard clinical 11:17 to weed the false assessment techniques improved diagnostic as possible so they don’t clog up the health

service any further,” Mr Walker explained.

The first series of patients included 117 new glaucoma referrals seen over a 10-week period from January 2008 at Leighton and Macclesfield Hospitals. Subsequent recall and application of GDx improved the initial discharge rate from eight per cent to 35 per cent. In addition, GDx proved strongly influential in management decisions in 40 per cent of cases where it was performed.

The second series of patients included 51 new glaucoma referrals seen over a seven-week period from February 2010 at Leighton Hospital and the Victoria Infirmary, Northwich. Patients attended either a new one-stop glaucoma clinic or one of two general ophthalmology clinics. Mr Walker noted that the discharge rate improved overall to 38 per cent, and was clearly higher from the one-stop service where all tests were being conducted.

“We have to be absolutely confident when we discharge a patient. GDx provides insightful objective data regarding the health or otherwise of the retinal nerve fibre layer. In cases of mildly suspicious or physiologically cupped optic discs with more than likely

“

In cases of mildly suspicious or physiologically cupped optic discs with more than likely artefactual learning curve type visual field defects, a normal GDx scan can be extremely helpful Simon Walker FROphth

artefactual learning curve type visual field defects, a normal GDx scan can be extremely helpful. The patient can be reassured and discharged back to their optometrist. GDx not only reduces the need for multiple further assessments as was traditionally undertaken, but also provides us with an incredibly useful baseline, should the patient ever genuinely develop glaucoma in the future,” Mr Walker added.

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EUROTIMES | Volume 15 | Issue 11

21

escrs on your time Symposia, free papers, videos and more from ESCRS Congresses in your home ss Congre I I I V X X SCRS, E e h t of France Paris, nline Now O

escrs on demand Visit www.escrsondemand.org

contact

Alain Bron - alain.bron@chu-dijon.fr

Update

23

GLAUCOMA

Measuring RNFL Images courtesy of Alain Bron MD

Head-to-head comparison of three OCT devices favours newer technology

by Roibeard O’hEineachain in Madrid

N

ewer spectral domain OCT devices provide higher definition scans with greater signal strength than older time domain machines, said Alain Bron MD, Service d’Ophtalmologie CHU Dijon at the ninth Congress of the European Glaucoma Society.

A prospective study which directly compared RNFL measurements in 197 patients with the time domain Stratus™ OCT (Carl Zeiss Meditec) and two spectral domain OCT machines, the Cirrus™ (Carl Zeiss Meditec) and the Spectralis® (Heidelberg Engineering), showed that although the retinal nerve-fibre layer (RNFL) measurements were not clinically different with the three machines, the signal strengths were higher with the spectral domain machines than with the time domain machines and therefore more reliable, said Dr Bron.

“The current thinking is that you can reliably interpret the results when the signal strength is over six but we have found that the signal strength with time domain OCT is only five on average. What that means is that in most instances you cannot have a proper interpretation with time domain machines, but in the same eye on the same day you can have a much stronger signal strength which means you can make decisions based on the investigation,” Dr Bron told EuroTimes in an interview.

The study included 197 consecutive patients attending a specialised glaucoma clinic. Each patient underwent an OCT RNFL evaluation with each of the three machines. Dr Bron and his associates compared mean RNFL thickness values obtained with the machines both globally and among different sectors. They also compared the three machines’ signal strengths and used the Bland-Altman

A patient receives OCT RNFL evaluation with Spectralis machine

method and intra class coefficient (ICC) time domain and spectral domain OCT to assess the agreement between the three is the number of scans, which is 300 per machines. second to 400 per second with time domain The researchers found that the average OCT, compared to 26,000 to 40,000 scans RNFL thickness was higher with Spectralis per second with spectral domain. As a result, than for Cirrus or the Stratus, with values of the spectral domain machines provide better 86.0 µm, 81.0 µm and 77.0 µm, respectively definition, with more reliable measurements (p=0.006). The 95 per cent confidence due to a better signal strength. intervals varied from -33.0 µm to + 18.0 µm “The RNFL measurements were not fully with the Bland-Altman method. The ICC interchangeable between the three OCT was higher with the Spectralis versus the machines evaluated in this study. However, Cirrus and the Cirrus versus the Stratus, the differences were acceptable in clinical than with Spectralis versus Stratus, 0.808, terms and lay within the range of inter-test 0.819, 0.725, respectively. In addition, the variability. On the other hand, with spectral signal strength was significantly better with domain OCT there is a clear advantage to Cirrus than with Stratus, (6.9 vs. 5.1 ± 1.8, obtaining a better signal strength even in a p< 0.0001). non ideal11:21 routineUhr practice setting,” Ins_easyPhaco_120x120_EuroTimes 6.5.2010 Seite 1 Dr Bron He noted that the main difference between added.

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OS3 A patient receives evaluation with Cirrus machine

EUROTIMES | Volume 15 | Issue 11

24

Update

RETINA

UNDERSTANDING PVR

Key to improving success rates of retinal detachment surgery

by Dermot McGrath in Berlin

A

better understanding of the biological processes underlying the development or recurrence of proliferative vitreoretinopathy (PVR) may lead to more targeted treatments for the condition in the future and eventually produce more widespread benefit in the management of primary retinal detachment and other forms of retinal disease, according to Louisa Wickham FRCOphth.

Addressing delegates attending the World Ophthalmology Congress (WOC) 2010, Dr Wickham said that PVR remains a difficult management problem despite advances in vitreoretinal surgery in recent years.

“PVR continues to hamper successful retinal detachment surgery and even though surgical techniques have improved, the prognosis of this condition is still very poor with only about 11 per cent of patients achieving a visual acuity of 6/36 or better,” she said.

As well as primary retinal detachments, Dr Wickham noted that PVR is also a significant pitfall in the development of newer surgical techniques such as retinal translocation and RPE transplantation.

She explained that most of the current understanding of PVR derives from studies of animal models and from retinal tissue taken from patients at the time of PVR surgery.

“What we know is that PVR can essentially be considered as a form of wound healing which involves a number of cell types, particularly retinal pigment epithelium (RPE), fibroblasts, glial cells and macrophages,” she said.

Dr Wickham said that it was useful to think of retinal detachment in terms of defined stages that might be targeted in order to prevent PVR in the future: an initial retinal tear, followed by retinal detachment, and then the breakdown of the bloodocular barrier which allows the ingress of growth factors, inflammatory mediators and extracellular proteins. This process results in cellular proliferation and migration and finally the contraction phase.

Looking at the use of adjuvant treatments to try to prevent PVR, Dr Wickham said that the results to date have been mixed.

One of the first drugs used to treat PVR, Daunomycin, showed quite encouraging results in some of the initial trials but failed to gain clinical acceptance as a treatment for EUROTIMES | Volume 15 | Issue 11

PVR. Researchers have also investigated the use of a combination of 5-fluorouracil and low molecular weight heparin (LMWH) in the prevention of PVR. Dr Wickham said that early trials of 5-fluorouracil/LMWH combinations at Moorfields Eye Hospital on patients that had been identified as high-risk of developing PVR delivered promising results.

“That initial trial was very encouraging and we showed a significant reduction in PVR for patients who had 5FU and LMWH in the infusion bag at the time of their initial surgery. However, when we went on to look at the effect of this combination in patients with established PVR we did not find the same results. In fact, the patients in the control group had very similar success rates, although macular pucker was slightly reduced in treated patients,” she said.

In a subsequent trial, adjuvant therapy with 5FU and LMWH did not significantly improve the anatomic or visual success rate of unselected primary retinal detachments undergoing vitrectomy, nor was there any significant difference in the incidence of PVR between treated patients and those in the control group.

Other adjuvant therapies that have been tried include anti-inflammatory steroidal drugs, again with mixed results, noted Dr Wickham. In animal studies intravitreal triamcinolone did show a decrease in retinal detachments from 84 per cent to 34 per cent, but the drug was shown to have a bimodal effect on cellular proliferation with inhibition only occurring at supra-physiological doses.

Clinical studies of intravitreal steroidal compounds have proved inconclusive, said Dr Wickham, although this approach did reduce postoperative inflammation and haze. Trials of oral cis-retinoic acid have also found no significant difference in retinal detachment rates although there is some evidence that the drug may reduce macular pucker and improve visual acuity after surgery, she said.

In seeking to understand why efforts to prevent PVR have been largely unsuccessful to date, Dr Wickham said it really begs the question of whether clinicians truly understand the process of PVR.

contact Louisa Wickham - Louisa.Wickham@moorfields.nhs.uk

17-21 SEPTEMBER REED MESSE VIENNA AUSTRIA www.escrs.org

European Society of Cataract & Refractive Surgeons

26

Update

global ophthalmology

ORBIS MEDAL 2010

Study researching causes of visual disability in urban school children in India wins medal

by Roibeard O’hEineachain

R

ahul Doctor MD, Mumbai, India has won the second annual ORBIS Medal at the XXVIII Congress of the ESCRS in Paris.

“This work will have been worthwhile if it helps prevent blindness in even a single child. I am still pinching myself to see if I’m awake after winning the ORBIS Medal. It is a tremendously good feeling, that perhaps comes with a hint of responsibility,” Dr Doctor said.

The ORBIS Medal is awarded for the best presentation at the ESCRS Congress on preventing or treating avoidable blindness in developing countries – in line with the international sight-saving charity’s mission.

Dr Doctor’s study involved a survey into causes of visual disability in school children in Mumbai.

“The ORBIS Medal is about stimulating thought and awareness of avoidable blindness in developing countries. Dr Doctor has highlighted the importance of screening and the findings echo the work of ORBIS on preventing and treating blindness,” said Robert Walters, chairman of the ORBIS International Board of Directors.

In their study, Dr Doctor and his

associates screened 52,060 secondary school students, aged eight to 16 years, for visual disabilities. They sought to determine the prevalence and causes of the disability and deliver treatment wherever possible. They found that, overall, 15.4 per cent had at least one ocular morbidity and that refractive error was the commonest cause of visual disability, occurring in 13.9 per cent of students screened.

“The prevalence of uncorrected significant refractive errors is high enough to justify a regular school eye-screening programme in schools in India. Hence, we can initiate a sea change in their economic and social lifestyles by this simple early correction,” the study’s authors noted.

Other causes of reduced vision included xerosis (3.94 per cent), squamous blepharitis (3.65 per cent), strabismus (2.59 per cent), non-trachomatous acute conjunctivitis (2.59 per cent), nystagmus (0.38 per cent), corneal opacity (0.19 per cent), meibomitis (0.10 per cent), cyst (0.10 per cent), foreign body (0.10 per cent) and congenital cataract (0.10 per cent).

ORBIS is a non-profit organisation dedicated to the prevention and treatment

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EUROTIMES | Volume 15 | Issue 11

Robert Walters, Chairman of ORBIS International and José Güell, ESCRS president, present the second annual ORBIS Medal 2010, to Rahul Doctor MD (centre) at the XXVIII Congress of the ESCRS in Paris

of blindness in the developing world. Since 1982, ORBIS has treated 12.5 million people in over 87 countries, and has trained more than 260,000 medical professionals involved in ocular health.

ORBIS supports school screening throughout India and worldwide as part of its work to eliminate preventable and treatable blindness in developing countries.

More than 12 million people in India are blind, among whom there are 320,000 children under the age of 16, which

constitutes one fifth of the world’s blind children.

“The enormous difficulties that are presented to surgeons in the developing world are completely different from those of us who are fortunate enough to work in established and sophisticated units. We therefore like to bring forward the scientific study of ways of dealing with this enormous problem of 140 million people in the world who are blind or severely visually disabled, and that’s a big issue,” Mr Walters said.

27

Update

global ophthalmology

access to care

Programme for delivery of paediatric cataract care in developing countries

Keratograph Topographer Conquers the Elements

by Roibeard O’hEineachain

A

new global initiative has recently been set in motion with the aim of eliminating blindness from paediatric cataracts worldwide.

Co-sponsored by Lions Club and Bausch + Lomb, The Pediatric Cataract Initiative (www.PediatricCataract.org) will organise research into the incidence and epidemiology of the condition and work towards identifying and funding the prevention and treatment of the condition.

“This new initiative has the potential to reach families and communities around the globe, both in direct funding support and the identification and extension of innovative, highly effective programmes,” Al Brandel, chairperson, Lions Clubs International Foundation, told the press.

The Pediatric Cataract Initiative has a global advisory council which provides guidance concerning the programme’s ongoing commitments, including the selection of grant recipients. It has as its chairman Gullapalli “Nag” Rao MD, MBBS, PhD, who is the founder of the L V Prasad Eye Institute, Hyderabad, India, and is also well known for his humanitarian efforts to prevent blindness.

Paediatric cataract is a major cause of largely preventable childhood blindness in many parts of the world, particularly in developing countries, where its prevalence ranges from one to four children per 10,000 births. That is up to 10 times higher than in developed countries. During its first year, the Pediatric Cataract Initiative’s efforts will focus primarily on the People's Republic of China, where at least 40,000 children have paediatric cataracts.

If treated early many children with EUROTIMES | Volume 15 | Issue 11

cataracts will grow into fully sighted adults requiring minimal or sometimes no additional vision correction. But in the very countries where the incidence is greatest, the treatment is the least accessible. The blindness that results completes the vicious circle by adding to the economic burden of the affected patients’ families and their society as a whole. Current estimates are that the global economic loss over 10 years of childhood cataract is between US$1bn and US$6bn.

“Infants born with dense cataracts must undergo surgery within the first two months otherwise the child will be very amblyopic.

This is almost never done in developing countries. In developed countries we do surgery on these very small children within two or three weeks. Then there are the late developing cataracts. The children could have been born without any cataracts at birth, they develop it during childhood and that is much more common in poorer countries.

The causes are overexposure to sunlight, malnutrition, trauma, and hereditary disease,” Charlotta Zetterström MD, PhD told EuroTimes in an interview.

The things most needed in countries with a high incidence of paediatric cataracts include improving access to care, for the detection of cases within the population, and good surgery with good lenses, said Dr Zetterström, Ullevål University Hospital, University of Oslo, Oslo, Norway.

“In Sweden and Norway I think we find nearly all of the children with paediatric cataracts and we do surgery rather early compared to Africa or India, where there is a huge backlog. Lack of money is the main problem,” she added.

Water and oxygen are important for the cornea Non-contact assessing of the tear film in less then 30 seconds – Modern Topographers can do more then only topography. Two new software applications are now available: “TF-Scan” (Tear Film Scan), analyses the quality (NIBUT, BUT) and quantity (tear meniscus height) of the tear film and displays it as a coloured map “OxiMap” (Oxygen Map), displays the oxygen transmissibility of soft contact lenses OCULUS – We focus on progress

www.oculus.de

contact

News

RESEARCH

MICS

Cataract patients will benefit from better and safer cataract surgery outcomes

by Jorge Alio MD, PhD

C

ataract surgery is one of the most frequently performed surgeries in the world, with millions of procedures each year.

We may consider that the first modern cataract surgery was done by Sir Harold Ridley in 1949, with the implantation of the first PMMA intraocular lens. On that occasion, the incision was longer than 10mm and the intraocular lens was far from perfect, but demonstrated that cataract surgery had reached a new stage in its development.

Since then, the spectacular progress of cataract surgery has been driven by the aim of decreasing the surgical aggressiveness, improving the technology used inside the eye for cataract removal, for IOL implantation and, finally, to obtain visual recovery as fast as possible. Such technical progress has been made possible by decreasing the incision size. The concept of small incision cataract surgery was created by Charlie Kelman in the early 70s, with the introduction of phacoemulsification. The idea to perform cataract surgery bimanually with a phaco tip sleeve was introduced at the end of the 80s.

Fluidic Control In 1985, Shearing was the first to announce this concept, which was aiming for a separation of functions between irrigation and aspiration to have a better fluidic control. In 2001, I registered a concept of microincisional cataract surgery (MICS), as the surgery was performed through incisions of 1.8mm or less. This minimally invasive cataract surgery approaches the end

stage development of modern technology.

Fluidics are to be implemented to control a surgical environment in which a minimal incision size allows also minimal irrigation.

More effective pumps, control of the aspiration flow, pressurised infusion to implement inwards fluidics, minimal use of phacoemulsification and an overall decrease in the aggressiveness by decreasing phaco time and phaco power are the consequences of the development of this concept and the main hallmarks of MICS as a different surgical technique for cataract removal.

The limits of cataract surgery at this moment can be considered at 1mm with the use of 0.7mm instruments and phaco tips.

Almost every type of cataract is possible to be removed through sub 1mm incisions with the help of modern phacoemulsification platforms. It is true that the limit for IOL implantation should be currently considered at 1.6mm due to the commercially available lenses using the so-called corneal assisted injection technique and, as usual, surgical skills have developed to a stage beyond IOL technology, something that has been occurring since the beginning of the new era of small incision surgery. Today, the cutting edge of MICS is sub 1mm surgery, performed successfully assisted by femtosecond technology which is, no doubt, offering a completely new perspective and a new era in cataract surgery.

The move into this MICS concept requires further transition for the cataract surgeon.

Phacoemulsification platforms should be

implemented, some new instruments are necessary (coaxial capsulorhexis forceps, 0.7mm phaco tips, new irrigation canulas and devices to manipulate the cataract inside the eye and to keep adequate fluidics), among other changes. Does this technology add value to cataract surgery? The answer is Yes. The peer review literature available demonstrates that sub 1.8mm cataract surgery definitely eliminates the induction of astigmatism during the cataract procedure, minimises or even eliminates the change in the optical aberrations of the cornea, decreases the use of phaco power by the better use of fluidics, with no further negative impact on the endothelial cell level and no more complications.

Learning curve The learning curve of surgeons influences these outcomes, as in every new emerging technology, but in the hands of experienced surgeons, this surgery is, simply, better than the standard phacoemulsification. Also, and in spite of negative reports concerning the quality of incisions following MICS, recent studies have demonstrated that with adequate experience and the use of adequate phaco parameters and instruments, the incisions have at least the same quality as the standard ones as analysed by high performance corneal OCT. How can we classify cataract surgery today to avoid misunderstandings? We can consider that sub 1.8mm surgery (MICS) is the real cutting edge standard in the progress of cataract surgery. Sub 1mm MICS (microMICS), is the real limit of cataract surgery research today. Mini-incision cataract surgery should be considered as that in which cataract removal with IOL implantation is performed through 2.2mm incisions.

Standard coaxial phacoemulsification can be considered from 2.75mm and more. You may choose to be a standard coaxial surgeon, a mini-incision coaxial surgeon or a MICS surgeon. It is your decision, as quality in cataract surgery can be achieved using all

Jorge Alio - jlalio@vissum.com

of them. It might be your decision, but the trend towards minimising incisions is clearly defined and open for future development.

Femtosecond technology In the immediate future, the use of femtosecond technology to soften the nucleus of the cataract, to create the capsulorhexis with a perfect size, dimensions and location and to really control the incision size at the cornea will implement the quality of cataract surgery. IOLs will come later to accomplish optical substitution of the crystalline lens in the coming years. This process will probably end in the development of punctural cataract surgery in which cataract removal will be performed with needles capable of eliminating the already softened cataract nucleus, with the epithelial cells, and to substitute with an adequate polymer that maintains the elasticity of the capsule and recovers accommodation. This has been a dream for 25 years and might continue to be a dream, but we are getting closer to achieving these standards.

In summary, MICS is a concept that involves the leadership in the progress of cataract surgery towards minimising incisions. This progress in cataract surgery is made possible thanks to the contribution of creative surgeons and industry in close cooperation. The final destination of this progress is the cataract patient who will benefit, in the immediate future, from better and safer cataract surgery outcomes.

Jorge Alio MD, PhD, is professor and chairman of ophthalmology, Miguel Hernandez University, medical director Vissum Corporation.

Reference: Alio J.L.; Fine Howard I.: Minimizing Incisions and Maximizing Outcomes in Cataract Surgery: Springer-Verlag. Berlin Heidelberg. ISBN-978-3-642-02861-8 (200)

EUROTIMES

ESCRS

28

â&#x201E;˘

A EUROPEAN OUTLOOK ON THE WORLD OF OPHTHALMOLOGY

TĂźrkiye Turkish language edition now online Visit: www.eurotimesturkey.org

EUROTIMES | Volume 15 | Issue 11

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News

EUREQUO

EUREQUO HELPS audit

Netherlands registry includes 75% of cataract cases, helps surgeons assess performance

by Howard Larkin

I

f experience with The Netherlands national registry is any guide, EUREQUO, the European Registry of Quality Outcomes for Cataract and Refractive Surgery, will be a valuable tool for surgeons to assess their operating technique and outcomes, says Ype Henry MD, Amsterdam. For example, his analysis of the first 200,000 cataract cases shows a slow shift from retrobulbar to topical anaesthesia, and what may be a gradual improvement in outcomes since the national cataract quality registry was established in 2007.

“Everywhere you hear that everyone is going to topical anaesthetic, but here we can see more people are still using retrobulbar and sub-Tenon’s,” Dr Henry said. However, practices are changing.

For the 70,000 cases added to the registry between August 2009 and August 2010, 44 per cent used topical compared with 37 per cent in the 130,000 cases registered previously.

Similarly, the latest data suggests rates of complications including endophthalmitis, cystoid macular edema, posterior capsular ruptures and dropped nucleus may be edging down, but the numbers are not conclusive. Still, the data shows that the quality bar is high and surgeons can immediately check their own performance against the norms of an ever-growing database. Experience with the Swedish cataract database suggests that such national benchmarking can contribute to significant improvement in outcomes over time.

Along with data on incision site, lens preferences and other information from Dr Henry’s annual survey of Dutch surgeons, the data is valuable for assessing individual techniques and results. “It gives you some confidence to know that what you are doing is not so different from everybody else. We know what is going on in Holland, at least,” Dr Henry says.

About 220,000 cases from the Dutch national registry were transferred to the EUREQUO database this Autumn, where with data from the Swedish national registry and individual participants, it is now available in aggregate for comparison online. Dr Henry believes that when surgeons in other countries see the value of benchmarking their practices against EUROTIMES | Volume 15 | Issue 11

EUREQUO European Registry of Quality Outcomes for Cataract & Refractive Surgery

“

Everywhere you hear that everyone is going to topical anaesthetic, but here we can see more people are still using retrobulbar and sub-Tenon’s Ype Henry MD

the EUREQUO database, participation will go up.

“The system is invented to have internal auditing,” Dr Henry says. He notes that individual data is masked and participants may only view data in aggregate. The EUREQUO input pages, which were designed and tested in a pilot programme with The Netherlands, Scandinavia and Spain, are simple to fill out and can be networked with most electronic record systems for automatic submission.

About 75 per cent of Dutch ophthalmic surgeons now participate in the registry and about 50 per cent of surgeries are recorded, Dr Henry says. Participation is high in part because Dutch insurers require electronic reporting of cataract outcomes as a condition of contracting with hospitals. As a result, surgeons using a computer database in their practices rose from just over 50 per cent in 2005 to 88 per cent in 2009, according to his annual survey of cataract surgeons. “It is not easy getting people to do something new. I am convinced from our own system that if pressure comes from the outside, that is when people start moving,” Dr Henry says.

contact Ype Henry - y.henry@vumc.nl

Young Ophthalmologists’ Resource Centre Visit our new website

http://youngophthalmologist.escrs.org to find out more about the new

ESCRS Observership Programme. n

The ESCRS has developed a grant programme to support European trainee ophthalmologists who wish to observe clinical practice in a hospital or university setting.

n

The society is currently seeking interest from centres willing to offer observerships of one-to-two weeks’ duration in cataract and/or refractive surgery.

n

Those centres wishing to participate will be added to a database of centres available on this website.

European BOard of ophthalmology

LEARNING FROM EACH OTHER

New EBO president sets sights on further expansion In December 2010, Wagih Aclimandos FRCS, FRCOphth, FEBO, a consultant ophthalmic surgeon at King’s College Hospital, London, officially takes up his duties as president of the European Board of Ophthalmology (EBO). In an interview with EuroTimes contributing editor Dermot McGrath, Mr Aclimandos discusses the current state of EBO and the main challenges facing the organisation over the next two years of his mandate.

Q:

How did you first become involved with the EBO?

I became involved some years back when the Royal College of Ophthalmologists in the UK wanted a delegate to represent them at the EBO examinations. It was very crucial at that time for delegates to be able to question candidates in more than one language, so I was nominated because I also speak fluent French. And since that initial involvement I’ve become more and more active in the EBO because it’s a cause that I believe in passionately.

Q:

countries discussing how ophthalmology is run, how training is conducted, and so forth in their part of the world. It certainly gives you new perspectives and ideas. It is not always easy to copy or change things but it is important to try to advance and find new ways to approach issues.

Q:

Have attitudes changed towards the EBO from national ophthalmic societies in recent years?

How would you define EBO’s cause and why is it important?

The main aim is to harmonise and improve training in ophthalmology across Europe. With increasing mobility of doctors and patients it is crucial to ensure that the standards of care are similar wherever you are in Europe.

People may agree or disagree with what politicians are doing, but I do not think that even politicians today can change the momentum towards greater European cooperation and integration. I find that I cross the English Channel and I feel equally at home in Paris as in London.

The more we travel, the more we come to realise how small the world really is and how much people have in common.

In this profession we are lucky to be able to meet like-minded people who share a passion for ophthalmology. I think if people approach each other with an open mind and put aside racism, fanaticism and all these other ‘isms’, then it is possible to make all sorts of fruitful contacts and networks.

So I think that the ethos and underlying philosophy of the EBO is that we are all different but that there is much that we can learn from each other and that we are stronger for this collaboration. For instance, at the end of an international congress, you may sit and have a drink with 10 different people from 10 different

www.eurotimes.org

It really depends on the country. It’s a long process to gain acceptance for something like the EBO but we have made huge progress in recent years. The UK, for instance, had initially been a bit slower to accept the EBO because it already had its own long-established Royal College exams and a long tradition in ophthalmology. In countries like France that had no national exam, having an exam that is recognised nationally and which is compulsory has been a positive development for ophthalmology in that country and it has now been adopted by Switzerland, Belgium, Austria, and many other countries. Once you have the structure in place, then you can raise the standards.

But first you have to gain acceptance for the concept, join the club, and then once everyone is in the club then you can finetune the details.

Q:

One of the EBO’s professed goals is the harmonisation of training and standards across Europe. How can this process be accelerated in the next few years?

The reality is that there is a disparity in terms of resources and standards across member countries. The key is to strike the right balance by putting in place protocols or guidelines that are within the reach of all the EBO members. We want to raise standards, not create divisions, so there is an element of diplomacy and common

contacts

News

Wagih Aclimandos - waclimandos@nhs.net

sense in applying this. Take the example of cataract extraction. If you have some delegates that are still practising a means of cataract extraction that is obsolete in some countries, but they have neither the means nor the equipment to implement the same approach as some of the other countries, then there is no point in issuing directives saying that this is how cataract operations should be performed. Rather, we can say that this is the preferred procedure and give them an incentive to raise their standards accordingly. So it is a fine line to draw sometimes. You don’t want the standards to be set at the lowest limit and neither to have them too high that they are not practically achievable for some member countries because they don’t have the same facilities. It is more feasible to set realistic long-term targets and work towards those.

Q:

What changes would you like to see implemented during your term as president of EBO? I think the emphasis will be on continuity rather than wholesale change because a lot of excellent work has been achieved in recent years and we simply need to maintain the momentum. With that said, I would definitely like to get the EBO more involved in the accreditation of higher subspecialty training because I think there is a definite demand for this across Europe. We don’t want to take away the basic training from each country, but when it comes to subspecialties we can definitely play an enhanced role and draw on the expertise and experience of the EBO network to move this forward.

Wagih Aclimandos was interviewed

by EuroTimes contributing editor Dermot McGrath

The latest ophthalmology news and views online from EuroTimes

Visit www.eurotimes.org to access our complete range of online services: EUROTIMES

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PODCAST EuroTimes Blog is posted by our team of journalists who break the news from the major international meetings as they happen from Bangalore to Boston and from Russia to Rome www.myeurotimes.blogspot.com

EUROTIMES | Volume 15 | Issue 11

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Feature

outlook on industry

Dry-eye breakthrough

Because the eye drop interacts with extracellular structure rather than human tissues, it qualifies in Europe as a medical device rather than a drug. Mr Prinz believes the current registration trials will be quickly concluded, and the product will be on the market in mid-2011. He also is discussing clinical trials with the US FDA.

CROMA’s eye drop mimicking mucines could stay on eye for hours; glaucoma implant also in trials

by Howard Larkin

Courtesy of Pierre Jean Pisella MD, PhD

T

Four groups of rabbits received different 124I radio labelled eyedrop solutions. They were monitored immediately after instillation, at three hours, six hours, nine hours and 22 hours

Courtesy of CROMA GmbH

hiomer technology is about to revolutionise treatment of dry eye syndrome – and other ocular conditions, predicts pharmacist Martin Prinz, managing director of CROMA GmbH, Vienna, Austria. Some time next year, he hopes to market a thiomer-based eye drop that will form a protective layer on the eye for hours, providing not just relief of dry eye, but also promoting healing of its underlying corneal surface.

With about 20 per cent of the adult population suffering dry-eye at one time or another, Mr Prinz believes the market in 2015 could easily exceed €500m annually in Western Europe (€3bn worldwide). “I think it will be a blockbuster. It’s like the announcement of latanoprost,” he predicts, referring to the compound that revolutionised glaucoma treatment.

Thiomers are biopolymers, including sodium hyaluronate and chitosan, to which thiol groups from the amino acid cysteine are covalently attached. This allows thiolated polymers to form disulfide bonds with other biomolecules, greatly enhancing properties such as mucoadhesion, viscosity, and cohesion without compromising biocompatibility.

As a dry-eye treatment, a thiomer solution has been shown to remain on the eye surface for 22 hours in animal models, compared with approx. 15 mins for a sodium iodine solution control group (Hornof et al. ARVO 2009). Mr Prinz believes the thiol groups bond covalently with the natural mucines on the eye surface.

“This mimics how nature expresses mucines and binds them to the surface of the eye. This is ubiquitous; it is a thiol disulfide exchange reaction.”

Halting the inflammatory cycle

The ability of thiomer compounds to bind with the extracellular matrix that makes up the combined mucine-aqueous layer of the tear film could interrupt the self-reinforcing cycle that leads to dry eye, says Prof PierreJean Pisella MD, PhD, University Hospital, Tours, France. Chronically dry eyes, whether from contact lenses, allergies or other causes, typically display a reduction in mucineproducing goblet cells in the conjunctiva, he explains. Reduced mucine increases tear film osmolarity which provokes an inflammatory response. “It’s a vicious cycle. The loss of goblet cells leads to a loss of mucine production, which increases osmolarity and EUROTIMES | Volume 15 | Issue 11

Eye Layers

inflammation, which leads to more loss of goblet cells.”

The thiomer-based eye drop that CROMA now has in human trials interacts with the aqueous and mucine layer, producing a gel that protects the eye for hours, Mr Prinz says. “The liquid eye drop is released on the surface of the eye, and with the first blink it is dispersed to create a transparent gel film.

Within a second, due to the shift in pH and oxygen in the air, the drop polymerises with the mucines across the entire surface of the eye.”

The thiolated chitosan solution also has been shown to significantly reduce dry-eye markers in a mouse model, as have artificial tears and fluorometholone eye drops (T. Hongyok et al. 2009. Arch. Ophthalmol.

127(4):525-32).However, the greater mucoadhesion of the thiomer, which prevents it from being washed out of the eye within minutes, could make a significant clinical difference, Mr Prinz believes. “This therapy stays for such a long time that beneath the film a new layer of mucine is produced. It could be the first healing of the disease.”

Glaucoma implant CROMA also is beginning registration trials of a thiomerbased implant for maintaining bleb space for non-penetrating deep sclerectomy. The biggest problem with existing collagen and other implants for this glaucoma procedure is they tend to encapsulate, leading eventually to a failure of the surgical treatment. In preclinical tests conducted at Bascom Palmer Eye Institute, Miami, Florida, US, no such problems were found. “There was no fibrosis, no encapsulation, no giant cells of any kind.

The researchers at Bascom Palmer were euphoric about the biocompatibility,” Mr Prinz says. He expects this implant will be available next year as well.

Perhaps five years out are ocular inserts that will take advantage of thiomer compounds’ mucoadhesive, controlled permeation and biodegradability to create microtablets that adhere to the conjunctiva and release medications over time. Prototypes releasing substances from eight hours to six days have been tested, Mr Prinz says. They could be used for everything from delivering antibiotics after surgery to glaucoma medications.

Thiomer technology also can increase the ability of medicines to penetrate the cornea by interacting with thiols between cell membranes on the eye surface, he adds.

Innovation leads to growth In development for a decade, thiomer technology reflects CROMA’s commitment to innovation, Mr Prinz says. Over the past five years the firm has brought out 15 new products, including CorneaProtect, a 2.0 per cent solution of hydroxypropyl methylcellulose that hydrates and clarifies the cornea for about 20 minutes during surgery. Following its acquisition of Cornéal and Xcelens in 2007, the firm now offers advanced preloaded lenses and injectors and a full line of conventional IOL products. Long a contract producer of viscoelastics and devices, CROMA now offers a full line of dispersive and cohesive OVDs, and is well-known for its vitreoretinal products including FluroCrom perfluorocarbons and VitreoCrom silicon oils. CROMA is also a major player in the consumer eye care market with a line of eye drops including an overnight gel using hyaluronic acid.

CROMA’s goal is products that are “surprisingly simple, limitless and fair,” Mr Prinz says. “Simple to use means safe. The easier it is to use a product the more likely you will do it right.”

31

An Exceptional Mid-Winter Meeting A Spectacular and Convenient Location Next winter, join us for the 4th Annual ASCRS Winter Update. Hosted at the Forbes Travel Guide Five Star Ritz-Carlton Palm Beach, the 2011 program will continue the tradition of excellent education in a spectacular location.

Register Now for Early Bird Savings! www.WinterUpdate.org

New for 2011 â&#x20AC;&#x201C; ASOA Practice Management Track for Administrators ASOA is pleased to announce a new program track designed and developed specifically for administrators. Sessions are scheduled to minimize time away from the office. Donâ&#x20AC;&#x2122;t miss this opportunity to delve into critical issues and take home pearls to improve your practice!

Program Chair Steve Robinson, COE, OCS Faculty Debi Dilling Nancey K. McCann E. Ann Rose James L. Spires, MBA, COE Vonda L. Syler, COE Gil Weber, MBA

Interactive sessions. Accessible faculty. Pertinent topics.

Practical tips.

The Physicians Program is designed to provide the busy ophthalmologist with cutting-edge information and pearls that can be immediately implemented.

Program Chairs Edward J. Holland, MD Stephen S. Lane, MD Program Planning Committee David F. Chang, MD Eric D. Donnenfeld, MD Herbert P. Fechter, MD Roger F. Steinert, MD Keith A. Warren, MD Faculty Kevin J. Belville, MD Rosa Braga-Mele, MD Vincent P. de Luise, MD Gary J. Foster, MD

David A. Goldman, MD Norman S. Jaffe, MD Terry Kim, MD W. Barry Lee, MD Nick Mamalis, MD Nancey K. McCann William F. Mieler, MD Stephen A. Obstbaum, MD F. Rick Palmon, MD Steve Robinson, COE, OCS E. Ann Rose Jonathan B. Rubenstein, MD Steven R. Sarkisian Jr., MD Kerry D. Solomon, MD R. Doyle Stulting Jr., MD, PhD

Preliminary Program

Preliminary Program (subject to change)

(subject to change)

Thursday, January 27

12:45 PM â&#x20AC;&#x201C; 2:15 PM

Networking/Welcome Reception

Optional Luncheon Workshops

2011 Legislative Update

Friday, January 28

5:30 PM â&#x20AC;&#x201C; 7:00 PM

Nancey K. McCann

8:00 AM â&#x20AC;&#x201C; 10:00 AM

4:15 PM â&#x20AC;&#x201C; 5:45 PM

Managing Cataract Complications / Complicated Cases: "You Make the Call"

Friday, January 28 2:30 PM â&#x20AC;&#x201C; 4:00 PM

Medicare Reimbursement Challenges

E. Ann Rose

Saturday, January 29 8:30 AM â&#x20AC;&#x201C; 10:00 AM

Moderator: David F. Chang, MD 10:30 AM â&#x20AC;&#x201C; 12:30 PM

Cornea and External Disease: Practical Topics and Interactive Panel Discussion

Interpreting & Using Financial Statements

Moderator: Edward J. Holland, MD

James L. Spires, MBA, COE

12:45 PM â&#x20AC;&#x201C; 2:15 PM

10:30 AM â&#x20AC;&#x201C; 12:00 PM

Iâ&#x20AC;&#x2122;m a Leader â&#x20AC;&#x201C; Now What?

Steve Robinson, COE, OCS 12:00 PM â&#x20AC;&#x201C; 1:00 PM

Networking Luncheon

1:00 PM â&#x20AC;&#x201C; 2:30 PM

Effective Marketing Tracking Methods

Debi L. Dilling 3:00 PM â&#x20AC;&#x201C; 4:30 PM

Managed Care Contracting Nightmares

Optional Luncheon Workshops 5:30 PM â&#x20AC;&#x201C; 6:30 PM

ASOA for MDs: Legislative Update Nancey K. McCann

8:00 AM â&#x20AC;&#x201C; 10:00 AM

Challenging Cases in Ophthalmology Moderators: Eric D. Donnenfeld, MD, and Edward J. Holland, MD 10:30 AM â&#x20AC;&#x201C; 12:30 PM

Best of the Worst: Common Complications of the Usual Glaucoma Procedures Moderator: Herbert P. Fechter, MD 12:45 PM â&#x20AC;&#x201C; 2:15 PM

Optional Luncheon Workshops

7:40 AM â&#x20AC;&#x201C; 8:00 AM

E. Ann Rose

Guest of Honor: Norman S. Jaffe, MD 8:00 AM â&#x20AC;&#x201C; 10:00 AM

New Technology in Anterior Segment Surgery

Sunday, January 30

10:30 AM â&#x20AC;&#x201C; 12:30 PM

Nancey K. McCann Vonda L. Syler, COE

Sunday, January 30

5:30 PM â&#x20AC;&#x201C; 6:30 PM

Moderator: Stephen S. Lane, MD

Keeping an Eye on the Future: Medical Office Technology in 2015

Moderator: Stephen S. Lane, MD

Saturday, January 29

Gil Weber, MBA

8:30 AM â&#x20AC;&#x201C; 10:00 AM

Video Complications Seminar

Posterior Segment Challenges for the Anterior Segment Surgeon Moderator: Keith A. Warren, MD

ASOA for MDs: Medicare Update

Monday, January 31 7:00 AM â&#x20AC;&#x201C; 9:00 AM

Refractive Cornea and IOL Surgery: Improving Outcomes/Happier Patients Moderator: Eric D. Donnenfeld, MD 9:30 AM â&#x20AC;&#x201C; 11:30 AM

Faculty Roundtables/Wrap-Up Moderators: Edward J. Holland, MD, and Stephen S. Lane, MD

10:30 AM â&#x20AC;&#x201C; 12:00 PM

Internet Marketing: Website or Web Fright?

Debi L. Dilling

) )*!%$ %& * & )* )) *&!!%$ ) * $%*

Feature

PRACTICE DEVELOPMENT

contacts

34

Kris Morill – kmorill@medeuronet.com Laurent Morin – Infos@expert-vision-center.com

Business planning

Know yourself, research your market and be prepared to work to make your plan a success

by Howard Larkin

I

n 2007, Laurent Morin brought together five of the region’s most skilled refractive surgeons to create a new laser refractive-cataract clinic, the Expert Vision Center in Strasbourg, France.

Three years later the centre is profitable, providing about 1,200 procedures annually.

By the end of 2010, the group will open two more locations, and is collaborating with other centres to broaden its reach.

“The plan is to create a referral system throughout France,” says Mr Morin, the centre’s chief executive officer.

With more than a decade of experience in refractive applications and sales with a major laser manufacturer, Mr Morin knew that establishing a new centre in the face of entrenched competition would be challenging. So he and his surgeon colleagues developed a unique business model designed to mitigate the risks while building a solid reputation for quality and high technology, and a five-year business plan to carry it out.

As with any start-up practice, one of the biggest concerns was financial risk.

Mr Morin’s market research showed that quality outcomes and technology are key to attract patients and grow over time.

Journal Watch

So investing in the latest technology was critical to differentiate the practice.

Dividing risk Spending €1m for state-of-the-art laser equipment, modern office space, a marketing campaign, and payroll in the early months would make anyone think twice. The approach that Mr Morin’s centre took was to divide the risk.

An annual budget was developed for each of the five years. Each of the five surgeons agreed to pay a set amount toward the budget each month. The centre, which is equipped with Carl Zeiss Meditec’s latest femtosecond and excimer lasers and offers the new ReLEx femtosecond procedure in addition to the entire range of excimer procedures and premium IOLs, also makes its facilities available to outside ophthalmic surgeons for a fee of €1,400 for a bilateral procedure.

Surgeons receive fees for the procedures they perform, but all profits are reinvested in the corporation. The structure helped surgeons with different goals and interests pool resources, Mr Morin says. “It is easy if you divide the risk by five. You get different surgeons with small and high volume with the same level of risk.”

by Sean Henahan

Darkness and light

The human retina appears to dedicate slightly more attention to darkness rather than light, a new study suggests. Retinal cells that respond to a dark spot on a light background, or “OFF” cells, are smaller but clustered more densely than their counterpart “ON” cells. This clustering allocates more neural processing, via synapses, to dark regions. US researcher Charles Ratliff and colleagues hypothesised that this structural asymmetry evolved to match the ratio of light to dark contrasts in natural images. The researchers tested the hypothesis by measuring the spatial contrasts in natural images and quantifying the statistical distribution of lightness and darkness. At all spatial scales, the authors found, natural images contain relatively more dark contrasts than light. The researchers then constructed artificial images that matched the statistical characteristics of natural images, and computed the optimal configuration of OFF and ON cell mosaics for visual processing. Information throughput peaked for smaller mosaics with more densely clustered OFF cells, as in the human retina, suggesting that human vision has evolved to efficiently represent visual information in the natural world. n

C Ratliff et al., Proceedings of the National Academy of Sciences (PNAS), “Retina is structured to process an excess of darkness in natural scenes”, PNAS early online publication, September 20, 2010.Article #10-05846.

EUROTIMES | Volume 15 | Issue 11

The payoff comes with the growth of the value of the centre overall. The centre promotes high quality surgery rather than the individual surgeon’s practices. By promoting a brand the practice is not limited by an individual surgeon’s availability. It also enables investors to benefit from the greater equity that a successful brand can generate.

Still, Mr Morin sees ownership by surgeons and the active involvement of the best surgeons available as essential to deliver the high-quality results and excellent patient services needed to grow a practice. The centre is now also selling training, technical marketing and clinical expertise to other surgeons to help develop their practices.

The centre’s early budget included major investments in marketing. First up was a website with full information on the services and technology the clinic provides, which Mr Morin likens to a display window. An interactive site may cost €20,000 to €30,000 to set up and requires constant monitoring and updates to stay current. The website should reinforce your practice concept, as should advertising, brochures and scripts used by practice staff. Effectiveness of all marketing efforts should be monitored and adjustments made as needed.

For the centre, it took three ad campaigns to build awareness and hone effective messages, Mr Morin says. The clinic also sponsors sporting events and sends out cars with its logo to events. “Sportsmen are a big market.” As its visibility has risen in the region, the clinic now spends about half as much on marketing as it did the first year, and has met its goal of tripling procedure volume in three years.

Commercial viability All of Expert Vision Center’s decisions were based on

a rigorous, fact-based business planning process. Such a plan greatly increases your chances of success, notes Kris Morrill, co-founder of medeuronet, a pan-European firm with offices in France and the UK that works with medical start-ups in the US and Europe.

The first step is to determine commercial viability. This requires market research.

You will need to find out how much your competition is charging, how they treat patients, etc. This can be done by using secret shoppers, marketing consultants or with assistance from students in MBA or marketing programmes.

The goal is to reduce the level of unknowns and risk, and to spot opportunities. Your plan should target them. Project target client capture rates and volume. Be reasonable and also look at a worst-case scenario. Your plan should include specific performance goals and be thoroughly prepared and executed. Regular reviews will help keep the plan on track and respond to an evolving market.

Financial projects are also essential. How much working capital is needed? How long will it take to generate positive cash flow? A three-year financial plan will help.

Ms Morrill also recommends talking over your plan with someone with business development experience, such as a banker.

Legal structure is also important. Ms Morrill recommends consulting with a lawyer who is familiar with business rules in your country.

Most importantly, consider your own capabilities, motivations and personal and professional circumstances, Ms Morrill says.

“Ambition is especially important if you are moving from a public practice to a private practice because it does entail risk.”

Feature

35

Book review

Feed your eyes

Good sense and good cheer at the table can help preserve eyesight â&#x20AC;&#x153;A proper diet means loving oneself.â&#x20AC;? So reads the subtitle of the introduction to Lucio Burattoâ&#x20AC;&#x2122;s excellent book. Is it a surprise that this lavish book on nutrition and the eye, the centrepiece of which is a collection of mouth-watering recipes, is written by an Italian? Italy has become, in the global media eye, synonymous with a combination of good food and convivial living.

Diet is an area which has become somewhat eclipsed in mainstream medical practice. Of course, we tend to recommend to our patients the general principles of a healthy diet, but we are somewhat suspicious of the claims of miracle foods and vitamin supplements. This healthy scepticism (and a sense that to simply prescribe â&#x20AC;&#x153;lifestyle modificationâ&#x20AC;? is rather too simple for a doctor) may lead us to underrate the importance of diet.

Burattoâ&#x20AC;&#x2122;s introduction begins by describing the vast difference between the environments and lifestyles that underlay the evolution of our physiological systems. In so many ways, our modern lives are vastly different from those of our remote ancestors. As is well known, this phenomenon goes some way to explain the modern prevalence of heart disease and obesity â&#x20AC;&#x201C; our systems evolved for scarcity, not the superabundance of the consumer society. We also see this phenomenon impinging on ophthalmology.

The advent of a working world in which staring at computer screens is central is only part of the enormously increased workload of the eye.

Buratto, in his introduction, states the credo that essentially underpins the entire work. A correct diet should be followed if we wish to enjoy good health and maintain an optimal body weight. But what is a correct diet? Firstly, we must consume the right amount of food, balancing calorific intake with energy requirements. Secondly, we must take a sufficient and proportioned approach to the components of nutrition. We must eat larger quantities of raw and cooked fruit and vegetables. Finally, Buratto argues that we should eat good food in smaller quantities during the day rather than in two or three large meals.

The theory about diets is easy â&#x20AC;&#x201C; everyone knows, more or less, what to do. The application is more difficult. To that end, EUROTIMES | Volume 15 | Issue 11

the range and variety of recipes provided is salutary. The book is divided into four sections. The first, on dietary prevention and written by Eugenio del Toma, covers the general area of sensible approaches to diet.

The usual areas are covered, such as avoiding excess sugar and alcohol, and reducing salt intake. A sensible and moderate approach is taken in this section.

Secondly, we have the most perhaps â&#x20AC;&#x153;ophthalmologicalâ&#x20AC;? section, on nutrition and eye disease, by Nazareno Marbottini. This discusses oxidative stress and the antioxidant system, and the role of nutrition in protecting the retina. Mauro Febbrari Defendente contributes what many will consider a very Italian-sounding chapter â&#x20AC;&#x201C; â&#x20AC;&#x153;good cheer at the table.â&#x20AC;? Finally we have 275 pages of recipes.

Snacks, risotto, pasta, soups, meat, vegetables, fish, sauces, fruit, smoothies, shakes, desserts â&#x20AC;&#x201C; all are covered in a style that is the equal of any commercial cookery book I have seen.

Indeed this book simply takes the prize of the most beautiful I have ever reviewed in this section. The design is crisp, uncluttered and clear. The book is a joy to read and to handle. As readers of this column will know, I usually recommend a book for a particular group â&#x20AC;&#x201C; medical students, trainee ophthalmologists, general practitioners, practising specialists or subspecialists. In this case, the target market is surely everyone.

Buon appetito!

books editor: Seamus Sweeney publication: The Eye and nutrition BY: LUCIO BURATTO SLACK INCORPORATED 2010

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36

Feature

bio-ophthalmology

Alzheimer’s diagnosis by retina?

Imaging of retinal plaques may hold promise for assessing patients with Alzheimer’s

by Gearoid Tuohy

R

esearchers have found that noninvasive in vivo imaging of a hallmark of Alzheimer’s disease may be feasible through retinal

imaging.

The researchers, led by Dr Maya Koronyo-Hamaoui and Dr Daniel L Farkas at the Cedars-Sinai Medical Centre in Los Angeles, California, detected Ab plaques in post-mortem retinas of individuals suspected and confirmed to have Alzheimer’s disease. Once validated in the retinas of live Alzheimer’s patients, the technology may provide a significant clinical tool in assessing patients for diagnosis, monitoring and response to medical treatment.

According to the researchers, the current definitive diagnosis of Alzheimer’s disease is determined only after brain autopsy through the detection of b-amyloid peptides (Ab) and intercellular neurofibrillary tangles. To date, research into non-invasive detection of Ab plaques in live Alzheimer’s patients has yet to yield tools of high resolution and specificity. An alternative approach suggested through the current study proposes direct optical imaging of the retina to detect Ab plaques.

The research, published in Neuroimage (Koronyo-Hamaoui, M et al, doi:10.1016/ j.neuroimage. 2010.06.020) reports the “presence of Ab plaques in retinas of post-

Journal Watch

mortem eyes from Alzheimer’s patients, and moreover, in retinas from those suspected as early-stage cases”. In addition, the research presents evidence for the formation of Ab plaques in the retina of Alzheimer’s animal models prior to their appearance of plaques in the brain.

Accumulation of hallmark proteolytic products of amyloid precursor protein b-amyloid peptides (Ab) – have been widely documented to form extracellular aggregates termed Ab plaques in the neuronal tissues of Alzheimer’s patients.

While non-invasive imaging of such Ab plaques remains clinically challenging and of limited resolution, an alternative approach to visualise such plaques through the retina by direct optical imaging may represent a valuable clinical tool in Alzheimer’s medicine. The value of such a tool would rest on the assumption that Ab plaques forming in patients’ retinas are similar to those that form in the brain. On that basis the researchers set about a series of experiments to test to what extent Ab plaques in the retina were relevant to those in the brain.

Curcumin staining First, the researchers used transgenic mouse models of Alzheimer’s to test the specificity of a natural and safe flurochrome, “curcumin”, to bind and label Ab plaques. Following

systemic injection of curcumin (7.5mg/ kg/day), flurochrome labelling was shown to be coincident with established antiAb monoclonal antibody labelling in the transgenic model brain tissue.

Curcumin staining, found in Alzheimer’s mouse models but not in wild type subjects, was shown to be present in several retinal locations including the nerve fibre layer, retinal ganglion cell layer, inner and outer plexiform layers and the inner nuclear layer. The bioavailability of the flurochrome following systemic injection showed that the dye could readily cross the blood-brain and blood-retinal barriers.

Ab plaques appeared to be detected in the retina but not the brain of transgenic models at 2.5 months which the authors interpreted as a suggestion that Ab plaques in the retina may precede their appearance in the brain. If such findings translate to human Alzheimer’s patients, an early diagnostic of Alzheimer’s could be developed further.

A key component of validating the relevance of Ab plaques in the retina to Ab plaques in the brain was to assess how both plaques responded to immunisation with an altered myelin derived peptide, previously shown to restrict Ab plaque burden in the brains of transgenic models.

The researchers aimed to investigate if retinal plaques and brain plaques behaved

by Sean Henahan

Progress with biosynthetic cornea

Researchers from Sweden and Canada report remarkable results in a clinical study of biosynthetic cornea transplantation. A preliminary clinical trial involving 10 patients showed that biosynthetic corneas could help regenerate and repair damaged eye tissue and improve vision in humans. This is the first study to show that an artificially fabricated cornea can integrate with the human eye and stimulate regeneration.

Patients did not experience any rejection reaction or require long-term immune suppression. The biosynthetic corneas also became sensitive to touch and began producing normal tears to keep the eye oxygenated. Vision improved in six of the 10 patients, and after contact lens fitting, vision was comparable to conventional corneal transplantation with human donor tissue. The promising clinical results are a culmination of more than a decade of work using synthetically cross-linked recombinant human collagen moulded into the shape of a cornea. The researchers report that further biomaterial enhancements and modifications to the surgical technique are ongoing, and new studies are being planned that will extend the use of the biosynthetic cornea to a wider range of sight-threatening conditions requiring transplantation.

Dr May Griffith displays a biosynthetic cornea that can be implanted into the eye to repair damage and restore sight.

n

Photo courtesy of the Ottawa Hospital Research Institute

EUROTIMES | Volume 15 | Issue 11

P Fagerholm et al., Science Translational Medicine, “A Biosynthetic Alternative to Human Donor Tissue for Inducing Corneal Regeneration: 24-Month Follow-Up of a Phase 1 Clinical Study”, 25 August 2010: 46ra6.

similarly in response to the same therapy.

Following delivery of the peptide, loaded on dendritic cells, (0.5X106 cells/200ul phosphate buffered saline) a substantial reduction of Ab plaque burden was observed in both retinal and brain tissues using curcumin staining.

The researchers advanced to applying curcumin staining on post-mortem eyes from patients who had been diagnosed with Alzheimer’s. Similar results and labelling patterns of retinal Ab plaques by curcumin were recorded in the human tissues and further, staining could also be detected in Alzheimer’s patients that were possibly at early stages of the disease.

Qualitative correlation The researchers observed “a qualitative correlation between the severities of the clinical diagnosis verified by post-mortem neuropathology and retinal Ab plaque burden”. They were also able to identify Ab plaques, which were specifically detected with curcumin, in the retinas from definite and suspected early Alzheimer’s patients.

In conclusion, the researchers proposed that the transgenic model data showed that Ab plaques could be detected in the retina before becoming visible in the brain and that the plaque burden correlated with the progression of brain pathology.

The reduction in plaque size following immunisation provided further weight to support the hypothesis that retinal plaque pathology “faithfully represents the brain disease.”

Prior research into Alzheimer’s disease has suggested that neuropathological abnormalities may occur decades prior to a clear clinical manifestation. Such studies had identified abnormalities, including Ab plaques, at a prodromal phase of the disorder further under-scoring the clinical need for early diagnosis allowing for potentially earlier opportunities for medical intervention.

According to the researchers, their latest findings demonstrate the first proof for an amyloid plaque pathology in the retina that appears to be specific for Alzheimer’s disease. In addition, the study is thought to provide the first demonstration of Ab plaques in post-mortem retinas from suspected and definite Alzheimer’s patients that reflected Alzheimer’s brain pathology. As the detection occurred in the inner layers of the retina live imaging of this “accessible part of the brain” may be achievable through an improvement in currently available ophthalmic imaging tools. “Based on their unique size, signature and distribution within the retinas, Ab plaques observed in Alzheimer’s patients could be eventually used for differential diagnosis,” the researchers stated.

Feature

industry news

Recent developments in the vision care industry

New Sterimedix manufacturing facility

Alcon launches Refractive Suite

Due to the continuing expansion of its business, Sterimedix has moved to a new, state-of-the-art manufacturing facility.

Sterimedix is still based in Redditch in Worcestershire, UK and the company says the new facility provides it with the opportunity to increase its production and R&D capabilities.

For more information please visit www.sterimedix.com.

Alcon has announced the launch of the AcrySof IQ ReSTOR Multifocal Toric intraocular lens and the WaveLight Refractive Suite, which includes the firm’s first femtosecond laser integrated with its fastest excimer laser yet, at the XXVIII Congress of the ESCRS. Both technologies are now available in markets outside the US. The AcrySof IQ ReSTOR Multifocal Toric IOL brings together the multifocal performance and aspheric image clarity of the AcrySof IQ ReSTOR with the precise astigmatism correction of the AcrySof Toric IOL. Four models of the IQ ReSTOR Toric are currently available, with cylinder power ranging from 1.00 to 3.00 D. “The AcrySof IQ ReSTOR Toric will be a powerful option to offer my cataract surgery patients where I can predictably manage their astigmatism without the need for an additional surgery,” said Francesco Carones MD, co-founder and medical director of Carones Ophthalmology Center, Milan, Italy. He implanted the first IQ ReSTOR Toric lenses, and reported achieving spectacle independence at all distances and 20/15 distance vision in an active 49-year-old female cataract patient in his first case.

The WaveLight Refractive Suite combines the WaveLight EX500 Excimer Laser and WaveLight FS200 Femtosecond Laser, which, at 500 Hz and 200 kHz, are the fastest in their respective classes. It also links the two lasers via the WaveNet network, allowing them to share data with each other as well as WaveLight diagnostic devices and medical records.

The result is the world’s fastest laser refractive platform, said Arthur Cummings MB, ChB, MMed(Ophth), FCS(SA), FRCSEd, Wellington Eye Clinic, Dublin, Ireland. “Speed is very important to good quality vision. Speed and precision go hand in hand, ” he said.

Wavelight EX500 Excimer Laser, part of the Alcon WaveLight Refractive Suite

Wavelight FS200 Femtosecond Laser, part of the Alcon WaveLight Refractive Suite

EUREQUO

What is EUREQUO?

European Registry of Quality Outcomes for Cataract & Refractive Surgery

EUREQUO is a European Quality Registry for visual outcomes of cataract and refractive surgery

The project aims to:

1

Improve treatment and standards of care for cataract and refractive surgery

2

Develop evidence-based guidelines for cataract and refractive surgery across Europe

3 with the kind contribution of

EUROTIMES | Volume 15 | Issue 11

Make significant impact on the exchange of best practice between practitioners in relation to patient safety

EA authorisation for OZURDEX

Allergan has announced that the European Medicines Agency (EMEA) has granted marketing authorisation for OZURDEX® (dexamethasone 700mcg intravitreal implant in applicator) in the 27 member states of the EU. It is the first licensed treatment in Europe for macular oedema in patients with retinal vein occlusion (RVO), said a company spokesman.

“We are delighted that the European Medicines Agency has granted marketing authorisation for OZURDEX®,” said David Endicott, president, Allergan, Europe, Africa and the Middle East.

“As a leading company in ophthalmology, Allergan are pleased to enter the retina market and to provide physicians and their patients with the first European-licensed drug treatment for macular oedema following retinal vein occlusion.”

Join the network EUREQUO gives a unique opportunity to monitor and compare results Quality registries create a sufficient basis for studying rare diseases, treatments and complications Collecting data will support you to make an audit report The collection of your data will facilitate the analysis of surgical outcomes and the development of evidencebased European Quality Guidelines

See www.eurequo.org for more information

37

38

Feature

LEGAL matters

Dampen expectations

Ophthalmic patients who understand the limitations of their operations don’t complain – and don’t sue

by Paul McGinn

Capacity Most courts want to be sure that the patient who consents has the capacity to do so. If a patient is mentally impaired, you should ask yourself whether your country requires you to follow special laws or guidelines to determine the manner in which you can operate – if at all. Do not operate on a patient until you are sure he or she is competent to consent

D

on’t ever promise what you can’t guarantee. There is no better advice that I can give ophthalmic surgeons when they explain an upcoming operation to their patients.

I repeated that advice during the ESCRS Practice Development Workshops at the XXVIII Congress of the ESCRS in Paris in September. From my talk, “Managing Expectations: Using the consent process to keep your patients on your side,” I would suggest that you keep in mind some principles about the consent procedure the next time you counsel a patient about an upcoming operation.

Put yourself in the place of a surgeon who is planning to perform LASIK or another refractive procedure on a middle-aged patient. You overhear the patient telling your nurse that he’s looking forward to getting rid of his glasses. Your nurse says nothing to correct the patient’s expectation.

And neither do you. Instead, your preoperative consultation focuses on the mechanics of the operation, potential risks, and postoperative care.

The operation proceeds without any difficulty, but two weeks after the operation, you receive a telephone call from the

Journal Watch

patient. He’s angry that no one ever warned him that he might still have to wear glasses after the operation. What can you say? Very little, to be honest.

Such an awkward situation could have been averted if you had informed the patient about the possibility that he might have to continue using glasses. In this particular case, your patient was clearly operating

by Sean Henahan

Multi-wavelength fundus imaging

A new imaging system using six different wavelengths to illuminate the ocular fundus could greatly enhance the screening of age-related macular degeneration and diabetic retinopathy. British researchers have developed an imaging system combining a highsensitivity CCD camera with wavelength-specific illumination from light-emitting diodes that provides multispectral images of the ocular fundus. The multispectral images are affected differently by the pigments present in the eye, and through a sophisticated algorithm they can be used to generate a pixel-by-pixel “parametric map” of the distribution of substances in the eye. This approach could allow clinicians to screen for and identify pathologies at a much earlier stage of development than other imaging modalities. And the new system is fast. It can acquire a sequence of multispectral images at a fast enough rate (0. 5 seconds) to reduce image shifts caused by natural eye movements. In contrast with snapshot systems, the system’s images retain full spatial resolution. Also, the system uses only the specific wavebands that are required for the subsequent analysis, minimising the total light exposure of the subject, ensuring patient safety and improving image quality, the researchers report. n

N Everdell et al., Review of Scientific Instruments, “Multispectral Imaging of the Ocular Fundus using LED Illumination”, in press.

EUROTIMES | Volume 15 | Issue 11

can make a free decision about his care, particularly when that procedure has significant risks or limitations. For the purposes of ensuring that you obtain a valid consent to every procedure you perform, I’d suggest looking at consent in four steps: capacity, information, understanding, and choice.

under a false expectation that he would be able to throw away his glasses. You and your nurse knew that but said nothing to correct his unrealistic expectation. If a patient knows what to expect of a procedure and its side-effects, he will more easily accept a poor outcome as a post-surgical complication and not the result of your error – and thus be less likely to complain or sue.

But telling the patient about those risks isn’t all; you have to write down what you tell the patient. If a patient is warned about what to expect and still complains, good records – including a rigorously documented informed consent procedure – will provide a potent defence. There are many reasons why you may excuse your failure to warn your patients and to write down those warnings. The problem is that such excuses are not of any help if your patient complains or sues.

Ophthalmic surgeons should remember that in obtaining a patient's consent to an operation, it is important not only to describe the procedure but also its complications – and its limitations.

There are different court systems in Europe, but they share a relatively similar approach to what is required of a doctor when he or she looks for consent to an operation.

At the core of the consent process is the idea that a competent patient who is properly informed about a procedure

Information Most European countries also require doctors to inform their patients about the nature, risks, and complications of their operations. Generally speaking, no courts impose an absolute rule about what must be disclosed. Rather, courts will hold that the level of disclosure is guided by what ophthalmic surgeons in that particular country generally disclose to their patients about such procedures and by the level of understanding and interest of the particular patient in that case. If your colleagues are warning patients about the risks and limitations of a procedure, you should too.

Also, if a patient is particularly inquisitive about the upcoming operation, you should make the extra effort to answer her or his questions.

Understanding Providing information isn’t enough. You have to provide information in a manner that makes sense to him or her and which the patient has the time to digest. You can’t throw a leaflet at a patient on the morning of an operation and expect her or him to really understand the nature of the operation. You have to provide the information in a form and manner that allows the patient to think over what the operation means for her or his life.

Choice You and your staff can recommend a type of refractive procedure or brand of premium IOL for a cataract patient – that is your job as the caring professional. However, you should not cross the line and insist that the patient undergo the procedure or choose the lens you want.

It’s about the patient’s choice. You have to allow the patient to say “No”.

When a patient says, “No,” it doesn’t mean you gave the wrong advice; it just means that the patient doesn’t feel it’s the right advice – at that time. All you can do is offer the advice – and remember that in accepting the refusal you may have avoided the heartache of defending a claim from a patient whose expectations were too high.

39

Review

JCRS Highlights Journal of Cataract and Refractive Surgery

Blue blockers

Most current IOLs are designed to block ultraviolet light, with the goal of preventing photic retinopathy. Many of the newest IOLs on the market go one step further, blocking some light in the blue spectrum.

Does this actually help the retina? Might it possibly have a negative effect on visual acuity? It is an area of active, sometime heated debate. German researchers designed an experiment to evaluate the potential effect of blue-light filtering on visual processing. They recorded multifocal electroretinograms (ERGs) monocularly after pupil dilation in pseudophakic patients with a colourless IOL under two conditions: stimulus perception through a yellow-tinted filter and, stimulus perception through a neutral filter. First-order kernel multifocal ERGs were extracted at 61 visual field locations and averaged for five stimulus eccentricities. The study found that the bipolar cell-dominated multifocal ERG was largely unaffected by short-term effects of blue-light filtering. The induced change in the spectral composition of the stimulus did not significantly alter the activity at the input stage of the visual system, specifically the retinal network comprising photoreceptors, horizontal cells, and bipolar cells. The researchers suggest the need for a study to look at longer-term effects. n MB Hoffmann et al., JCRS, “Minor effect of blue-light filtering on multifocal electroretinograms”, Volume 36, Issue 10, Pages 1692-1699 (October 2010).

Toric IOL vs. relaxing incisions

The advent of toric IOLs gave ophthalmic surgeons an alternative to peripheral corneal relaxing incisions for dealing with astigmatism. Do toric IOLs do a better job in patients with mild to moderate astigmatism? Spanish researchers addressed that question with a prospective randomised comparison study. Forty consecutive cataract patients with up to 3.0 D of regular astigmatism received either a toric IOL or a spherical IOL and relaxing incisions. After three months of follow-up, both groups showed significant decreases in refractive astigmatism postoperatively. The residual refractive cylinder was statistically significantly lower in the toric IOL group than in the relaxing incisions group (P<0.01). The residual refractive astigmatism was 1.0 D or less in 18 eyes (90 per cent) with a toric IOL and eight eyes (40 per cent) with peripheral corneal relaxing incisions. The researchers

Don’t miss Calendar, see page 40 EUROTIMES | Volume 15 | Issue 11

noted that implantation of a toric IOL does not require special surgical skills or instrumentation and does not increase surgical risks. n D Mingo-Botín et al., JCRS, “Comparison of toric intraocular lenses and peripheral corneal relaxing incisions to treat astigmatism during cataract surgery”, Volume 36, Issue 10, Pages 1700-1708 (October 2010).

Long-term refractive stability

Millions of patients have now undergone LASIK and PRK to reduce or eliminate myopia. Both procedures have been around long enough to begin to answer the question of long-term visual stability. A longitudinal retrospective cohort study of an Australian population compared patients who had PRK, LASIK, or both, with a follow-up of up to 13 years. The study evaluated 389 eyes of 229 patients. The PRK patients with low to moderate showed a change in spherical equivalent from −4.05 D preoperatively to -0.64 D. High myopes undergoing PRK improved from −7.97 D preoperatively to −1.06 D. Eyes in the low myopia LASIK group improved from −3.98 D to −0.33 D, while those with higher myopia improved from a mean of −7.64 D to −0.63 D. Overall, refractive stability was achieved within one year postoperatively, with LASIK showing better stability than PRK for up to nine years. n M Dirani, JCRS, “Long-term refractive outcomes and stability after excimer laser surgery for myopia”, Volume 36, Issue 10, Pages 1709-1717 (October 2010).

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To find out more, visit www.escrs.org European Society of Cataract & Refractive Surgeons, Temple House, Temple Road, Blackrock, Co. Dublin, Ireland Tel: +353 1 209 1100 Fax: +353 1 209 1112 Email:escrs@escrs.org www.escrs.org

40

Reference

Calendar of events Dates for your Diary

November

4-6

2010

Delhi, India

5th International Congress on Glaucoma Surgery ICGS www.oic.it/icgs2010/

February 2011

18-20 TURKEY

ISTANBUL,

15th ESCRS Winter Meeting www.escrs.org

December

9-12

2010

MACAU, CHINA

The International Symposium on Ocular Pharmacology and Therapeutics – ISOPT ASIA www.isopt.net

27-28

11

January

February

BELGRADE, SERBIA

Mid Term Conference of Delhi Ophthalmological Society www.dosonline.org

2011

12-14

Vienna, Austria

2nd International course on ophthalmic and oculoplastic reconstruction and trauma surgery www.ophthalmictrainings.com

3rd International Symposium on Macular Disease www.milosklinika.com

3-5

2011

Verona, Italy

Present & Future Challenges in severe Retinal Diseases www.retinaldiseases2011.com

24-27

Athens, Greece

25th International Congress of the Hellenic Society of Intraocular Implant and Refractive Surgery www.hsioirs.org

March 2011

March 2011

20-24 3-6 Alicante, 11-12 Spain 25-30 Barcelona, Spain

2nd World Congress on Controversies in Ophthalmology (COPHy) www.comtecmed.com/cophy

ARI Monographic 2011 “The best and most updated information about Lens, Cataract and Refractive Surgery” www.alicanterefractiva.com

Australia

Joint Congress of SOE/AAO www.soe2011.org

World Glaucoma Congress 2011 www.worldglaucoma.org

6-10 Argentina 26-29 Mar del Plata,

London, UK

11th EURETINA Congress www.euretina.org

SAN DIEGO, CA, USA

ASCRS/ASOA Symposium and Congress www.ascrs.org

2011

1-3 4-7 PARIS, 29-2 FRANCE GENEVA, SWITZERLAND

2011

2011

19th Argentinian Ophthalmology Congress www.oftalmologia2011.com.ar

July

June 2011

2011 Congress of the APAO www.apaosydney2011.com/

Sydney,

May

April

September Leuven, Belgium

Leuven Retina Meeting www.leuvenretinameeting.eu

2011

vienna, austria

16-17 17-21 2nd EuCornea Congress www.eucornea.org

November

13-16

2011

Seoul, Korea

2011 APACRS-KSCRS Annual Meeting www.apacrs.org

XXIX Congress of the ESCRS www.escrs.org

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*The effects of this aspheric design feature have been clinically studied on AcrySof® IQ IOL Model SN60WF. is a registered trademark of Alcon Inc. ©2010 Alcon, Inc. 7/10 TOR10292JAD-EU

Precisely where you need to be.