Volume 15_Issue 12-Volume 16_Issue1

VOLUME 15 ISSUE 12 DECEMBER 2010

Endothelial keratoplasty

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VOLUME 16 ISSUE 1 JANUARY 2011

ESCRS

EUROTIMES

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December 2010 / January 2011 Volume 15/16 | Issue 12/1 This month...

Special Focus: Cornea 4

Cover Story: Analysis on developments and techniques for corneal surgery

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Benefits of femtosecond-enabled technique

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Procedure corrects hyperopia and hyperopic astigmatism

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Topical AMX treatment promotes healing of epithelial defects

Cataract

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Studies look at IOL materials and PCO

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Stereoacuity tests carried out on cataract surgery patients

Refractive Lens 15

Dual-optic IOLs have an added benefit

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High patient satisfaction with bilateral multifocal IOL implantation

Refractive Laser 18

Femtosecond laser platforms evaluated

Glaucoma

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Early treatment best in high-risk patients

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Call for change in approach to glaucoma management

Retina 23

Patients need to be aware of vitrectomy procedure risks

News 24

Preview of 11th EURETINA Congress in London, UK

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Benchmarking young ophthalmologists

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Looking ahead to the 15th ESCRS Winter Meeting in Istanbul

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Experts call for clinical trials for presbyopic IOLs

Features 29

Practice Development

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Bio-Ophthalmology

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Letter from America

Cover image: Slit-lamp photograph of a cornea one week after Descemet’s membrane endothelial keratoplasty (DMEK).

With some residual oedema in the cornea periphery, the best spectacle corrected visual acuity had already returned to 20/20.

Image is courtesy of Gerrit Melles MD, PhD, Netherlands Institute for Innovative Surgery (NIIOS).

32, 38 Journal Watch 33 Outlook on Industry

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With this month’s issue...

editorial staff

ESCRS

EUROTIMES

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Industry News

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EU Matters

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JCRS Highlights

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Calendar

Innovations in refractive IOL & Laser technology supplement, EURETINA 2011 Preliminary programme & 2011 wallplanner

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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

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Editors Sean Henahan Paul McGinn

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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

Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland.

No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.

ESCRS EuroTimes is not responsible for statements made by any contributor. These contributions are presented for review and comment and not as a statement on the standard of care. Although all advertising material is expected to conform to ethical medical standards, acceptance does not imply endorsement by ESCRS EuroTimes.

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 15/16 | Issue 12/1

José Güell

Ioannis Pallikaris

Clive Peckar

Paul Rosen

Exploring new frontiers

The 21st century is an exciting time for the corneal surgeon

by Prof Boris Malyugin MD, PhD

International Editorial Board

Emanuel Rosen Chairman ESCRS Publications Committee

Noel Alpins australia Bekir Aslan TURKEY Bill Aylward UK

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phthalmic surgeons have explored the idea of replacement of the diseased corneal layers for many years. Unfortunately, various techniques proposed were unable to provide the optical and visual results equal to penetrating keratoplasty (PKP). That is why for many years lamellar keratoplasty was in the “shade” of its younger sister – PKP, implemented into clinical practice much later.

About 10 years ago, an international cohort of gifted corneal surgeons focused on the research and improvement of lamellar corneal grafting and the situation started to change dramatically.

As a result, replacement of posterior corneal layers in the form of Descemet stripping (automated) endothelial keratoplasty (DSAEK) procedure became a standard of care in treatment of patients with corneal endothelial dysfunction.

Nowadays, as we report in our Cover Story in this issue, we have a lot of evidence on the advantages of the endothelial keratoplasty over PKP. The former has become the mainstream of surgery because it can provide faster visual rehabilitation, minimal changes in corneal topography, highly predictable and stable corneal power, healthy donor endothelium, tectonically stable globe, an easy and reproducible technique.

Of course, we can talk about the postoperative optical purity of the cornea only to a certain extent because fewer patients usually achieve 20/20 vision after replacement of the posterior corneal layers.

Nevertheless, early clinical studies have shown that using ultrathin posterior corneal grafts has the potential to provide higher functional outcomes. The next frontier is the pure Descemet’s membrane transplantation, Descemet’s membrane endothelial keratoplasty (DMEK). This kind of surgery is extremely promising but quite challenging due to the fragility of tissue and its sensitivity to any mechanical impact.

Peter Barry IRELAND Various modifications of the DSAEK and DMEK surgical technique, including different folding and carrying devices, have been proposed to overcome the difficulties and decrease the damage to the endothelial layer, most of which occurs during the insertion, unfolding and fixation of the tissue in place.

Similar to phacoemulsification in cataract surgery, selective replacement of posterior corneal layers can be characterised as a giant step in corneal surgery. Now we are on a technical level where this kind of surgery can be performed by treating only the diseased portion of the cornea, in the controlled intraocular environment and with the sutureless manner.

The 21st century is an exciting time for the corneal surgeon.

Multiple abbreviations reflect the evolutional steps of the posterior lamellar grafting - PLK/DLEK/DSEK/DSAEK/FS-DSAEK/DMEK. But there is a high chance that none of them will survive in the future. The current research is focused on the human corneal endothelial cell regeneration. Biopsy and cultivation of the patients' remaining own cells followed by their transfer back into the anterior chamber is already on the horizon.

Roberto Bellucci ITALY Hiroko Bissen-Miyajima JAPAN 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

BORIS MALYUGIN MD, PhD Boris Malyugin MD, PhD, Moscow, Russia is a member of the International Editorial Board of EuroTimes. He is also the medical editor of EuroTimes Russia, a Russian language online publication at www.eurotimesrussian.org

Gisbert Richard GERMANY Robert Stegmann SOUTH AFRICA Ulf Stenevi SWEDEN Emrullah Tasindi TURKEY Marie-Jose Tassignon BELGIUM Manfred Tetz GERMANY Carlo Enrico Traverso ITALY Roberto Zaldivar ARGENTINA Oliver Zeitz germany

EUROTIMES | Volume 15/16 | Issue 12/1

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AZARGA® Suspension offers you and your patients: Proven IOP reduction – up to 9.1 mmHg from baseline1 Superior comfort compared to Cosopt† Solution2,3

When you review your use of a TCAI combination – select AZARGA® Suspension

PRESCRIBING INFORMATION: Consult the Summary of Product Characteristics before prescribing, particularly in relation to side-effects, precautions and contraindications.

AZARGA® 10 mg/ml + 5 mg/ml eye drops, suspension.

Presentation Plastic bottle containing 5ml eye drops. Each 1 ml contains 10 mg brinzolamide, 5 mg timolol (as maleate), benzalkonium chloride 0.1 mg. Indication Decrease of intraocular pressure (IOP) in adult patients with open-angle glaucoma or ocular hypertension for whom monotherapy provides insufficient IOP reduction. Dosage/Administration Adults, including the elderly One drop twice daily. Paediatric patients Not recommended.

Use in hepatic and renal impairment No studies conducted.

Contraindications Hypersensitivity to any component. Presence or history of bronchial asthma, severe chronic obstructive pulmonary disease. Sinus bradycardia, second or third degree atrioventricular block, overt cardiac failure, cardiogenic shock.

Severe allergic rhinitis and bronchial hyperreactivity.

Hyperchloraemic acidosis. Severe renal impairment.

Hypersensitivity to other beta-blockers and/or sulphonamides.

Warnings and precautions Systemic effects Cardiovascular and pulmonary adverse reactions as seen with systemic beta-blockers may occur (death due to bronchospasm in patients with asthma and to cardiac failure, have been reported following use of timolol). Cardiac failure should be adequately controlled before beginning therapy with timolol. Patients with history of severe cardiac disease should be watched for signs of cardiac failure and have pulse rates checked. Beta-blockers may mask the signs and symptoms of acute hypoglycaemia and hyperthyroidism, and cause worsening of Prinzmetal angina, severe peripheral and central circulatory disorders and hypotension.

Give with caution in patients subject to spontaneous hypoglycaemia or labile insulin-dependent diabetes. Adverse effects attributable to sulphonamides and acid-base disturbances may occur and there is a potential for additive systemic effects in patients receiving oral carbonic anhydrase inhibitors. Concomitant administration with oral carbonic anhydrase inhibitors is not recommended. Anaphylactic reactions While taking beta-blockers, patients with a history of atopy or severe anaphylactic reaction may be unresponsive to usual doses of adrenaline used in treatment. Concomitant Therapy Effect on IOP or known effects of systemic beta blockade may be potentiated when AZARGA® is given to patients already taking oral beta-blockers. Use of two local beta-blockers or local carbonic anhydrase inhibitors is not recommended. Ocular effects There is limited or no experience in patients with narrow-angle, pseudoexfoliative or pigmentary glaucoma. Carbonic anhydrase inhibitors may affect corneal hydration. Careful monitoring of patients with compromised corneas (such as in diabetes mellitus and corneal dystrophies) and contact lens wearers is recommended. Benzalkonium chloride may cause eye irritation, discolour soft contact lenses and has been reported to cause keratopathy. Soft contact lens wearers should remove contact lenses prior to use and wait 15 minutes after instillation before reinsertion. Interactions No studies performed. Potential exists for additive effects resulting in hypotension and/or marked bradycardia when eye drops with timolol are administered concomitantly with oral calcium channel blockers, guanethidine, beta-blockers, antiarrhythmics, digitalis glycosides, parasympathomimetics or CYP2D6 inhibitors (e.g. quinidine, cimetidine).

Beta-blockers may potentiate hypoglycaemic effect of antidiabetic agents and hypertensive reaction to sudden withdrawal of clonidine. Pregnancy Do not use unless clearly necessary. Lactation May be used. Driving /use of machines May blur vision and has potential to impair mental alertness or physical coordination in the elderly. Undesirable effects Ocular: Common blurred vision, pain, irritation, foreign body sensation.

Uncommon: corneal erosion, punctate keratitis, dry eye, discharge, pruritus, hyperaemia, blepharitis, allergic conjunctivitis, corneal disorder, anterior chamber flare, conjunctival hyperaemia, eyelid - margin crusting/pruritus/ erythema, asthenopia, abnormal sensation, allergic blepharitis.

Systemic: Common dysgeusia. Uncommon insomnia, decreased blood pressure, chronic obstructive pulmonary disease, pharyngolaryngeal pain, rhinorrhoea, cough, hair disorder, lichen planus. * Refer to SPC for additional information and before prescribing*.

Overdose Symptomatic and supportive treatment. Timolol does not dialyse readily.

Incompatibilities Not applicable. Shelf life 2 years, discard 4 weeks after first opening. Special precautions for storage/ disposal None. MAH Holder/Further Information Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom. MAH Number EU/1/08/482/001 Date of Preparation of Prescribing Information August 2010 (V3). Packaging Quantities/Basic NHS/GMS price(s) 5ml (£11.05, 16.64) Legal Category POM.

Adverse events should be reported. Reporting forms and information can be found at www.yellowcard.gov.uk Adverse events should also be reported to Alcon Medical Information on 01442 341234.

Email: gb.adr@alconlabs.com References: 1. Manni G, Denis P, Chew P et al. J Glaucoma 2009; 18(4): 293-300.

2. Mundorf TK, Rauchman SH, Williams RD et al. Clin Ophthalmol 2008; 2(3): 623-8.

3. Vold SD, Evans RM, Stewart RH et al. J Ocul Pharmacol Ther 2008; 24(6): 601-5. †Cosopt is a registered trademark of Merck & Co., Inc., Whitehouse Station, NJ, USA.

Date of preparation: November 2010.

AZG:EU:JA:11/10:LHC

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Cover Story

CORNEA

Endothelial keratoplasty update

An evolving technique that revolutionised transplantation surgery

by Cheryl Guttman Krader

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Damage can still occur as the tissue is loaded and compressed by the device to fit into whatever tube or channel is used for delivery into the eye Mark A Terry MD

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Improvements since then are helping to reduce early endothelial cell loss so that graft survival rates from a contemporary series should be even better Marianne O Price PhD

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As DMEK may become a preferred modality, we have tried to standardise the donor preparation and surgical technique Gerrit Melles MD, PhD

EUROTIMES | Volume 15/16 | Issue 12/1

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ess than a decade after its debut, Descemet stripping (automated) endothelial keratoplasty (DSAEK) has become standard of care in many areas of the world for eyes requiring corneal transplantation because of endothelial dysfunction. While DSAEK now reliably provides good visual outcomes with a low risk of complications, the procedure continues to evolve as surgeons develop new techniques and instrumentation to facilitate the surgery and further improve safety and efficacy.

Compared with penetrating keratoplasty (PKP), DSAEK provides faster visual recovery, minimises induced astigmatism, and has a safety advantage for better maintaining globe integrity. However, greater early endothelial cell loss after DSAEK has raised concern about graft survival relative to PKP. While good longterm data on the latter issue have been limited, a study presented at the XXVIII ESCRS Congress showed the five-year graft survival rate for DSEK was at least as good as for PKP. Francis Price, MD, and colleagues at Price Vision Group in Indiana performed the first North American cases of DSEK and have the largest North American database on corneal transplants. The study, presented by Marianne O Price PhD, reviewed the first 200 consecutive DSEKs performed by Dr Price from December, 2003 to May, 2005. Indications were Fuchs' dystrophy (89 per cent) and pseudophakic/ aphakic corneal edema (11 per cent).

At five years, 136 eyes (68 per cent) were examined and clear, only 12 grafts (six per cent) had failed, and the rest were lost to follow-up or the patient was deceased.

Survival was calculated by Kaplan-Meier analysis and compared with data from a published study of almost 4,000 PKP eyes operated on between 1982 and 1996 at the same centre1, 2.

The five-year graft survival rates were 96 per cent for DSEK and 95 per cent for PKP

among eyes with Fuchs' dystrophy and 72 per cent for DSEK and 90 per cent for PKP in those with corneal edema. However, in the DSEK study, prior glaucoma surgery (tube or trabeculectomy) was the main risk factor for early graft failure, and this history was more common in the DSEK series (33 per cent) versus the older PKP cohort (three per cent). In the DSEK series, the five-year survival rate was 95 per cent for eyes with no or pre-existing medically managed glaucoma versus 36 per cent in eyes with a history of trabeculectomy or tube surgery, Dr Price reported.

“The DSEK eyes are also early cases done up to seven years ago. Improvements since then are helping to reduce early endothelial cell loss so that graft survival rates from a contemporary series should be even better,” she said.

Minimising donor trauma Since donor endothelial damage is the major determinant of graft survival, there has been significant interest in strategies for minimising surgical DSAEK graft manipulation to reduce EC loss. Results of laboratory and clinical studies identify compression during insertion as the major source of trauma, and support using a wider 5.0mm scleral incision through which to insert the tissue, rather than a smaller 3.0mm incision, said Mark A Terry MD, director of corneal services, Devers Eye Institute, in Portland, Oregon.

Speaking at the 1st EuCornea Congress in Venice, Italy, Dr Terry discussed his research on this topic, including a laboratory study showing endothelial cell loss rates of 29 per cent for DSAEK grafts inserted through a 3.0mm incision versus 18 per cent using a 5.0mm incision. The technique for inserting the tissue, ie, Busin glide, forceps, or pull-through technique, did not matter, only the incision size made a difference. He also cited a recently published clinical study in the journal CORNEA that confirmed these laboratory results. A

comparison of forceps insertion through a 5.0mm incision by Price (n=64) or a 3.2mm incision by Gorovoy (n=103) resulted in 40 per cent cell loss with the smaller 3.2mm incision and only 27 per cent with the larger 5.0mm incision3.

Dr Terry also reported a primary graft failure rate of only 0.4 per cent in his institution’s five-year series of 850 consecutive DSAEK cases performed by two experienced and five novice surgeons using a standard forceps insertion technique with a 5.0mm incision, indicating that the specific technique of DSAEK surgery may be just as important as surgical experience.

Commenting on DSAEK donor insertion devices, Dr Terry said they may make graft insertion technically easier, but further follow-up is needed to determine their effect on endothelial cell loss.

“By avoiding wound compression, these devices may reduce endothelial damage.

However, damage can still occur as the tissue is loaded and compressed by the device to fit into whatever tube or channel is used for delivery into the eye,” he observed.

“There are no outcomes data for these devices published in the peer-review literature, and the results being reported at conferences seem on par with those obtained by experienced surgeons using good forceps insertion techniques,” Dr Terry told EuroTimes.

Endothelial keratoplasty in evolution Attainment of better

visual outcomes is another driver in the development of endothelial keratoplasty as the proportion of patients achieving 20/25 or better BSCVA after DSAEK is less than hoped for. Outcomes for Descemet’s membrane endothelial keratoplasty (DMEK), in which the implanted tissue is only Descemet’s membrane and endothelium, show promise for achieving this goal. DMEK represents pure anatomic replacement surgery for endothelial disease and has potential for better final vision than

EUROTIMES | Volume 15/16 | Issue 12/1

Amnitrans Eyebank who helped to develop DMEK into a procedure that can be readily taught and easily learned using a stepwise protocol.

“Posted on our website (www.niios. com) and YouTube, a video of DMEK largely performed by one of our fellows demonstrates the surgery is straightforward and not too technically demanding,” Dr Melles said.

Because of difficulties in handling the very thin DMEK grafts, Pavel Studeny MD, Sokolov Hospital, Czech Republic, developed another endothelial keratoplasty variation using a hybrid graft in which only the central anterior stroma is removed by hand dissection and then Descemet’s membrane is isolated with a central big bubble technique. Dr Francis Price modified this approach into DMAEK, substituting use of a microkeratome for hand dissection.

Ultrathin DSAEK DSAEK with an “ultrathin” graft is another approach being investigated as a strategy to improve vision outcomes after endothelial keratoplasty.

This technique was discussed by Boris Malyugin MD, PhD, and Massimo Busin MD, professor of ophthalmology, University of Bonn, Germany and Head Ophthalmology Department, "Villa Serena" Private Hospital, Forli', Italy, at the XXVIII ESCRS Congress.

“Making the graft as thin as possible may give better quality of vision and make implantation through a smaller incision easier as well,” said Dr Malyugin, S.Fyodorov Eye Microsurgery Complex, Moscow, Russia. He makes two or three microkeratome (Moria LSK One) cuts under pachymetric control to create a graft about 100 microns thick. The first cut is made with the 300 or 350-micron microkeratome head, while the 2nd and the 3rd time the surgeon is choosing from the 200- or 130-micron head options. The maximal standard deviation of 50 microns in flap thickness is kept in mind while choosing the final head size.

“Ultrathin flap is not so easy to handle because it has a tendency to roll over itself during manipulations. It is advisable to wet the instruments with BSS, especially the surface plate of the Busin glide in order to prevent folds formation in the flap”.

Dr Malyugin compared outcomes for 12 ultrathin and 28 standard DSAEKs (mean central graft thickness, 81 vs. 197 microns).

There were no major complications or graft dislocations, and endothelial cell loss at 12 months was about 34 per cent in both groups. However, mean BCVA data showed the ultrathin group had faster visual recovery than the controls (7th day postop - 0.2 vs.

0.1, respectively) and a better visual outcome at 12 months (0.9 vs. 0.55, respectively).

Dr Busin similarly reported that in early experience, ultrathin DSAEK provided the visual recovery advantages of DMEK plus the ease of DSAEK without increasing endothelial cell loss.

In a series of 16 eyes, BSCVA was ≥20/25 in 50 per cent at one month. At three months, 94 per cent were ≥20/25 and 50 per cent achieved 20/20.

Dr Busin performs a two-step technique for graft preparation that involves a debulking step using the 300-micron Moria CB microkeratome head and a refinement step.

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Conv. DSAEK

Ultrathin DSAEK OCT comparison of UT vs Conventional DSAEK

One month post-DSAEK high magnification

Courtesy of Massimo Busin MD

DSAEK as no stroma is transplanted.

Gerrit Melles MD, PhD, Netherlands Institute for Innovative Surgery (NIIOS), Rotterdam, who reported on the first successful endothelial keratoplasty procedures in 1998, introduced DMEK in 2006. At the XXVIII ESCRS Congress, he presented outcomes from up to three years of follow-up for 200 eyes. Rates of endothelial cell loss after DMEK were comparable to published findings for DSAEK and PKP, but the functional data showed DMEK resulted in more rapid and often complete visual rehabilitation.

In analysis of 158 eyes (excluding failures and those with low visual acuity potential), BCVA was ≥20/40 in 82 per cent at one month, while at six months was ≥20/25 in 76 per cent, with 15 per cent achieving 20/16.

“To my knowledge, these visual outcomes are unprecedented and have been confirmed in the hands of others, including Drs Francis Price and Art Giebel4,” commented Dr Melles.

One-year outcomes from a prospective study being conducted by Drs Price and Giebel were reported by Dr Price at the ESCRS Congress. Their series comprised 123 eyes representing the first DMEKs for both surgeons. At three months, BSCVA was ≥20/25 in 62 per cent of eyes and ≥20/20 in 33 per cent. Excluding eyes with retinal problems, BSCVA was ≥20/25 in 79 per cent of eyes at one year and ≥20/20 in 40 per cent.

An analysis of the DMEK learning curve based on the first 135 consecutive cases performed by Dr Melles and colleagues at NIIOS was presented at the ESCRS Congress. The series was divided into three groups of 45; all of the first 45 cases were performed by an experienced surgeon (Dr Melles) while novice surgeons performed 31 per cent of the last 45 cases. Comparing the three groups, complications decreased and the number of functional grafts increased across the series, but there were no statistically significant differences for BCVA or endothelial cell loss outcomes.

“An unexpected advantage of DMEK was found to be a larger yield of donor tissue.

Since donor corneas unsuitable for DSAEK of PKP (eg arcus senilis) can preferably be used for DMEK, and a full ‘anterior button’ is left available for DALK after stripping the Descemet membrane for DMEK, more surgeries can be performed out of the same pool of donor tissue. Although DMEK may go with a five per cent preparation failure, we found that the overall discard rate was significantly reduced.

“Every new technique involves a learning curve, and while I’ve regretted not better standardising DLEK and DSEK, I was not convinced those procedures were a ‘final’ endothelial keratoplasty solution,” Dr Melles told EuroTimes.

“DMEK seems different as there is little more to do beyond selectively replacing the diseased Descemet’s membrane and endothelium. As DMEK may become a preferred modality, we have tried to standardise the donor preparation and surgical technique,” Dr Melles said.

He acknowledged the enthusiastic collaboration of his corneal fellows (Chandra Balachandran, Isabel Dapena, Kyros Moutsouris, Konstantinos Droutsas, Martin Dirisamer) and co-workers at the

One month post UT-DSAEK low magnification

Double tissue removal of UT-DSAEK

References: 1. Price MO, Fairchild KM, Price DA, Price FW. Descemet’s stripping endothelial keratoplasty: Five-year graft survival and endothelial cell loss. Ophthalmology 2010 in press.

2. Thompson RW, Price MO, Bowers PJ, Price FW. Long-term graft survival after penetrating keratoplasty.

Ophthalmology, 2003; 110(7):1396-1402.

3. Price MO, Bidros M, Gorovoy M, Price FW, Benetz BA, Menegay HJ, Debanne SM, Lass JH. Effect of incision width on graft survival and endothelial cell loss after Descemet stripping automated endothelial keratoplasty.

Cornea. 2010;29:523-7.

4. Price MO, Giebel AW, Fairchild KM, Price FW. Descemet membrane endothelial keratoplasty: prospective multicenter study of visual and refractive outcomes and endothelial survival. Ophthalmology 2009;116:2361–2368.

contacts

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Cover Story

CORNEA

Mark A Terry - mterry@deverseye.org Francis W Price, Jr - fprice@pricevisiongroup.net Marianne Price - marianneprice@cornea.org Massimo Busin - mbusin@yahoo.com Gerrit Melles - melles@niios.nl Rudy Nuijts - rudy.nuijts@mumc.nl Boris Malyugin - boris.malyugin@gmail.com

Courtesy of Gerrit Melles MD, PhD

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We hope that the standardised method of creating thin grafts with microkeratome cut surfaces may translate into better visual outcomes

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Massimo Busin MD

B (A) Slit-lamp photograph of a cornea one week after Descemet’s membrane endothelial keratoplasty (DMEK). With some residual oedema in the cornea periphery, the best spectacle corrected visual acuity had already returned to 20/20.

(B) With specular microscopy at six months, the donor endothelial cell layer appears healthy with a cell count of approximately 2000 cells/mm2

Originally, the refinement was performed using the 130-micron head after artificially hydrating the debulked cornea. However, new 50-micron and 90-micron heads from Moria eliminate the need for hydration and will make preparation of the ultrathin grafts easier, Dr Busin said.

Using corneas preserved in tissue culture medium at 37° C, the cut is made with the 90 micron head if the residual thickness is greater than 150 microns (90 per cent of cases) and with the 50 micron head if the residual thickness is less or cannot be measured by conventional pachymetry.

Making the second cut in the opposite direction to the first cut nearly eliminates the risk of perforation, said Dr Busin.

“Now, I am only performing ultrathin DSAEK, and we are investigating it to see if it will give us maximum results with the least effort. We hope that the standardised method of creating thin grafts with microkeratome cut surfaces may translate into better visual outcomes,” he told EuroTimes.

Femtosecond laser-assisted endothelial keratoplasty While

use of the microkeratome for automating DSEK is well accepted, further work is needed before the femtosecond laser becomes a standard tool for preparation of the posterior lamellar disc. In 2005, Rudy Nuijts MD, and colleagues, Academic Hospital Maastricht, the Netherlands, began feasibility studies using the 30 kHz IntraLase laser (AMO) available at that time. Published results from 12 months' follow-up in a randomised, controlled trial indicated the visual outcomes of femtosecond laser-assisted DSEK (FLEK) were not as good as after PKP or relative to DSAEK series. However, unpublished data show BCVA continues to improve gradually after FLEK, with eyes gaining approximately 1.5 lines between one and three years, perhaps due to improvement in the quality of the graft-recipient interface, Dr Nuijts told EuroTimes.

The early visual acuity results may be

attributable in part to the fact that the laser cut is rougher in the posterior cornea compared with more anteriorly, perhaps due to regional differences in collagen fiber organisation. Additionally, because the laser tracks relative to the cornea’s anterior surface and uses flat applanation, the cut is not planar and concentric folds are created, noted Dr Francis Price.

However, there is likely to be more to the femtosecond laser story as newer technology already commercially available or in development may provide better results. For example, faster lasers delivering less energy per spot may create smoother cuts, said Dr Price.

Dr Nuijts noted he is working on a prototype femtosecond laser that would be specifically designed for the purpose of cutting thin, 75-100 micron corneal grafts. Georges Baikoff MD, Clinique Monticelli, Marseille, France, has also described promising results using the 500 kHz VisuMax femtosecond laser (Carl Zeiss Meditec) in a reverse technique, cutting from the endothelial side with an interface fluid for tissue protection.

Dr Price speculated that the femtosecond laser may also have a role in DMAEK where it might be used to facilitate Descemet’s membrane isolation via the technique described by Luca Buzzonetti MD, Bambino Gesù Hospital, Rome, Italy, in his “IntraBubble DALK” procedure.

“In response to surgeons’ input, we hope AMO will be making some modifications to its femtosecond laser to enable this use and we expect other manufacturers may as well,” Dr Price said.

Endothelial keratoplasty in the future More data are needed

to determine the roles of DMAEK and ultrathin DSAEK. Along with its promise for better visual acuity, DMEK has a practical advantage in that it requires only routine surgical instruments. However, Dr Terry noted that while DMEK appears to offer faster visual rehabilitation than DSAEK, he questioned whether it will

Don’t miss EURETINA Preview, see page 24 EUROTIMES | Volume 15/16 | Issue 12/1

maintain an advantage over the longer term. He cited his DSAEK data presented in October 2010 at the AAO meeting that, similar to Dr Nuijts' experience, demonstrated that the vision continues to improve over time following DSAEK, presumably because stromal remodeling improves the optics of the interface. In a cohort of 96 eyes with complete followup at serial visits, rates of 20/20 BSCVA increased steadily, rising from 15 per cent at six months to 44 per cent at 36 months in the same exact group of eyes.

“Our initial experience with DMEK also confirms the faster visual rehabilitation than what we have had with DSAEK. However, with the absence of a stromal interface, vision outcomes after DMEK are unlikely to show the same pattern of dramatic improvement over time,” said Dr Terry.

Currently, DMEK is also more technically difficult and time-consuming than DSAEK. With DMEK, intraoperative donor manipulation is challenging and may cause more endothelial damage. The DMEK grafts have also been shown to be less likely to totally adhere to the host leading to high rates of air reinjection. Finally, current techniques for DMEK donor harvesting have been accompanied by a significant risk of tears that can necessitate discarding the tissue, something that is now never seen with DSAEK tissue preparation.

“DMEK donor tissue loss is happening too often in the early learning curve, and even Dr Melles is still reporting a rate of five per cent. Neither the eye banking system or the average surgeon can tolerate this type of loss,” said Dr Terry. “While I am excited about the future of DMEK, I’m not sure that the technique has been optimised, and at this time the risks may outweigh the benefits.”

The idea that an ultrathin graft may be the answer to better DSAEK outcomes is also controversial as there are conflicting data from studies evaluating the relationship between DSAEK donor graft thickness and visual acuity outcomes.

As an impetus for ultrathin DSAEK, Dr

“

Making the graft as thin as possible may give better quality of vision and make implantation through a smaller incision easier as well Boris Malyugin MD, PhD

Busin cited a report by Edward Holland MD, showing better visual acuity in DSEK patients who received donor tissue <130 microns thick. However, Dr Terry noted finding no correlation between graft thickness and dislocation rates or vision outcomes in analysis of over 900 DSAEKs performed at his centre. He also pointed to a recently published study by Mayo Clinic in the journal CORNEA that showed no correlation between graft thickness and visual acuity results. Finally, he mentioned a recent study at the 2010 ARVO meeting from Duke University in over 300 eyes which showed no statistically significant difference in BSCVA at six months in subgroups of DSEK eyes with grafts ≤100, 101-150, or >150 microns in thickness.

With so many techniques to choose from, what is the individual surgeon to do? Dr Melles believes the multiple endothelial keratoplasty options should not be regarded as competitors but rather embraced for broadening the field and the opportunity to optimise patient care.

“Outcomes and preferences for the endothelial keratoplasty procedures may vary among individual surgeons depending on a number of issues, and not all patients are candidates for DMEK. We still perform DS(A)EK in eyes with low visual potential, a glaucoma implant, previous posterior segment surgery, a large iris defect, or an extremely shallow anterior chamber, and DMAEK may also have unique advantages,” he explained.

“No one road leads to Rome, and the range of endothelial keratoplasty procedures allows surgeons to best manage each case based on individual needs,” he said.

TH E FIR ST MICRO-INCISION IOL WITHOUT COMPROMISE 180째 Contact angle between the loops and the capsule 360째 Sharp edge that deserves the name 6 mm optic diameter, 13 mm overall diameter Mix of hydrophobic & hydrophilic monomers

www.medicontur.com

8

Special Focus

CORNEA

Early ‘iDALK’ outcomes

Femtosecond laser-enabled procedure facilitates big bubble

by Cheryl Guttman Krader in Venice

E

ncouraging early results with femtosecond laserenabled deep anterior lamellar keratoplasty (“iDALK”) with the big-bubble technique in patients with corneal ectatic disease suggest that it will provide the benefits of both the partial thickness corneal transplantation procedure and of tissue preparation with the femtosecond laser, said Alaa El Danasoury MD, at the 1st EuCornea Congress.

Dr El Danasoury, medical director and chief, cornea and refractive surgery, Magrabi Hospital, Jeddah, Saudi Arabia, reported results from the first 16 consecutive eyes of 16 patients that underwent iDALK and compared them with a control group consisting of 70 consecutive eyes that were treated with conventional DALK using mechanical trephination. All procedures were performed using the bigbubble technique to expose Descemet’s membrane. iDALK was completed successfully in all 16 eyes without any inadvertent postoperative detachments of Descemet’s membrane, and all grafts cleared within two weeks after surgery. With 14 (87.5 per cent) eyes seen prior to suture removal at one year, mean SE was similar in the iDALK and DALK control groups, -1.7 ± 3.4 D vs. -1.4 ± 2.9 D. However, there was a significant benefit for less refractive cylinder in the iDALK eyes compared with those in whom the donor and host tissues were prepared using a traditional trephine.

Refractive cylinder in the iDALK eyes averaged 2.7 ± 2.2 D with a range between 0.75 and 5.5 D, while mean refractive cylinder was 4.4 ± 3.8 D in the control group and ranged from 1.3 to 8.0 D. Functional outcomes were also slightly better in the iDALK eyes. Best-corrected acuity was 20/40 or better in 80 per cent of the iDALK group and 73 per cent of the control eyes, while 40 per cent of iDALK eyes and only 26 per cent of the control eyes achieved BSCVA of 20/25 or better.

“In considering the favourable results achieved in the iDALK eyes, it is important to recognise they represent our first iDALK cases whereas the control group was operated on with a procedure we have been performing for more than 10 years,” he observed.

“However, the data on refractive and BSCVA outcomes are all from evaluations performed prior to suture removal after iDALK. Importantly, outcomes from longer follow-up are needed, especially to answer important questions about what will happen with respect to postoperative astigmatism and graft displacement after the sutures are removed.”

For eyes with a healthy endothelium, iDALK aims to combine the benefits of DALK versus penetrating keratoplasty (PKP) with those established previously using the femtosecond laser enabled PKP (IEK). Since the patient’s healthy endothelium is preserved in DALK, it has advantages relative to PKP for mitigating the risk of endothelial rejection and allowing less rigid criteria for donor tissue selection. With its precise incisional capability, the use of the femtosecond laser for tissue preparation optimises host to donor wound apposition by allowing better interlocking side cuts and matching of the anterior surfaces, Dr El Danasoury explained.

EUROTIMES | Volume 15/16 | Issue 12/1

“

Another advantage of the femtosecond laser-enabled technique is that you know the exact depth of the needle insertion Alaa El Danasoury MD

“There are still some disadvantages associated with using the femtosecond laser, as it is more expensive and takes more time than mechanical trephination. However, our OR time is improving as we are getting over the learning curve.”

The 16 iDALK eyes in Dr El Danasoury’s series included 13 with moderate to advanced keratoconus and three with advanced post-LASIK ectasia. As a selection criteria for iDALK, all eyes had to have corneal thickness >500 microns at the site of trephination, 7.5 to 8.0mm.

“The iDALK procedure is not suitable for corneas that are thinner than 500 microns in the periphery because adequate thickness is needed to be able to achieve a customised tailored edge,” explained Dr El Danasoury.

The donor and host tissues were prepared using the 150 kHz, 5th generation of the IntraLase femtosecond laser (IFS, AMO). The donor tissue was mounted on a Hanna artificial anterior chamber (Moria) and cuts were made using the mushroom pattern.

“We prefer the Hanna platform because it affords excellent centration and achieves the high pressure needed to maintain a good seal. The mushroom configuration affords ease in suturing and provides a large anterior donor surface.

The smaller posterior surface is not an issue since the host endothelium is preserved in DALK,” said Dr El Danasoury.

The donor is cut with an outer diameter of 8.2mm and inner diameter of 7.7mm, and the recipient cornea is prepared with a 0.2mm disparity for the outer and inner diameter dimensions.

The lamellar ring dissection in the host cornea is made at 300 microns, and the laser is programmed to maintain an 80 micron posterior residual bridge of uncut tissue.

The “big bubble” is introduced using a 27g needle inserted at the lamellar plane.

“Another advantage of the femtosecond laser-enabled technique is that you know the exact depth of the needle insertion,” noted Dr El Danasoury.

The injected air separates Descemet’s membrane from the stroma. Then the anterior corneal stroma is debulked using a round tip blade, the bubble is perforated using a sharp knife, and a blunt Vaness scissors is used to excise remaining stroma, leaving Descemet’s membrane well exposed.

While these initial cases were done with a plan to perform suture removal at 12 months, Dr El Danasoury noted the possibility of earlier removal of sutures is being considered.

contact Alaa El Danasoury - malaa@magrabi.com.sa

contact

Vikentia Katsanevaki – vikentia_katsanevaki@

yahoo.gr

Special Focus

CORNEA

Hyperopic SBK safe and effective

Procedure provides functional near vision for presbyopes

by Cheryl Guttman Krader in Venice

H

yperopic sub-Bowmans keratomileusis (SBK) is safe and effective for correcting hyperopia and hyperopic astigmatism and can substantially improve unaided near vision in presbyopic hyperopic patients, reported Vikentia Katsanevaki, MD, PhD, at the 1st EuCornea Congress.

Dr Katsanevaki summarised the clinical outcomes achieved in a series of 146 eyes of 76 patients who underwent hyperopic correction under a thin flap (~100 microns).

The patients ranged in age from 19 to 71 years (mean 46.2 years) and more than 90 per cent of the cohort was older than 40 years.

Data were analysed from postoperative visits at one, three, six, and 12 months.

Patients had a minimum follow-up of six months and 68 per cent were seen at 12 months. The results showed stable refractive and distance UCVA outcomes. In binocular testing, about 87 per cent of enrolled patients achieved J4 or better near UCVA at six and 12 months.

At 12 months there were no eyes with loss of more than one line of BSCVA, and results from serial assessments of Schirmers test and tear breakup time showed no changes from preoperative tear function.

“Not long ago, a thin flap was considered a complication in LASIK. Now, based on new understanding of corneal biomechanics, the risk of iatrogenic ectasia, and the effect of the LASIK flap on dry eye, SBK, or thin flap LASIK, probably represents the best technique,” said Dr Katsanevaki MD, PhD, head, Refractive Department, Orasis Eye Centre, Athens, Greece.

“The outcomes in this series show there is no increased risk of complications when performing SBK for hyperopia. Rather, this thin flap surgery is a less aggressive procedure that can be used successfully to realise treatment goals and thereby achieve satisfied, happy patients.”

The patients in the series had a mean sphere of +2.87 D (range +1.00 to +6.00 D) and mean cylinder of -1.11 D (range -1.00 to -6.00 D). Dr Katsanevaki performed all of the surgeries using the Wavelight Allegretto laser platform (Alcon) and a mechanical microkeratome for flap creation (Carriazo Pendular, Schwind). Mean ± SD flap thickness was 98 ± 16 microns (range 72 to 130 microns).

EUROTIMES | Volume 15/16 | Issue 12/1

In presbyopes (patients older than 45 years), the ablation was planned based on the cycloplegic refraction aiming for -0.50 D in the nondominant eye and plano in the dominant eye. In the younger patients, the targeted correction was based on the manifest refraction plus half of the difference between the manifest and cycloplegic refractive error.

“Patients can suffer for weeks or months after hyperopic LASIK because of residual myopia. In addition, in younger patients who have some reserve in accommodation, there can be considerable discrepancy between the manifest and cycloplegic refraction, especially in those with higher hyperopia,” said Dr Katsanevaki.

“Adjusting for the difference between the cycloplegic and manifest refractive errors helps to minimise the residual myopia that can be very annoying to patients during the first few months after their surgery.”

The surgeries were uneventful except for the creation of an irregular flap with a central buttonhole in one eye of a 34-year-old patient. However, the ablation was still performed after scraping off the epithelium in the centre of the cornea and treating with mitomycin-C, and the patient suffered no adverse optical or visual effects postoperatively.

“Another advantage of thin flap surgery is that if a buttonhole occurs, the irregularity is not so significant as to necessitate aborting the procedure,” noted Dr Katsanevaki.

Mean SE was -0.41 D at one month after surgery, -0.31 D at six months, and +0.22 D at one year. Mean UCVA improved from 0.49 preoperatively to 0.89 at one month, 0.93 at six months, and 1.01 at one year.

Efficacy, calculated as the percentage of eyes whose postoperative UCVA was equal to or better than their preoperative BCVA, was better in the dominant eyes than in the nondominant eyes, which would be expected based on the myopic target used in the nondominant eyes of the presbyopes. At one year, the ratio of postoperative UCVA to preoperative BCVA was one or better in 54 per cent of nondominant eyes and 77 per cent of dominant eye.

In binocular testing of near UCVA, 57 per cent of all patients achieved J1 and 97 per cent could read J4 or better at one month after surgery. At one year, while 86

“

Now, based on new understanding of corneal biomechanics, the risk of iatrogenic ectasia, and the effect of the LASIK flap on dry eye, SBK, or thin flap LASIK, probably represents the best technique

Vikentia Katsanevaki MD, PhD per cent could still read J4 or better, only 29 per cent were J1.

“Patients are counselled preoperatively that the surgery should provide them with near

vision good enough to make functioning in daily life easier, but that it will not be the same as when they were 20 years old.

With J4 or better near UCVA, patients are able to read a restaurant menu, prices on supermarket shelves, or numbers on their cell phone,” said Dr Katsanevaki.

The safety analysis of BSCVA data showed that among 68 eyes seen at one year, there was loss of a single line in four (6.8 per cent) eyes and five (6.4 per cent) eyes that had higher levels of preoperative astigmatism gained one line.

“Loss of BSCVA has been a problem with hyperopic LASIK because of an irregular ablation profile, but this complication was minimised in our population because of the thin flap and relatively low corrections. Our results also show there is the potential for the surgery to improve BSCVA in those who do not attain 20/20 preoperatively,” said Dr Katsanevaki.

9

contacts

10

Special Focus

CORNEA

Novel amnion preparation

Topically applied reconstituted lyophilized amniotic membrane extract enables continued delivery of chemical mediators and proteins

by Cheryl Guttman Krader in Venice

T

the use of the topical AMX drops.

Of the five patients who did not achieve complete healing, one was lost to followup. In the others, each of whom had a highly compromised ocular surface from severe, longstanding disease, the response to topical AMX treatment was not adequate and the patients progressed to surgical intervention.

“The safety and effectiveness of amniotic tissue transplantation in reconstruction of a variety of ocular surface pathologies has been proven. AMX is essentially just a physically different form of amniotic tissue, and so it is nothing new. Nor is it intended to replace amniotic membrane transplantation. However, as a nonsurgical therapy that is easy to use and enables extended delivery of the beneficial growth factors and cytokines found in amniotic tissue, AMX has the potential to expand the applications of treatment with amniotic membrane,” said Dr Ghinelli, who is the inventor of AMX. “Dr Ken Kenyon and I have been fortunate to be able to use this modality to the benefit of several patients since 2001.

While further clinical trials investigating AMX are indicated, based on our overall clinical experience and the positive results of the multicentre study, I am excited that

Courtesy of www.keera.eu

opically applied lyophilized extract of human amniotic membrane (AMX, Keera, www. keera.eu) safely and effectively promotes healing of persistent epithelial defects, reported Emiliano Ghinelli MD, at the 1st EuCornea Congress.

Under the auspices of the Treviso Tissue Bank, Italy, an open-label multicentre trial was conducted at seven sites in Italy and Germany. Beginning in May 2009, it enrolled 62 patients with a sterile persistent epithelial defect resistant to conventional therapy. The most common underlying diagnoses were herpes zoster ophthalmicus, herpes simplex virus keratitis, and surgeryrelated defects. Patients were instructed to instill two drops into the affected eye hourly while awake until disease remission was achieved.

Weekly follow-up visits showed that some eyes began to exhibit benefits of reduced inflammation and neovascularisation within one week.

Among 45 cases that had been fully analysed at the time of Dr Ghinelli’s presentation, 40 (90 per cent) eyes achieved complete healing of the persistent epithelial defect after an average duration of therapy of 22 days. Visual function also improved, and there were no adverse events related to

Persistent corneal epithelial defect due to acoustic neuroma (top), completely healed by AMX therapy (bottom)

EUROTIMES | Volume 15/16 | Issue 12/1

practising ophthalmologists will soon be able to develop their own experiences with AMX.” Dr Ghinelli currently practices in the Department of Ophthalmology, Ospedale Civile di Volta, Mantovana, and Ospedale S. Pellegrino di Castiglione Delle Stiviere, Castiglione delle Stiviere, Italy. He began to develop his idea for AMX about 10 years ago as a research fellow in Rome. Next, he continued the project while working at the Harvard Medical School of Boston, MA with Ken Kenyon MD as his mentor.

Findings from initial laboratory studies conducted to characterise the composition and in vitro activity of the lyophilized extract showed that it retains the properties of human amniotic membrane from which it is derived. Assays performed using Western blot techniques and ELISA analysis demonstrated that the lyophilized extract contains the same growth factors, neurotrophins, cytokines, and structural proteins found in amniotic membrane, including particularly high concentrations of nerve growth factor (NGF), transforming growth factor-alpha, and interleukin-1 receptor agonist.

An initial in vitro controlled study investigating the response of human conjunctival cells obtained from scraping, to AMX showed that AMX stimulated epithelial cell survival and cell proliferation and demonstrated activity that was superior to individual neurotrophins (NGF, brain-derived neurotrophic factor, and neutrophin-3), and comparable to fetal bovine serum (FBS).

“Just as with FBS, the stimulatory effects of AMX were dose-related, increasing with exposure to a higher concentration,” said Dr Ghinelli.

Further preclinical testing was conducted in a mouse model of experimentally induced corneal injury. In that study, topical treatment with AMX was successful in promoting wound healing.

The laboratory research findings combined with the positive outcomes achieved among patients treated by Drs Ghinelli and Kenyon provided the necessary support for gaining authorisation from the human studies committee of the Banca dei Tessuti della Regione Veneto to begin the multicentre clinical trial. In their own practices, Dr Ghinelli and Dr Kenyon

Ken Kenyon - kenrkenyon@cs.com Emiliano Ghinelli - info@emilianoghinelli.com

“

The safety and effectiveness of amniotic tissue transplantation in reconstruction of a variety of ocular surface pathologies has been proven. AMX is essentially just a physically different form of amniotic tissue, and so it is nothing new.

Emiliano Ghinelli MD

used AMX to treat a range of treatmentrefractory, chronic epithelial defects that were secondary to alkali burns, ocular pemphigoid, infectious and neurotrophic keratitis, and topical mitomycin-C. AMX is prepared from human amniotic membrane obtained at Caesarean section from selected donor mothers by authorised tissue banks. AMX production is carried out in a GMP environment approved by the Italian Regulatory Agency of Medicine and using processing procedures that are in compliance with the European Union’s rules on human tissue and cells and adhere to quality controls recommended by the International Organization for Standardization.

The packaged lyophilized powder has a long shelf life of between 12 and 24 months. For clinical use, the soluble powder is dissolved in sterile BSS. The reconstituted AMX solution should be stored under refrigeration, protected from light and heat sources, and discarded after 72 hours.

Future outlook Dr Ghinelli anticipates that AMX will be distributed in Italy by Treviso Tissue Bank in 2011. There are no plans currently to obtain approval by the US FDA. Looking ahead and considering the safety, efficacy and convenience of AMX therapy, Dr Ghinelli speculated it may have application in a number of other common clinical scenarios, including moderate dry eye, inflammatory/traumatic ocular surface disorders including acute chemical injury, corneal transplantation and rejection, and even post laser vision correction haze or persistent epithelial defects.

Drs Ghinelli and Kenyon have a financial interest in KEERA, the developer of AMX. www.emilianoghinelli.com

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

18 â&#x20AC;&#x201C; 20 February 2011

Hilton Hotel, Istanbul, Turkey

www.escrs.org

European Society of Cataract and Refractive Surgeons

Rupert Menapace - rupert.menapace@

meduniwien.ac.at

contact

Update

cataract

Sharp-edged iols

Silicone IOLs have better long-term PCO performance than hydrophobic IOLs

by Robert Henahan in Paris

T

he sharp posterior optic edge of an acrylic IOL can at most delay posterior capsule opacification (PCO). Indeed, the IOL material plays a more important role in the long term, and silicone is best in that regard, according to Rupert Menapace MD, Vienna Medical University, Vienna, Austria.

“Our longer follow-up data with different IOLs indicates that there is a progressive barrier loss with sharp-edged acrylics, which after 6.5 to eight years fully catch up with their round-edged counterparts to exhibit the same poor PCO results. As opposed to these, both the sharp and round silicone IOLs lack this permanent increase, with the sharp-edged silicone model doing best with almost no performance loss over time,” Dr Menapace told the XXVIII Congress of the ESCRS in Paris, France.

He cited data from two prospective studies showing that the objective AQUA PCO score three years postoperatively was less than 1.0 in eyes with the Clariflex silicone sharp-edged optic IOL, compared to about 1.5 for the round-edged SI40 silicone IOL and only slightly more than that for the AR40e hydrophobic acrylic sharp-edged optic IOL (all from AMO). The round-edged AR40 hydrophobic IOL (AMO) had the worst performance, with an AQUA PCO score of 3.2 (Buehl et al. JCRS 2004; 30:1661-1667 and Buehl et al, JCRS 2002; 28:1105-1111).

In a more recent study the YAGcapsulotomy rate after 10 years was 42 per cent in eyes implanted with the Alcon sharp-edged three-piece hydrophobic acrylic AcrySof MA60BM IOL, compared to only 18 per cent in eyes with an AMO SI40 threepiece silicone IOL with round edges (Vock et al. JCRS 2009; 35 459-465).

Dr Menapace attributes the better longterm performance of silicone IOLs to the way the lens material induces strong and stable collagenous sealing of the anterior and posterior capsule leaves by catalysing myofibroblastic transdifferentiation of anterior lens epithelial cells (LECs). The sharp posterior optic edge primarily creates a sharp bend in the posterior capsule which constitutes a barrier to lens epithelial cell migration. However, long-term PCO prevention requires a firm collagenous sealing of the capsular fusion, and that is dependent on the IOL material (Figure 1).

“Soemmering's ring formation tends to

EUROTIMES | Volume 15/16 | Issue 12/1

secondarily re-divide the once fused capsular leaves, and acrylic IOLs apparently do not provide adequate collagenous sealing along the fusion line to withstand these forces, thus allowing for progressive secondary barrier failure by reversing posterior capsule bending,” Dr Menapace said (Figure 2).

PCO a multifactorial complication Dr Menapace noted that

there are many aspects of cataract surgery and IOL design that also influence PCO formation. All centre on the creation of a barrier to LEC migration across the posterior capsule, he said.

For example, it is essential that the capsulorhexis circumferentially overlap the IOL’s optic. Otherwise there will be no bending of the posterior capsule as a prerequisite for the formation of an effective edge barrier. Similarly it is important to not polish the anterior capsule, since the resulting absence of anterior LECs will interfere with the fusion and sealing of the anterior and posterior capsule.

As regards IOL design, even rounded optic edges can bend the posterior capsule to provide a barrier effect. However, the amount of the effect correlates with the sharpness of the posterior capsule and thus optic edge; thus, the sharper the edge, the greater the barrier effect. In addition, since the haptic insertion interferes with posterior capsule bending, the haptic base, or haptic-optic junction must be as slim as possible: “Traditional loop haptics are optimum since the slender insertion is jumped over by the posterior capsule bend. Broader hapticoptic junctions as seen with the now popular single-piece IOLs do interrupt the bend, as evidenced by the evading capsular fusion line,” Dr Menapace said.

Broad optic-haptic junctions are responsible for the higher incidence of PCO with some accommodating and microincision IOLs, he noted. In a study Dr Menapace and his associates carried out, eyes with the AT-45 CrystaLens (Bausch + Lomb) and the Humanoptics 1CU had YAG rates of 52.4 per cent and 36 per cent, respectively, he pointed out.

In other research, Dr Menapace said he has observed a high incidence of early PCO in eyes with the flange haptics, including micro-incision IOLs, such as the Bausch + Lomb MI60 micro-incision IOL and

Figure 1: Collagenous capsular sealing

Figure 2: Delayed ‘Secondary barrier failure’

Courtesy of Rupert Menapace MD

12

Figure 3: Posterior Optic Buttonholing

the Zeiss-Acritec Acri-Smart IOL. Newer micro-incision IOLs with slim optic-haptic junctions, such as the HOYA iMICS Y-60H, may have a better PCO performance.

Other important parameters in PCO prevention are the size and rigidity of the haptics. The haptics should be adaptable to the variable size of the capsular bag and should provide the maximum contact angle possible. Oversized or overly rigid haptics stretch out and distort the capsular bag and interfere with capsular fusion and bending.

Delayed secondary barrier failure

However, even when surgery and haptic and optic design enable complete capsular fusion, the barrier may fail later on, Dr Menapace said. Generally, about three to five years after surgery, eyes implanted with hydrophobic acrylic IOLs tend to develop a steady increase of PCO due to a phenomenon called delayed secondary barrier failure, he noted (Menapace R. Prevention of posterior capsule opacification. In: Koch DD, Kohnen T (eds) Essentials in Cataract and Refractive Surgery Springer 2004, Figure 2).

“Three-to-five years is the time required for Soemmering´s ring to form and, starting out from the capsular bag equator, progressively re-divide the formerly fused capsular leaves. When arriving at the fusion line along the optic edge, the mechanical force of Soemmering´s ring may force open the fusion line and annihilate the bend at the posterior optic edge, allowing the dormant LECs to resume migrating and proliferating beneath the optic,” Dr Menapace said.

He added that the capsular bag may not be the ideal place for fixation of hydrophobic acrylic IOLs. He also noted that he has achieved a much better threeto-five-year PCO performance in over a thousand cases with hydrophobic acrylic IOLs by placing them in such a way that the haptics are in the bag but the optic is trapped behind a posterior capsulorhexis (“Posterior optic buttonholing”: Menapace, JCRS 2006; 32:929-943, and Graefes Arch Clin Exp Ophthalmol 2008; 246:787-801, Figure 3).

contact

Teresa Ferrer-Blasco - Teresa.ferrer@uv.es

Update

cataract

Stereoacuity study

Fixed and threshold disparity tests generate different results

by Cheryl Guttman Krader in Paris

C

ataract surgery patients bilaterally performed in random order under photopic implanted with the aspheric conditions with best distance correction to bifocal AcrySof ReSTOR IOL eliminate confounding from refractive blur.

(Alcon Laboratories) maintain The vectographic tests were performed at a useful stereoacuity despite the presence of working distance of 40cm and the results for simultaneous images on the retina, according each patient were calculated based on his or to researchers at the GIO University of her measured interpupillary distance (IPD).

Valencia, Spain.

Mean stereoacuity values were similar in the The investigation included 30 patients Titmus test (44.55 ±1.08 sec arc, range 40 to whose stereoacuity was assessed at one year 80) and Random dot test (41.25 ±1.12 sec arc, after surgery using two commercially available range 20 to 70), while both were significantly fixed disparity vectographic stereotests different than that measured with the HD (Titmus and Random dot) and the Howard- 11:17 method ±6.10 faros_245x150_EuroT_e 6.5.2010 Uhr (18.42 Seite 1 sec arc, range 11 to 30).

Dolman (HD) method, which measures For all tests, the measured stereoacuity stereoscopic threshold. The three tests were values were consistent with data reported for

similarly aged populations of phakic patients without cataract and/or those implanted with a monofocal IOL. “Stereoacuity is a fine visual function that could reflect the quality of the optical system in some ways, and the results from this study confirm that retinal image blur associated with multifocality of the AcrySof ReSTOR IOL does not deteriorate stereoacuity,” said Dr Ferrer-Blasco.

The patients included in the study ranged in age from 50 to 60 years. Patients all had less than one dioptre of astigmatism, with no history of ocular surgery or ocular disease other than cataract. At one year after surgery, mean SE was 0.39 D, mean BCDVA and BCNVA were both about 20/20, and no patient had undergone or needed Nd:YAG laser capsulotomy.

The differences in outcomes using the vectographic and threshold methods for measuring stereoacuity reinforce the different roles of the tests.

“The HD method gives a continuous measure of stereoacuity and is more accurate than the vectographic tests for assessing

stereoacuity after IOL surgery. Due to its higher sensitivity for detecting subtle changes in stereoacuity, the threshold test is the standard for binocular vision research, but it is very time-consuming and would be less appropriate for use in clinical practice,” said Dr Ferrer-Blasco.

For the vectographic methods, it is important to note that disparity is constructed for a fixed distance of examination and interpupillary distance (IPD). Small differences in these parameters can significantly affect the test results and can explain in part the differences reported in previous studies using the Titmus test to measure stereoacuity in patients implanted with multifocal IOLs. “The test results are affected if there is no adjustment for actual IPD or the working distance is not controlled. A 1cm change in the IPD can translate into a 50 sec arc difference in stereoacuity, which represents a step in the regular vectographic method, and the same difference in working distance has an even stronger effect,” said Dr FerrerBlasco.

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EUROTIMES | Volume 15/16 | Issue 12/1

13

Don’t Miss...

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

Cornea Day 2011 Friday, March 25 www.CorneaDay.org

ASOA Specialty Forums March 26−29 www.ASOAForums.org

G N I S HOU ATION 1 1 20 TR S I G RE OPEN! D N A NOW rg o . s r sc a . w ww

Technicians & Nurses Program March 26−28 www.ASCRS.org

contact

Liliana Werner - Werner.liliana@gmail.com

15

Update

SECTION HEAD

REFRACTIVE LENS

Section sub head

Growing evidence suggests PCO prevention is best in eyes implanted with IOLs that separate the anterior and posterior capsules

by Roibeard O’hEineachain in Paris

I

OLs which open or expand the capsular bag appear to be very effective at preventing posterior capsule opacification (PCO), said Liliana Werner MD, PhD, John A Moran Eye Centre, University of Utah, Salt Lake City, Utah, US. Laboratory and clinical studies have shown that eyes implanted with disc-shaped IOLs and dual-optic accommodating IOLs tend to develop little in the way of lens epithelial cell (LEC) growth across the posterior capsule and only a slight amount of Soemmering’s ring formation even after several years of follow-up. The good PCO performance of such lenses may result from the separation they create between the capsules and between the anterior capsule and the optic, Dr Werner told the XXVIII Congress of the ESCRS. “There are probably a few different mechanisms by which these lenses achieve their effect. They include a lack of contact between the anterior capsule and the optic. Also, in some cases they completely fill the capsular bag leaving no space for lens epithelial cells to grow. Mechanical compression of the cells by the stretching of the capsular bag may also play a role, as may the constant irrigation of inner capsular bag compartment by aqueous humour,” she said.

Dual-optic IOLs have an added benefit Dr Werner noted that as far

back as the early 1990s a study with a prototype dual-optic accommodating IOL showed that rabbit eyes implanted with the lenses retained their anterior and posterior capsular transparency (Hara T, et al.

Ophthalmic Surg 1992; 23:632-635). The experimental IOLs maintained a distance between the IOL’s optics of 8.5mm, and the study’s authors attributed the lack of PCO to a mechanical compression inhibition of residual LECs inside the capsular bag, Dr Werner said.

The good PCO performance of that experimental lens has since been replicated in both animal and clinical studies with another dual-optic, the Synchrony from Visiogen/AMO. The one-piece, dual-optic silicone IOL has anterior and posterior components, connected by a bridge. The lens has several design features that help to maintain a space between the anterior EUROTIMES | Volume 15/16 | Issue 12/1

capsule and anterior optic surface and ensure expansion of the capsular bag.

At the ESCRS winter Meeting in Budapest, Ivan Ossma MD, Colombia, reported a YAG capsulotomy rate of less than five per cent at five years in 473 eyes implanted with the lens. Dr Werner noted that studies she and her associates conducted support those findings.

In one study, rabbit eyes implanted with the Synchrony lens had significantly greater clarity than those implanted with a plate silicone lens, which, by contrast, exhibited both PCO and a significant fibrosis of the anterior capsule (Werner et al, JCRS 2004; 30:1114-1123).

In another study, Dr Werner and her associates were able to show that the dualoptic IOL was not prone to interlenticular opacification. The study also showed that the same was true of piggyback implantation of silicone plate haptic IOLs. However, piggyback hydrophobic acrylic IOLs did develop the complication (Werner et al. JCRS 2006; 32:656-662).

Disc-shaped IOLs Among the discshaped IOLs are the Concept 360 IOL (Corneal), currently in clinical use, and a new IOL from Anew Optics. The concept 360 IOL is a single-piece hydrophilic acrylic IOL with six haptic components with 10-degree posterior optic-haptic angulation.

In vivo ultrasound imaging of patients' eyes with the lens show that clinical studies confirm that the anterior capsule is kept at a distance from the anterior optic surface.

In smaller eyes, the compression of the haptics creates a 360-degree barrier to LEC proliferation. In larger eyes the haptics are spread further apart and allow some peripheral LEC proliferation. Dr Werner noted that in cadaver eye studies she and her associates observed a tight contact between the periphery of the edge of the posterior IOL surface and the posterior capsule (Werner et al. JCRS 2005; 31:12311237).

“We also found excellent centration inside of the capsular bag, no ovalisation of the bag or of the rhexis, and there were no striae in the posterior capsule. In the series reported to date the YAG capsulotomy rate has been less than 2.0 per cent at two years, when a 360-degree barrier to LEC proliferation is created,” she added.

A

B

Courtesy of Liliana Werner MD, PhD

Open bag may be better

The lens from Anew Optics uses a different approach, consisting of two complete haptic rings connected by a C D pillar of haptic material, which supports the monofocal optic. High-frequency Gross photographs from the posterior or Miyake-Apple view ultrasound of rabbit eyes implanted with of the anterior segment of human and rabbit eyes implanted the lens shows that it maintains a space with IOL designs maintaining an open or expanded capsular bag.

A: Synchrony; B: Concept 360; C: Anew Optics; D: FluidVision. between the optic and the anterior capsule.

Photographs obtained from studies performed at the John A In addition, histopathological studies show Moran Eye Center, University of Utah that the only place that LECs proliferated was in the peripheral groove formed by the two haptic rings and their supporting pillar.

Another novel IOL that is showing their shape insures that the capsule bag promising PCO performance in animal remains open. studies is a new accommodating lens from “Basically what we are observing with Powervision. The hydrophobic acrylic IOL these IOLs is that when they are fully has a stable posterior lens and an anterior implanted inside of the capsular bag, the component that becomes filled with anterior capsule is kept away from the optic silicone oil in response to the eye’s natural surface, the posterior capsule is very clear accommodative forces, thereby increasing and there is a minimum proliferation of the IOL’s anterior curvature.

The haptics LECs in the capsular bag periphery,” Dr Ins_easyPhaco_120x120_EuroTimes 6.5.2010 11:21 Uhr Seite 1 serve as a reservoir for the silicone oil and Werner said.

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16

Update The contents of the ad may differ from the current status of approval of the product in your country. Please contact our regional representative for more information. Subject to change in design and scope of delivery and as a result of ongoing technical development. © 2010 by Carl Zeiss Meditec AG.

REFRACTIVE LENS

Happy Patient Project

Most MIOL patients satisfied, but there is room for improvement

by Cheryl Guttman Krader in Paris

P

Improved patient education with MPD Easy, quick and reproducible MPD measurements Transparency is key for educating patients about healthy living. With the new macular pigment density (MPD) module of the VISUCAM 200 and VISUCAM 500 fundus cameras, ophthalmologists now have an instrument for quickly, easily and objectively assessing macular pigment density – and better educating patients.

• Precision: fast, accurate MPD assessments with highly objective determination • Simplicity: convenient display of all image data as high-quality 3D visualizations at one workplace • Outcomes: easy monitoring of MPD progression to quickly identify changes

For more information, visit www.meditec.zeiss.com/VISUCAM200 and www.meditec.zeiss.com/VISUCAM500

Carl Zeiss Meditec AG Jena / Germany Phone: +49 36 41 22 03 33 info@meditec.zeiss.com www.meditec.zeiss.com

EUROTIMES | Volume 15/16 | Issue 12/1

reliminary analyses of data collected in the “Happy Patient Project” show bilateral multifocal IOL implantation resulted in excellent functional results and high patient satisfaction overall.

However, postoperative satisfaction was slightly lower than preoperative expectations as patients were essentially anticipating a perfect outcome. While it appears that the study’s goal of developing an easy tool to predict patient satisfaction after multifocal IOL implantation based on psychological profile may have been too ambitious, a number of correlations were identified and the investigators expect that the final results (available February, 2011) will facilitate the surgeon’s task.

Frank Goes Sr MD, director and senior surgeon, Goes Eye Centre, Antwerp, Belgium, spoke on behalf of the study group at the XXVIII Congress of the ESCRS in Paris, France.

“Achieving good outcomes after multifocal IOL implantation depends on proper patient selection, and patients must understand there are compromises because while multifocal IOLs have the potential to provide spectacle freedom, they also have disadvantages and particularly related to their association with photic phenomenon. Patients are satisfied when the advantages outweigh the disadvantages, but this is difficult to predict, not least because there is no adequate simulation to help in the preoperative consultation,” he said, explaining the challenges that motivated the study.

The study was organised by a group of ophthalmologists representing both private and university clinic settings and received logistical support from Abbott Medical Optics. It enrolled 159 patients undergoing cataract surgery (57 per cent) or having refractive lens exchange (43 per cent) who were followed to one year. A variety of multifocal IOLs were implanted according to the surgeon’s choice.

Patients completed a 50-item preoperative survey incorporating psychometric questions (NEO PI-R Personality Inventory and CI Compulsiveness Inventory) evaluating a number of personality aspects. Postoperative assessments included visual acuity, identification of photic phenomenon, and a questionnaire investigating overall satisfaction and spectacle use.

“

Improvements in satisfaction with vision outcomes were noted between three and 12 months, consistent with the phenomenon of neuroadaptation Frank Goes Sr MD

Overall, BCVA and UCVA at distance and near were excellent and about 90 per cent of patients did not use spectacles for distance, near, or intermediate vision tasks.

Although one-third of patients indicated they experienced photic phenomenon, none of the patients reported them as intolerable.

One of the most important findings from the data analyses was the identification of gender-related differences in patient expectations and satisfaction outcomes, with men seeming more “easygoing”, Dr Goes said.

For example, when asked preoperatively about limitations of visual quality, rates for acceptance of reduced contrast sensitivity, haloes around lights, and increased glare sensitivity were about 10 per cent higher among males than females. In terms of outcomes, three times as many women than men wore spectacles for intermediate vision tasks (29 per cent vs. 10 per cent) whereas females were less likely than males to use glasses for reading (16 per cent vs. 23 per cent) or distance vision (five per cent vs. 10 per cent).

Asked about satisfaction at three months after surgery, similar proportions of females and males were “not at all satisfied” (five per cent and four per cent), but males tended to be more satisfied overall, as 88 per cent of men and only 78 per cent of women were “completely satisfied” or “satisfied”.

“Improvements in satisfaction with vision outcomes were noted between three and 12 months, consistent with the phenomenon of neuroadaptation,” reported Dr Goes.

contact Frank Goes - frank@goes.be

contact

18

Cover Update Story //

SECTION Refractive HEADLaser

Perry S Binder - garrett23@aol.com

Section sub head

Femtosecond evolution

New capabilities for refractive and therapeutic applications

by Cheryl Guttman Krader in Paris

W

hen the XXVIII Congress of the ESCRS convened in September 2010, six different manufacturers were marketing femtosecond laser platforms for use in keratorefractive surgery, and all offer reliable technology for creating LASIK flaps with a number of advantages compared with mechanical microkeratomes. Therefore, surgeons looking at system selection will need to consider how the devices vary in their software and hardware capabilities, said Perry S Binder MD, MS. “All-laser LASIK provides patients with excellent visual and refractive outcomes.

Current femtosecond laser technology allows surgeons to cut flaps in most orbital configurations with greater safety and smoother surfaces than mechanical microkeratomes. Flap thickness is more predictable using the femtosecond laser and is not influenced by preoperative corneal curvature or pachymetry. The planar

flaps achieved induce fewer higher order aberrations than the meniscus flaps of a mechanical microkeratome. However, these devices vary with respect to a number of features and they are not all capable of creating the same procedures,” said Dr Binder, clinical professor, Gavin Herbert Department of Ophthalmology, University of California, Irvine, CA, and medical monitor for Abbott Medical Optics.

He noted that selection decisions should take into account the surgical needs of the practice against the available applications for each platform. Service and platform maturity are other issues to consider.

Of the six lasers available for LASIK flap creation, the IntraLase system (Abbott Medical Optics) is by far the most mature platform.

Now in its fifth generation with the 150 kHz iFS, the IntraLase technology has been used in more than four million cases worldwide.

The other available units include the VisuMax (Carl Zeiss Meditec) and two recent

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 15/16 | Issue 12/1

product line updates, the Technolas 520F (Technolas Perfect Vision) and Femto LDV Crystal Line (Ziemer). The SmartTech 150 (Schwind), a nanosecond laser with 355-nm wavelength (available in Autumn, 2011), and WaveLight FS200 (Alcon Laboratories) represent recent first entries into the market for their respective manufacturers.

Although engine speeds vary among the six lasers, all create flaps in about the same time (range of ~6 to 40 seconds for a 9.0mm flap) and most generate roughly the same energy per pulse. However, the units also vary in spot size and overlap that affects total energy placed into the cornea.

Even if the laser has a faster engine, if the spots are smaller and if there is more spot overlap, the procedure will take more time and deliver more energy into the eye, noted Dr Binder.

The platforms also vary in their options for flap customisation. Differences exist in the ranges for modifying side cut architecture, flap thickness and shape, and hinge angle, width, and location.

For example, only the iFS, WaveLight FS200, and SmartTech 150 can create oval flaps. The latter two platforms allow the advantage of allowing any shape oval while only the WaveLight FS200 allows the surgeon to put the oval axis in any meridian. The two newest platforms, WaveLight FS200 and SmartTech 150, allow hinge placement in any direction whereas the options using the other platforms are for nasal, superior, or temporal placement.

Operational characteristics Flap thickness is designed by computer control with all platforms except the Crystal LDV, which has metallic foils interspaced in the head that allow thickness selection. Only the Crystal LDV requires a masking fluid for coupling the laser to the cornea. The applanation is planar with the Crystal LDV, iFS, WaveLight FS200 and SmartTech 150 units, while the Technolas and VisuMax lasers have curved applanation surfaces.

With a curved applanation surface there is a limitation on the maximum diameter that can be achieved, Dr Binder said.

Focusing is done by computer control with the iFS, WaveLight FS200, and SmartTech 150, whereas for the Z-axis, it is necessary to move the handpiece using the Crystal LDV or the bed for the Technolas and VisuMax. Only

“

The power of femtosecond laser technology is yet to be realised, and in the future we will see surgeons continuing to come up with new ways of applying this technology to provide patients the best possible outcomes Perry S Binder MD MS

the Crystal LDV allows the surgeon to set spot overlap and raster speed control.

User-friendly features All of the platforms except for the Crystal LDV allow direct visualisation of the procedure by the surgeon as it takes place. Both the Crystal LDV and SmartTech 150 are mobile. The Technolas has no integration capability, the WaveLight FS200, VisuMax, and iFS are compatible with excimer lasers from their respective manufacturer, and the iFS is also compatible with excimer lasers from Nidek and Bausch + Lomb.

The iFS, VisuMax, and SmartTech 150 feature patient fixation lights that can help with centring the suction ring on the eye.

If suction is lost, the procedure can easily be repeated on the same day with all of the devices except for the Crystal LDV for which a suction break can change the prescription of the eye because Bowman’s layer is cut as the flap is created.

“Only the Crystal LDV has the disadvantage of cutting Bowman’s layer at the same time or before the raster pass is made, and that induces astigmatism into the eye if suction is lost,” Dr Binder explained.

Currently, about 30 different applications in refractive and therapeutic corneal surgery have been described for femtosecond lasers.

With its longest track record, the IntraLase technology leads the field with the greatest number of on- and off-label applications.

However, other platforms have unique uses.

For example, the Technolas 520F is used for the IntraCor procedure to treat presbyopia and low hyperopic refractive errors as well as femtosecond cataract surgery, and the FLeX and SMILE procedures for correcting myopia and astigmatism have been developed using the VisuMax laser.

“The power of femtosecond laser technology is yet to be realised, and in the future we will see surgeons continuing to come up with new ways of applying this technology to provide patients the best possible outcomes,” said Dr Binder.

LONDON 2011 11 EURETINA CONGRESS TH

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

www.euretina.org

contact

20

Cover Update Story //

SECTION Glaucoma HEAD

Richard K Parrish II - rparrish@med.miami.edu

Section sub head

OHTS: Who to treat?

Results of OHTS II indicate that early treatment yields benefit in high risk patients

by Roibeard O’hEineachain in Madrid

T

he long-term findings of the OHTS study suggest that an early prophylactic IOP-lowering eye drop regimen is unlikely to benefit most patients with ocular hypertension, but in those with known risk factors for glaucoma it can significantly reduce the rate of conversion to the disease, said Richard Parrish MD, Bascom Palmer Eye Institute, Miami, Florida, US.“Most ocular hypertension patients are at low risk and can be followed without medication. Delaying treatment for 7.5 years resulted in only a small absolute increase in POAG in low-risk participants. High-risk patients, who can be identified through the OHTS/EGPS risk calculator, may benefit from early treatment, taking into consideration their age, health status, life expectancy and personal preference,” he told the 9th European Glaucoma Society Congress.

Dr Parrish noted that the 13-year followup results of OHTS I and OHTS II studies showed that early treatment significantly reduced the rate of conversion to primary open-angle glaucoma among patients with multiple risk factors, such as highly elevated IOP, thin corneas and large cup/disc ratios

(Kass et al, Archives of Ophthalmology 2010; 128(3):276-287). However, early treatment had little impact on those with few risk factors.

The results of the first phase of the OHTS study showed that the rate of progression to primary open-angle glaucoma among ocular hypertension patients was 50 per cent lower among those who received IOPlowering therapy than it was among those randomised to observation alone (Kass et al, Arch Ophthalmol 2002; 120:701-713.), he said. The patients in the medication group had received therapy adequate to reduce IOP to 25 mmHg or lower and by at least 20 per cent from baseline, he explained.

At five years' follow-up, the rate of conversion to primary open-angle glaucoma was only 4.4 per cent in the treatment group, compared to 9.5 per cent in the observation group. However, that still meant that medication may have been unnecessary in just over 90 per cent of patients who received it. The OHTS study group therefore initiated a second phase of the study to better define which OHTS patients should and should not receive IOP-lowering eye drops.

The second phase of OHTS ran from June

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1.8 mm was the limit of We didn‘t believe that surgery! micro-incision cataract

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1.6 mm – SubMICS IO From the Leader in Lens

EUROTIMES | Volume 15/16 | Issue 12/1

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1, 2002 to March 9, 2009, during which time the patients who had previously only been monitored received an IOP-lowering topical regimen, and those who had been receiving medication from the beginning continued to do so. In this way they created an early treatment group and a delayed treatment group, Dr Parrish noted.

After a follow-up of a total of 13 years, the difference between the conversion rates of the two groups remained statistically significant (p=0.009) but was less pronounced than it had been at the completion of the first phase of the study. That is, the cumulative proportion with POAG at 13 years was 22 per cent in the delayed treatment group and 16 per cent in the group receiving medication from the beginning.

The difference between the groups’ mean length of time to conversion was statistically significant. In patients who developed glaucoma, its onset occurred after a mean of 8.7 years in the delayed treatment group, compared to 6.0 years in the early treatment group (P ≤ 0.001). Moreover, only four per cent in the early treatment group developed glaucoma in both eyes, compared to six per cent in the delayed treatment group.

Another finding of the study was that, according to the OHTS/EGPS Prediction Model for the Development of POAG, early treatment decreased the glaucoma incidence most among those at highest risk for the disease but provided negligible benefit to those at low risk. The OHTS/EGPS Prediction model is based on the five key factors influencing glaucoma progression identified in the OHTS and European Glaucoma Prevention study. They are a

patient’s age, IOP, cup/disc ratio, corneal thickness and pattern standard deviation.

The 13-year follow-up analysis showed that among those at low risk, glaucoma occurred in seven per cent of the early treatment group and eight per cent in the delayed treatment group. By contrast, among high-risk patients only 28 per cent of the early treatment group developed glaucoma, compared to 40 per cent in the delayed treatment group.

Patients of African heritage may also be at increased risk of developing glaucoma. During the initial phase of the OHTS study the proportion of patients of African descent developing glaucoma endpoints was 12.7 per cent in the observation group and 6.9 per cent in the medication group. That compared to rates of 10.2 per cent and 3.6 per cent, respectively, among patients of non-African ancestry.

By 13 years of follow-up the proportion of African Americans who had developed glaucoma was 29 per cent in the delayed treatment group and 26 per cent in the early treatment group. By comparison, among patients of different ethnicities, the incidence was 19.5 per cent in the delayed treatment group and 13 per cent in the early treatment group. However, the OHTS researchers found that race was not a predictive factor for developing POAG after adjusting for central corneal thickness and cup/disc ratio. Nonetheless, given that glaucoma is four times more common among people of African descent than it is among those of European descent, it is possible that racespecific factors might be found in a larger sample, the OHTS authors concede.

21

Update

Glaucoma

on the increase

Changing demographics in Europe call for a change in approach to managing glaucoma

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by Roibeard Oâ&#x20AC;&#x2122;hEineachain in Madrid

T

he incidence of glaucoma in Europe is likely to increase dramatically in coming decades, as the population ages and longevity increases. As a result, glaucoma management will require a more efficient use of medical resources than is currently the case, said David S Friedman MD, PhD, Wilmer Eye Institute, Baltimore Maryland, US. â&#x20AC;&#x153;We need to consider a different approach, one where patients go to a central location and obtain high-quality testing. Then we can evaluate the patients in our offices and see the ones who need direct contact with us. We need more resources to be allocated to educating patients and helping patients do a better job of managing their glaucoma. Health delivery systems can be improved in order to provide high-quality care to the rapidly ageing population in Europe,â&#x20AC;? Prof Friedman said in a keynote lecture at the 9th European Glaucoma Society Congress.

Current approaches to managing glaucoma are expensive and require large numbers of physicians to invest in expensive diagnostic equipment and conduct numerous tests while spending little time talking to patients about their symptoms and their adherence to prescribed regimens, he added. â&#x20AC;&#x153;Even though Europe is ageing and we are going to have many glaucoma patients out there, we can apply resources intelligently so that all patients can get the best care,â&#x20AC;? he said.

Highlighting the kinds of problems Europe will be facing as this century progresses, Prof Friedman noted that, according to current projections, one-third of the European population will be over 65 years old by the year 2050, and around 10 per cent will be over 80 years old, he said.

The increasing age of the population will bring with it a corresponding increase in the incidence of glaucoma and other eye diseases. In the Baltimore Eye Survey, the proportion with glaucoma was two to 10 times higher among those 80 years of age or older than it was among those 40 to 49 years of age. That is, among Caucasians aged 40 to 49 years the rate of glaucoma was 0.9 per cent, compared to 2.9 per cent among those 80 years or older. Among those of African descent the corresponding rates were 1.6 per cent and 13.8 per cent, respectively (Tielsch et al, JAMA, 1991; 266:369-374).

Europeâ&#x20AC;&#x2122;s changing ethnic profile may further increase the rate of glaucoma in the

EUROTIMES | Volume 15/16 | Issue 12/1

European population. Currently in Europe there are about 30 million immigrants.

They are mainly from Africa and Asia and account for about three per cent of the population. Therefore, there will be higher rates of primary open-angle glaucoma, particularly among the Africans, and angleclosure glaucoma, particularly among the Asian derived population. â&#x20AC;&#x153;This is important because angle-closure glaucoma in most population-based studies is a more severe disease than open-angle glaucoma. Even though in 2020 half as many people will have angle-closure glaucoma as will have primary open-angle glaucoma, nearly half the blindness will be from angle-closure glaucoma worldwide.â&#x20AC;?

The current way of dealing with glaucoma and other eye diseases will most likely prove unequal to the task of managing the large number of patients that will be presenting with the disease in the decades to come, Prof Friedman emphasised. At present, physicians spend so much time carrying out tests and measurements that they have little time to communicate with patients and insure that they understand the nature of their condition and the importance of adherence to their prescribed regimens.

Prof Friedman and his associates carried out a study in which they videotaped interactions between ophthalmologists and patients. They found that on average the physicians spent about eight minutes talking with their patients, and physicians asked most of the questions. As a result, the doctors only identified four of 13 patients who admitted they were not taking all their medications when interviewed by research nurses (Friedman et al, Ophthalmology, 2009; 116: 2277-2285).

He said that having regional centres of excellence for the diagnosis of glaucoma and for tracking disease progression would not only make better economic sense but also improve the efficacy of eye care for the patient. He noted that such an approach would relieve ophthalmologists in general hospitals and private practice of the obligation to constantly update their diagnostic equipment, while allowing their patients to avail of the latest technology employed by highly experienced staff.

contact David S Friedman â&#x20AC;&#x201C; David.Friedman@jhu.edu

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escrs on your time Symposia, free papers, videos and more from ESCRS Congresses in your home ngress o C I I I XXV , ESCRS e h t f o France Paris, nline Now O

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Camiel J F Boon – c.boon@ohk.umcn.nl

Update

retina

vitrectomy

Study warns of relatively high complication rate associated with vitrectomy

by Dermot McGrath in Paris

V

itrectomy offers an effective treatment for disturbing primary vitreous floaters, although patients need to be warned about the high complication rate associated with the procedure, according to a study presented at the 10th EURETINA Congress in Paris.

“Vitreous floaters can be very disabling, especially for patients who are still active professionally. We found that vitrectomy works well in tackling disturbing primary vitreous floaters, but it is important that patients are well aware of the risks of complications, and in particular of rhegmatogenous retinal detachment which

EUROTIMES | Volume 15/16 | Issue 12/1

occurred in just over nine per cent of patients in our series,” said Camiel J F Boon MD, PhD. Dr Boon’s non-randomised, interventional case series study included 107 eyes of 82 patients, 25 of them bilateral, with a mean age of 58. Dr Boon noted that 60 per cent of the patients had complained of floaters for more than a year prior to surgery.

Patients were treated by either 20-gauge or 23-gauge vitrectomy, with a mean follow-up of 13.6 months. Dr Boon defined primary vitreous floaters as floaters that were not secondary to other ocular conditions such as posterior uveitis, lymphoma or vitreous haemorrhage. A subjective patient

questionnaire received a 100 per cent response rate and provided valuable feedback to the medical team, said Dr Boon.

In terms of preoperative complaints, 93 per cent of patients said they had often or always suffered significant inconvenience due to disturbing floaters before surgery. Of those patients, 92 per cent said the problem was resolved after surgery. Some 83 per cent of patients said that they experienced significant preoperative difficulty with hobbies as a result of the floaters, whereas 85 per cent of those patients said it was much better after surgery.

More than half of patients (52 per cent) said that they experienced some difficulty in driving preoperatively, and 87 per cent of those patients said the problem was resolved postoperatively.

“One patient said that she has become a ‘very satisfied person’, the second said that she should have been referred to our centre much earlier, and the last patient even used the word ‘blessing’ to describe the result.

Overall, 87 per cent of patients said that they were very satisfied with the outcome and 90 per cent said that they would recommend the

procedure to a friend,” he said.

Dr Boon reported cataract in 21 per cent of the patients up to three years after surgery, adding that the figure would probably increase once all patients had reached the three-year follow-up point. Retinal detachment was also reported in 9.3 per cent of patients, a statistic Dr Boon described as an “unpleasant surprise”. Three out of the 10 patients had macular involvement and three out of 10 required more than one surgical intervention to treat the detachment.

Intraocular pressure higher than 30 mmHg was reported in 14 per cent of eyes in the postoperative period, all but one of which were successfully treated with topical drugs.

Prolonged cystoid macular oedema was present in three eyes.

“Complications are a delicate issue in this relatively benign condition, so informed consent is vital and the patients need to be fully informed of the risks involved. We need to further examine possible preventive measures that might be taken in the future to reduce the high rate of retinal detachment,” he said.

23

contact

24

News

Euretina preview

London welcomes EURETINA

High expectations after record attendance at 10th Congress in Paris, France

by Bill Aylward

T

he 11th EURETINA Congress will take place in The Queen Elizabeth II Centre in London from 26â&#x20AC;&#x201C;29 May, 2011. We have high expectations for this year's congress after a record number of medical and surgical retina specialists attended the 10th EURETINA Congress at the Palais des Congres, Porte Maillot, Paris.

A total of 2,700 delegates attended the congress making it not only the largest EURETINA meeting in the history of the society, but also establishing it as the largest retina meeting ever convened.

We now change destinations from one historic city to another and I am looking forward to welcoming friends and colleagues to my native capital. London is a wonderful city with a proud scientific and medical heritage.

Not only did the 10th Congress see an increase in attendance, but abstract submission numbers also showed a dramatic increase from previous years. Free paper submissions increased by 30 per cent from the Nice 2009 Congress, while video submissions doubled since last year.

We were overwhelmed by the record attendance and progress displayed in Paris

this year, but now we face the challenge of raising our standards to an even higher level.

In the coming months, we will be announcing some exciting innovations that will give added value to delegates who attend the 11th Congress and I would encourage retina specialists to visit our website at www.euretina.org for regular updates.

I am also pleased to announce that this is the first of a series of articles which will be published in EuroTimes in the lead up to the congress and in future issues my colleagues on the Board and Programme Committee will give you fresh updates on the 2011 programme.

Bill Aylward â&#x20AC;&#x201C; bill@aylwards.co.uk

The programme will include a combination of popular features from 2010 including the EURETINA Lecture, EUROLAM Symposium, Amsterdam Retina Debate and FanClub.

The Congress will also unveil the new EURETINA Innovation Award. The programme will include a session, which showcases the final shortlist of innovative and creative applications being reviewed and graded for their market potential.

On behalf of the Board and Programme Committee I encourage you to join us in London for what promises to be a stimulating and memorable congress.

It is not enough to host a big congress, we also want to be the best. I look forward to working with you to ensure that we achieve this target. * Bill Aylward is president of EURETINA and chairman of the Programme Committee for the 11th EURETINA Congress

Key Note Lecturers s 7OLFGANG $REXLER !USTRIA n 0USHING THE FRONTIERS OF RETINAL /#4 s !NDERS (EIJL 3WEDEN n ,ESSONS FROM THE EARLY MANIFEST GLAUCOMA TRIAL s 3HIGERU +INOSHITA *APAN n 4OWARDS SOPHISTICATED THERAPEUTIC MODALITIES FOR CORNEAL DISEASES s *ONATHAN 4ROBE 5NITED 3TATES n 4HE MANAGEMENT OF OPTIC NEURITIS WHY IS THERE SO MUCH CONTROVERSY

European Society of Ophthalmology

EUROTIMES | Volume 15/16 | Issue 12/1

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Vienna

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

Immediately preceding the XXIX Congress of the ESCRS

www.eucornea.org

26

News

young ophthalmologists

Benchmarking

Trainees could benefit from ESCRS EUREQUO project

by Colin Kerr

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urequo, the European Registry of Quality Outcomes for Cataract and Refractive Surgery, could make a major contribution to assisting young ophthalmologists in training, according to Oliver Findl MD, chairman of the Young Ophthalmologistsâ&#x20AC;&#x2122; Forum.

Prof Findl points out that while trainees do get feedback from their mentors and trainers through assessment and examinations at present, if they were able to become part of the EUREQUO project they could monitor all their patient outcomes and also compare them with trainees who input their outcome data in other countries.

Prof Findl also said that because the EUREQUO system guarantees anonymity, young doctors would not be afraid to input data where the outcome of a procedure was not always positive. â&#x20AC;&#x153;Sometimes trainees can get very discouraged if they have a bad outcome,â&#x20AC;? said Prof Findl. â&#x20AC;&#x153;However, with EUREQUO, they have the opportunity to see outcomes from other cases from other trainees which could be similar to their own experiences.â&#x20AC;?

Under the EUREQUO project surgical outcomes registries operated by 10 national ophthalmology societies serving 15 European countries are beginning to share data.

Prof Mats Lundstrom, EUREQUO clinical expert, believes Prof Findl's suggestion could be of major benefit to the project. â&#x20AC;&#x153;I think it is a very good idea to have trainees involved in the EUREQUO project,â&#x20AC;? he said. â&#x20AC;&#x153;I have talked to the EUREQUO project team and they think this is something we can add to the system in the future. One

EUREQUO European Registry of Quality Outcomes for Cataract & Refractive Surgery

of the areas we would have to look at is the issue of adding variables like â&#x20AC;&#x2DC;presence of tutor during surgeryâ&#x20AC;&#x2122; when inputting the data. Permission to report clinical data from a given clinic by the trainee would also have to be discussed with their heads of departments, but we think this should not be a problem as it would benefit both the trainees and their trainers,â&#x20AC;? he said.

Prof Findl welcomed Prof Lundstromâ&#x20AC;&#x2122;s support and said he would be discussing his proposal with the EUREQUO project team in the coming months. â&#x20AC;&#x153;If we can get young ophthalmologists in training involved in EUREQUO,â&#x20AC;? he said, â&#x20AC;&#x153;they will be the first generation of European ophthalmologists to have their outcomes monitored from the very start of their training to the end of their career. This information will help us in the future to evaluate and develop our training programmes, not only for young trainees but also for established ophthalmologists who are continuing their medical training in the various stages of their careers.â&#x20AC;?

contacts Oliver Findl â&#x20AC;&#x201C; oliver@findl.at Mats Lundstrom â&#x20AC;&#x201C; mats.lundstrom@ltblekinge.se

EUREQUO cataract report follow-up data with graphs Biometry prediction error, boxchart with correct signs

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EUROTIMES | Volume 15/16 | Issue 12/1 B$'9B1HZ ,QQRYDWLRQVB [ LQGG

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News

istanbul preview

Live surgery

Flexibility like never before!

Laser refractive surgery and cataract cases to be discussed by expert panel in Istanbul

by Dr Bekir Sıtkı Aslan

T

he live surgery programme will be one of the highlights of the 15th ESCRS Winter Meeting at the Hilton Hotel in Istanbul, Turkey.

An exciting Scientific Programme has been prepared by the ESCRS Programme Committee for the Winter Meeting which takes place from 18-20 February. As part of the meeting, the Turkish Ophthalmic Society Cataract and Refractive Surgery Division will appear on the podium with a Cataract and Refractive Live Surgery programme on Saturday February 19 at the Cerrahpaşa Medical Faculty Eye Clinic.

The modern medical education in Turkey started with the foundation of İstanbul Darülfünunu that was founded by Mahmut II on March 14, 1827. With the aid of the university reform, executed in 1933, the school of medicine was formed in the İstanbul University. One of the hospitals was named as Cerrahpaşa Hospital.

The name Cerrahpaşa is taken from surgeon Mehmet Paşa, who was the surgeon of the palace at the time of Sultan Murat III and Sultan Mehmet III and who had later become a grand vizier. On December 14, 1930, Atatürk had visited the hospital and been delighted to see its condition and stated his desire to enlarge the facilities.

Cerrahpaşa Faculty of Medicine is a result of the division of the İstanbul University Faculty of Medicine into separate units in 1967. With the latest medical equipment, the faculty upholds an innovative attitude

since the foundation year of the faculty. It trains its students to be abreast with the latest developments in the world of medicine, and the scientific research undertaken by its academic staff has a worldwide reputation. In 1987, a medical programme in English was established at the faculty.

The Live Surgery programme at the ESCRS Winter Meeting will include both laser refractive surgery and cataract cases in a high-definition (HD) live broadcast. This will be the first live surgery with HD broadcast in Turkey.

Four cataract surgeries with different lens densities will be presented and innovative microincisional technologies and techniques will also be demonstrated. A variety of advanced premium intraocular lenses will be implanted as part of the programme.

Wavefront LASIK both for myopia and hypermetropia with femtosecond laser assistance will be shown and a Live Avedro application will follow. A video of Intracore surgery will end the session.

I look forward to seeing you all in Istanbul.

For further information visit the ESCRS website at: www.escrs.org.

On behalf of TOD Cataract and Refractive Surgery Division Dr Bekir Sıtkı Aslan Head of Eye Clinic TOBB ETU Hospital

contact Dr Bekir Sıtkı Aslan – bekirsitkiaslan@gmail.com

OCULUS ImageCam 2 – A picture is worth a thousand words

Courtesy of Dr Bekir Sitki Aslan

This compact, high definition imaging system fits onto nearly every slit lamp.

Move the prism in or out of the slit lamp’s beam path for maximum illumination or no optical impairment.

www.oculus.de The Gate of Istanbul University

EUROTIMES | Volume 15/16 | Issue 12/1

contacts

28

News

research

Multifocal IOLs

Clinical trials are needed to sort out the indications and limitations of these different presbyopic IOLs

by Marie-Jose Tassignon and Thomas Olsen

T

oday’s cataract surgery is no longer simply extraction of the lens content and implantation of a spherical IOL. The surgeons can now make their choices between more complex optic IOLs which may better meet their patients’ expectations. The number of patients expecting to function without spectacles at all distances after uneventful cataract extraction has steadily increased in the last few years.

While some surgeons claim 100 per cent success, others warn to be very careful in “choosing the patients” who will be ideal candidate for these complex optic IOLs. However, the eligibility criteria remain vague and in case of unsatisfied patients, the surgeons blame this dissatisfaction on poor “brain plasticity”. The surgeons who are prudent (realistic) will state that “the patient should be informed preoperatively that there is no absolute guarantee of spectacle freedom”. Their message is that patient selection, informed consent and realistic

expectations are important for a successful postoperative result.

Why do these complex optics introduce new concepts like “brain education”, “realistic expectation”, and “patient selection”?

Being a surgeon, the last resort should be to blame the patient, but what does the doctor actually know about the optical quality of the IOL? Do you actually know that the optical properties of the IOL are always and exactly as the IOL company claims them to be? In the old days, we sometimes were faced with the problem of poor optical quality of the IOL. One of the authors (TO) have encountered several IOL mislabellings as well as significant astigmatism on IOLs claimed to be perfectly spherical. Now the situation is even more complex and the introduction of the multifocal IOL has made it more difficult to understand what you put into the patient’s eye. In physical terms what does it mean this ‘multifocality’? For example, do we know that every IOL is splitting the light in exactly 50/50 or 40/40 or whatever? Do we know the MTF of the distance power as well as the

near add? Do we know the tolerances of these properties?

The 21st century also introduced a new group of IOLs called “premium IOLs”. Also this term is vague and comprises aspheric, toric, diffractive, refractive multifocals and accommodating IOLs. The principal limitation of the aspheric IOLs is the lack in full compensation of the corneal curvature. Concerning the toric IOLs, the limitation relies mainly in the precise correction of the corneal astigmatism axis.

The diffractive, refractive or combined diffractive-refractive IOLs present an additional degree of difficulty related to pupil dynamics, which is more sensitive for IOL decentration.

After cataract surgery the pupil diameter will reduce, at far and at near. The central area of multifocal lenses is located in the geometrical centre of the lens. The questions that now raises is whether that geometrical centre corresponds to the visual axis of the eye once the multifocal IOL is located in the capsular bag?

Another question that needs to be addressed is whether PCO will cause active displacement of the IOL over time? The answer is clearly yes.

All the above factors will ultimately bear on patient satisfaction. Geometrical decentration will result in immediate postoperative visual complaints while PCO will cause visualrelated dysfunction later on.

If we further elaborate on the status of the pupil, the ideally positioned multifocal IOL

a €1,000 travel bursary to the XXIX Congress of the ESCRS in Vienna and a special trophy The John Henahan Prize 2011 My Best Teacher Young ophthalmologists, aged 40 or under, are invited to write about their memories of their best teacher in medical school or residency.

The prize is named in honour of John Henahan the founding editor of EuroTimes, who edited the magazine

from 1996 to 2001.

EUROTIMES | Volume 15/16 | Issue 12/1

See www.escrs.org for details

Marie-Jose Tassignon – Marie-Jose.Tassignon@uza.be Thomas Olsen – tkolsen@dadlnet.dk

will allow a perfect balance between the far and the near focusing of the central part of the IOL. In case of decentration a hyperopic shift will occur, reducing dramatically the reading capacity of the patient in favour of the far vision.

The same applies to the Mplus Oculentis (Germany – Topcon Europe – Medical) with an aspheric asymmetric distance vision and sector shaped near vision zone for near distance. Also this lens will be very sensitive to decentration and tilt.

Depending on the profile geometry of the multifocal IOLs, two or recently three foci will be generated, allowing far, intermediate (for the three foci IOLs) and near vision.

Reduced contrast sensitivity can be improved by adapting the edge and shape profile of the concentric rings.

Companies do not always disclose trademark specificities about their lens profile, although some did introduce patent protection (still in process of acceptance for some). Clinical investigation, however, already disclosed limitation in patient satisfaction urging companies to come up with adapted lens profiles, variable presbyopic addition between both eyes or proposing alternative options like accommodative dual lens designs.

Clinical trials are needed to sort out the indications and limitations of these different presbyopic IOLs in order to reduce the rate of IOL exchange out of which the multifocal IOLs became the number one indication in the US and Europe.

contact

Thomas S Harbin Jr – tomharbin@comcast.net

Feature

PRACTICE DEVELOPMENT

If I only knew then what I know now

Ophthalmologist distils 35 years of practice into physician’s business handbook

by Howard Larkin

What wasn’t taught in medical school Disruptive technologies aren’t

the only economic threats physicians face.

There’s also growing regulatory oversight, EUROTIMES | Volume 15/16 | Issue 12/1

Where do you want to be in 10 years? In his book, Dr Harbin lays

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out a practical assessment of the professional, practice and business issues that physicians face at every stage of their career. Throughout, he emphasises the importance of looking ahead.

For example, Dr Harbin cautions physicians entering practice from focusing too much on salary rather than whether a practice opportunity will take them where they want to go. While it may cost more in the short run to join or buy into a practice that gives you a chance to expand your skills or build a business over time, entering a practice with a reputation for churning through young physicians may

do you more harm than good – particularly if it has a reputation for questionable treatment patterns. He emphasises checking out a practice as thoroughly as possible before making a commitment.

Conversely, at mid-career, surgeons often find themselves with management issues including hiring physicians and staff, improving patient flow efficiency, attracting referrals and keeping patients happy. Is your practice on the right track?

If not, how do you correct midcourse?

Knowledge of organisational behaviour and how to deal with difficult colleagues become essential skills.

Dr Harbin also lays out a guide to the specific business skills physicians will need throughout their careers. These include communication, operations management and financial planning. “Often physicians have no idea what their economic potential is, or how to finance a practice that will meet their potential.”

He stresses, however, that you will need to put in some effort to develop the skills

to achieve your practice goals. No one can do it for you. “Doctors sometimes think they should be catered to more than people are willing to do,” Dr Harbin says. “But this is life. You have to do some things for yourself, and you can’t escape that.”

Dr Harbin’s book, What Every Doctor Should Know … But Was Never Taught in Medical School (F E P International, 2010), can be ordered from Amazon and Amazon UK.

“

Eye Chat with Oliver Findl

Prof Findl talks to Dr Bill Aylward (president of EURETINA, consultant at Moorfields Eye Hospital) about ‘Myopia: the Lens and the Retina’

Listen to our podcasts at

www.eurotimes.org

podcast EUROTIMES

ESCRS

pressure to improve efficiency while meeting rising patient expectations – and competition.

To address them, physicians need skills, Dr Harbin says. Such skills include process improvement, financial planning, personnel management, marketing, business communication, time management, and interpersonal skills. They are critical for building a successful private practice. But they are equally useful in academic and public settings, where surgeons must work with increasingly cost-conscious bureaucracies to achieve professional and personal goals.

Unfortunately, these topics are barely mentioned in most medical school curricula. Dr Harbin acquired them by taking an MBA fifteen years into practice – after he had assumed a leadership role in his group, which grew from five doctors when he joined to 24 today.

The two-year executive programme he took at Georgia State University was an eye-opener.

“In almost every course there was a theory that dealt with some issue we had addressed.

We had just been bumbling through, and I kept saying to myself ‘I wish I had known this 10 years ago,’” Dr Harbin says.

But not every doctor can take two years to study business – nor should they, Dr Harbin says. His goal is to distil the ideas into a manageable package. He works with the Student Doctor Network, an educational organisation that helps new doctors enter practice, and helps doctors at all career stages identify goals, and develop practice strategies that support them. “The reason I wrote this book was to reduce the floundering for doctors as they go through their careers.”

ESCRS

T

hree years out of fellowship, Thomas S Harbin Jr MD, MBA, had already built a successful regional glaucoma specialty practice, attracting referrals from more than 100 kilometres around. Then, in 1978, timolol eye drops hit the market.

“My referrals went down 75 per cent overnight,” recalls Dr Harbin, who has spent his career with Eye Consultants of Atlanta, Georgia, US. “As soon as the drops came out, it was clear many doctors said to themselves, ‘I can manage this glaucoma patient on my own, and I don’t have to send him to the super-specialist anymore.’”

Of course, it didn’t take long to realise that not every patient’s intraocular pressure could be controlled with timolol, and they started referring again. Still, it was a year before Dr Harbin’s referral volume recovered.

“It was an object lesson for sure,” says Dr Harbin, author of What Every Doctor Should Know … But Was Never Taught in Medical School (F E P International, 2010).

Dr Harbin responded to the downturn in referrals by reserving part of his practice for general ophthalmology, so he’d have his own patients to fall back on in case of a repeat.

So far, that hasn’t happened. But the rapid pace of technological advancement makes it a constant risk.

Examples are rife in other specialties, according to Dr Harbin. There’s the shift from cardiac surgery to interventional cardiology for myocardial infarction and the reduction of upper GI endoscopy due to alternate radiological procedures. And ophthalmology is not immune.

“If there is ever a treatment for diabetes that reduces diabetic retinopathy there will be a lot of retina doctors out of work,” Dr Harbin points out. Likewise, a drug that prevents cataracts could gut that procedure.

It’s even possible that widespread adoption of femtosecond laser cataract surgery could make it prohibitively expensive for small practices.

“If you are procedure-driven, a new technology could come along that supersedes your practice or shifts it to another specialty,” Dr Harbin says. “You need to be prepared.”

Podcasts are also available on iTunes

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Young Ophthalmologistsâ&#x20AC;&#x2122; 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 weeksâ&#x20AC;&#x2122; 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.

Feature

bio-ophthalmology

Retinitis treatment

Protein may restore vision in patients with retinitis pigmentosa

by Gearóid Tuohy PhD

S

wiss researchers have reported success in restoring light sensitivity in animals with retinitis pigmentosa using an ancient bacterial protein.

The researchers used the protein “halorhodopsin,” a light-activated chloride pump, to bypass the normal opsin found in cone photoreceptors. In patients with retinitis pigmentosa, rod photoreceptor cell death generally precedes cone cell death; however, while remaining cones survive, there may be an opportunity to maintain a level of visual function by transferring the light activated halorhodopsin into cone cells. If the cones maintain the ability to process signals to second-order neurons, then stimulation of the normal visual circuitry may sustain functional vision even in a damaged retina. Details of the study appear in the journal Science [2010;329:413-417].

The clinical onset of retinitis pigmentosa is often variable, arising for the most part from mutations in rod photoreceptor genes.

There is, however, a final common pathway of apoptotic cell death that is independent of the initial genetic mutation. As the rods die, cone cell sensitivity is lost despite the fact that downstream visual circuitry appears to remain intact. The central concept behind the recent Swiss research was to investigate if restoring photosensitivity in the cones would activate the cone photoreceptor visual pathways and restore visual function.

When stimulated by light, photoreceptors become hyperpolarised, which results in the signalling of the light stimulus to

neighbouring neurons and a message to the brain. To bring about photoreceptor hyperpolarisation in their retinitis pigmentosa mice, the Swiss research group introduced the gene for microbial halorhodopsin. The gene produced a similar hyperpolarisation of the cones, albeit with a sensitivity less than that found in normal healthy cones.

The researchers, based at the Friedrich Miescher Institute for Biomedical Research in Basel, and led by Volker Busskamp, PhD, isolated and cloned the genetic sequence of halorhodopsin from the archae-bacterial species, Natronomonas pharaonis. To limit which cells in the retina expressed the new halorhodopsin, the researchers incorporated specific promoter sequences: human rhodopsin, human red opsin and mouse-cone arrestin 3.

The incorporation of the cell type specific promoters was designed to minimise the chances of the halorhodopsin being expressed in other cell types such as downstream ON-bipolar or ON-ganglion cells. Expression of the new halorhodopsin gene in such cells could potentially inhibit the flow of information across the retina and cause a jumble of conflicting signals.

The halorhodopsin gene and an appropriate promoter sequence were packaged into a delivery viral vehicle – the adeno-associated virus or “AAV” – for sub-retinal injection into the eyes of mouse models of retinitis pigmentosa.

Two animal models were chosen for the experimental work – one where the retinal

www.eurotimes.org

degeneration occurred rapidly and one where it occurred more slowly. A key question for the research team was to test if the new transduced cone photoreceptor cells receiving the halorhodopsin replacement gene were capable of shunting information to downstream retinal circuitry. In human retinitis pigmentosa, and in mice retinitis pigmentosa, the photoreceptorto-bipolar synapses become disorganised as the disease progresses, which leads to a disturbance in signal flow. However, in the retinitis pigmentosa mice that received the halorhodopsin gene, the researchers recorded excitatory currents from ganglion cells, which indicated the presence of outer and inner retinal connections. In contrast, the researchers found no measurable lightevoked currents in the retinas of control injected animals.

The Swiss researchers additionally examined basic forms of spatial processing in control and test animals receiving the halorhodopsin gene. Visual stimulation with spots of increasing size and with bars moving in different directions demonstrated that some level of spatial contrast enhancement and directional selectivity was maintained.

In both models, the results showed a similar magnitude of photocurrents in transduced photoreceptors, each model displaying robust light-evoked excitatory responses. In addition, behavioural assays demonstrated significantly improved performance over controls in both fast and slowly degenerating retinas however, in optomotor reflex tests, only the

more rapidly degenerating models showed an improvement in visually guided behaviour.

Having established a proof-of-principle in animal models researchers turned their attention to the prospect of applying the strategy to human retinal tissues. Human ex vivo retinal explants were cultured in laboratory dishes for up to two or three weeks and used to assess the response to delivery of the halorhodopsin gene. Using lentiviral vectors, rather than AAV, to reduce the length of time for efficient gene expression, the research team was able to demonstrate halorhodopsin expression in human photoreceptors within one or two days of incubation. Analysis showed that photoreceptors in the parafoveal region of the retina elicited photocurrents and photovoltages within a wavelength spectrum indicative of halorhodopsin activation. To translate such gene therapeutic strategies to patients the research group has already identified potential candidates who may one day benefit from the approach through Phase I/II human clinical trials.

In addition, the Swiss researchers proposed that combining the halorhodopsin approach alongside existing technologies may provide new opportunities for extending photoreceptor function in the degenerating retina.

In an accompanying commentary article about the findings of the Swiss researchers, Prof Constance Cepko of Harvard Medical School suggested that the therapeutic benefit of the technology may be enhanced further by combining halorhodopsin gene therapy with specially designed eyeglasses containing light-emitting diodes (LEDs).

While normal cones are active over a wide range of light intensities and can adapt to different intensities of light, halorhodopsin is less sensitive and has a fixed sensitivity range. Consequently, human recipients of halorhodopsin therapy alone would experience a rather monochromatic view of the world.

The latest ophthalmology news and views online from EuroTimes

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

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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 15/16 | Issue 12/1

On the move? Listen to and download our Eye Contact podcasts at www.eurotimes.org/podcasts.asp

Subscribe to eTIMES our bimonthly electronic newsletter with the latest breaking news from the ESCRS and the world of ophthalmology.

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Feature

letter from america

Is the us ready for reform?

Newly empowered Republicans move to block landmark health legislation, but battle will continue

by Howard Larkin

E

mboldened by mid-term elections that cost the Democratic Party control of the US House of Representatives and trimmed its majority in the Senate, Republican leaders announced that repealing President Barack Obama’s signature healthcare reform is a top priority – second only to pushing Obama himself out of the Oval Office in 2012.

“If our primary legislative goals are to repeal and replace the health spending bill; to end the bailouts; cut spending; and shrink the size and scope of government, the only way to do all these things is to put someone in the White House who won't veto any of these things,” Republican Senate minority leader Mitch McConnell told reporters the day after the election.

The 2010 election apparently reinforced Republican confidence that their strategy of unanimous opposition to virtually any Democratic domestic policy is a winner.

Still, McConnell’s analysis shows he is aware that repeal won’t stick unless the Republicans control the presidency.

Political hurdles ahead But there’s still plenty that the Republican House can do to obstruct reform. The US Constitution requires that the House approve the spending of all government funds.

Republican leaders already have vowed to deny funding for elements of reform that are scheduled to phase in over the next four to eight years. Targets include adding 16

Journal Watch

million people to Medicaid, the programme for low-income Americans that is jointly funded by federal and state governments.

Several states have filed lawsuits challenging the federal government’s right to do so, since it requires states to come up with their share of cost.

“Recent opinion polls suggest that many Americans favour repeal of at least some of the reform legislation” Other targets could include state highrisk pools, established this year to cover uninsured people rejected by private insurers because of an ongoing illness or because of a high-risk medical history.

Extending funding beyond 2013 for statesupported children’s insurance, which Republicans opposed the last time around, may also be denied. Grants to establish state insurance exchanges for individuals and small businesses that cannot find affordable private coverage in the current fractured market may also be cut.

Such actions could gut plans to extend health insurance coverage to about 33 million of the 50+ million Americans

by Sean Henahan

Cataract prevention in salmon

Farmed salmon fed one key nutrient appear to be protected from cataract formation. An international research team reports that adding the nutrient histidine to the salmon’s diet stopped cataract development.

The rate of cataracts in salmon increased markedly in the early 1990s following the BSE scare and subsequent withdrawal of blood meal from fish food. Histidine is abundant in blood meal, but was missing from the replacement diet. Thanks in part to the work by this research group, a synthetic histidine compound has recently been approved for use within the EU. n J. Rhodes et al., American Journal of Physiology - Regulatory, Integrative and Comparative Physiology, September 30, 2010.

EUROTIMES | Volume 15/16 | Issue 12/1

without it. How effective these tactics are may turn on budget deals cut to keep the government running each year. But Republicans are sure to make a very public show of fighting health reform.

Public opinion mixed Recent opinion polls suggest that many Americans favour repeal of at least some of the reform legislation. A review by the Kaiser Family Foundation of eight national polls taken in September and October show support for repeal ranging from 26 per cent to 51 per cent. The wording and placement of the repeal question in the survey appeared to influence responses, making the results difficult to interpret, the Kaiser analysis says.

The few polls delving into the specifics of reform also suggest that the issue is more nuanced than simply rejecting reform, the Kaiser analysis says. For example, a Bloomberg poll that found while 47 per cent of likely voters favoured repeal overall, 78 per cent favoured retaining state high-risk pools, and 75 per cent favoured prohibiting insurance companies from denying coverage for pre-existing conditions. These provisions address some of the most egregious abuses of the existing private insurance system.

However, 62 per cent favoured repeal of taxes on health benefit plans costing more than a set threshold, and 51 per cent favoured repeal of a mandate that everyone buy private insurance coverage. This abiding desire among the electorate to get

something for nothing has frustrated health reform efforts for decades.

Nonetheless, repeal is unlikely, said William Rich MD, medical director of health policy for the American Academy of Ophthalmology. “Too many things benefit too many people,” he said.

Doctor income at risk Reform won’t affect ophthalmology much in part because most patients are older and already covered

by Medicare, Dr Rich added. However, if reform survives to 2014, it will generate new demand for paediatric ophthalmology services, as well as glaucoma and retinal services. That’s because about 22 million of the 33 million newly insured will be of Hispanic or African-American origin, and both groups have higher rates of glaucoma and diabetic ocular complications than the general population, he said.

Reform also includes many provisions that will affect how care is paid for and delivered. These include reducing Medicare payments to hospitals and physicians who do not report standard outcome measures or fall outside the norm for complications, readmissions and failure to provide specific, evidence-based care. These provisions also put providers at financial risk for the total cost of care by bundling all services associated with an “episode of care” into a single payment to be shared among doctors, hospitals and others. These episodes may be procedure-related, such as cataract surgery, or chronic-care oriented, such as covering all care for glaucoma for six months or a year.

Since everybody wants Medicare to be more efficient, these provisions are far less controversial, according to Michael Repka MD, secretary for federal affairs at the American Academy of Ophthalmology.

“This is a bipartisan effort,” he said, noting that it had started under President Obama’s predecessor, Republican President George W Bush. “We are going to be graded on quality metrics and they are going to be publicly reported.”

According to Dr Repka, the bottom line is that payments to doctors and hospitals will be squeezed while battles rage over coverage and funding. “We’re at the beginning of reform, not the end,” he said. “It is likely to go on for years.”

contact

Eva Sesselmann – e.sesselmann@meditec.zeiss.com

Feature

outlook on industry

helping to advance care

Carl Zeiss Meditec shows how integrating diagnostics, lenses and surgical devices helps to simplify and improve cataract and retina treatment

by Howard Larkin

A

s one of the world’s premier ophthalmic device manufacturers, Carl Zeiss Meditec offers a wide range of state-of-the-art products. The firm, based in Jena, Germany, sold €640m worth of leadingedge products in 2009. These included diagnostic equipment like the IOLMaster and Cirrus OCT, premium microincision intraocular lenses such as the AT TORBI and AT LISA toric, a complete line of viscoelastics, the OPMI LUMERA 700 microscope and the VISULAS retinal laser.

Carl Zeiss Meditec prides itself on the precision engineering and performance of its products, explains Ludwin Monz PhD,

AT LISA toric lens

OPMI LUMERA 700 microscope

Don’t miss Industry News, see page 36 EUROTIMES | Volume 15/16 | Issue 12/1

the company’s president and chief executive officer. But high technology alone isn’t enough, Dr Monz adds. To be useful in a world increasingly demanding better outcomes and higher efficiency, ophthalmic devices must also be easy for surgeons to use – and generate superior patient outcomes.

Therefore, Carl Zeiss focuses on integrating a range of products to provide comprehensive solutions, said Dr Monz.

“To us, it is not a basket of products. The idea is that things fit together and complement each other and work together.”

The ZEISS microincision cataract surgery (MICS) platform is a good example of how the concept is applied, explains Jan Willem de Cler, who heads the firm’s surgical ophthalmology unit. The advantages of MICS are clear, he notes, pointing to reduced risks of induced astigmatism and other complications.

But performing all necessary surgical steps through a sub1.8mm incision requires not only special lenses, but special equipment, Mr de Cler points out. Thanks to the recent addition of a new phaco system and a new preloaded lens injector, the firm now offers everything required to support true MICS. Such support for MICS begins with the lenses. Carl Zeiss began manufacturing its first monofocal microincision IOLs in 2001 and has offered advanced lenses such as the multifocal AT LISA and AT TORBI since 2006. “We have had MICS lenses for a long time,” Mr de Cler says. The entire range of Zeiss MICS lenses, including all dioptre powers and toric combinations, can be implanted through a 1.8mm or smaller incision.

Managing cataract surgery through microincisions also requires specialised phaco technology that can maintain a stable chamber and adequate flow through smaller diameter hand pieces. The Visalis 100 phaco machine was designed from the ground up with this in mind. It features lightweight hand pieces and vacuum and fluidics control for optimum performance and safety, Mr de Cler adds.

Initially, the portable Visalis system was introduced in India and other developing markets and featured reusable tubing and hand pieces. The high volume and specialised needs of these markets gave Carl Zeiss important feedback quickly to refine the system, Mr de Cler notes. For the European market, disposable tubing and hand pieces are available. Because the tubing system is entirely external, the Visalis can be turned around very quickly between cases.

A more advanced model, the VISALIS 500, was launched in late October at the congress of the German ophthalmic surgeons (DOC) in Hamburg. “We describe the VISALIS platform as a family, and that family will soon be extended with bigger brothers and sisters,” Mr de Cler predicts.

Sometimes overlooked in surgery is the importance of viscoelastic devices, Mr de Cler says. Carl Zeiss also offers a full line of OVDs, including TWINVISC, which combines a dispersive and a cohesive viscoelastic in the same syringe.

“

To us, it is not a basket of products.

The idea is that things fit together and complement each other and work together Ludwin Monz PhD

The dispersive agent is used first to aid in evacuating the lens.

It is separated from the cohesive agent, which can be used to inflate the chamber during IOL insertion once the dispersive agent is cleared. “Instead of two syringes you have only one,” Mr de Cler explains. All Zeiss viscoelastics are produced by a biofermentation process involving no animal tissue. “We are in control of every step from production to distribution.”

Finally, a suitable injector is needed to reliably insert IOLs through microincisions. At this year’s ESCRS Congress, Carl Zeiss introduced the BLUEMIXS 180 injector designed specifically for MICS. The system eventually will be available preloaded with any ZEISS MICS lens, which also enhances surgeon productivity Dr Monz says. One surgeon the company works with compares the preloaded injector to using a preassembled pen. “If you are going to write 30 times a day, would you want the pen delivered as a cap and a spring and a cartridge and make sure it is all the right way and then start writing? If you have a lot of time and this is your hobby, maybe. But there is enormous pressure on healthcare systems to increase productivity and quality.”

Carl Zeiss takes a similar system approach to implanting toric lenses, eliminating the need to mark the axis on the eye to align the lens in future, Mr de Cler notes. This is done by integrating data captured by the IOLMaster with the OPMI LUMERA 700 operating microscope. The IOLMaster photographs the sclera as it captures data. The lens power and axis are calculated using Zeiss’ Z CALC software.

The data is transferred via FORUM to the CALLISTO eye system, where the axis is projected on to the eye during surgery based on landmarks on the sclera. The axis appears on both a display monitor and through the operating microscope. The result is precise, accurate surgery and enhanced surgeon productivity.

On the retina side, the new VISULAS Trion VITE offers three colours of lasers along with flexible, surgeon controlled multi-spot cascades to avoid damaging blood vessels or other sensitive retinal tissues. Pulse times of 20 to 50 milliseconds shorten treatment times and reduce pain for patients.

All of these technologies are designed with better patient outcomes in mind, Dr Monz emphasises. “We judge the performance of our products by clinical evidence. If it doesn’t help the patient, it doesn’t work.”

33

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

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

36

Feature

industry news

Recent developments in the vision care industry

Non-mydriatic fundus camera

Cornea marking for premium toric IOLs

CSO has launched a non-mydriatic digital fundus camera. A company spokesman said the new camera, Cobra, integrates every function required for easy retinal screening.

“Integrating an innovative imaging optical system, Cobra realises digital fundus imaging of high resolution and fine gradation,” he said.

“Ergonomically designed Cobra provides clear and detailed display of the entire fundus image at true 60° field of view. The system offers retinal photography with minimum flash exposure allowing quick and efficient fundus photography, thereby minimising patient discomfort. Cobra shares the use of the high resolution CCD camera (2 MegaPixel) for alignment (IR illumination) and capture (White light flash),” said the spokesman. n www.csoitalia.it

Geuder says that highly precise preoperative marking can now be realised with a new corneal marker TOMARK. A company spokeswoman said the new instrument makes it possible to mark the final torus position on the cornea. “Direct adjustment of the angle with an accuracy of 5° enables TOMARK to exactly stain the calculated cylinder axis. Precise preoperative marking is of the utmost importance for perfect correction of corneal astigmatism,” she said.

Ziemer announces major upgrades to flagship products

Ziemer unveiled its new Femtosecond Surgical Laser at the recent American Academy of Ophthalmology annual meeting in Chicago. “Based on the experience from over half a million Z-LASIK procedures, Ziemer engineers have continuously further improved and optimised all key components of the Ziemer FEMTO LDV. The result of their effort is now available as an allnew package, named the ‘Crystal Line’”, said a company spokesman.

Ziemer has also launched the GALILEI G2, a new generation of its Dual Scheimpflug Camera System. “Based on a new, powerful computer system, system response, performance and computing power have been improved by 30 to 40 per cent,” said the Ziemer spokesman. n www.ziemergroup.ch

Xalatan receives paediatric indication in Europe

Pfizer has announced that Xalatan 0.005 per cent (latanoprost) has been approved by the European Commission for reduction of elevated intraocular pressure (IOP) in the treatment of paediatric patients with elevated intraocular pressure and paediatric glaucoma. The company said Latanoprost is the first prostaglandin analogue to complete safety and efficacy trials in the paediatric population and be indicated for use in patients aged 18 years or younger in Europe.

The EU approval is based on these Phase III and Phase I PK studies, which were contained in Pfizer’s Paediatric Investigation Plan as agreed with the European Medicines Agency (EMA), in accordance with the EU Paediatric Medicines Regulation. The objective of this Regulation is to improve the health of children in Europe by facilitating the development and availability of medicines.

EUREQUO European Registry of Quality Outcomes for Cataract & Refractive Surgery

Carl Zeiss Meditec announces revenue and earnings increase

Carl Zeiss Meditec AG, in its preliminary annual statement on 30 September 2010, has said that revenue and earnings are well above expectations.

The company said revenue totalled €676.7m (FY 08/09: €640.1m) and the operating result (EBIT) stood at €86.7m (FY 08/09: €76.1m). Adjusted for interest and currency effects the consolidated net income after non-controlling interests amounts to €54.9m or €0.68 per share (FY 08/09: €50.5m or €0.62 per share).

The company said this growth is attributable in particular to sales in the Asia/Pacific region.

“A rise in high-margin products contributes to the increase in net income. An encouraging increase was recorded in both the Microsurgery and Surgical Ophthalmology segments,” said a company spokeswoman.

What is EUREQUO? 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 15/16 | Issue 12/1

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

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

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

European Society of Cataract & Refractive Surgeons

38

Feature

eu matters

Fewer referrals?

EU court rules that health service can require prior authorisation for outpatient treatment

by Paul McGinn

A

ruling by Europe's highest court could slow or even block patients from travelling outside their own country for ophthalmic treatment.

In a decision delivered last October, the European Court of Justice ruled that French law can require any patient seeking outpatient treatment outside of France to receive prior authorisation in France if that treatment requires the use of expensive medical equipment.

If a patient fails to obtain such prior authorisation, he or she must pay for the treatment or investigation personally without any reimbursement from a French health insurance fund.

Although the French law does not now specify any ophthalmic equipment in its prior authorisation rules, the implications for ophthalmology could be profound if France – or any other European Union country – were to use the Court of Justice decision as the basis on which to introduce prior authorisation rules for referrals involving expensive equipment used in cataract and refractive procedures and investigations.

The French case drew the interest of a number of countries that submitted legal opinions in support of the concept of prior authorisation. Spain, Finland and the UK all argued that prior authorisations are necessary

Journal Watch

to ensure the economic stability of their own health services.

The particular French law stated that reimbursement for any treatment planned in a non-hospital setting outside of France must be first authorised by a National Centre for Healthcare Abroad whenever that treatment required the use of five specified types of equipment, including any scanners based on positron emission tomography, magnetic resonance imaging, or computed tomography. France defended such a rule on the basis that such pieces of equipment were expensive to buy and run and were already subject to strict controls within France.

Under existing EU law, France as well as every other EU country already had a right to reject reimbursement for any patient who obtained planned hospital treatment outside of its borders before receiving prior authorisation for that care. By contrast, reimbursement for any care that an EU citizen might require while already visiting or temporarily living in another EU country is automatically covered under the European Health Insurance Card.

The Court of Justice ruling followed a referral to the court by the European Commission. The commission, which is charged with ensuring that the EU’s 27 member countries comply fully with EU

by Sean Henahan

Avastin, Lucentis - therapeutically equivalent?

The development of anti-VEGF agents has revolutionised the treatment of age-related macular degeneration (AMD). Two leading treatments, bevacizumab (Avastin) and ranibizumab (Lucentis) were developed by the same biotech company, Genentech.

The first, an existing cancer drug, is not expensive, the second, developed specifically to treat AMD, is quite expensive. Early comparison studies showed little difference in therapeutic efficacy. Researchers at Boston University School of Medicine now report results from a new prospective, double-masked, randomised study that reaches the same conclusion. Patients received intravitreal Avastin or Lucentis every month for the first three months, followed by monthly examination and testing. They received further injections on an as-needed basis for one year. Fifteen patients received Avastin and seven patients received Lucentis. There was no significant difference in visual acuity and anatomic outcomes between the two groups. Both groups had an average improvement in vision of 1.5 lines, and only one patient (who was in the Lucentis group) lost three lines or more. In addition, patients in the Avastin group underwent an average of eight injections over one year, while patients in the Lucentis group underwent an average of four injections. Long-term studies are currently under way comparing the two drugs. n M. Subramanian et al., Eye, October 2010, online publication.

EUROTIMES | Volume 15/16 | Issue 12/1

law, challenged the French rules on prior authorisation as contrary to EU law. The commission argued that by requiring a patient to obtain prior authorisation France was illegally interfering with that patient’s right to travel within the EU to obtain medical services.

In its referral, the commission acknowledged that prior authorisation for hospital treatment was justifiable on the basis of the financial burden that unregulated access to hospital treatment outside of France would place on French health insurance funds. However, the commission argued that prior authorisation was not justifiable because non-hospital treatment would not generally represent such a financial burden for the health insurance funds.

The commission added that such diverse factors as language, geography, and living expenses already militated against “a huge exodus of insured persons” leaving France to travel to other EU countries for nonhospital care.

For its part, France argued that the commission’s distinction between in-hospital and non-hospital care was irrelevant. Rather, the high cost of buying, maintaining and using major medical equipment – regardless of where it was sited – was the important issue. In that vein, then, France argued that it had a right to require prior authorisation for treatment and investigation that could have a significant impact on the budget of its health insurance funds.

Although the Court of Justice acknowledged that medical services fall within the ambit of freedom to provide services and that a requirement of prior authorisation for such services is capable of deterring, or even preventing, persons insured in France from travelling abroad for treatment, France had a right to require such prior authorisation to help protect its health insurance system from the cost of uncontrolled access to such expensive equipment.

Consequently, having regard to the dangers both to the organisation of public health policy and to the balance of the financial social security system, the requirement of prior authorisation for that kind of treatment is, as European Union law

Don’t miss Calendar, see page 40

now stands, a justified restriction, regardless of whether the patient received treatment inside or outside of a hospital, the court said.

“Regardless of the setting, hospital or otherwise, in which it is intended to be installed and used, it must be possible for the major medical equipment exhaustively listed in Article R.6122‑26 of the Public Health Code to be the subject of planning policy, such as that defined by the national legislation at issue, with particular regard to quantity and geographical distribution, in order to help ensure throughout national territory a rationalised, stable, balanced and accessible supply of up-to-date treatment, and also to avoid, so far as possible, any waste of financial, technical and human resources,” the Court of Justice ruled.

“Such waste would be all the more damaging because the conditions for the installation, operation and use of the five types of equipment exhaustively listed in Article R.6122‑26 of the Public Health Code are especially onerous, while the budgetary resources which the Member States are able to make available for up‑to-date treatment and, in particular, the subsidising of such equipment, are not unlimited, whatever the mode of funding applied,” the court added.

The Court noted, however, that a prior authorisation scheme must be based on objective, non-discriminatory criteria known in advance, in such a way as to circumscribe the exercise of the national authorities’ discretion so that it is not used arbitrarily.

The court added that such an authorisation system must, furthermore, be based on procedures that are easily accessible and capable of ensuring that a patient’s request for authorisation will be dealt with objectively and impartially within a reasonable time. Also, EU countries imposing such authorisation requirements must provide a legal mechanism for the patient to appeal any possible refusals of an authorisation.

39

Review

JCRS Highlights Journal of Cataract and Refractive Surgery LASIK, followed by a multifocal IOL, followed by LASIK

What do you do for the LASIK recipient who develops cataracts and would like to remain spectacle free? A recent study evaluated the long-term refractive and visual outcomes of apodised diffractive multifocal intraocular lens implantation after myopic LASIK with or without subsequent excimer laser enhancement. This study comprised consecutive patients implanted with an AcrySof ReSTOR multifocal IOL after previous LASIK. Some 43 per cent of eyes underwent subsequent laser refractive surgery enhancement. The enhancement was for hyperopia in 12 eyes, for myopia in six eyes, and for mixed astigmatism in three eyes. Although the uncorrected distance visual acuity (UDVA) was significantly worse in eyes with enhancement than in those with no enhancement at one month and six months, there was no significant difference in UDVA at the last follow-up.

At the last follow-up, 36 (73.5 per cent) of the 49 eyes had a UDVA of 20/25 or better and an uncorrected near visual acuity of Jaeger 1 or better concurrently; 46 eyes (93.9 per cent) were within ±1.00 dioptre (D) of emmetropia, and 41 (83.7 per cent) were within ±0.50 D. Corneal refractive surgery can decrease contrast sensitivity and increase spherical aberration, glare, haloes, and straylight. Subsequent implantation of a multifocal IOL may synergistically exacerbate these problems. The researchers suggest that aspheric IOLs might help decrease the dysphotopsia, straylight, and contrast sensitivity problems associated with combining the two procedures. n O Muftuoglu et al., JCRS, “Apodized diffractive intraocular lens implantation after laser in situ keratomileusis with or without subsequent excimer laser enhancement”, Volume 36, Issue 11, pages 1815-1821.

Phakic IOLs

Phakic intraocular lenses (IOLs) have become an increasingly important tool for refractive surgery, particularly where keratorefractive laser surgery would not be considered the best option. In the absence of contraindications, phakic IOL implantation may be the best approach in young patients with moderate to high refractive errors and in those who have a contraindication to a corneal refractive procedure (eg, thin corneas). Advantages are that phakic IOL implantation maintains accommodation and is conceptually reversible. A new twopart overview reports the current status of phakic intraocular lenses, reviewing the three categories of lenses now available.

The first part of the series reviews the main models, the selection criteria, and the surgical techniques. It also addresses bioptics, adjustable refractive surgery, EUROTIMES | Volume 15/16 | Issue 12/1

and enhancements, as well as reviewing applications of the new anterior segment imaging techniques. n J Güell et al., JCRS, “Phakic intraocular lenses: Part 1: Historical overview, current models, selection criteria, and surgical techniques”, Volume 36, Issue 11, pages 1976-1993.

New model

Presbyopia is generally attributed to a failure of the biomechanical process of lens accommodation. However, the details of this process continue to be debated. In particular the original hypothesis proposed by Helmholtz has been challenged by Schachar and others. A new modelling analysis may go some way towards reconciling the various proposals. Researchers at Princeton University used finite element methods and ray-tracing algorithms to model the deformation and optical power of the human crystalline lens during accommodation.

The mechanical model treats the lens as an axisymmetric object, and the optical model incorporates a gradient refractive index.

Using these models, the accommodation of a broad range of lenses with different geometries and mechanical properties were investigated. The most significant finding was that reshaping the 45-year-old lens to the geometry of the 29-year-old lens, while retaining the mechanical properties, restored the former’s accommodation amplitude to 72 per cent to 94 per cent of that of the 29-year-old lens, depending on ciliary body displacement. That is, reshaping can add 1.8 to 3.7 dioptres of accommodation. A sensitivity analysis showed that this result was robust over a wide range of mechanical and geometrical properties. The researchers conclude that a significant amount of the loss of accommodation is due to changes in lens geometry. n D Van de Sompel et al., JCRS, “Model of accommodation: Contributions of lens geometry and mechanical properties to the development of presbyopia”,Volume 36, Issue 11, pages 1960-1971.

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 was 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:

Thomas Kohnen Associate Editor of JCRS

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

www.europeanyearoflasik.com for further information

40

Reference

Calendar of events Dates for your Diary

December

9-12

2010

MACAU, CHINA

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

February 2011

18-20 TURKEY

ISTANBUL,

15th ESCRS Winter Meeting www.escrs.org

11

belgrade, serbia

February 2011

Verona, Italy

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

24-27

May 2011

6-10 Argentina 26-29 Mar del Plata,

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

11th EURETINA Congress www.euretina.org

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

2011

March 2011

3-6 Barcelona, Spain

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

11-12 Alicante, Spain ARI Monographic 2011 – “Presbyopia… its treatment” www.alicanterefractiva.com

2011 Congress of the APAO www.apaosydney2011.com/

25-30 SAN DIEGO, CA, USA

ASCRS/ASOA Symposium and Congress www.ascrs.org

July

June London, UK

12-14

Vienna, Austria

Athens, 20-24 Sydney, Australia Greece

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

2011

2011

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

3-5

April

January

2011

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

Joint Congress of SOE/AAO www.soe2011.org

Leuven, Belgium

Leuven Retina Meeting www.leuvenretinameeting.eu

World Glaucoma Congress 2011 www.worldglaucoma.org

September 2011

vienna, austria

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

XXIX Congress of the ESCRS www.escrs.org

September

8-9

2011

Gothenburg, Sweden

1st World Congress on Surgical Training www.surgicon.org

23-24 France

October 2011

November

22-25 FL, USA 13-16 ORLANDO,

American Academy of Ophthalmology Annual Meeting www.aao.org

2011

Seoul, Korea

2011 APACRS-KSCRS Annual Meeting www.apacrs.org

Bordeaux,

Eurokeratoconus II www.jbhsante.fr

Advertising Directory: Alcon Laboratories: Pages: 3, 17, OBC; ASCRS / Eyeworld Pages: 14, 34-35; Carl Zeiss Meditec AG Page: 16; D.O.R.C International BV Page: 26; IROC AG Page: 18; Katena Products Inc Page: 8; Khairabad Eye Hospital Page: 9; Medicel AG Page: 20; NIDEK Page: 23; Oculus Optikgeraete GmbH Page: 27; Oertli Instruments AG Pages: 13, 15; Rayner Intraocular Lenses Ltd Page: IBC; SOE Page: 24; VSY Biotechnology Page: IFC; Zeimer Page: 21

RAYNER IOL experts, the world over.

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superb centration and stability • Excellent biocompatibility of Rayacryl® with the uveal tract

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Note: Sulcoflex® Pseudophakic Supplementary IOLs are not yet approved for sale in the US and Canada. 11/10 Copyright Rayner Intraocular Lenses Limited.

GLAUCOMA DOESN’T QUIT AT THE END OF THE DAY. NEITHER SHOULD YOUR PG. Get the 24-hour endurance of TRAVATAN® Eye Drops.1 • Enduring IOP control is critical to visual field preservation 2-4 • Multiple studies show time and again that TRAVATAN ® controls IOP a full 24 hours and beyond. 1,5-7

Trust the proven endurance of TRAVATAN® for patients treated with PGs.1,5-11

40 micrograms/ml eye drops solution-travoprost References: 1. Dubiner HB et al. Clin Ther 2004;26(1):84-91. 2. The AGIS Investigators. Am J Ophthalmol 2000;130(4):429-440. 3. Nordmann JP et al. Clin Drug Investig 2003;23(7):431-438. 4.

Kass MA et al. Arch Ophthalmol 2002;120:701-713. 5. Yan DB, Battista RA. Presented at World Glaucoma Congress; July 18-21,2007, Singapore. P 311. 6. Garcia Feijoo J et al. Invest Ophthalmol Vis Sci 2006;47:E-Abstract 444-B179. 7. Sit AJ et al. Am J Ophthalmol 2006;141(6):1131-1133. 8. Netland PA et al. Am J Ophthalmol 2001;132(4):472-484. 9. Maul E et al. Presented at American Glaucoma Society Annual Meeting; March 2-5, 2006, Charleston, SC. P 61. 10. Chew PTK et al. Asian J Ophthalmol 2006;8(1):13-19. 11. Konstas AGP et al. Presented at World Ophthalmology Congress; February 19-24, 2006, Sao Paulo, Brazil.

PRESCRIBING INFORMATION: Consult the Summary of Product Characteristics before prescribing, particularly in relation to side-effects, precautions and contraindications. TRAVATAN® (travoprost) Name and Composition: TRAVATAN® 40 micrograms/ml eye drops, solution; 1 ml of solution contains 40 micrograms travoprost, 0.15 mg benzalkonium chloride. Indication: Decrease of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.

Dosage and Administration: Remove protective overwrap before initial use.

Adults, including the elderly: One drop in the affected eye(s) once daily, optimally in the evening. Children and adolescents: Not recommended. Hepatic and renal impairment: No dosage adjustment necessary. Contraindications: Hypersensitivity to travoprost or any of the excipients. Precautions: TRAVATAN® may gradually change eye colour. This occurs slowly and may not be noticeable for months to years. Before treatment is instituted, patients must be informed of the possibility of a permanent change in eye colour. Unilateral treatment can result in permanent heterochromia. Long term effects on melanocytes and any consequences are currently unknown. After discontinuation of therapy, no further increase in brown iris pigment has been observed. TRAVATAN® may gradually increase the length, thickness, pigmentation, and/or number of eyelashes in the treated eye(s). Exercise caution in patients with inflammatory ocular conditions and other types of glaucoma, aphakic patients, pseudophakic patients with a torn posterior lens capsule or anterior chamber lenses, and in patients with known risk factors for cystoid macular oedema or iritis/uveitis. Skin contact with TRAVATAN® must be avoided.

Benzalkonium chloride may cause keratopathy and irritation and is known to discolour soft contact lenses. Close monitoring is required in dry eye patients, or where the cornea is compromised. Patients must remove contact lenses prior to application of TRAVATAN® and wait 15 minutes after instillation before reinsertion.

TRAVATAN® contains polyoxyethylene hydrogenated castor oil 40 which may cause skin reactions. Interactions: No studies performed. Pregnancy and Lactation: Pregnancy: Do not use unless clearly necessary. Avoid contact with the skin and cleanse area immediately if accidental contact occurs. Women of child-bearing potential: Do not use unless adequate contraceptive measures are in place. Breastfeeding women: Not recommended. Driving: If blurred vision occurs, wait until vision clears before driving or using machinery. Undesirable Effects: Eye disorders: Very common: hyperaemia. Common: punctate keratitis, anterior chamber cells and flare, pain, photophobia, discharge, discomfort, irritation, abnormal or foreign body sensation in the eyes, visual acuity reduced, vision blurred, dry eye, eye pruritus, lacrimation increased; erythaema, oedema and/or itching of eyelid; growth, and/ or discolouration of eyelashes; iris hyperpigmentation. Please refer to SmPC for other eye disorders. Systemic disorders: Common: headache, skin hyperpigmentation (periocular). Please refer to SmPC for other systemic disorders. Overdose: Symptomatic treatment. Incompatibilities: None known.

Pharmaceutical Precautions: No special precautions for storage, 3 year shelf life, discard 4 weeks after first opening. Presentation: Plastic bottle containing 2.5 ml eye drops.Cartons containing 1 or 3 bottles. Legal Category: POM.

Pack Size and Basic NHS Price: 2.5ml £9.98. GMS Price: 2.5 ml 17.91.

Marketing Authorisation Holder: Alcon Laboratories (UK) Ltd., Boundary Way, Hemel Hempstead, Herts HP2 7UD, United Kingdom. MA Numbers: EU/1/01/199/001-002. Date of preparation of PI: August 2010 (V3).

Adverse events should be reported.Reporting forms and information can be found at www.yellowcard.gov.uk Adverse events should also be reported to Alcon Medical Information on 01442 341234 Email gb.adr@alconlabs.com

Alcon Laboratories (UK) Ltd., Pentagon Park, Boundary Way, Hemel Hempstead, Herts. HP2 7UD. Tel: (01442) 341234 Fax: (01442) 341200 Trademarks are the property of the respective owners.

Date of Preparation: August 2010

TRA:EU:JA:08/10:LHC