Volume 15_Issue 4

VOLUME 15 ISSUE 4 APRIL 2010

Special Focus

Keratoconus

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Editorial April

Medical Editors

Emanuel Rosen FRCSE José Güell

Ioannis Pallikaris

Clive Peckar

Paul Rosen

International Editorial Board

Emanuel Rosen Chairman ESCRS Publications Committee

Noel Alpins

australia

Bekir Aslan

TURKEY

Bill Aylward Peter Barry

UK

IRELAND

Roberto Bellucci

ITALY

Hiroko Bissen-Miyajima John Chang

CHINA

Joseph Colin

FRANCE

Alaa El Danasoury Oliver Findl

SAUDI ARABIA

AUSTRIA

I Howard Fine Jack Holladay

Boris Malyugin

RUSSIA

Marguerite McDonald

Ulf Stenevi

USA

INDIA

Thomas Neuhann

GERMANY

GERMANY SOUTH AFRICA

SWEDEN

Emrullah Tasindi

TURKEY

Marie-Jose Tassignon Manfred Tetz

BELGIUM

GERMANY

Carlo Enrico Traverso Roberto Zaldivar

LETTER TO THE EDITOR

GREECE

HONG KONG

Robert Stegmann

Yet was EuroTimes wrong to report the Moorfields departure from limiting therapy to trained physicians? The answer is no because it is happening and is newsworthy. It does not mean that EuroTimes condones the process. It simply reported fact and in so doing has engendered a healthy debate within the profession. The medical editors of EuroTimes encourage further debate on this issue but at this time draw a timely reminder to readers of the disclaimer published in each issue: “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”.

Clearly therapeutic interventions by non-medically trained paramedical staff is a major issue and is worthy of further comment and discussion. Whilst Moorfields Eye Hospital is a UK National Health Care Trust and thereby responsible for its own professional indemnity, it is an institution which has led the way in many eye care initiatives and the development of the highest standards of ophthalmic care.

The medical editors of EuroTimes do subscribe to the philosophy that eye surgical treatment, for that is the nature of Nd.YAG capsulotomies (and is so recognised by the medical indemnity organisations), should be the preserve of medically and surgically trained ophthalmologists who are individually responsible for their patient care and the burden of defending unfortunate complications.

EuroTimes reserves the right to publish meeting reports that are in the profession’s interest. erosen9850@aol.com

* Emanuel Rosen, chairman of the International Editorial Board of ESCRS EuroTimes and on behalf of the medical editors

GREECE

GERMANY

Anastasios Konstas

Gisbert Richard

A recent report from an ESONT meeting in Barcelona (EuroTimes Vol 14 /11 Nov 2009 pg12) described how Nd.YAG laser capsulotomies were being delegated to nurses at Moorfields Eye Hospital in London.

The report stated that there were no complicating issues, ie the treatments had been carried out successfully by non-medically (nonophthalmologically) trained staff.

Ophthalmologists have long relied on technical and para-ophthalmic professionals to carry out measurements in eye clinics, eg tonometry, biometry, topography and tomography, where the operative word is measurement as opposed to treatments. Nd.YAG capsulotomies are clearly treatments and could represent the thin edge of a wedge into the territory of the ophthalmologist.

What will be next in line? Iridotomies, intra-vitreal injections, PRK or even cataract surgery itself? Not so long ago, a senior English professor of ophthalmology attempted to gain government support for nurses to perform cataract surgery, a proposal which was immediately howled down by united UK ophthalmic surgeons.

So we have been there before, but the situation is not unique to the UK or Europe. In the US, the optometric profession has long been itching to get its hands into the refractive surgery domain. Surgeons devote years of training in general medicine and surgery and further years of specialist training to ensure that patients in their care receive the highest standards of treatment for which professional indemnity is carefully controlled to add a further layer of protection.

Team work, embracing measurements by trained staff as distinct from therapeutic intervention is, and has been, the way to manage patients with each team member being particularly skilled in their tasks. These points have been eloquently voiced by Dr Rene Trau (EuroTimes Vol 15/2 Feb 2010 pg1) and in this issue by Italian Society of Ophthalmology president Matteo Piovella (see below).

USA

Thomas Kohnen

Cyres Mehta

Ophthalmologists’ interests must be supported but healthy debate is also important

USA

Vikentia Katsanevaki

Dennis Lam

JAPAN

From the Editor

ITALY

ARGENTINA

Dear Editor, I was astonished to read in a recent issue of EuroTimes (Vol 14/11 Nov 2009 pg 12), the official magazine of the ESCRS, that “Nurseperformed YAG laser capsulotomy offers benefits...”.

In this article, it was specified that at Moorfields Hospital a nurse-performed more than 1500 YAG laser capsulotomies and that “nurse performed laser capsulotomy improves efficiency and continuity in patient care”… (sic!!!). Declan W Flanagan, consultant ophthalmic surgeon and deputy medical director Moorfields Eye Hospital in London, was described in this article as “A champion for the nurse”.

In the Italian ophthalmic community, a question has immediately arisen: What is the

purpose of publishing this type of article in the official magazine of ESCRS? What is the “added value” for ESCRS and for its members?

I would like to remind you that education and training is accepted worldwide as the way to provide better patient care and safety. For this reason, the European community recently promoted a law to increase in all member states, the number of years of training for eye doctor certification.

We are well aware that, in general, European legislation is very respectful of national differences and peculiarities. The final target is to harmonise professional practice around the community, in such a way as to provide healthcare at the same level all around Europe.

Therefore, all health regulations approved in European countries must follow these rules: “…delegation must not be used to compensate for lack of staff, or as routine, or for economical reasons. It should not be

used to solve problems to man a unit. The care provider is responsible to have the staff, premises and equipment necessary for a good care…”

January 1 marked the start of my term of office as president of the Italian Society of Ophthalmology (SOI), a role I will be committed to for the next four years. SOI, on behalf of all the 7000 Italian eye doctors, judges the management of eye patients as described in the EuroTimes article as unacceptable, because a YAG capsulotomy is considered a medical act.

I totally agree with my association and my colleagues on this matter and call on EuroTimes and ESCRS to take a clear position against nurse-performed YAG laser capsulotomy.

Yours sincerely, Matteo Piovella, President Società Oftalmologica Italiana

1

Contents

Cover images courtesy of José Güell MD, PhD, Institute of Ocular Microsurgery, Barcelona, Spain.

Top images show thin slit comparison at the biomicroscope, middle images show Rizzuti sign comparison, bottom images show Munson’s sign comparison.

Special Focus – Keratoconus 6 Cover Story: Preventable measures for keratoconus 10 Studies show benefits of femtosecond lasers

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6-7

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11

Cover Story

11 Keratoconus patient wins gold at Winter Olympics

Cataract Update 12 Expert says no increased risk of AMD progression after cataract surgery

Special Focus

Refractive Lens 14 Promising early clinical results with NuLens accommodative IOL

Refractive Laser

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14 Refractive Lens

16 Health workers should be screened prior to laser surgery to rule out MRSA 17 Lower postoperative complications with femtosecond laser

18 New treatment options for irregular astigmatism

Cornea Update

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20 Cornea

19 Risk factors for infectious crystalline keratopathy

20 Mitomycin C can help prevent return of pterygium 2

More Contents

Contents

>

Ocular Update

34 Features

EUROTIMES

ESCRS

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26

™

Published by The European Society of Cataract and Refractive Surgeons

Editorial Staff

Glaucoma Update 21 Detecting progression important in managing glaucoma

Publisher Carol Fitzpatrick Executive Editor Colin Kerr Editors Sean Henahan Paul McGinn

Retina Update 24 Can early detection of CNV improve the final visual outcome of patients?

Managing Editor Caroline Brick Production Editor Angela Sweetman Senior Designer Paddy Dunne

Ocular Update 26 3D-induced headache may be result of underlying ocular condition

28 New didactic courses added to EBO education programme

ESCRS News 30 Young ophthalmologists invited to enter John Henahan Prize competition 31 BSCRS already using EUREQUO and encourages others to take part

ESCRS Winter Meeting Report

Assistant Designer Janice Robb Circulation Manager Angela Morrissey Contributing Editors Howard Larkin Dermot McGrath Roibeard Ó hÉineacháin Contributors Devon Schuyler Eisele Stefanie Petrou-Binder Maryalicia Post Seamus Sweeney Gearóid Tuohy Colour and Print Times Printers

Advertising Sales

ESCRS, Temple House, Temple Road Blackrock, Co. Dublin, Ireland Tel: 353 1 209 1100

32 Coverage from the 14th ESCRS Winter Meeting in Budapest

Features

Regulars

34 Out & About

8 Newsmaker

35 In Your Good Books

34 Journal Watch

37 Outlook on Industry

36 Product Update

38 Practice Development

40 JCRS Highlights

39 Bio-Ophthalmology

43 Journal Watch

42 EU Matters

43 Industry News 44 Calendar

4

Fax: 353 1 209 1112

email: escrs@escrs.org Published by the European Society of Cataract and Refractive Surgeons Temple House, Temple Road, Blackrock, Co Dublin, Ireland. No part of this publication may be reproduced without the permission of the managing editor. Letters to the editor and other unsolicited contributions are assumed intended for this publication and are subject to editorial review and acceptance.

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

As certified by ABC, the EuroTimes average net circulation for the 11 issues distributed between 01 January 2009 and 31 December 2009 is 29,537.

Preventing severe keratoconus possible due to new diagnostic treatments

Roibeard O’hEineachain in Budapest

NEW diagnostic technologies and treatments may make it possible to halt keratoconus progression in its early stages, and correct the refractive error with corneal or lenticular surgical approaches, reducing the need for corneal transplantation.

In advanced disease there is visual distortion, and external features such as Munson’s sign, a v-shaped conformation of lower-lid convergence. Slit-lamp findings indicative of the condition include stromal thinning, Vogt’s striae, Fleischer ring, prominent stromal nerves, and epithelial and subepithelial scarring, said George D Kymionis MD, PhD, Institute of Vision and Optics, University of Crete, Medical School, at a session dedicated to keratoconus held during the 14th ESCRS Winter Meeting.

“The problem is in early disease there are no symptoms or signs, so clinical diagnosis is not enough for patients with early disease,” he added.

Topography has its shortcomings The development of topography placidobased videokeratography has allowed earlier keratoconus diagnosis through the detection of localised increases in curvature, usually inferiorly, and by asymmetry of inferior and superior curvature or a relative skewing of the steepest radial axes, Dr Kymionis said.

However, normal eyes can have topographic patterns similar to those of eyes with subclinical keratoconus, such as round oval superior steepening, inferior steepening, and asymmetric bow tie with inferior steepening, he pointed out. Often, warping of the cornea’s anterior surface from years of wearing contact lenses can mimic early keratoconus. Other factors are technical errors during video capturing and previous corneal surgery, he added.

Technical problems can also result in cases being missed. To avoid false negatives, it is best to evaluate topography with 0.5 D steps rather than 2.0 D steps, Dr Kymionis noted. Another important consideration is the topography mode used for generating the topographic maps. Axial maps provide a more generalised picture of the eye’s topography while tangential maps are better at detecting localised variations of corneal curvature and therefore enable more accurate diagnosis.

But probably the biggest problem with Placido-based topography is that while its findings are very consistent and reproducible with normal corneas, they are much less so with irregular corneas such as those with keratoconus.

New technologies are more reliable Recent years have seen the introduction of new technologies such as scanning slit systems like the Orbscan® (Bausch & Lomb) 6

and Scheimpflug imaging systems like the Pentacam (Oculus). These imaging systems provide data from anterior and posterior surface and generate pachymetric maps, in turn providing the ability to detect posterior thinning of the cornea in areas where the anterior surface is still fairly regular.

Another approach to diagnosing keratoconus is to use the Ocular Response Analyzer (Reichert) to measure corneal hysteresis, a principle component of the cornea’s biomechanics. Research has shown that there is a strong correlation between reduced hysteresis and the degree of keratoconus present.

“The combination of different diagnostics technologies could be used in the future for the evaluation of patients with subclinical keratoconus as a predicting parameter for progression or for screening refractive surgery candidates,” Dr Kymionis added.

Cross-linking combined with surface ablations show promise The potential for earlier detection brings with it the potential for earlier treatment. One possible treatment could be a combination of corneal collagen cross-linking (CXL) to halt the progression of the condition, and surface ablation, to correct the irregular astigmatism, according to Mirko R Jankov II MD, PhD, Belgrade, Serbia and University of Sao Paulo, Brazil.

CXL involves the application of UVA light to corneas treated with riboflavin.

The resulting production of oxygen radicals induces the cross-linking of collagen tissue, which in turn stiffens the cornea, stabilising its shape, and halting keratoconus progression, he explained.

However, there remain several technical limitations to combining UVA with excimer laser therapy in eyes with keratoconus, Dr Jankov pointed out.

For example, if the laser is used first there is the danger that it will leave the cornea thinner than 400 micron, making the treatment unsafe for the endothelium.

In addition, cross-linking itself changes the shape of the cornea, which would alter the refractive outcome from that expected from the laser ablation.

On the other hand, if cross-linking is used first, an interval of at least six months between the two treatments may be necessary to allow the cornea to stabilise before applying the laser. Moreover, the ablation rate after cross-linking is not likely to be the same. Since the cornea will have a greater collagen density it will probably absorb more UVA laser energy.

The limitations of the combined treatment restrict its use to corneas that are still relatively thick. In addition, the ablations must be shallow and guided by topography, whether applied before or after the CXL. Dr Jankov suggested that the ablation should

Figure 1: Non-progressive keratoconus/pellucid marginal degeneration OS with astigmatism ATR in a 78-year-old patient with cataract

Courtesy of Rudy Nuijts MD

Cover Story

Keratoconus

Figure 2: Slit-lamp photograph of toric IOL aligned at seven degrees

have maximum ablation depth 50 microns with a small 5.5mm optical zone and a large 9.0mm transition zone.

“You need to have a laser that can deliver a predictable topography-guided treatment. A standard treatment will not do any good for these patients. The aim of this treatment is the regularisation of the cornea rather than completely correcting the spherical error and the ablation should be concentrated on the cylinder, leaving the patient using glasses or contact lenses.”

He told the Budapest meeting that in five eyes of three forme fruste keratoconus patients who underwent PRK followed

immediately with cross-linking at his centre, there were significant improvements in visual acuity and no eyes lost any lines of BCVA. All corneas were treated with T-CAT software and WaveLight Allegretto excimer laser, he noted.

At three months, all five eyes had visual acuity at least as good as their preoperative vision, and by six months mean BCVA improved from a preoperative value of 0.62 to 0.73 (range: 0.5 to 1.0 (p<0.001), he said.

In addition, the mean sphere improved from -6.35 D preoperatively to -0.41 at six months, and mean cylinder improved from -1.40 D to –0.62 D.

Rudy Nuijts

Courtesy of Massimo Busin MD

Joseph Colin

Cover Story

Keratoconus

(a) Keratoconus – preoperative appearance, (b) two months post-anterior lamellar keratoplasty with cone collapse

“The combination of surface laser ablation and cross-linking is definitely possible in eyes with keratoconus but it should only be carried out in thicker corneas in the early stages of keratoconus.

The aim is to make it more regular and not to remove the complete sphere and cylinder,” Dr Jankov added.

Ring segments perform well Another treatment for keratoconus that has gained popularity over the past decade has been the use of intracorneal ring segments.

The devices can be used with or without CXL and serve to regularise the curvature of the cornea, improve vision and make eyes more amenable to contact lens use, and possibly help patients avoid the necessity for corneal transplantation.

There are currently two main types of intracorneal ring segment available, Intacs™ (Addition Technology) and the Keraring (Mediphacos), and each have their advantages and disadvantages, said Joseph Colin MD, CHU Bordeaux, France.

Intacs are available in one arc length of 150 degrees, and their flattening effect is wholly dependent on the thickness of the rings, which ranges from 0.25mm to 0.45mm in 0.05mm increments. The newer Intacs SK, which are designed for severe keratoconus, have thicknesses ranging from 0.4mm to 0.45mm in 0.05mm increments.

Meanwhile, the Keraring, in addition to ranging in thickness from 0.15mm to 0.35mm in 0.05 increments, also has variable arc lengths ranging from 90 degrees to 210 degrees. The Keraring therefore allows surgeons a greater ability to customise the corneal remodelling and refractive correction according to each case, Dr Colin noted.

“The longer the arc, the more sphere and less cylinder is corrected. The shorter the

arc, the more cylinder and the less sphere is corrected,” Dr Colin said.

In addition, because of its smaller diameter, the Keraring also provides greater refractive correction. However another result of the Keraring’s smaller diameter is a smaller optical zone, which leads to reduction in optical quality.

Patient selection is important, Dr Colin emphasised. A review of 120 peer-reviewed studies reporting the results show that although around 70 per cent to 80 per cent of keratoconic eyes receiving the ring segments gained lines of visual acuity, there are still around five per cent who lost lines of UCVA and about 12.5 per cent who lost lines of BCVA, he noted.

The factors associated with poor visual results included a preoperative keratometry greater than 55.0 D, preoperative pachymetry less than 350 microns and the presence of paracentral opacities, he added.

Dr Colin noted that the long-term results at his centre in Bordeaux indicate that the results achieved with Intacs remain stable over the first five postoperative years. In 25 eyes implanted with Intacs in 2000, the mean MRSE improved from a preoperative value of -7.6 D to -3.86 D at one year and -3.95 D at five years, he said.

In addition, mean BSCVA improved from 0.34 to 0.49 and 0.46 at one and five years, respectively, and there was a mean decrease of the average k value 4.6 at one year and 4.0 D at five years, he said.

A role for toric IOLs In eyes with keratoconus that is no longer progressing, whether due to the patient’s age or CXL, one potential treatment is the implantation of a toric intraocular lens, said Rudy Nuijts MD, University Hospital, Maastricht, The Netherlands.

Dr Nuijts presented data on two keratoconus patients with cataracts who underwent implantation of an AcrySof toric IOL (Alcon). The AcrySof toric IOL is a single piece lens that can be implanted through a 2.2mm incision. It is available in spherical powers from +6.0 D to 30 D and toric powers from 1.5 D to 6 D in 0.75 D steps.

The first patient was a 78-year-old man with a preoperative plano sphere and -6.0 D of cylinder at 85 degrees, and a BCVA of 0.125 (Figure 1). Postoperatively, the patient had 0.5 D of sphere and -1.5 D of cylinder.

In addition his uncorrected visual acuity was 0.6 and his BCVA was 0.8 (Figure 2).

The second patient was a 64-year-old woman who underwent the procedure bilaterally. The preoperative refraction was a sphere of -12 D and a cylinder of 5.0 D at 40 degrees. Her preoperative BCVA was 0.4. Because of her high axial length preoperatively that could not be fully corrected with the lowest available spherical IOL power, her eye remained somewhat myopic postoperatively, with a sphere of -3.5 D and 1.0 D at 75 degrees. Moreover, her uncorrected visual acuity was only 0.2, although her BCVA was 0.5.

The second patient’s second eye had forme fruste keratoconus and preoperatively had a sphere of -8.0 D and 2.5 D at 17 degrees and a BCVA of 0.5. Postoperatively, the cylinder was completely eliminated and there was only -1.0 of sphere. Her postoperative UCVA and BCVA were 0.6.

“The AcrySof toric IOL was effective in reducing refractive error in eyes with keratoconus and cataracts, reducing astigmatism by 75-80 per cent with a marked improvement in vision and no complication,” Dr Nuijts added.

New lamellar approach less challenging In eyes with more advanced central opacities and higher K readings that can’t be corrected with contact lenses or other approaches, corneal grafting may become necessary.

Since the endothelium is usually healthy in eyes with keratoconus, anterior lamellar keratoplasties are a possibility and avoid endothelial rejection. Stromal and epithelial rejections are still possible with anterior lamellar grafts, but are reversible and do not usually affect final vision.

However, such procedures result in reduced visual quality when the interface is of poor optical quality. This is usually the case with manual dissection, whereas generally, excimer laser or microkeratome dissected surfaces are smooth enough to allow 20/20 vision. Other methods such as the big-bubble technique, which bare the host cornea’s Descemet’s membrane, provide visual quality equivalent to that achieved with penetrating grafts. However, baring Descemet’s can be technically challenging.

Massimo Busin MD, “Villa Serena” Hospital, Forli, Italy, said that he has adopted a technique that can be performed in a manner very similar to a penetrating procedure. The technique involves performing a microkeratome-assisted dissection of the recipient stroma 9.0mm in diameter. This is followed by a full thickness trephination of the residual stromal bed with a 6.5mm diameter trephine.

He noted that the larger graft diameter aids in reducing the post-keratoplasty astigmatism whereby the central trephination releases the tension of the collagen corneal lamellae thus collapsing the recipient bed and eliminating any keratoconus memory.

After complete suture removal, best spectacle-corrected visual acuity was 20/40 or better in 90 patients, 20/25 or better in 65 patients and 20/20 in 40/100 patients Furthermore, 76/100 had less than 4.0 D of astigmatism, and endothelial cell loss ranged from four per cent to 20 per cent with an average of 8.5 per cent. The only major complication was two cases with a double chamber one day after surgery, both of which were resolved through injection of air into the anterior chamber.

“Combined microkeratome-assisted lamellar keratoplasty and incomplete fullthickness trephination of the recipient bed to collapse the cone can effectively treat advanced keratoconus,” Dr Busin said. kymionis@med.uoc.gr mirko.jankov@laserfocus.eu joseph.colin@chu-bordeaux.fr mbusin@yahoo.com rudy.nuijts@mumc.nl

7

Newsmaker Interview

Keratoconus

New techniques and technology may bring experts closer to finding cure for keratoconus François Malecaze

Although the last decade has seen tremendous progress in the diagnosis and treatment of keratoconus, the disease remains the foremost-indicated cause of corneal transplantation among young adults. In this interview, François Malecaze MD, professor of ophthalmology at Purpan Hospital, Toulouse, France, one of the two designated national reference centres for keratoconus in France, discusses recent developments in keratoconus research with EuroTimes contributing editor Dermot McGrath.

Dr Malecaze: I don’t see any reason why keratoconus prevalence should increase. I think what we are seeing is that detection of the onset of the disease has improved, especially with the advances in topographic devices in recent years. Ophthalmologists today also have better knowledge and understanding of the disease.

ET: What do we know about the epidemiology and pathogenesis of keratoconus?

Dr Malecaze: There is no gold standard in terms of treatment for suffering patients. Several strategies are possible including spectacles, contact lenses, intraocular lenses, intracorneal rings, cross-linking or corneal grafting. The choice of the method depends on the patient’s tolerance to contact lenses, the evolution of the disease and the transparency or opacity of the cornea.

Dr Malecaze: The incidence of keratoconus is between one in 1,500 and one in 2,000 per year. To date, the disease’s physiopathology is unknown but we know that it must have a genetic component as we find at least 15 per cent of keratoconus patients have a family history of the disease. Atopy exists in approximately 25 per cent of cases associated with keratoconus but the nature of this association is uncertain, as atopy is also common in the general population. Eye rubbing has also been described as a possible risk factor inducing keratoconus. The scientific literature suggests that ethnicity could also be a risk factor.

ET: Are we seeing an increase in the incidence of keratoconus in recent years?

ET: We have seen a tremendous evolution in recent years in the treatment and management of keratoconus. Is there now a recognised gold standard in terms of treatment for these patients?

ET: Cross-linking seems to be delivering particularly encouraging results. Do you think these benefits will be sustained over the longer-term for keratoconus patients?

Dr Malecaze: Since Theo Seiler’s seminal publication, more and more corneal collagen cross-linking (CXL) studies have been published. A review of the literature shows that few patients need to be retreated. Moreover, given the fact that cross-linking treatment is effective for several years, and that the risk of progression of keratoconus decreases in

the third and fourth decades of life, we can speculate that only a few retreatments will ultimately be necessary.

ET: Do you think that the future lies in stand-alone CXL treatments or combination treatments with other approaches such as intracorneal rings, rigid contact lenses, etc?

Dr Malecaze: Cross-linking only succeeds in slowing down the evolution of keratoconus, but does nothing to address the underlying pathology of the actual corneal deformation. It is therefore necessary to associate CXL with other treatments in order to improve patients’ visual acuity using methods such as contact lenses (whose tolerance is not worsened after the cross-linking has been performed), intraocular corneal rings or intraocular implants.

ET: What imaging/diagnostic tools should clinicians be systematically using in their practices to identify corneas at risk of developing keratoconus?

Dr Malecaze: Topography remains the most vital diagnostic tool for keratoconus.

Ideally it would be best to also have a method to evaluate the biomechanics of the cornea, as this has shown to be altered in patients with keratoconus.

Different methods have been proposed such as ocular response analyser or elasticity imaging based on high-speed OCT or ultrasound. However, none of these methods have been perfectly validated yet for clinical use.

ET: Can you give us an update on your own research into genetic and environmental factors in keratoconus?

:LOOV (\H Knowledge Portal

8

Dr Malecaze: As for many other diseases, genetic and environmental factors are implicated in keratoconus, although we still do not fully understand the role of each factor and their additional effects together in the evolution of the disease. The future is that a better understanding of these genetic and environmental effects will enable better targeting of treatment.

The best treatment for keratoconus would be physiopathology based. Identifying a pharmaceutical target for the treatment of keratoconus would represent a significant step forward in management of the disease.

We are currently working together with Moorfields Eye Hospital in London to analyse the genetic data from a joint keratoconus database, which includes over 300 family members with a known history of keratoconus. We hope to have the results of this analysis in a couple of months and we will then have a clearer idea of how to proceed. While we had initially suspected that the gene responsible for keratoconus might be located in chromosome two, we were ultimately disappointed because there was no mutation that we could identify in any of the genes that we mapped on this chromosome. So we may have to alter our strategy somewhat in the future.

ET: What are the implications of identifying the gene responsible in terms of clinical diagnosis?

Dr Malecaze: It would represent a major breakthrough, because at the moment one of the main problems for clinicians, even using the most sophisticated topographers, is trying to establish if a patient has forme fruste keratoconus or pseudokeratoconus.

If we can identify the gene responsible, then a simple blood sample should be sufficient to tell us whether or not we are dealing with a genuine case of keratoconus. This would be very useful, for instance, in screening borderline patients for refractive surgery.

ET: Is it conceivable that one day we may find a ‘cure’ for this disease or is it more likely to be a case of controlling or managing its progression over the course of a patient’s lifetime?

Dr Malecaze: The problem is that keratoconus is perhaps more a symptom than an actual disease. In other words, the deformation we see may be secondary to different causes. If in the future we find one or several major genes responsible for keratoconus then we could think about developing a physiopathology-based treatment (such as genetic therapy) to cure the disease. I think we have good reasons to be cautiously optimistic. While keratoconus remains a mysterious disease, there is a huge amount of effort being made to help us understand it and new techniques and technology are bringing us closer to this goal.

1st EuCornea Congress Venice

2010 June 17-19

In conjunction with Società Italiana Cellulle Staminali e Superficie Oculare (S.I.C.S.S.O.), Refr@ctive.on-line and Societa’ Oftalmologica Universitaria (S.O.U.) Local Organiser: Giancarlo Caprioglio ITALY Scientific Co-ordinator: Paolo Vinciguerra ITALY

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Special Focus

Keratoconus

Femto-assisted penetrating keratoplasty provides better fitting grafts Georges Baikoff

Roibeard O’hEineachain in Budapest

Conventional penetrating surgery using a guided trephine system has an excellent prognosis among keratoconus patients, with FEMTOSECOND laser-assisted penetrating clear grafts in more than 95 per cent at five keratoplasty can enable earlier suture years. Visual acuity is generally around 0.7 removal compared to procedures to 0.8, and nearly all keratoconus patients performed with guided trephine systems, who have undergone the procedure say they according to the results of two studies would again if they had it to do over again, presented at the 14th ESCRS Winter said Thomas Reinhard MD, University Eye Meeting.

Hospital Freiburg, Germany.

However, there are some problems with the procedure with regard to suture complications, which occur in seven per cent to nine per cent of cases, and they are more common among keratoconus patients. The complications include loosening of the sutures, infection of the suture site, and triggering of immune reactions.

Furthermore, the procedures leave patients with an average of four to six dioptres of astigmatism, he said.

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cornea. The profiles include the zigzag, the mushroom, and the top hat, he said.

Dr Reinhard noted that since acquiring an IntraLase™ (AMO) femtosecond laser, he and his associates have performed 109 femtosecond laser-assisted penetrating keratoplasties out of a total of 552 corneal transplants. The femtosecond-assisted procedures included eight eyes with bullous keratopathy, 36 with Fuchs’ endothelial dystrophy, and 65 with keratoconus.

“We tried to perform femtosecond laserassisted keratoplasties whenever possible, but it was not possible in about 80 per cent of eyes overall and in about 60 per cent of eyes with keratoconus,” he said.

Earlier suture removal Dr Reinhard and his associates carried out a study comparing 18 keratoconus eyes that had undergone femtosecond-assisted grafts, with mushroom or top hat profiles, to 63 eyes that had undergone conventional penetrating keratoplasty. They found that there was no significant difference between the groups regarding visual outcome, keratometry or astigmatism. However, those in the femtosecond groups had their sutures out earlier, he noted.

The time to suture removal was 19.3 months in the guided trephine group, compared to 9.8 months in the top hat group and 13.1 months in the mushroom group. The median postoperative visual acuity was 0.7 in the guided trephine group, 0.8 in the top hat profile group and 0.6 in the mushroom group. The keratometric cylinder was -4.5 D in the guided trephine group, -5.5 D in the top hat group and -6.3 D in the mushroom group.

“BCVA and astigmatism were no better than that achieved with the guided trephination system. That is probably because of artefacts arising from the applanation that occurs when suction is applied,” Dr Reinhard said.

Dr Reinhard noted that, when using the femtosecond-assisted technique, there were steps at the graft-host junction if he used eight single stitch sutures or if he used one running suture with eight bites. However, he was able to reduce the steps to minimum by using a double-running suture with 16 bites, he said.

He reported that he and his team no longer use the mushroom profile. Intraoperative wound closure was better with the top hat, he noted. Furthermore, in the mushroom group bacterial infiltrates and ointment deposits in the suture arcades and interface. “If you have the IntraLase I would recommend that you use it with the top hat profile for the penetrating keratoplasties in keratoconus eyes. If you don’t have the laser you must remember the high costs for the laser and remember it is only possible in relatively clear corneas which is only one fifth

of keratoplasties and three fifths of the eyes with keratoconus,” he added.

Oblique side cuts may provide optimum results In another study, keratoplasties performed with the Visumax (Zeiss) femtosecond laser resulted in less astigmatism than generally occurs with lamellar keratoplasty or conventional penetrating keratoplasty, said Georges Baikoff MD, Marseille, France.

The study involved 15 eyes with stage III and IV keratoconus. Dr Baikoff used the femtosecond laser to perform the creation of the donor button and the dissection of the recipient’s cornea. He made oblique side-cuts at an angle of 110° with a reduced endothelial disk and a larger epithelial surface. He used eight interrupted cardinal sutures and one deep running suture to hold the graft in place.

“Oblique side cuts at 110 degrees reduces the endothelial surface transplanted, avoiding rejection and increases the area of Bowman’sto-Bowman’s contact to reducing the amount of astigmatism at the surface,” he noted.

In nine keratoconus eyes with at least eight months of follow-up after undergoing femtosecond-assisted penetrating keratoplasty, UCVA improved from 0.06 preoperatively to 0.3 while BCVA improved from 0.28 to 0.7 and mean topographic astigmatism improved from 6.3 D to 3.3 D, Dr Baikoff noted.

“The level of astigmatism is much less than that achieved with lamellar keratoplasty previously and there is no problem with the endothelium because the mean central density after eight months is over 2000 cells/ mm2 ,” he noted.

Dr Baikoff said that the Visumax may have some advantages over other femtosecond lasers. For example, it cuts at a speed of 500 kHz but uses 10 times less energy than the IntraLase. Furthermore, it has 1.5mm spots spaced just 1.6 microns apart. It also uses concave applanation and therefore distorts the cornea less when the suction is applied.

In addition, because it comes equipped with a high quality surgical microscope, the Visumax also allows surgeons to perform both donor eye surgery and recipient surgery in the same room with the same laser. That means there is no need to move the patient after making the cut in the recipient’s eye, he pointed out.

“The quality and rapidity of the optical results obtained and the low risk of tissue rejection due to a reduced endothelial surface show this technique to be safe and reproducible for the treatment of keratoconus and can be considered as a safe and simple alternative to deep lamellar anterior keratoplasty,” Dr Baikoff concluded.

Monika.Arva@uniklinik-freiburg.de g.baik.opht@wanadoo.fr

Keratoconus

Sean Henahan

WHEN Steve Holcombâ&#x20AC;&#x2122;s four-man bobsleigh team finished their gold medal-winning run at the Vancouver Olympics, his eye surgeon was waiting to congratulate him. Without the help of Los Angeles-based refractive surgeon Brian Boxer Wachler MD, there is little chance that Steve Holcomb would have been able to compete at world-class level.

Indeed, the athlete was ready to retire three years ago because of problems with keratoconus and high myopia. â&#x20AC;&#x153;I was so nearsighted, I was ready to quit.

I had to get right up to the eye chart just to make out the big E at the top,â&#x20AC;? said Holcomb at a press conference.

However, members of the US Olympic team did some research and put him in touch with Dr Boxer Wachler. That meeting set the stage for what would ultimately be the first Olympic medal in a bobsleigh event for an American team in 50 years. â&#x20AC;&#x153;Steveâ&#x20AC;&#x2122;s passion for the sport was apparent from the moment I met him. His vision was rapidly deteriorating, but we quickly deemed him as a potential candidate for C3-R to stabilise the keratoconus and Visian ICL (Staar) to correct his vision. I am honoured to have been able to help Steve finally achieve his dream of competing in the 2010 Olympics,â&#x20AC;? said Dr Brian Boxer Wachler.

After the combination of C3-R (corneal collagen cross-linking riboflavin) procedure and the Visian ICL implantation, Holcombâ&#x20AC;&#x2122;s vision improved from 20/500 to 20/20, and his keratoconus stabilised.

Dr Boxer Wachler performed the C3-R procedure in March of 2008. C3-R is a variation on corneal collagen cross-linking (CXL) used in the treatment of progressive keratoconus. The approach, pioneered by

Special Focus

Keratoconus patient wins bobsleigh gold medal at Winter Olympics

Dr Boxer Wachler, is done on an intact he had trouble being able to see well again by seeing so well. The happy compromise epithelium (â&#x20AC;&#x153;epi-onâ&#x20AC;?). He has been using this following the procedure. He had developed was to wear a helmet that was scratched and approach for some five years and reports a method for driving the sleigh based more dirty, allowing him to both feel and see where good results with less trauma to the patients. on â&#x20AC;&#x2DC;feelâ&#x20AC;&#x2122; than sight, and was at first distracted he was going.

CXL is another approach, advocated by Theo Seiler MD, PhD, and others. The main us at difference is that with CXL the See S '10 R cornea undergoes abrasion to ASCth #2114 remove the epithelium (epi-off) Boo prior to instilling the riboflavin and irradiating with UV light.

Proponents believe this facilitates the cross-linking process.

Dr Boxer Wachler maintains that the Dextran solution used by Â&#x2022;Â&#x2019;Â?Čą Â&#x160;Â&#x2013;Â&#x2122;Čą ČąĹ&#x;Ĺ&#x2013;Ĺ&#x2013;Č&#x203A;Čą ČąÂ&#x2122;Â&#x2DC; Â&#x17D;Â&#x203A;Â&#x17D;Â?

CXL proponents to deliver the riboflavin is too heavy to permit the riboflavin to penetrate the cornea with an intact epithelium.

He believes the correct solution should be carboxymethylcellulose along with the preservative BAK, which he asserts does allow the riboflavin to penetrate the intact epithelium. â&#x20AC;&#x153;With the media surrounding Steveâ&#x20AC;&#x2122;s success with the C3-R procedure transforming his 20/500 vision to 20/20, hundreds of people suffering from similar ailments are contacting us in 6KDUSHU WKDQ D UD]RU EODGH hope of restoring their lost sight,â&#x20AC;?

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11

Cataract Update

No evidence for increased risk of AMD progression after cataract surgery Susan B Bressler

Dermot McGrath in Paris

“Eyes with varying levels of AMD can have vision and quality of life improvements with cataract surgery and I think we would be THERE is no clear evidence that cataract remiss if we withheld cataract surgery from surgery accelerates vision loss in patients with individuals who could benefit from it. All age-related macular degeneration (AMD) individuals with AMD should be counselled and therefore no reason to deny the visual as to the natural course of their disease and and quality of life improvements that cataract given reassurance that no great risk of disease removal could potentially bring to these acceleration as a result of cataract surgery has patients, according to Susan B Bressler MD. been identified,” she told delegates attending the Macular 2010 meeting in Paris.

Dr Bressler, the Julia G Levy, PhD professor of ophthalmology at the Johns Hopkins University School of Medicine, Baltimore, US, said for there are several compelling reasons to consider K20-2135 Vidaurri Fluid Retention cataract removal Ring, 8.7mm diameter in addition to the potential improvements to patients’ visual acuity and quality of life.

“Removing the lens opacity may also improve our ability clinically to differentiate the level of macular degeneration that • Retain solution on is present and cornea alone properly classify the disease. By so Minimize leakage • doing, we would with double walled simultaneously suction ring improve the quality of images • Reduce the amount that we receive cross-hairs for centration of solution used in from fluorescein every case angiography and OCT scans, which would also • Eliminate cross linking effects on limbal and help to improve conjuntival cells confidence in the appropriateness of treatment • Designed with and retreatment cross-hairs for recommeneasy centration dations,” she said. solution retained on cornea Dr Bressler • Supplied sterile and noted that the disposable visual acuity benefits to be Developed with Jesus Vidaurri, MD of Monterrey, Mexico gained from cataract removal in AMD patients has been amply 4 Stewart Court, Denville, NJ 07834 • USA ☎ 973-989-1600 • 800-225-1195 • www.katena.com underscored by the Age-Related Eye Disease Study

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12

(AREDS), the only large prospective study in which the severity of AMD was documented before and after cataract surgery and which included more than five years of in-depth participant follow-up.

Within AREDS, following enrollment 1,939 eyes underwent cataract surgery, with a mean time from cataract surgery to measurement of postoperative best-corrected visual acuity of 6.9 months. After adjustment for age at surgery, gender, type and severity of cataract, the mean change in visual acuity at the next follow-up visit after cataract surgery showed an average gain of 8.4 letters of acuity for eyes without AMD. Eyes with early AMD gained 6.1 letters of visual acuity, eyes with intermediate AMD gained 3.9 letters, and eyes with advanced AMD gained 1.9 letters.

Furthermore, the statistically significant gain in visual acuity after cataract surgery was maintained for at least 18 months after cataract surgery.

“This clearly shows the dubious nature of the claim that cataract surgery somehow leads to progression of AMD,” she said.

Given such strong evidence concerning the visual acuity benefits of cataract surgery in AMD patients, Dr Bressler posed the question as to why clinicians worry so much about the potential risk of cataract surgery accelerating AMD development or progression.

She cited two main reasons for this.

First, the theories associating light toxicity and retinal damage, particularly from low wavelength blue light. Proponents of blue-light blocking IOLs believe that removal of the crystalline lens permits toxic light to reach the macula, accelerating maculopathies and other diseases. Second, she said that the role of inflammation in the development or progression of AMD had also given clinicians pause for thought.

“There is concern that a surgical insult such as cataract surgery might incite inflammation, either acutely or chronically, that may lead to progression of both non-neovascular and neovascular AMD,” she said.

Added to these theories, the observational data from several population-based AMD studies (Beaver Dam, Blue Mountain, Salisbury Eye Evaluation, Baltimore Eye Survey and Proyecto VER) also continue to fuel the controversy as to whether or not cataract surgery has a role to play in AMD progression. The key advantages of these studies include the fact that they are population based and provide a standardised measure across the board to grade the level of macular degeneration and assess lens status, said Dr Bressler.

Nevertheless, the population-based studies also have some important weaknesses that should not be overlooked, she said.

“The findings have been inconsistent within individual studies and between studies. These inconsistencies may stem in part from the

other criticisms that can also be levelled at these studies. For example, none of them has used angiography as an endpoint to define late AMD. Furthermore, there are relatively small numbers of late AMD cases in all of these large populations, which leads to an unstable measure of disease association,” she said.

Most crucially, it was vital to remember that the findings of these studies show associations but do not necessarily imply causation, said Dr Bressler.

Dr Bressler said that a survey of clinical studies in the scientific literature exploring a possible link between cataract surgery and AMD also showed conflicting evidence and was usually based on small case series.

While most retinal physicians have, at one time or another, made a diagnosis of advanced AMD for the first time directly after a patient had undergone cataract surgery, the temptation to automatically blame the surgery for the progression of the AMD should be resisted.

“Explanations could include the fact that cataract surgery really does increase the risk of AMD progression. However, another alternate, equally plausible answer could be that advanced AMD or moderate non-neovascular AMD may be present preoperatively but the clinician failed to detect its presence through the lenticular opacity. The vision change that contributed to the recommendation for cataract surgery may have been due to the progression of AMD rather than cataract,” she said.

To explore this further, Dr Bressler and co-workers carried out a prospective study of 71 patients who underwent cataract surgery at the Wilmer Eye Institute. All patients had fluorescein angiography and fundus colour photographs a week before surgery, and one week, three months and one year postoperatively.

At the one-year postoperative time-point, nine of the 71 non-neovascular AMD eyes developed CNV, an incidence of 12.7 per cent. However, when the patients were isolated only to those who manifested the AMD after the one-week examination, the incidence was just three cases (4.6 per cent).

Furthermore, two of 61 eyes developed geographic atrophy by the time of the one year exam but these were also seen at the one-week stage, said Dr Bressler.

“So we had several cases of presumed progression that may have been present prior to the cataract surgery. Our study showed that the low incidence rate of CNV or geographic atrophy developing between one week and one year after surgery does not support the theory that surgery accelerates AMD development or progression,” she said. sbressler@jhmi.edu

Scientific program

World Ophthalmology Congress® 2010 Berlin, Germany XXXII International Congress of Ophthalmology 108th DOG Congress 5 - 9 June 2010

More than – 650 sessions and courses – 1,100 speakers – 1,800 abstracts – 1,100 posters – 600 free papers.

Commercial Exhibition

AAD Congress 2010 3 - 6 June 2010

More than – 160 international exhibitors from more than 25 countries – 30 Non Profit Organizations – 4.300 sqm Venue

WOC 2010

See you

®

ICC Berlin www.woc2010.org We are looking forward to welcoming you to Berlin in June 2010!

Sponsor International Council of Ophthalmology (ICO) www.icoph.org Host Deutsche Ophthalmologische Gesellschaft e. V. (DOG, German Society of Ophthalmology) www.dog.org Co-Host Augenärztliche Akademie Deutschland (AAD, German Academy of Ophthalmology) www.augeninfo.de

We are happy to announce the following sponsors of the WOC® 2010: Diamond Sponsor Carl Zeiss Meditec AG, Jena, D Gold Sponsors Alcon Laboratories, Inc., Fort Worth, TX, USA Bausch & Lomb Pharmaceuticals, Zug, CH Chibret Pharmazeutische GmbH, Haar, D

WOC® 2010 Congress President: Professor Gerhard K. Lang DOG President

WOC® 2010 Honorary President Professor Dr. Bruce E. Spivey, ICO President

Merck, Sharp & Dohme, White House Station, NJ , USA

WOC® 2010 Executive Committee: President Professor Gerhard K. Lang

WOC® 2010 Scientific Program Committee Chair: Professor Stephen J. Ryan Co-Chairs: Professor Bernd Bertram Professor Gabriele E. Lang

Pfizer Ophthalmics, New York, NY, USA

Secretary General Professor Anselm Kampik Treasurer Professor Jochen Kammann Program Director Professor Gabriele E. Lang Executive Director of the DOG Dr. Philip Gass

design alliance Büro Roman Lorenz München March 2010

Professional Congress Organizer Monika Porstmann Porstmann Kongresse GmbH pco@woc2010.de

Santen Pharmaceutical Co, Ltd, Osaka, J Silver Sponsors ALLERGAN AG, Nordics, GB Novartis Pharma GmbH, Basel, CH

Jorge Alió

Sean Henahan in San Francisco

EARLY clinical results with the NuLens IOL (NuLens Ltd.) suggest it may be an important step towards the long sought goal of restoring true accommodative vision.

Jorge Alió MD and colleagues at the VISSUM Institute of Ophthalmology in Alicante, Spain recently reported the one-year results from an initial series of 10 patients who received the NuLens accommodative IOL. The study included 10 patients with cataract and atrophic macular degeneration, each of whom received the accommodating IOL in the eye with the worst visual acuity.

Patients gained a mean of 3.8 lines, with ultrasound biomicroscopy indicating up to 10.0 dioptres of accommodative amplitude. Patients’ near visual acuity improved without compromising distance visual acuity. Low-vision patients gained angular magnification and could read at a distance of 10cm.

“The principle mode of accommodation seems to be functional and provides accommodation up to 10.00 D. In my opinion this is going to be one of the products we have been waiting for.

This lens has the capability to function accommodatingly, independent of many variables in the capsular bag. Our experience with the lens is extremely promising,” Dr Alio told EuroTimes in an interview conducted at the annual meeting of the American Academy of Ophthalmology.

The NuLens is a soft gel IOL that uses a piston and aperture device to achieve its effects.

It consists of a flexible gel contained in a small chamber attached to the eye wall in a fixed position. A piston operated by the empty and collapsed capsular bag pushes the contained flexible gel through a round hole to form a bulge that functions as a lens. The steeper the bulge, the stronger the lens. As the ciliary muscles respond to the naturally occurring retinal–brain blur stimulus, they apply force to the piston via the capsular diaphragm. This force deforms the silicone gel curvature until the best image is achieved on the retina at any given distance, creating a dynamic highpower lens.

The NuLens has PMMA haptics that are secured by internal scleral fixation to the sulcus without sutures. A PMMA anterior reference plane also provides basic vision correction for distance. This design requires a large incision. In the reported series, the surgeons enlarged an initial 3.2mm limbal incision to 9.0mm to allow implantation of the lens.

14

In order to implant the lens the surgeon uses a specially designed forceps to hold the accommodating IOL by its body with the distal haptic in the leading end. As that side enters the anterior chamber, it slides along the anterior capsule into the ciliary sulcus 180 degrees to the entry site. The surgeon then inserts a hook in a hole at the proximal haptic endplate to push it into the anterior chamber just behind the pupil edge. He then pulls the hook backward toward the ciliary sulcus at the proximal site. After anchoring the end plate in the proximal ciliary sulcus, the surgeon pulls the hook out in a direction opposite to the insertion path and sutures the incision with 10-0 nylon.

“Considering the large incision size, we were not surprised to see postoperative astigmatism, averaging less than two dioptres. However, the patients in this study all had severe AMD, so astigmatism was the least of their problems. It was really a secondary issue for these patients. Moreover, most patients ended up with good far vision without glasses, and good near vision with magnification,” Dr Alio commented.

Endothelial cell loss, PCO Mean endothelial cell counts decreased 27 per cent from the time of surgery to the three-month follow-up visit, a statistically significant change. However, changes seen between three and 12 months were not statistically significant, suggesting that the experimental lens does not have a chronic effect on the cornea, he said.

Six of the 10 patients developed posterior capsule opacification within one year of IOL implantation. Nd:YAG laser capsulotomy was performed successfully in all cases. This intervention did not change the mechanism of functioning of the IOL. “This was an important problem.

We have to remember that this was a pioneering study with a prototype lens design. The IOL is being improved so that future models will have a posterior square edge and an acrylic base lens that will press against the collapsed lens capsule to prevent PCO formation,” he emphasised.

Two serious adverse events occurred during the study. One was a posterior synechia between the back of the iris and the anterior capsule that induced IOL tilt. The other was capsulorhexis edge capture by the haptic endplate, which stretched the anterior capsule and placed pressure on the IOL, inducing high myopia. The first problem resolved by itself and the second was treated successfully.

Implanting the NuLens IOL

Courtesy of Jorge Alió MD

Refractive Lens

Clinical results suggest NuLens may be step towards accommodative vision

NuLens IOL in the human eye, pupil dilation 8mm

Improved IOL design now in clinical studies “Important work has to be done to reduce the incision size, and to make the surgery more similar to standard cataract surgery, but with those improvements we will have a terrific lens available in the near future for our cataract patients,” Dr Alio told EuroTimes.

Researchers have begun to address some of the concerns raised in this study.

For example, a new version of the IOL is available that can be implanted through a 4.0mm incision, and a new injector has

been designed to simplify the placement of the lens. Clinical studies with the new lens design are now under way.

“This is not the 2.0mm incision that we use for standard MICS, but I think it is a very acceptable incision size for a lens that restores 8.0 dioptres of accommodation,” he commented.

Dr Alio and colleagues published their study in the Journal of Cataract & Refractive Surgery, Vol. 35, Issue 10, pp.1671-1678. jlalio@vissum.com

Refractive Laser

Sheraz Daya

Health workers should be screened before refractive laser surgery because of risk of MRSA infection

Sanjay Mantry

Gary Finnegan in Leeds

PATIENTSHIGHRES_LDV_Venus_ET_A07L04_5.51x9.06in.pdf working in frontline health services should be screened prior to refractive laser

1

surgery given their increased risk of Methicillin Staphylococcus Aureus (MRSA) infection, according to experts speaking at 01.03.10 15:36 the United Kingdom and Ireland Society of

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16

Cataract and Refractive Surgeons (UKISCRS) Annual Meeting.

Studies suggest the overall rate of recorded infections after laser eye surgery has been on the wane, but the proportion of cases caused by MRSA is rising. Healthcare professionals have a markedly higher chance of carrying the bug, which can cause serious complications after ophthalmic procedures.

The Femtolaser for Z-LASIK Sheraz Daya MD, East and Lamellar Corneal Surgery Grinstead, UK, said infection rates had changed over time, but so too has the proportion of cases caused by the three main sources of infection: mycobacterium, Staphylococcus aureus and MRSA. Delivering a keynote lecture on complications in laser surgery, he said that ASCRS had shown that health workers are particularly vulnerable to MRSA infection and this should be considered when such patients present for surgery. â&#x20AC;&#x153;In 2001, 48 per cent of infections were caused by mycobacterium. By 2004, mycobacterium was almost wiped out but, instead, what we saw was Staphylococcus accounting for 62 per cent of cases. And in the most recent survey we got MRSA â&#x20AC;&#x201C; and many of these were healthcare workers,â&#x20AC;? Dr Daya said. â&#x20AC;&#x153;The bottom line when dealing with health workers is to put them on some anti-MRSA prophylactic. Thatâ&#x20AC;&#x2122;s what we do for these patients before surgery,â&#x20AC;? he added.

Sanjay Mantry MD, Glasgow, UK, echoed this concern and said there is a growing trend towards screening health professionals due to the heightened risk of MRSA. â&#x20AC;&#x153;If somebody is working on the wards and they come to get ;JFNFS s '&.50 -%Vâ&#x201E;˘ refractive surgery, I tend to ask 'FNUPTFDPOE 4VSHJDBM -BTFS them to get a nasal swab from &OHJOFFSFE JO 4XJU[FSMBOE their GP to make sure they are not carrying any infections,â&#x20AC;? he said.

The increased volume of laser vision correction procedures saw an associated rise in infections a decade ago. However, evidence from a series of ASCRS studies International: Ziemer Ophthalmic Systems AG indicates significant improvement.

Allmendstrasse 11, 2562 Port, Switzerland Phone +41 32 332 70 50 Fax +41 32 332 70 70 Tracking the number of e-mail innovation@ziemergroup.com infections reported by ophthalmic United States: Ziemer USA, Inc. surgeons, the research found 116 321 Ridge Street, Alton, IL 62002, USA Phone +1 618-462-9301 toll-free 866-708-4490 cases in 2001. In his presentation, e-mail usa@ziemergroup.com Dr Daya said surgeons appear www.ziemergroup.com to have changed their practice following the publication of those figures, and the number of

infections had fallen to 48 by 2004. In 2008, the figure had been reduced to just 19 cases.

He said some of the decreases may also be attributable to the availability in the US of 4th generation antibiotics.

Dr Daya said that when infections occur, the response depends on severity. Discussing sterilie inflammation which can be confused with infection, he discussed the Linebarger/ Lindstrom classification dividing this into four grades. Grade I inflammation is evidenced by isolated cells in one section while Grade II is characterised by the presence of cells throughout the flap. â&#x20AC;&#x153;When they start to cluster, youâ&#x20AC;&#x2122;ve got Grade III and then Grade IV. In these cases you need to intervene quite aggressively.

Certainly at Grade IV you need to lift the flap and irrigate,â&#x20AC;? he said.

Itâ&#x20AC;&#x2122;s important to identify infections quickly, according to Dr Daya. Reviewing the development of infections in refractive surgery, he said femtosecond lasers can help reduce risk and he stressed the need for vigilance in sterilising the equipment. â&#x20AC;&#x153;I do believe we should be going down the route of using femtosecond LASIK as opposed to surface ablations. Infections are six times more likely with PRK than with femtosecond lasers,â&#x20AC;? Dr Daya said.

A risk with femotsecond surgery is the development of transient light sensitivity (TLS), which can occur up to five months after treatment.

Picking up many of the same themes, Dr Mantry advised colleagues to postpone surgery any time they identify an infection and to treat it aggressively. â&#x20AC;&#x153;Itâ&#x20AC;&#x2122;s important to lift the flap at the first opportunity. If you have what you presume to be DLK after 10 days of surgery, I think you should lift and scrape â&#x20AC;&#x201C; this is your best chance of a good result,â&#x20AC;? he said.

He agreed that early identification is the key to rehabilitating patient vision and highlighted the differences in cases caused Gram negative and Gram positive bacteria. Focal infections presenting early are likely to be the result of Gram positive bacteria, while diffuse infections are caused by Gram negative bacteria. Latepresenting cases are more frequently due to mycobacterium and opportunistic infections, according to Dr Mantry.

Prompt intervention with antimicrobial treatments can help curtail the duration of infection, he said, even if it takes time to confirm the precise nature of the infection. â&#x20AC;&#x153;After you scrape, donâ&#x20AC;&#x2122;t wait for the results to come back before you treat with antibiotics,â&#x20AC;? Dr Mantry said.

Most infections begin to clear up after five days, but if they do not, it is advisable to question whether compliance with medication is a problem. sdaya@centreforsight.com sanjay.mantry@ggc.scot.nhs.uk

Steve Schallhorn

Dermot McGrath in Barcelona

CREATING LASIK flaps with the femtosecond laser resulted in faster visual recovery and better uncorrected visual acuity in a retrospective study of over 65,000 eyes, according to Steve Schallhorn MD. “The patients whose flaps had been created by femtosecond laser had faster visual recovery, less chance of a loss of best-spectacle corrected vision and lower intraoperative and postoperative complications,” he told delegates attending the XXVII Congress of the ESCRS. Dr Schallhorn’s multicentre study retrospectively analysed 65,759 eyes consecutively treated for low to moderate myopia and astigmatism by 24 different surgeons at Optical Express. 41,762 eyes of 22,165 patients had their LASIK flaps created with the IntraLase FS60 femtosecond laser (AMO Inc.) and 23,997 eyes of 12,312 patients had flaps created with a Moria One Use-Plus mechanical microkeratome, with all eyes receiving wavefront-guided LASIK treatments performed with a Visx Star S-4 excimer laser (AMO).

The patients were differentiated according to which procedure they had requested and both groups were closely matched for age, gender, refraction and spherical equivalent.

The refractive accuracy was very similar for both groups, said Dr Schallhorn. At all time points measured – one day, one week, one month and three months – the percentage of eyes that achieved a postoperative uncorrected visual acuity (UCVA) of 20/20 or better was significantly higher in the femtosecond laser group than in the mechanical keratome group.

A higher percentage of eyes in the femtosecond laser group also achieved a postoperative UCVA of 20/16. A lower percentage of eyes in the femtosecond laser group also lost two or more lines of best-corrected visual acuity (BCVA) at the one week and one month postoperative time point.

In terms of refractive predictability, the results for both patient groups were very similar, said Dr Schallhorn. After one week, 94 per cent of femtosecond patients and 93 per cent of mechanical keratome patients were within 0.5 D of target refraction. At one month and three months postoperatively, the figure was 92 per cent and 91 per cent respectively for both groups.

Looking at the data in more detail, Dr Schallhorn noted that at one week, the patients with femtosecond-generated flaps had better uncorrected visual acuity compared to the mechanical keratome group.

He said that this was particularly evident at the 20/20 threshold of vision or better, with 59 per cent of patients achieving 20/16 in the mechanical keratome group compared to 65 per cent for the femtosecond group, and 84

per cent attaining 20/20 for the mechanical keratome compared to 88 per cent for the femtosecond laser. The mean spherical equivalent was 0.06 for the mechanical group and 0.04 for the laser group.

This trend for better UCVA outcomes for the femtosecond laser group was sustained to the one month mark, but at three months the only statistically significant difference was at the 20/16 vision level, said Dr Schallhorn.

Surmising as to why the patients with the femtosecond-generated flap might have better postoperative vision than those treated with the traditional microkeratome, Dr Schallhorn said there might be a number of factors responsible.

“In the early postoperative time period, the flap created by femtosecond laser is very uniform and smooth. So when this flap is laid down, there is less chance of developing microstraie because the femtosecond flap is planar and beds down very precisely.

That difference is visible to the surgeon if it becomes necessary to perform an enhancement at a later stage, because we are used to seeing microstraie with the keratome flaps and underneath the epithelium.

I think that is part of the healing process that makes a difference in terms of postoperative quality of vision and that is why you see a slower visual recovery, in general, with the mechanical keratome,” he said.

The slight downside of the smooth flap adhesion, however, is the difficulty of re-lifting such flaps for enhancement procedures one or two years after the initial treatment, said Dr Schallhorn.

“It is difficult to lift a femtosecond-created flap two years out. That is why if the flap has been there for more than a year, I tend to do a PRK enhancement procedure on top of the flap,” he said He noted that in terms of safety 1.0 per cent of eyes lost more than two lines of best-corrected vision in the femtosecond laser group compared to 1.5 per cent with the mechanical blade after one week. The statistical difference was maintained at all time-points said Dr Schallhorn (0.2 per cent for the laser group and 0.3 per cent for mechanical at one month, and 0.1 per cent for femtosecond and 0.2 per cent for mechanical keratome after three months).

The femtosecond laser group also scored better than the mechanical keratome group in terms of intraoperative complications relating to flap creation, said Dr Schallhorn.

“The data favoured the femtosecond group by a factor of three to one. There were eight flap creation complications with the microkeratome group for an incidence of 0.03 per cent and represents one in every 3,001 cases (1:3,001). For the femtosecond laser there were seven intraoperative issues for an incidence of 0.01 per cent or 1:8,184. For all but one of the femtosecond procedures the surgeon was able to complete the

procedure on the same day, whereas all the microkeratome complications meant that the patients had to delay their surgery because of issues such as buttonhole, incomplete flap and loss of suction during the microkeratome pass,” he said.

In terms of postoperative complications, eight eyes in the mechanical for safety. However, the safest procedure keratome group had a flap displacement for for creating LASIK flaps is the femtosecond an incidence of 0.05 per cent or 1:2,205, laser and because of the better UCVA, we all of which occurred within the first two would expect a lower enhancement rate and weeks postoperatively. There were two flap ultimately happier patients,” he said. displacements with the femtosecond laser steveschallhorn@opticalexpress.com group for an incidence of 0.004 per cent or 1:22,267.

There were four incidences of epithelial NOW ingrowth, FDA Approved 1:4,410, in the mechanical keratome group and five in the femtosecond laser group, 0.01 per cent or 1:8,907.

Summing up, Dr Schallhorn said that both the femtosecond laser and the mechanical microkeratome were safe and efficient for flap creation in LASIK procedures, but that the laser provided an edge Accommodating. Aberration Free. Aspheric. in performance.

“I think the take home message is that both procedures are safe, as the complication rate and loss of lines of BCVA for both groups of patients exceeds all the regulatory requirements Crystalens® Accommodating Posterior Chamber Intraocular Lens BRIEF STATEMENT Rx only.

Indications for Use: The Crystalens® is intended for primary implantation in the capsular bag of the eye for the visual correction of aphakia secondary to the removal of a cataractous lens in adult patients with and without presbyopia. The Crystalens® provides approximately one diopter of monocular accommodation which allows for near, intermediate, and distance vision without spectacles

Warnings: Careful preoperative evaluation and sound clinical judgment should be used by the surgeon to decide the risk/benefit ratio before implanting a lens in a patient. Some adverse events which have been associated with the implantation of intraocular lenses are: hypopyon, intraocular infection, acute corneal decompensation, and secondary surgical intervention.

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SU5786 12/09

17

Courtesy of Steve Schallhorn MD

Refractive Laser

Faster visual recovery and better visual outcomes with femtosecond laser technique

Refractive Laser

All-laser treatment offers new treatment options for patients with high irregular astigmatism Isaak Schipper

Dermot McGrath in Barcelona

The combination of precise preoperative topographic, sophisticated ablation software

18

and an excimer laser capable of delivering a transepithelial ablation is giving ophthalmic surgeons a viable new treatment option for irregular astigmatism, according to Isaak

Schipper MD. “It is still early days but we have achieved very promising results for these patients with high irregular astigmatism, most of whom had previously undergone one or more corneal surgeries and who were contact lens intolerant.

The treatment delivered a more regular corneal surface and improved their visual acuity by a mean of two lines (and up to six lines),” he told delegates attending the XXVII Congress of the ESCRS. Using an approach called cTEN (customised, transepithelial, no touch surgery), Dr Schipper, Eye Clinic, Lucerne, Switzerland, said that there were many advantages to using this technique to treat complex cases of high irregular astigmatism.

He explained that cTEN is a one-step, no-touch, all-laser process in which a custom refractive treatment is performed without the discomfort of keratome or laser keratome high level suction on the eye, and with the safety advantages of not creating a flap in the stroma thus avoiding flap induced complications and further aberrations.

“The message is that irregular astigmatism is now treatable, including eyes after refractive or other corneal surgeries.

Our results show that the best-corrected visual acuity can be improved. The refractive results are not perfect but they are a great improvement for many patients. Retreatments are possible with this approach although we need to bear in mind that corneal thickness might be a limitation in some patients,” he said.

Dr Schipper said that the cTEN system incorporates a 1,000-Hertz excimer laser (iVis Technologies, Taranto, Italy), with a spot size of 0.65mm, combined with the CIPTA (corneal interactive program topographic ablation) software package (iVis Technologies).

He noted that CIPTA is a fundamental departure from traditional wavefront-guided systems. CIPTA incorporates a synthesis of corneal topography and pupillometry data. The surgery is executed on the surface that is mapped in high definition to within three microns accuracy (a congruence of two following topographic examinations has to be ≤3μ in order to be accepted).

“In terms of planning the ablation profile, Dr Stojanovic showed in 2005 that wavefront or placido topography are centred on the visual axis. Wavefront and placido image guided refractive surgery tries to optimise corneal aberration of a pathological axis.

Removing tissue at a pathological axis where the cornea is already thin might be problematic or even impossible, and, the transition zone will be steep,” he said.

The CIPTA approach, however, means that the ablation will be centred on the morphological axis, taking into account the patient’s real anterior corneal surface and not in the visual axis.

“This reduces the volume of the tissue removal, directs the ablation to areas with thicker cornea and enables a smoother transition zone. To do this properly requires a three-dimensional topographic system such as the Precisio, Orbscan or Pentacam.

Dr Schipper noted that earlier studies

by Dr Stojanovic showed that treating the cornea on the visual axis in eyes with irregular astigmatism resulted in a mean maximum ablation depth of 48 microns and a mean transition gradient of 26 microns compared to 26 microns and nine microns respectively if the eyes were treated based on the corneal morphological axis.

Another key issue in treating eyes with irregular astigmatism is epithelial thickness, said Dr Schipper. “The epithelium is not the same thickness in different areas of the cornea and this is especially true for patients with keratoconus or after intracorneal ring segment implantation. If you are removing the epithelium manually like in LASEK, the corneal surface will remain irregular even after the treatment. With the transepithelial approach the custom refractive treatment is performed simultaneously with the epithelium removal and the end result is a very nice regular cornea,” he said.

The cTEN treatment works by removing a constant epithelial depth across the full treatment area. This depth approximates the epithelium thickness. Crucially, the epithelial area is atraumatically removed with smooth Gaussian shaped epithelial borders in order to encourage rapid re-epithelialisation. Thus, inflammation after the treatment is minimal, as well as pains. Eighty per cent of patients report only slight, or no pains at all after therapeutic or refractive cTEN. Dr Schipper said that 45 eyes of 43 patients have been treated thus far with cTEN for a variety of indications, including 15 postpenetrating keratoplasty, 12 post lamellar keratoplasty, five post LASIK or PRK and 13 with different disease-related conditions.

The visual acuity improved significantly in a majority of patients. He added that the incidence of haze was very low overall. isaak.schipper@ksl.ch

Harminder Singh Dua

PATIENTS who abuse topical anaesthetics after corneal surgery may be increasing their risk of infectious crystalline keratopathy, according to Harminder Singh Dua FRCS, Infectious crystalline keratopathy in a patient with penetrating keratoplasty. The infection started in relation to the FRCOphth, sutures as a regular ulcer and branching pattern appeared at the central margin of the ulcer during treatment with MD, PhD, antibiotics and steroids University Hospital, is unreliable as a prophylaxis against some Queens Medical Centre, Nottingham, UK, at species of streptococcus. Yet another theory the 6th International Refractive Meeting. is that an extracellular matrix, or biofilm, Prof Dua noted that infectious crystalline forms around the cells and masks the bacterial keratopathy is a rare but difficult to treat antigens. condition which can be defined as microbial However, it may be that corneal infection or colonisation of the cornea in the anaesthesia or hypoaesthesia alone can absence of the host immune response. It can account for most of the reduction or absence be caused by a variety of microbes including of the innate immune response to the bacteria and fungi. The condition derives microbial pathogens, Prof Dua suggested. its name from the characteristic crystal-like “My hypothesis is that whenever there corneal infiltrates that form in branching is corneal hypoaesthesia or anaesthesia arborescent patterns as the infection extends there will be no inflammation to trigger the into the deeper stromal layers. vasodilation of the limbus. As a result you Microscopic examination of biopsies taken won’t get an influx of inflammatory cells. from the lesions will show an interlamellar Anaesthesia cuts across all the conditions spread of microorganisms but an absence where infectious crystalline keratopathy of inflammatory cells. Patients are often occurs,” he said. Topical anaesthetic abuse is a asymptomatic, and where symptoms occur classical example. they are generally mild, and progression of Clinical examination of corneas with the the condition is generally slow. However, it condition will reveal the presence of branching is often unresponsive to antibiotic treatment, crystalline deposits located in the stroma and surgery, including keratectomy and often near suture sites in the superficial or penetrating keratoplasty is necessary in deep stroma. The lesions become more many cases. arborescent or fernlike in structure the Predisposing factors for the condition deeper they are in the stroma. There is include previous corneal grafts, topical usually minimal limbal injection and there anaesthetic abuse, and prolonged use of can be areas of suppuration remote from antibiotics and steroids. Other risk factors are the lesions. Scrapes and biopsies can help previous corneal refractive surgery, especially determine the causative organisms and the incisional techniques, as well as bullous antibiotic to which they are most sensitive. keratopathy and HSV or HZV keratitis. The The first line of therapy is the cessation of potential infective organisms include steroid medication and the use of an intensive several different species of streptococcus, regimen of topical antibiotics with bactericidal staphylococcus, haemophilus and rather than bacteriostatic properties. enterococcus as well as other gram-negative However, such treatment is often ineffective bacteria and some species of fungus. unless the host’s normal inflammatory There are several theories regarding the response is re-established. lack of an inflammatory response in eyes “It is best to stop all antibiotics, steroids with infectious crystalline keratopathy. and topical anaesthetics. This will sometimes One theory is that there is a reduced host enable the host response to recover so immunity in affected eyes that results from that the lesion becomes a ‘regular’ ulcer or unhealthy corneas or long-term steroid use. abscess. You can then retreat the infection Another theory is that the condition arises with appropriate antibiotics,” Prof Dua said. from opportunistic infections, such as can When antibiotics fail to bring about a occur when using gentamicin, an agent that sufficient response, it is still sometimes

Courtesy of Harminder Singh Dua FRCS, FRCOphth, MD, PhD

Roibeard O’hEineachain in Dublin

Cornea Update

Topical anaesthetic abuse an important risk factor for infectious crystalline keratopathy

possible to excise the lesion in some cases eyes, the bacteria grow in globular clusters in or perform a phototherapeutic keratectomy. the wide spaces between the lamellae. “Our Unfortunately, some cases will require a findings indicate that the pattern of spread primary or repeat penetrating keratoplasty. of bacteria within corneal tissue is largely Prof Dua noted his own research indicates determined by the compactness of the corneal that it is the tissue architecture rather than stroma,” he added. This work was published the type of pathogen that causes the lesions of in the journal Investigative Ophthalmology and infectious crystalline keratopathy to spread in Visual Sciences in 2001. its characteristic arborescent pattern. profdua@gmail.com He described an experiment that he and his associates carried out using human corneal buttons in which they compared the growth of bacteria ™ in corneas that were in a turgid and non-turgid condition. They maintained the corneal buttons in organ culture with

Eagle’s medium 21st century material keeping them in + integrated muscle anchor platform either a turgid or non-turgid state + no tedious preparation or wrapping by the omission or addition of 5.0 per + simplified surgical procedure cent Dextran. + advanced ceramic surface They then inoculated each of the buttons orbtex cermamic orbital implant with one of three separate types of bacteria, namely streptococcus viridians, klebsiella oxytoca, and wild and genetically modified pseudomonas species. They then observed the colonisation Internal porous, interconnected, pattern of the Absorbable suture platform uniform architecture microorganisms using light and electron Also available: microscopy.

They found that in the non-turgid eyes, regardless of the infecting organism, the standard, value-priced orbital implants bacteria spread through the compact tissue in a branching e: sales@orbtex.com network with the t: +44 (0) 1382 774 777 same needle-like w: www.orbtex.com structures that occur in infectious crystalline keratopathy. In contrast, in the hydrated, turgid Manufactured by Ceramisys Ltd.

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19

Ehab Ghoneim

Dermot McGrath in Barcelona

THE adjunctive use of mitomycin C for pterygium surgery appears to provide a safe and effective means of preventing recurrence, according to a number of studies presented at the XXVII Congress of the ESCRS. “Our study showed that using 0.15 mg/ ml of mitomycin C for surgery of primary pterygium with either preoperative local injection or intraoperative application is equally effective in the prevention of recurrence of pterygium after surgical removal and was associated with minimal complications on the operated eyes,” said Ehab Ghoneim MD, associate professor of ophthalmology, Suez Canal University Hospital, Ismailia, Egypt.

Pterygium is defined as a triangular fibrovascular subepithelial ingrowth of degenerative bulbar conjunctival tissue over the limbus, but the exact cause of pterygium is not well understood.

However, long-term exposure to sunlight, especially ultraviolet rays, and chronic eye irritation from dry, dusty conditions seem to play an important role.

“Pterygium is a common health problem in Egypt because of the hot climate and simple excision of the pterygium alone has a very high rate of recurrence of anything between 30 per cent to 70 per cent,” Dr Ghoneim said.

He noted that various adjunctive strategies such as irradiation treatment, anti-metabolites, and conjunctival and limbal grafts have been employed over the years to try to reduce the high rate of recurrence, with mixed success. In the last decade, mitomycin C has become more commonly used in pterygium surgery.

“The mechanism of action of mitomycin C seems to inhibit fibroblast proliferation at the level of the episclera,” said Dr Ghoneim.

In the comparative study carried out at Suez Canal University Hospital, 70 eyes of 70 patients with primary pterygia were randomly allocated into two groups. The first group received 0.1ml of 0.15mg/ml mitomycin C injected subconjunctivally into the head of the pterygium 24 hours before surgical excision using the bare sclera technique. The second group of patients underwent surgical removal with the bare sclera technique together with intraoperative application of 0.15 mg/ml of mitomycin C to the scleral bed for three minutes.

Dr Ghoneim noted that the theoretical advantages of the latter approach include the use of mitomycin C only in the operating room and the fact that the drug is targeted at the area of pathology rather than the entire ocular surface. He also stressed the importance of using an optimal dosing regimen for the drug.

20

“We tried to reduce the concentration of mitomycin C for the surgery in order to minimise possible side effects while also trying to maintain the efficacy of the drug. Studies by Chen et al showed that a concentration of 0.1 mg/ml inhibits fibroblast replication and that concentrations of 0.3 mg/ml actually cause the death of fibroblasts. We selected a 0.15 mg/ml concentration because this was slightly higher than the therapeutic window but still well below the toxic level associated with cell death,” he said.

One year after surgery, the rate of pterygium recurrence was 5.7 per cent for the group treated with preoperative mitomycin C followed by excision, and 8.57 per cent for the second group in which mitomycin C was applied topically after pterygium excision. The difference was not statistically significant. In terms of postoperative complications, scleral thinning was found in one eye in each group but resolved within three months after surgery and no other serious postoperative complications were reported.

Putting the results in context, Dr Ghoneim said that rate of pterygium recurrence reported in the scientific literature usually ranged from 35 per cent to 70 per cent.

“This is why we did not use a control group as we expected a high rate of recurrence with more surgical difficulty in management of recurrent pterygium and more morbidity to the patients. There were no serious complications such as corneal ulceration or perforation, scleral perforation, secondary glaucoma and sudden onset mature cataract which are well known complications of mitomycin C usage,” he said.

The benefits of using subconjunctival mitomycin C prior to pterygium surgery were also underlined in a separate study carried out at the Ophthalmology Department, Suez Canal University Hospital, Egypt.

“Subconjunctival mitomycin C is an effective treatment before pterygium excision to minimise its recurrence.

Furthermore, the subconjuctival injection allows exact titration of mitomycin C delivery to the activated fibroblasts and minimises epithelial toxicity,” said Mervat El-Shabrawy MD, associate professor of ophthalmology at the Suez Canal University.

Dr El-Shabrawy surmised that the high rate of recurrence of pterygium may be due to a number of possible factors: inadequate surgery, stimulation of an excessive inflammatory process at the site of surgery or continued exposure to the same factors that produced the primary pterygium, especially exposure to sunlight.

Courtesy of Ehab Ghoneim MD

Cornea Update

Studies suggest mitomycin C may help in the prevention of pterygium recurrence

The postoperative left eye of a patient showed no signs of recurrence after 10 months of pterygium removal with bare sclera technique and preoperative local injection of mitomycin C of 0.1ml of 0.15 mg/ml mitomycin C injected subconjunctivally into the head of the pterygium 24 hours before surgical excision

Dr El-Shabrawy stated: “I am a certified trainer of research ethics from Maryland University, US, so, from the ethical point of view, we intended in our study to enhance the potential benefits and minimise the risks by using a low concentration of mitomycin C (0.15mg/ml), using a small dose of 0.1ml of the drug and minimising the exposure time to 24 hours before the operation, so, it is considered a minimal risk study”.

Dr El-Shabrawy’s study included 60 patients divided randomly into two groups, the first of which received a subconjunctival injection of mitomycin C into the head of pterygium in low dose (0.1ml of 0.15mg/ ml), and short exposure time (24 hours before the operation) and the second group which was treated with bare scleral technique without the use of mitomycin C. The group pre-treated with mitomycin C had a total of two recurrences of the pterygium over the six-month follow-up period (6.7 per cent) compared to nine recurrences (30 per cent) in the control group. Also, there were no serious complications in both groups. One case only (3.3 per cent) had scleral thinning in study group; appeared in the 2nd month of follow-up and improved markedly by discontinuation of corticosteroid drops.

Dr El-Shabrawy’s study recommended the proper patient selection for this technique which is very important; to avoid the serious complications of mitomycin C and for further studies for longer periods of follow up to approve the efficacy and the safety of mitomycin C when injected subconjunctivally before the pterygium surgery by a short time.

Another potentially interesting approach to preventing the recurrence of pterygium is to follow the excision surgery with an amniotic membrane graft to cover the scleral-conjunctival defect, according to Hasan Khakshour MD, Isfahan University of Medical Sciences, Isfahan, Iran.

“We found that amniotic membrane graft transplantation is more effective in preventing pterygium recurrence and the treatment is as safe as using conjunctival flap and mitomycin C for the treatment of the ocular surface after excision of primary pterygia,” he said.

Dr Khakshour’s prospective, randomised study included 68 patients with primary ptergyia who were randomly assigned into two groups. In the first group, the amniotic membrane transplant was used to cover the sclera conjunctival defect after excision of the pterygium, while in the second group mitomycin C was applied intraoperatively for 60 seconds followed by irrigation and the defect was then covered with a rotational flap of conjunctiva.

After six months, 5.9 per cent of the amniotic membrane group had reappearance of the pterygium, compared to 23.5 per cent in the mitomycin C group. There was one incidence of scleral melting and one case of infection in the mitomycin C group and none in the amniotic membrane group, but the difference was not statistically significant, said Dr Khakshour. eeghoneim@hotmail.com ershabrawy@yahoo.com khakshour@mui.ac.ir

Howard Larkin in Boston

ADVANCES in visual field (VF) testing technology and statistical analysis have made functional assessments much more reliable in detecting the onset and progression of glaucoma. In many cases functional tests reveal progression before it can be detected by structural exams, making it an essential tool for making timely therapy adjustments, according to Stefano Miglior MD, University of Milan, Italy.

Even so, functional assessment tools are still limited due to fluctuations in patients’ vision over time, reliability of instruments and non-glaucomatous conditions that interfere with vision, most notably cataracts. Understanding these limits is essential to make full use of the clinical advantages that today’s functional assessment tools offer, Dr Miglior told the World Glaucoma Congress.

Even though preventing loss of visual function is the goal of glaucoma and ocular hypertension therapy, the utility of functional assessments in detecting onset and progression has been questioned for at least some stages of the disease.

“We have been told over the past 20 years that in the glaucoma continuum the patient passes through an asymptomatic phase during which structural assessment is better able to detect the disease, and that functional impairment only comes later.”

This model, which was widely accepted in the 1990s, was based on research suggesting that detectable VF loss did not occur until about 30 per cent of retinal ganglion cells were lost, Dr Miglior noted.

“Actually, we have found this is not really true. Information from two big studies the EGPS (European Glaucoma Prevention Study) and OHTS (Ocular Hypertension Study), of patients at risk for glaucoma that start with a normal visual field and a normal optic disc, shows there are a number of patients where VF examination can detect the change earlier than the optic disc examination,” Dr Miglior said. At least 35 per cent of patients in the OHTS and 60 per cent in the EGPS reached the endpoint, which was development of glaucoma, based on VF assessment.

This means that VF is important even in the early stages of the disease, Dr Miglior noted. He also pointed out that recent research shows that combining functional tests using frequency doubling technology with nerve fibre structural evaluations by means of scanning laser polarimetry (GDx) or Stratus optical coherence tomography led to a clear increase in sensitivity.

“So the answer to the question is yes, visual function should always be assessed to detect the disease.”

Detecting progression Detecting progression is even more important in managing glaucoma, Dr Miglior said. The objective is to detect the slightest change in order to adjust therapy and prevent further irreversible vision loss.

Conducting visual function tests over time is one way to detect progression. But the precision required to detect progression strains the limits of all diagnostic techniques, and VF examinations in particular, Dr Miglior said.

He pointed out that the smaller the change we try to detect the greater the interference of the variability of the biological factor we are trying to measure.

In the case of glaucoma, progression is generally slow, ranging from 1.0 per cent to 1.5 per cent annually. Variations in patients’ vision from exam to exam can easily mask changes of such a small magnitude. Reproducibility of results on a given instrument adds another layer of uncertainty.

“On top of that, we have biological variability of ageing itself. We all know that as patients get older they have a harder time adjusting to the machine, and you get biological factors related to ageing, such as cataracts that also affect visual function.”

Distinguishing visual loss due to cataract from loss due to glaucoma can be challenging but is essential to guide effective therapy decisions.

Then there is diagnostic uncertainty. The criteria used to evaluate VF results have a huge influence on whether disease is detected. To illustrate the impact he showed how applying the objective outcome criteria developed for the Advanced Glaucoma Intervention Study (AGIS) and Collaborative Initial Glaucoma Treatment Study (CIGTS) would change the results of the earlier Early Manifest Glaucoma Trial (EMGT).

“The EMGT criteria are subjective and showed poor reproducibility compared with AGIS and CIGTS. If you apply the AGIS criteria to EMGT study you would have found 50 per cent less patients reaching the endpoint.”

Dr Miglior believes that subjectively comparing VFs over time is the least robust method for detecting progression. He further believes that the AGIS and CIGTS scoring methods are too complex and difficult to use in a clinical setting.

Statistical software packages have made functional assessment much more powerful, Dr Miglior noted. Mean deviation (MD) trends are useful but can be difficult to interpret. The development of the visual field index (VFI), which assigns different weights to central and peripheral areas, is a huge step forward because it makes it easier to differentiate between cataract-related vs. glaucoma-related vision loss. Typically, when cataracts are present MD trends are

Glaucoma Update

Advances improve functional tests for glaucoma monitoring, but limits remain

much steeper than VFI trend lines. When detection of glaucoma and even more crucial the cataract is removed, MD and VFI for assessment of progression. Of course, trends typically show much closer rates of the limitations of functional examination progression. always should be taken into account. These VFI can be valuable over time to include long term fluctuation of vision, distinguish between patients who are reliability of measurement instruments and progressing quickly and those who are not. biological variability, most especially the Recent research suggests that conducting impact of cataract,” he concluded. more-frequent functional assessments can stefano.miglior@unimib.it sharply reduce the time it takes to detect progression.

Relying on one VF per year can detect a 1 dB loss in six years in a patient with low vision variability but may take 13 Lamellar Donor Insertion Instrument for atraumatic insertion for a patient with of the donor lamella high variability.

Increasing to 13-136 two exams 13-136 annually cuts the time to detect Corneal Dissector for intrastromal dissection progression to

DEEP LAMELLAR ENDOTHELIAL KERATOPLASTY

6.5 years for a patient with high variability, Dr Miglior noted.

The development of trend-based evaluation software, such as the Glaucoma Progression Analysis II, further increases the diagnostic power of functional assessments.

These tests have been shown to detect progression in patients missed by standard VF examinations.

GPA also helps differentiate between glaucomatous and non-glaucomatous vision loss.

“The visual field with standard perimetry is the mainstay because functional impairment is the target of our management.

Functional examinations are crucial for

13-138

13-137

13-137 straight 13-138 curved

Endothelial Stripper, irrigating for Descemet's Stripping

13-139/I 13-139/I

Reverse Sinskey Hook for scoring the recipient bed and to position the donor lamella 5-0322 5-0322

Lamellar Donor Insertion Forceps 4-2019 4-2019

DLEK Scissors for the manual excision of endothelial layers

11-0360

11-0361

11-0360 medium curve 11-0361 strong curve

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paris

10

TH

EURETINA Congress

Available at www.euretina.org: • • •

Preliminary Programme Online Registration Hotel Bookings

2–5 September Le Palais des Congrès

s 2010

XXVIII Congress of the ESCRS Available at www.escrs.org: • • •

Preliminary Programme Online Registration Hotel Bookings

4–8 September Le Palais des Congrès

Retina Update

Fluorescein angiography remains the gold standard for early detection of CNV Diana Do

Dermot McGrath in Paris

FLUORESCEIN angiography remains the triedand-trusted gold standard for detecting new

onset choroidal neovascularisation (CNV) secondary to age-related macular degeneration (AMD) and cannot be replaced by techniques such as optical coherence tomography (OCT), Amsler grid or preferential hyperacuity

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24

perimeter (PHP), according to Diana V Do MD. “Our study showed that OCT, Amsler grid, and PHP all have moderate sensitivity for the detection of new onset CNV. Although OCT has higher specificity than PHP or Amsler grid, fluorescein angiography remains the gold standard for detecting new onset CNV and cannot be replaced by any of these approaches,” she told delegates attending the Macular 2010 meeting.

Presenting the results of the AMD DOC study (AgeRelated Macular Degeneration: Detection of Onset of New Choroidal Neovascularisation), Dr Do, assistant professor of ophthalmology at the Wilmer Ophthalmological Institute, Johns Hopkins University School of Medicine, Baltimore, US, said that early detection of CNV has the potential of significantly improving the final visual outcome of patients.

She noted that the main cause of visual loss in AMD is the development of choroidal neovascularisation. Furthermore, individuals with unilateral CNV in one eye and high-risk nonneovascular AMD characteristics in the fellow eye have around 50 per cent chance of progressing to neovascular AMD in their nonCNV eye within a five year period.

“This is why early detection of CNV is so important. We have learned from the MARINA and ANCHOR studies that approximately 33 per cent of patients treated with ranibizumab can gain three lines or more of visual acuity. The majority of patients treated with ranibizumab do not have significant visual acuity gains. We suspect that when we treat eyes with smaller CNV lesions, those eyes are more capable of gaining or retaining vision than those with larger CNV lesions. So it is important to detect CNV when it is small so that we can treat it and hopefully preserve vision in the long term,” she said.

Dr Do said that the primary goal of the AMD DOC prospective, multicentre study was to determine the sensitivity of stratus OCT in detecting new onset neovascular AMD in eyes with high-risk characteristics within a two-year period. Secondary objectives of the study were to assess the specificity of OCT, as well as the sensitivity and specificity of PHP

and supervised Amsler grid tests. A total of 98 patients with a mean age of 79 years were enrolled in the study.

Inclusion criteria included patients with CNV in one eye, and in whom the eligible study eye needed to have at least one large drusen, defined as greater than 125 microns, as well as the presence of pigmentary changes within 3,600 microns of the foveal centre. Additional inclusion criteria included a negative OCT scan and fluorescein angiography at baseline that showed no sign of CNV in the eligible study eye, with all tests performed within two weeks of one another. Non-foveal geographic atrophy was allowed in the study eye.

Key exclusion criteria included known allergy to fluorescein dye or advanced AMD with CNV in both eyes, as well as foveal geographic atrophy in the study eye.

Looking at the different techniques in more detail, Dr Do said that a positive Amsler grid test was defined as when the participant reported any blur, hole or distortion on the Amsler grid while being supervised by a certified vision examiner. The definition of a positive PHP test was a grading outside normal limits according to the PHP algorithm and with a P value of less than 0.1. The definition of positive OCT scan was a 10 per cent increase in central subfield thickness on a macular map (and a greater than 25 micron increase from baseline) or the presence of questionable or definite subretinal fluid, or a combination of questionable or definite intraretinal cystoid abnormalities and questionable or definite interstitial retinal fluid.

In terms of the results, the sensitivity of each test at the first visit where the fluorescein angiography was labelled as positive for CNV based on reading centre grading was 0.40 per cent for OCT, 0.42 per cent for Amsler grid and 0.50 per cent for the PHP machine.

Looking at the sensitivity of each test at the first visit where the angiography was labelled as positive for CNV based on reading centre grading and the clinician had recommended treatment, the result was 0.69 per cent for OCT, 0.50 per cent for Amsler grid, and 0.70 per cent for PHP. The OCT was found to have the highest specificity among the three tests.

Putting the data in context, Dr Do acknowledged some limitations to the study.

“We used the Stratus time-domain OCT (Carl Zeiss Meditec) for this study. We know that spectral domain OCT may be more sensitive in picking up abnormalities associated with CNV, but may be less specific. In addition, in some patients the conversion to new onset CNV occurred at non-study interim visits, and at those visits some tests such as PHP or Amsler grid were not routinely performed.

So the true sensitivity and specificity may be somewhat different. And, finally, we have only a small number of conversions to new onset CNV and so this clearly limits the precision of the results,” she said. ddo@jhmi.edu

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Ocular Update

3D headache may be ‘avatar’ of strabismus or other binocular vision condition David Granet

IF THE Western-warrior-rescues-noblenatives plot of James Cameron’s Avatar isn’t enough to give you a headache, focussing for 162 minutes on its lush, 3D images very well could. And if it does, it could indicate the presence of a treatable ocular condition.

“There are a number of somatic symptoms people might have watching 3D, and they could be based on a number of things,” says Michael A Rosenberg MD, Northwestern University, Chicago, US, who specialises in neuro-ophthalmology as well as cataract and refractive surgery. “If someone told me they got a headache watching Avatar I would look for the reason why.”

In the case of Dr Rosenberg’s wife, he suspects her slight anisometropia may have been the cause. “I didn’t have any problem and my son didn’t have any problem, but about 90 minutes into the film, my wife became nauseous. She took her 3D glasses off for about 20 minutes and it went away, and then she was fine when she put them back on.”

Dr Rosenberg believes the strain of trying to merge the slightly different images presented to each eye without relief fatigued her. “To see the image in 3D you need the images in each eye to be equally clear. If your eyes are not seeing the same image you can still get stereo vision, but it ups the ante for what your brain has to do to merge the two images. Ultimately it is what your brain is doing that gives you the headache but it is your eye situation that is creating the extra work for your brain. Under normal circumstances this may not be a problem.

When you get eyestrain at your computer you get up for five minutes and rest your eyes. But when you are at a movie you have to concentrate longer.”

Even patients with normal vision can have difficulty with 3D in part because it is not possible to focus on background objects as you can in the real world, notes David Granet MD, University of California-San Diego, California, US. “In the movie the focus stays where James Cameron wants it. If you look at a creature or animal off to the side, you can’t focus on it. It’s one way 3D falls apart. You can shift your focus, but it does not clear the image. To avoid a headache you have to go with the flow.” Adapting to 3D glasses also can cause some discomfort, but for most people it is temporary, he adds.

But a big, long-lasting headache or an inability to perceive movie images in 3D may indicate a treatable problem, Dr Granet says. “It may be a red flag, especially in a child. It becomes almost a screening test for anisometropia, strabismus or amblyopia.”

Ocular motility Patients with abnormal retinal correspondence or imbalance in the muscles 26

Picture from the movie Avatar, courtesy of 20th Century Fox UK

Howard Larkin

‘If someone told me they got a headache watching Avatar, I would look for the reason why’

“There are a number of somatic symptoms people might have watching 3D, and they could be based on a number of things” Michael A Rosenberg MD

controlling the eyes are more likely to have 3D symptoms, Dr Granet notes. It’s partially because 3D films tend to exaggerate the separation of the two images projected beyond what occurs in everyday situations.

The greater convergence that this requires makes images pop off the screen because it is interpreted by the brain as a depth cue.

But while a patient with a minor imbalance may never have a problem merging images with the relatively small amounts of convergence they experience every day, the greater convergence required to view a 3D image may strain their muscles and their neuroadaptive ability.

“I went with my 14-year-old and nineyear-old and we all walked out with fatigue.

I have a mild convergence insufficiency and it was a workout,” Dr Granet notes.

For patients who have problems with 3D, Dr Rosenberg suggests testing for an ocular motility disturbance. They may have a problem that they are not aware of. He recommends testing for phoria and tropia. Patients with a phoria have a muscle

imbalance but no diplopia because they can overcome it. Patients with tropia will have diplopia in at least some circumstances, and if they have it at all times they will not be able to see the 3D image at all. Either condition may be congenital or may develop in life as a result of trauma, tumours or nerve palsies brought on by diabetes or other systemic disease, such as multiple sclerosis, myasthenia gravis or thyroid conditions.

They may also be treatable, even in adults. Dr Rosenberg recently operated on a woman to cosmetically correct strabismus.

She had seen Avatar, but could not perceive the 3D effect at all.

“Before the surgery her one eye was pointed in so far she was only using one eye.

I didn’t think she would have much ability to regain 3D vision, but when she came in two days after surgery, her eyes were straight and when I put the 3D glasses on her she could see all the 3D images we use in the tests. Now she’s going back to see Avatar in 3D.” Dr Granet, too, sent a patient who had no binocular vision to Avatar after prescribing spectacle prisms.

“She came back so excited because she could finally see the 3D.” 3D TV In some respects it’s ironic that Avatar has drawn so much attention to the problems with 3D imaging. If anything, it was carefully made to reduce headache-inducing effects, Dr Rosenberg says. “Cameron designed this movie intelligently. He fixed it so that

there is only one thing on the screen that he wants you to look at – when the tank is moving toward you, that is in focus and the background isn’t.” Also, nothing moves too fast. Both techniques make it easier for the brain to keep up with the 3D illusion.

However, as 3D moves to television, Dr Rosenberg suspects more viewers will have problems. He has a hard time imagining how a sporting event like football could be produced without quick movements. “People will be much more likely to be symptomatic watching on a small screen. I think that will cause the novelty to wear off,” Dr Rosenberg predicts.

Research by the sports cable network ESPN seems to bear out that assessment.

While viewers of test 3D sports broadcasts have been “wowed” by the experience, many also found quick camera shifts “hard on the eyes”, according to published reports.

Nonetheless, ESPN is set to debut its 3D network with a World Cup soccer match June 11 with as many as 85 more events televised by the end of the year. And 3D TVs are already on the market and selling well.

A wave of 3D headaches may follow.

“There is definitely a subset of the population that will find 3D TV uncomfortable or unwatchable,” Dr Granet says. “People need to be aware that if they respond to it differently than everyone else they need to get their eyes checked.” neuro-oph1@northwestern.edu dgranet@ucsd.edu

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

Marie-Jose Tassignon

Colin Kerr in Budapest

THE growing importance of the European Board of Ophthalmology Diploma (EBOD)

examination was indicated at the 14th ESCRS Winter Meeting in Budapest where two of the didactic courses were accredited by the EBO as part of their education programme. â&#x20AC;&#x153;This is a very important development for

EBO and we are pleased to be co-operating with ESCRS to improve the quality of the education for trainees who wish to sit the exam,â&#x20AC;? said Marie-Jose Tassignon MD, PhD, FEBO. â&#x20AC;&#x153;The didactic courses at the ESCRS Winter Meeting have become a great source of information for ophthalmologists and the EBO is hoping that these courses will also prove useful to our younger members who plan to sit the EBOD exam.â&#x20AC;?

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Basic Optics The first EBO accredited exam was a Basic Optics Course, chaired by Prof Tassignon and Ioannis Pallikaris MD, PhD. The course was divided into three parts: Visual Optics, Visual Behaviour and Imaging.

The Visual Optics course included presentations on the epidemiology of the optical parameters of the eye, light propagation in the eye, aberrations of the optical system, optics of crystalline lens, IOL optics and retinal image quality.

The discussion then moved on to Visual Behaviour with presentations on understanding presbyoptics, visual psychophysics, contrast sensitivity and modelling the optics of the human eye.

The Basic Optics course concluded with Imaging the Human Eye and looked at the imaging of the anterior segment, evaluating the cornea with Scheimpflug imaging, advanced retinal imaging and adaptive optics and IOL power calculation.

Refractive Surgery The second EBO accredited course was the Refractive Surgery Didactic Course which was divided into two parts.

This gave trainees and young ophthalmologists hoping to sit the EBOD exam the opportunity to learn about a wide range of topics including corneal topography and IOL power calculation, patient selection and preoperative preparation, lasers in refractive surgery and surface ablation techniques.

The Refractive Surgery Didactic Course also looked at incisional and coagulative corneal procedures, quality of vision evaluation, intrastromal corneal implants and an overview of phakic IOLs. Other topics discussed included refractive

VOX DOC

Ocular Update

EBO expands education programme for diploma exam

Angyal Judit HUNGARY â&#x20AC;&#x153;I am a first-year resident and I am planning to do the EBOD exam. I think the didactic courses are useful not only for ophthalmologists but also for traineesâ&#x20AC;? â&#x20AC;&#x153;I understood almost everything and there was a good level of communication and teaching.â&#x20AC;?

lens exchange, multifocal IOLs, presbyopia, microkeratomes, the biomechanics of the cornea and customised ablation procedures.

Excellence in ophthalmology Prof Tassignon told EuroTimes that she hoped that young trainees and those planning to sit the EBOD exam had benefitted from the didactic courses at the Winter Meeting. â&#x20AC;&#x153;I think the Winter Meeting was a real success and there were very good attendances at all of the courses,â&#x20AC;? she said. â&#x20AC;&#x153;The European Board of Ophthalmology Diploma examination is a test of excellence in ophthalmology. It is designed to assess the knowledge and clinical skills requisite to the delivery of a high standard of ophthalmic care both in hospitals and in independent clinical practices,â&#x20AC;? she said. â&#x20AC;&#x153;We believe that the excellent teaching offered at the ESCRS Winter meeting will be of great use to the young ophthalmologists sitting the exam and we are looking at ways to accredit further ESCRS courses in the future, including courses at the XXVIII ESCRS Congress in Paris later this year.â&#x20AC;?

Prof Tassignon said that she hoped the Young Ophthalmologistsâ&#x20AC;&#x2122; Forum established by the ESCRS would encourage more young interns and trainees to sit the exam.

For further information on the EBOD exam visit: http://ebo-online.org/newsite/home.asp.

Marie-Jose.Tassignon@uza.beÂ

ISTANBUL 15 th ESCRS Winter Meeting in conjunction with TOS Cataract & Refractive Surgery Society

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ESCRS News

Young Ophthalmologists

Entries are invited for the John Henahan Prize 2010 for young ophthalmologists

Young ophthalmologists are invited to enter The John Henahan Prize for 2010. The prize, for an original piece of writing on an

ophthalmological subject, was launched at the 14th ESCRS Winter Meeting in Budapest.

Ophthalmologists who are members of the

ESCRS and who are under 40 years of age are eligible to apply for the prize. Entrants are invited to write a 1,000-word article on the topic of, The Outstanding Memory of My Residency.

The article can focus on the educational highlights of the residency, your favourite teachers/ e new lecturers, your fellow students, the See th onus toc patients you treated and your most Kera ftware* at So Risk difficult case during your residency.

The judges are Emanuel Rosen, 0 0 15 chairman ESCRS Publications Booth Committee, Jose Guell, president ESCRS, Oliver Findl, chairman ESCRS Young Ophthalmologists’ Forum, Sean Henahan, editor EuroTimes, Paul McGinn, editor EuroTimes, Robert Henahan, contributing editor EuroTimes.

The two main criteria for consideration by the judges are the clinical content of the story and the writing style, punctuation and grammar which should reflect the high standard of material published in EuroTimes. The competition is open to ophthalmologists under 40 years of age and the prize is awarded to the author of the winning essay on a given theme.

Winner receives travel bursary The winner will receive a travel bursary worth €1,000 to attend the XXVIII Congress of the ESCRS in Paris and will also be presented with a special trophy at the Young Ophthalmologists’ Programme in Paris. The winning entry will be ® Only Ocular Response Analyzer measures Corneal Bio-mechanics. published in the October edition of EuroTimes.

Entries, which must be The information obtainable using the Ocular Response Analyzer® accompanied by an ESCRS complements corneal topography, providing a higher level of confidence in determining refractive surgery candidacy than is attainable with topography alone. We implemented the ORA as a standard part of our refractive surgery screening process over 3 years ago and have never looked back.

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membership number, should be sent to Colin Kerr, executive editor, EuroTimes at colin.kerr@escrs.org. The decision of the judges is final and no correspondence will be considered once they have announced the winner.

The 2009 recipient of the John Henahan Prize was Indian ophthalmologist, Kaladevi Ranganathan MD. Dr Ranganathan’s entry, “Judgement comes from experience”, detailed her experience with the case of a six-year-old girl who very nearly had a disabling and stigmatising loss of vision in one eye following a fireworks accident, but who through timely and resourceful intervention now has normal vision and a good quality of life.

John Henahan The prize is named in honour of John Henahan the founding editor of EuroTimes, who edited the magazine from 1996 to 2001. John’s work has inspired a generation of young doctors and journalists, many of whom continue to work for EuroTimes.

“The prize will not only bring satisfaction to the winner and credit to all the contributors but may enhance all their prospects of pursuing a medical writing aspect to their future careers. We look to their further contributions to EuroTimes and the Journal of Cataract & Refractive Surgery,” said Dr Emanuel Rosen, chairman of the judging panel.

Entry forms are available online from colin. kerr@escrs.org. Requests for entry forms should be marked Henahan Prize 2010.

The closing date for entries is Friday June 26, 2010. Entries received after this date will not be considered. The decision of the judges is final and no correspondence will be considered once they have announced their decision.

”

Director, UCLA Laser Refractive Center Assistant Professor of Ophthalmology Jules Stein Eye Institute

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Emanuel Rosen presents Kaladevi Ranganathan with the John Henahan Prize 2009 at the XXVII Congress of the ESCRS in Barcelona

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Marie-Jose Tassignon

ESCRS News

EUREQUO

Collection of data from ophthalmologists could be compulsory in the future

Colin Kerr in Dublin

THE Belgian Society of Cataract and Refractive Surgeons (BSCRS) has already started collecting data for the EUREQUO project but according to Marie-Jose Tassignon MD, PhD, FEBO, a lot of work has to be done to encourage ophthalmologists to take part in the project.

The project aims to support improved treatment and standards of care for cataract and refractive surgery. This will be achieved through the development of a Europe-wide network of National Registries reporting clinical outcomes of cataract and refractive surgery.

EUREQUO aims to make a significant impact on the exchange of best practice between practitioners in relation to patient safety in this field and Prof Tassignon, the leader of the Belgian project, believes that while some ophthalmologists may be reluctant to take part in the early stages, they will soon see the benefits of the work that EUREQUO is doing.

“We have to convince ophthalmologists that they can benefit from the project.

We also have some technical issues to resolve but we are making progress. I think the next step, if EUREQUO is to be really successful, is that the software should be adaptable to data collection

programmes that are available in different hospitals and clinics all over Europe.”

Prof Tassignon said that one of the questions ophthalmologists will ask before they agree to take part in the project is: How does EUREQUO benefit me?

“Up to now there has not been a direct benefit from having your data collected and analysed,” she said, “but in the future, it may be compulsory for doctors to present their results for inspection. In the Netherlands, for example, your insurance premium is dependent on your outcomes and that system could be introduced in other European countries.”

According to a recent survey of primary care doctors in the journal Health Affairs, when asked about comparative information systems, doctors in the UK were most likely to routinely receive and review data on clinical outcomes (89 per cent), followed by Sweden (71 per cent), New Zealand (68 per cent), and the Netherlands (65 per cent). Less than half of doctors in other surveyed countries including the US at 43 per cent reported such reviews (Health Affairs, 28, no. 6 (2009): w1171-w1183; Published online 2 November 2009).

This survey, admittedly in a primary care setting, shows the difficulty of establishing a European wide data collection network, but Prof Tassignon believes it is important to have outcomes

“Up to now there has not been a direct benefit having your data collected and analysed, but in the future, it may be compulsory for doctors to present their results for inspection. In the Netherlands, for example, your insurance premium is dependent on your outcomes and that system could be introduced in other European countries” and to compare those outcomes between different centres. “We have started to collect the data in Belgium and we have ophthalmologists collaborating with us, but it will take time,” she said. “It is interesting that many of the ophthalmologists who are co-operating with EUREQUO are the same ophthalmologists who participated in the ESCRS Endophthalmitis Study.”

Prof Tassignon said that she is already sharing her results with her Belgian colleagues in an effort to demonstrate that the project is completely confidential and transparent. “The project was not established to identify if you are a good or an average ophthalmologist,” she said. “That might be one of the fears of ophthalmologists but by talking to them directly we can show them that is not the case.”

Education is important A major focus of the project is on collecting data and talking to established ophthalmologists, but Prof Tassignon believes that the project should also reach out to young ophthalmologists in training.

“If young ophthalmologists are made aware that their data will be collected in the future, they will be more motivated to seek information on the project.

“I would like to see universities in Belgium informing trainees about the existence of the project and prepare educational programmes supporting the project.”

Marie-Jose.Tassignon@uza.be

EUREQUO European Registry of Quality Outcomes for Cataract & Refractive Surgery

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

The project aims to:

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Improve treatment and standards of care for cataract and refractive surgery

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

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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 evidence-based European Quality Guidelines

See www.eurequo.org for more information Funded by

31

Budapest 2010

Meeting Report

Record attendance at 14th ESCRS Winter Meeting in Budapest

T

HE 14th ESCRS Winter Meeting attracted a record attendance with more than 1,200 delegates attending the meeting in Budapest, Hungary.

There was a truly international spread of delegates with 380 from Hungary and over 200 from Austria, Croatia, Romania, Ukraine, Serbia, Slovakia and Slovenia, also present.

The meeting was hosted by the Hungarian Society of Cataract and Refractive Surgeons (SHIOL) and ESCRS president José Güell MD paid tribute to the host society and the ESCRS members who worked very hard to ensure the success of the meeting.

“It was very pleasing to see so many delegates from all over Europe at the meeting,” said Dr Güell. “One of the reasons the ESCRS Board decided to choose Budapest as the venue for this year’s meeting was that it allowed us to pursue our policy of developing initiatives to help both our existing members as well as members in the ‘new’ European countries,” he said. “The main fear in going to Eastern Europe was not the location or the political or economic infrastructure.

There was some concern that the weather might be too cold for some delegates but this proved not to be the case and the crisp Budapest winter air added to our sense of history and occasion.”

“We put a lot of work into refreshing the format of the winter meeting,” said Dr Güell, “and the wide variety of courses available to delegates reflected the changes we introduced. As always we are open to suggestions as to how we can improve the winter meeting in the future,” he said.

Education profile increases Dr Güell said the educational profile of the winter meetings was increasing all the time and the ESCRS’s decision to introduce didactic courses in refractive surgery, cataract, cornea and visual optics had proven to be very popular with delegates who attended the meeting in Budapest.

“The didactic courses received a very positive reaction and were very well attended and the other sessions were also excellent,” said Dr Güell. “The main goal of the ESCRS is education and we demonstrated in Budapest that we can provide first-class educational courses anywhere in Europe.

“It has been argued in the past that our winter meetings should be held in major western European centres like Rome or Barcelona, but we have demonstrated in Budapest that a strong educational programme will guarantee a very good attendance,” he said.

Focus on Istanbul The ESCRS has already started planning the 15th ESCRS Winter Meeting which will be held in Istanbul, Turkey from 18-20 February 2011. “I think that we can look forward to another successful meeting, but it is important that our primary focus is not just on the number of delegates attending, although that is important,” said Dr Güell.

“As I stated earlier, our goal as a society is to provide the highest standard of education for our members and if we can achieve this once again at the 15th Winter Meeting in Istanbul, then we should be happy.” guell@imo.es

* For more information on the 15th ESCRS Winter Meeting visit the EuroTimes Turkey website at www.eurotimesturkey.org and www.escrs.org.

ESCRS president José Güell speaking at the opening of Cornea Day

Poster prize winners address important questions in cataract and refractive surgery Robert Henahan

The prize for the best cataract poster went to Liga Radecka MD, Pauls Stradins Every year at its annual winter meeting the ESCRS Clinical University Hospital, Riga, Latvia. awards a prize of €1000 to the best Cataract and Her presentation described a study which Refractive Posters Presentations of the congress. indicated that patients with wet AMD who This year’s winner of the refractive poster prize have successfully undergone treatment with went to Suphi Taneri MD, Münster, Germany. His Bevacizumab (Avastin, Genentech) cataract presentation sought to elucidate the influence of surgery will not cause a reactivation of their the epithelial flap after EPI-LASIK and LASEK for condition. the correction of low to moderate ametropia on The retrospective study involved 69 eyes visual recovery, epithelial closure, pain and haze of 65 patients aged from 56 to 87 years with formation. The findings indicated that the flap may wet age related macular degeneration (ARMD) have no significant effect at all.

Dan Epstein presents the awards to the Cataract and Refractive Poster winners. Pictured left is Suphi Taneri and right is Liga Radecka who received treatment with Bevacizumab by In the prospective single-centre study, 20 monthly injections in 2008. In 52 eyes (75.4 patients underwent bilateral EPI-LASIK using the per cent) there were complete resolution from 0.37 to 0.92 without it.

Zyoptix XP microkeratome with EPI Separator, of subretinal and intraretinal fluid after three to seven Postoperative pain levels on a subjective visual analogue and Technolas Perfect Vision excimer laser system, and 20 injections and remained stable for a minimum of three scale decreased comparably in all groups.

At day four, patients underwent LASEK with the same laser. Each patient months. Of these eyes, 13 underwent cataract surgery, and epithelial closure was completed in all eyes. In addition, at had one eye with a repositioned epithelial flap and one the remaining 39 eyes served as a control group. After a three months’ follow-up, there was no significant difference eye with a discarded flap. The trial was single-masked until follow-up of nine to 12 months, wet ARMD reactivation between the four groups in terms of the mean haze levels, postoperative day two and double-masked thereafter. occurred in four eyes (30.8 per cent) in the cataract the mean safety indices or the mean efficacy indices.

From the first postoperative day to three months’ followsurgery group, and in 14 eyes (35,9 per cent) in the control “No clinically significant differences of LASEK and EPIup, the average uncorrected visual acuity among those in the group.

LASIK could be detected regardless of epithelial flap retention Epi-LASIK group increased from 0.32 to 0.99 in eyes retaining “There was no significant difference of reactivation rate in terms of visual recovery, epithelial closure time, pain the epithelial flap and 0.41 to 0.98 among those from whom of wet age related macular degeneration after cataract perception and haze formation.

These treatment modalities the flap was discarded. Among those in the LASEK group, surgery and controls in Bevacizumab treated patients,” Dr may be used at the surgeon’s discretion,” Dr Taneri visual acuity improved from 0.26 to 0.96 with the flap and Radecka concluded. concluded.

32

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Feature

Out & About

A

WOC 2010 offers delegates the chance to see the great museums of Berlin

s it has regained confidence and pride of place at the centre of Europe, Berlin has been polishing its cultural credentials along with its buildings.

Always a city with culture in its heart, over the past couple of decades it has been restoring and adding to its museums so much that it’s difficult to know where to start – especially if you are a visitor with limited time.

The buzzy Berlin of new art and events happens all over the city, but to see its more traditional collections begin on the patch of land in the Spree known as Museuminsel – “Museum Island” – at the far end of Unter den Linden from the Brandenburg Gate. To get an overview of the clutch of great institutions gathered on this UNESCO Heritage Site, climb the 270 steps up into the 70-metre-high cupola of the restored Berliner Dom (open Mon-Sat, 9am-8pm, Sun noon-8pm, €5, www.berliner-dom.de), Berlin’s restored Italian Renaissance style cathedral which celebrated its centenary in 2005. On a fine day you’ll see as far as the Reichstag, and in any weather you will get a close-up of the dome’s splendid mosaics. Or, if you can only manage 170 steps, climb up to the dome’s outer walkway. Back on the ground, you will find that the cathedral has its own museum, too.

Nearby on Lustgarten is the Altes Museum, announced by a row of 18 classical pillars, which guard part of the island’s treasure of Greek and Roman antiquities.

Opened in 1830 as the Royal Museum, and designed by Karl Friedrich Schinkel, Prussia’s finest architect, one of the museum’s glories is the rotunda inspired by that of the Pantheon in Rome. Until last year, it

was also home to an Egyptian collection but this has now been moved to the restored Neues Museum which reopened in October last year [2009], with much fanfare.

Among the Neues Museum’s highlights are a room devoted to the archaeologist Heinrich Schliemann, who uncovered the site of the city of Troy in 1873 and gave his finds, including the hoard called Priam’s Treasure, to the museum. Amid the crowd of exhibits going back to the Stone Age, make sure to seek out on the second floor the famed Berliner Goldhut – usually translated as “Gold Hat”, a Bronze Age conical headdress of thin gold leaf stamped with astronomical symbols, and one of only four surviving in Europe. The jewel of its Egyptian collection is probably the bust of Nefertiti, still bearing traces of colour, though the Berlin Green Head is also a must-see. Named for the greenish colour of its stone, it is a rare sculptural portrait of a man, looking remarkably contemporary, from the late period when Egyptian was influenced by Greek culture.

Should you now go straight to the Alte Nationalgalerie, the Neues Museum’s neighbour on Bodestrasse, you may feel as if you’ve taken a trip in a time machine since its walls are hung exclusively with 19th-century art. The core of the collection was amassed by a banker, Joachim Wagener, and since its founding in 1861 has remained devoted to the art of that century. (Works of the 20th century acquired by the National Gallery can be seen at the Neue Nationalgalerie, or New National Gallery, at Kulturforum Potsdamer Platz, where you’ll also find the Gemäldegalerie collection of European Old Masters from the 13th to 18th century. Contemporary art is on

Journal Watch

by Sean Henahan

Closantel, a broad-spectrum salicylanilide anthelmintic used to treat parasitic liver disease in the veterinary setting appears to offer promise in the treatment of onchocerciasis, say researchers.

The discovery followed earlier research identifying a potential strategy of interfering with the filarial nematode Onchocerca volvulus parasite’s chitin metabolism. A database review suggested that closantel might do the trick. Further research confirmed that the compound was a potent and specific inhibitor of filarial chitinases. Notably, closantel was found also to completely inhibit molting of O. volvulus infective L3 stage larvae.

The WHO has achieved some success in slowing the course of onchocerciasis in Africa, primarily through the use of ivermectin. However, the fact that some 37 million people are still affected, and that resistance to ivermectin may be emerging, suggests that closantel provides promise in the hunt for new therapies against river blindness.

C Gloeckner, PNAS, “Repositioning of an existing drug for the neglected tropical disease Onchocerciasis”, 2010 107:3424-3429.

34

Credit: WHO

Old drug offers new approach to river blindness

show at the Hamburger Bahnhof – Museum für Gegenwart.)

On the top floor of the Alte Nationalgalerie you’ll find German Romantic paintings by Caspar David Friedrich and others, as well as art from the Biedermeier period. One floor down, the Germans are joined by the French masters – Manet, Renoir, Degas, Cézanne, Monet and Rodin are all represented, demonstrating the National Gallery’s foresight in collecting Impressionists from early on.

Take another whirl in your time machine and move further along the island to the Pergamon Museum and you’ll uncover a world-class pile of ancient treasure. Several blockbuster exhibitions in recent years have raised this museum’s profile and spread its renown. Though its offerings may not be German, so compelling are its riches that it is the highlight of many a visitor’s stay. The Pergamon is effectively three museums in one, with a collection of classical antiquities (Antikensammlung), a museum of the Near East in ancient times (Vorderasiatisches Museum) and a museum of Islamic art (Museum für Islamische Kunst).

Here, making your way through the 2,000 square metres of the Vorderasiatisches Museum, you can walk like a Babylonian, a Sumerian or even an Assyrian. Six thousand years of history unfold in rooms that contain huge reconstructions of great architecture of the past. Great lions still stalk the tiles of Babylon’s Processional Way, leading to the fabulous blue Ishtar Gate, ordered by King Nebuchadnezzar more than 2,500 years ago. It’s easy to imagine how our eastern ancestors would be impressed by its magnificence, since today’s visitors are equally awed by the sight.

It’s a similarly humbling experience to stand at the foot of the steps of the museum’s huge Pergamon Altar – made more so when you realise that this partial recreation is only one-third the size of the original. Don’t miss the 17-metre-high and 29-metre-wide Roman Market Gate of Miletus, the model of the Tower of Babel and the copy of the stela on which was written the code of King Hammurabi – one

by Renata Rubnikowicz

Bode Museum, Berlin

of the earliest examples of a legal system, or overlook the much smaller though equally significant clay tablets and seals showing some of the earliest uses of writing in Sumeria.

Do you still have any energy left? Then make your way to the tip of Museuminsel where the cupola of the Bode Museum arising from the water provides a neobaroque final flourish to the concentrated glories of this patch of land in the River Spree. Inside its spacious halls you will find one of the world’s largest sculpture collections as well as half a million coins, works from the Gemäldegalerie collection of Old Masters – the Mannheim High Altar, which dates from the 14th century is particularly noteworthy – and Byzantine art.

Opening Hours Altes Museum: daily 10am-6pm, Thursday 10am-10pm Neues Museum: Sunday-Wednesday 10am-6pm, Thursday-Saturday 10am-8pm Altenationalgalerie: daily 10am-6pm, Thursday 10am-10pm Pergamon Museum: daily 10am-6pm, Thursday 10am-10pm Bode Museum: daily 10am-6pm, Thursday 10am-10pm

A three-day pass giving admission to 70 Berlin museums costs €19. A museum pass combined with a Berlin Welcome Card (www.visitberlin.de) which gives unlimited bus and train travel and reduced-price admission to 150 other attractions costs €34 for 48 hours, €40 for 72 hours or €47 for five days.

More information: www.smb.museum.de For further information on WOC 2010, which takes place from June 5-9, 2010, visit www.woc2010.org.

by Seamus Sweeney

Classic knowledge and innovation combine in clinically relevant discussion of corneal disease

Keratoconus and Keratoectasia: Prevention, Diagnosis and Treatment Edited by Ming Wang and Tracy S Swartz. SLACK Incorporated, New Jersey, US, 2010

experts, from India, Norway, Brazil, Australia, the UK, Serbia, and the US. This was to allow the production of a single volume containing all the requisite information about the current state of the knowledge on the pathology of the condition, management approaches and n recent years, there has been a diagnostics. resurgence of interest in keratoconus and A thorough review of the anatomy, physics, keratoectasia. The former is the genetic and physiology of the cornea begins the book. form of corneal ectasia disease, while the The biomechanics of the cornea is an area latter is the non-genetic one. just beginning to be understood. Overall This, writes Dr Wang in the preface to corneal strength is the most important this book which he has edited, is due to factor in corneal shape maintenance, but three factors: Firstly, a new form of corneal the use of corneal thickness (pachymetry) ecstatic disease – keratoectasia – has been as an approximation for corneal strength is created, which is iatrogenic rather than less than ideal, as the assumption is made genetic, being a product of keratorefractive that corneas of equal thickness are equally surgery. Secondly, the imaging revolution strong in all individuals. This is a key point in which has left no area of ophthalmology distinguishing between the pathogenesis of untouched has created more powerful keratoconus and keratoectasia. Therefore, diagnostic instruments. Thirdly, several this section goes beyond purely theoretical innovative treatments have been developed concerns to bring us back to clinical for keratoectasia, such as Intacs ring segments application. and UV cross-linking.

Keratoconus has been with us for a long Dr Wang, whose Wang Vision Institute is time, and the first described incidence in the faros_250x140_EuroT_e 2.10.2009 14:49 Uhr dates Seite 1 1729. It was described based in Nashville, US, has assembled, and literature from then edited, a stellar cast of international in much greater detail by the British physician

I

Dr John Nottingham in 1854, in a meticulous account which differentiated keratoconus from other ectatic conditions. The German ophthalmologist Johann Horner dubbed the condition “keratoconus”. Stephen S Khackikian and Michael W Belin review this history, and lead on to a discussion of the clinical characteristics of keratoconus.

This is a useful review. This book, overall, combines established, “classic” knowledge with discussion of innovation and future directions very well, and this section overall is a good example. The focus returns to clinical relevance and applicability at all times.

We move on to a consideration of keratoectasia, which is put in the context of keratorefractive surgery to illustrate the key concepts for prevention, diagnosis and treatment. The medicolegal aspects of an approach to an acquired, iatrogenic condition is also discussed. Keratoectasia is a good example of a side effect of a surgical approach which initially was hailed as miraculous, but as time goes by and the miraculous becomes mundane, it is the side effect that begins to preoccupy clinicians, patients and indeed the media (not to mention the lawyers).

Feature

In Your Good Books

The book reviews the progress in diagnostics. It also discusses a new diagnostic modality, the posterior cornea. There is material on the wide range of major corneal imaging technologies, from ultrasound biomicroscopy for epithelial mapping to corneal wavefront measurements. This is very comprehensive and will certainly be of use to clinicians who have to order and interpret these diagnostic tools.

The traditional, non-surgical approach to management is the use of contact lenses.

This is discussed by Shawna L Hill of the Wang Institute. This is a detailed review which will be of much use to clinicians.

Then we move on to discussing surgical and innovative approaches. The use of riboflavin and ultraviolet irradiation is discussed in the penultimate chapter, with the book ending with a look at excimer laser lamellar keratoplasty and advanced cross-linking.

Overall, this is an extremely impressive book, which is well presented and laid out, and covers the entire range of clinically relevant material in a clear, concise and useful way.

Brings Light to the World

Ecknauer+Schoch ASW

by Oertli®, another milestone in eye surgery. Designed for cutting-edge surgical techniques and optimal results in cataract and vitreoretinal interventions, it is light, elegant and compact – a simply smart device made for you!

OS3

www.oertli-faros.com

35

Product Update

Product Update

New SCHWIND Artificial Chamber for Lamellar Keratoplasty Schwind has announced that with the new SCHWIND

Artificial Chamber, the Carriazo-Pendular microkeratome can now be used for an exact, reliable and easy preparation of the donor cornea in all methods of lamellar keratoplasty: anterior lamellar keratoplasty (ALK) as well as posterior lamellar keratoplasty.

“Thus the company offers two highly developed

technologies for corneal transplantation that perfectly complement each other,” said a Schwind spokeswoman. “With the SCHWIND Artificial Chamber and the Carriazo-Pendular, the donor graft is optimally prepared.

Pachymetry Assisted Laser Keratoplasty (PALK) with the SCHWIND AMARIS allows exact removal of damaged corneal layers on the recipient eye when the endothelium is intact.”

Oertli announces Faros milestone Oertli says that its new product Faros heralds another milestone in eye surgery, making cutting-edge operating techniques accessible to surgeons throughout the world.

“It fulfils the requirements of the most modern clinics just as well as it meets the challenges in developing regions and is therefore a light at the end of the tunnel for the healthcare sector, surgeons and patients,” said a company spokesman.

“Faros has been designed from scratch as a combined platform for work on the anterior and posterior eye segments but is also available as pure phaco machine with permanent upgrade possibilities to the posterior segment,” he said.

Handling is based on the DirectAccess® control by key pressure. “Oertli deliberately avoided a touch screen. Faros can be individually programmed by up to 50 surgeons. The device is controlled via a new dual linear pedal. In addition, the device has standard cable-free remote control,” said the Oertli spokesman.

Ellex announces first integrated yellow laser Ellex Medical Lasers Limited recently announced the launch of a new yellow laser photocoagulator, Integre Yellow™, at the 33rd Annual Meeting of the Japanese Society of Ophthalmic Surgeons (JSOS) in Tokyo.

Ellex said the Integre Yellow is the first and only laser system to offer highpower 561nm yellow in a unique, fully integrated design. The yellow wavelength

is considered a more gentle and patient-friendly option than other laser wavelengths used in ophthalmology to treat sight-threatening eye diseases, such as diabetic retinopathy.

“Compared to traditional 514/532nm green wavelengths, 561nm yellow creates a more gentle retinal burn and results in low scotoma (blind spot) formation.

Most importantly, treatment can be performed at lower energy settings, thereby improving patient comfort,” said Ellex CEO, Simon Luscombe.

Geuder says Megatron S4 offers perfection through flexibility Megatron S4 is a new combined system for the anterior and posterior segments of the eye which offers maximum flexibility, according to Geuder.

“Its revolutionary hybrid pump system with its three different types of vacuum (peristaltic, venturi-effect and venturi mode) enables a more immediate vacuum build-up – with only one cassette. Additional highlights include the revolutionary Inview Display, a display of relevant operation parameters in the microscope’s field of view, and the independence of external compressed air. Important economic aspects are the compatibility of the accessories with previous models and the maximal lifespan of the ultrasonic handpieces (ageing compensation). The S4 is easy and flexible to handle and requires minimal space,” she said.

36

by Howard Larkin

Acquisitions, new products, emerging markets consolidate Alcon’s position as leading eye care firm

W

ith operations in 75 countries, products sold in 180 countries and 2009 revenues of €4.8bn, Alcon Inc, Huenenberg, Switzerland, is the largest player in the global eye care market.

By aligning spending with strategic initiatives, the firm achieved organic sales growth of 6.3 per cent in 2009, increasing its market share worldwide and positioning itself for further growth through product development and acquisitions. Doug MacHatton, Alcon’s vicepresident of treasury and investor and public relations, spoke with EuroTimes about Alcon’s future.

Q: Alcon has announced several partnerships and acquisitions recently that significantly broaden your product offerings. These include AstraZeneca, Optonol, maker of the Ex-PRESS® Mini Glaucoma Shunt, Sirion, maker of ophthalmic anti-inflammatory and anti-viral drugs, and biotech firms ESBATech, which is developing anti-inflammatory drugs, and Potentia, which is developing a drug for macular degeneration. What is the overall strategy and how will it benefit patients and surgeons?

A: Our strategy is two-pronged: first, to establish platforms and capabilities that will enhance our ability to discover and develop innovative products and second, to increase our individual opportunities with specific transactions. The AstraZeneca and ESBATech deals fall into the first category of enhancing our capabilities as AstraZeneca brings us access to hundreds of potential molecules in multiple classes, many of which have been validated for activity in eye disease.

ESBATech will allow Alcon to become the “biotech company of ophthalmology.” We believe biotechnology is the next frontier in ophthalmology and we are positioned to move aggressively in that direction. Our deals with Philogene and Potentia are examples of the second part of our strategy in that they provide us additional potential compounds that we can validate through our process and add to our “shots on goal”. The Optonol and Sirion transactions are more commercially driven as they contribute to core growth with currently marketed products. We expect that Alcon’s global commercial capability will result in faster growth for these products as we go forward. Alcon’s global infrastructure and sound financial condition will allow these platforms, compounds and products to gain greater development resources and wider global distribution. Essentially this means more innovative products to help more people see better.

Q: Pharmaceuticals, particularly glaucoma medications, led sales growth in the fourth quarter. With the acquisition of Optonol, you

seem to be committing heavily to a broad range of glaucoma solutions. How do you see this market growing?

A: We expect that the treatment of glaucoma will be an important long-term growth driver for Alcon, supported by the ageing global population and the resulting increase in age-related conditions. We are intently focused on glaucoma both from a commercial standpoint and in our research activities. After a slight dip in usage in 2008/2009 in some areas, demand for glaucoma medications has recovered along with the global economy and also the recognition by patients that taking their medications for glaucoma is essential to maintaining their vision. Our global portfolio of glaucoma medications provides quality IOP control in all subclasses of therapy. By adding Optonol we gain an immediate entry into the surgical glaucoma segment with an innovative product that helps surgeons deliver the best possible outcomes to their patients. You can see by our actions that Alcon is committed to providing doctors and their patients with a full range of treatment options that reduce vision loss to glaucoma, the world’s second leading cause of blindness.

Q: In the fourth quarter you reported that premium IOL sales increased sharply on the strength of ReSTOR +3.0 gaining market share and the continued adoption of toric lenses. Yet industry-wide figures suggest that the overall share of cataract surgeries using presbyopiacorrecting lenses has stabilised. How do you see the market for premium lenses developing over the next year or so?

A: Over the long haul, it is without question that the total vision benefit advanced technology IOLs bring to surgeons and their patients will make these lenses the most important growth driver in the cataract market. As you note, the total market for these lenses has been fairly stable, but we have been able to gain market share with the introduction of new technologies in this category, especially the AcrySof® IQ ReSTOR® +3.0 and AcrySof® Toric IQ. As technology evolves and patients expect more from their cataract surgery, surgeon adoption of advanced technology IOLs will increase. In fact, we are hoping to introduce a ReSTOR Toric lens in Europe toward the end of 2010, which blends these two separate capabilities into one lens.

Q: What are you doing to increase your presence in emerging markets, particularly China and India?

A: With almost 90 per cent of the world’s visually impaired people living in developing countries, there are significant unmet medical needs in these emerging markets. Fortunately,

Feature

Outlook on Industry

most of these conditions can be treated with this seems to be levelling out recently. As currently available products. Our focus in the economy continues to recover and these countries is to build local infrastructure these countries get through their budget and sales force support, and to support difficulties, we expect growth rates will be physician education and training programmes more consistent with underlying demographic on advanced cataract surgery including foldable trends, which are clearly positive for eye IOLs and small incision phacoemulsification. care. We have significantly expanded our We are in the process of establishing a phaco commercial infrastructure in Europe, including training programme in China that will create the creation of a special sales force focussed four training centres. These programmes entirely on our broad portfolio of glaucoma have standardised curriculums designed to products including Travatan® and DuoTrav®, as well as the recently launched AZARGA®. As a provide education to Chinese ophthalmologists result, glaucoma sales growth was very strong so that they can perform phaco surgery in Europe at 14.8 per cent excluding currency. independently. And this effort in China is just the latest thing we are doing as we have more Q: How has the laser vision correction market than 15 partnerships with local institutions and been and when do you expect it to recover? doctors in India doing much the same thing.

We also partner with non-governmental A: Weak global economic conditions have organisations that are focussed on skills resulted in a significant decline of refractive transfer to achieve sustainable access to laser procedures on a global basis since early quality eye care in these emerging markets, 2008. We expect the laser vision market including China and India. We have also to remain weak, but stabilise in 2010. But, developed specific technology suited for use in as the economy and consumer confidence emerging markets with the Laureate® World Phaco System that is designed with advanced strengthen, we believe growth will return to phaco technology, but easyPhaco_sw_95x140_EuroTimes is more economically this market. 5.10.2009 10:43 Uhr Seite 1 priced for emerging markets. We expect rapid growth from these markets as their healthcare delivery systems widen and more people have access ® to care. They are experiencing Fluidics on… rapid economic Turn up vacuum (600 mm Hg/50ml for development peristaltic, 500 mmHg or more for venturi), and represent a and let the elaborate fluidics concept of significant area of the Oertli system work for you! both near- and long-term growth Even though it sounds implausible – Oertli easyPhaco® Technology brings to you potential because • unprecedented chamber stability there are millions • perfect emulsification of people who • efficient fragment aspiration can benefit from current and future And all of this without the undesired side eye care products effects hitherto caused by high vacuum. in these developing New and faster: Oertli easyPhaco® – the countries.

Discover the Magic of easyPhaco

technology which makes fluidics to your best friend

Q: Sales in Europe seem a little weak compared with other regions.

What growth opportunities do you see in Europe?

A: Sales in certain geographic regions, including Europe, have been affected by the global economic weakness, although

New and better: The Oertli easyTip® 2.2 mm Intelligent needle design and drastically improved fluidics properties – Oertli easyPhaco® Technology brings visible and perceptible advantages.

OS3

37

Feature

Practice Development

To buy or to lease?

Let lifespan of equipment, needs of practice and goals of business drive your decision

E

quipping an ophthalmology practice gets more expensive all the time. If you’re doing laser vision correction, the latest excimer and femtosecond lasers will set you back hundreds of thousands of euro.

Even if you don’t, advanced diagnostic equipment such as OCT, corneal topographers, Scheimpflug cameras and IOL Masters, are increasingly the price of entry for any sort of practice.

Basics – like slit lamps, fundus cameras and patient chairs aren’t cheap either – especially if you need five or six to support ambitious expansion plans.

In economics parlance, equipment costs are a barrier to entry to independent practice, notes Keith Willey BSc, MBA of London Business School, who gave the inaugural EuroTimes Practice Development Masterclass held at the XXVII Congress of the European Society of Cataract and Refractive Surgeons.

The question is how do you clear the barrier? Absent a deep-pocket investor, cash, loan or lease are the options.

One attendee of Prof Willey’s masterclass on entrepreneurship who runs a large practice in Singapore believes cash is the only way to go. “I only had one piece of equipment leased in my entire life. I added up how much I paid for it, and now I buy everything with cash. Why should I give money to the banks?”

But while paying interest may seem like an unnecessary expense, the cost of

delaying an equipment acquisition until you can pay out of pocket is often much higher, Prof Willey says. The time you wait while saving delays the revenues and referral base you could gain from launching your practice sooner. These losses can never be recovered and permanently reduce the return on your investment in the medical and surgical skills that are your primary practice asset.

Even if you don’t have to wait for the cash, large outlays tie up working capital that might be more productively deployed.

You may be able to generate a return on your assets by using it to start up or expand operations that exceeds your lease or loan costs. Having cash on hand also gives you flexibility to adjust your business strategy as market conditions change.

Leveraging skills, assets, credit – and ideas – to reach your practice goals fits one popular definition of entrepreneurship, which is “the relentless pursuit of opportunity without regard to resources currently held,” Prof Willey says. “I’m not saying go without [equipment]. I’m saying, ‘Why would you pay for it if you can get someone else to take the risk?’ I would encourage you not to.”

It’s an approach that another masterclass attendee from India applied to good effect.

“We built a $2m practice without paying anything upfront. We got some surgeons to try the place and some companies to deliver the machines and finance them.

Now our practice is paying, and we are

In economics parlance, equipment costs are a barrier to entry to independent practice, notes Keith Willey BSc, MBA of London Business School paying as the revenues come in.”

So the question often becomes whether a lease or a loan is the better alternative.

Straightforward financial considerations like the price and effective interest rate you pay are significant. But so are less certain factors, such as the expected useful life of the equipment in your particular situation and its resale value, if any. Whether you should lease or buy depends on your practice goals, local market situation, the type of equipment you are buying and your own values and risk tolerance. Here are three things to consider: Projected equipment lifespan Many ophthalmic technologies are advancing at a breakneck pace, including refractive lasers and diagnostics. Others don’t change much, like slit lamps and phoropters.

Generally speaking, the quicker a piece

Advantages and pitfalls of buying and leasing Ownership

Taxation

Capital costs

38

Advantage

Once paid, you own it.

Total costs may be lower over long periods.

At the end of the lease you can opt to buy.

You have no risk if you need to trade up.

Pitfall

You may be stuck with obsolete equipment

Buying out residual value may be costly if you decide to keep equipment

Advantage

Depreciation extends over longer period

May be able to write off entire expense as operating expense as it is incurred

Pitfall

Extended depreciation may delay and/or limit deductions

Advantage

Overall financing costs may be lower

Pitfall

Ties up capital that might generate better returns invested in practice operations

No or reduced capital outlay freeing assets for more-productive use

by Howard Larkin

of equipment is likely to become obsolete, the more sense it makes to lease. You may be able to use the device for five years and then exchange it for a new one having paid a fraction of the purchase price. On the other hand, if the equipment will last long beyond the scheduled payments, it may make sense to go for a capital lease, with which you may buy the device for a nominal sum at the end of the lease, or a straight loan. In either case you will be paying the entire price rather than just depreciation.

Note that the effective lifespan of a piece of equipment is also influenced by market considerations. If you are in an area where you must compete based on having the latest technology you will need to upgrade more often. Also, if you are targeting the high end of any market you may get less use out of equipment. This may even apply to equipment with a long mechanical life. “If you go the Dickensian route and have a dusty second-hand, slit lamp, your patient will notice that,” one masterclass participant observed.

Resale value and market Related to equipment life is its resale value and the second-hand market for such equipment. If a piece of equipment will have little or no value when you need to replace it, or if it is difficult to find a buyer, a lease may be advantageous since it will reduce your risk and the hassle of selling.

However, a global market exists for used medical equipment and a broker may be able to help you as you trade up.

Accounting and tax considerations Leases and purchases are often handled differently under accounting and tax rules.

When buying equipment the expense you can write off in a given year may be limited to the interest you paid and a portion of the equipment as determined by a depreciation schedule. On the other hand leases often can be structured so the entire cost can be written off as an operating expense as it is incurred, which may make it possible to reduce tax payments. Also, accounting for a lease may be simpler since it is a single charge instead of two charges.

Of course, tax laws vary by country and your individual market, financial and practice circumstances are unique. It may be worthwhile to consult an accountant or practice consultant experienced in practice development to help you develop an equipment acquisition plan that will meet your practice goals and save you the most money.

O

ne of the biggest challenges in converting the promise of stem cell therapies into clinical use is to define the elixir that directs the embryonic stem cell to produce the desired fully differentiated specialised cell type. Following significant tinkering and a little luck, researchers at the HadassahHebrew University Medical Centre in Jerusalem have now reported the production of fully differentiated functioning retinal pigment epithelium (RPE) cells, cultured in the lab and delivered to animal models.

The new findings are set to invigorate the field of stem cell therapies for ocular disease and represent a significant milestone on the road to clinical use.

Dysfunctional and degenerating RPE cells are found in several retinal disorders, including Best disease, sub-types of RP, and age-related macular degeneration (AMD), all of which may stand to benefit if the technology can be developed for human application.

While many research groups are active in the field of stem cell therapies the major achievement by the Israeli group was the increase in the proportion of RPE cells produced from a stock of human embryonic stem cells (hESCs). The “magical” ingredient bringing about such an increase appears to be nicotinamide (NIC) – a precursor of the co-enzyme b-nicotinamide adenine dinucleotide [NAD+] involved in the production of ATP (adenosine triphosphate) in the mitochondria.

The apparently serendipitous addition of nicotinamide to floating embryoid bodies increased the number of observed developing pigmented areas from 13 per cent to 78 per cent after eight weeks. While still a significant step away from a 100 per cent pure RPE cell population, the increase represents a dramatic improvement on previous protocols.

RPE function The loss of RPE function leads to the eventual degeneration of photoreceptors in ocular diseases such as AMD, Best’s disease and certain forms of retinitis pigmentosa. The RPE layer itself sits between the neural retina and the choriocapillaris where it plays a critical role in the maintenance and function of the photoreceptor cell layer. Disruption of the RPE in AMD has driven many academic and commercial groups worldwide to focus on the potential of cell-based therapies to replace dysfunctional RPE cells with working RPE cells. A key challenge in this process is the limited availability of

functioning RPE cells. Human embryonic stem cells (hESCs) represent an attractive source for such RPE cells. If culture conditions can be controlled to reliably increase the yield from the starting hESCs to the fully differentiated RPEs then a significant barrier to the clinic will have been overcome.

Previous research work from several groups has clearly demonstrated the potential of this field by showing rescue of photoreceptor function in animal models using transplanted RPEs. In 2007 a partial restoration of visual function was shown in humans following autologous RPE layer transplantation however, the goal has been to replace the autologous source of cells with stem cell derived RPEs. Harvesting of RPE cells from hESC cultures after spontaneous differentiation has been hugely inefficient, often providing yields of one per cent or lower. The addition of neural cell factors and antagonists known to play an important role in development has increased the yield somewhat but efficiency remains a challenge.

The new findings by the Israeli research team, led by Drs Maria Idelson and Ruslana Alper, have opened new ground in the field by dramatically increasing the yield of RPE cells through the addition of nicotinamide (NIC) to cultures of hESCs. Cell cultures supplemented with NIC promoted the differentiation of hESCs to neural and then to RPE cell fate. [Idelson et al, Cell Stem Cell 5, 396-408, 2009.]

The new findings are set to invigorate the field of stem cell therapies for ocular disease How NIC works is not yet clear; however, gene expression microarray analysis of the differentiating hESCs shows a 2.9-fold decrease in genes associated with apoptosis. This observation suggests that prevention of programmed cell death rather than proliferation somehow promotes neural differentiation and such information may contribute to further finetuning of the system.

Detailed analysis across a range of time points have shown that the addition of NIC to hESC cultures promotes a course of differentiation which essentially replays the steps of embryological development of RPE cells in vivo. In other words the research team may have found the precise path required to direct a pluripotent stem cell into a mature fully differentiated

Credit: National Eye Institute, National Institutes of Health

By Gearoid Tuohy

Stem cell production of functional RPE cells marks milestone in therapeutic development

Feature

Bio-Ophthalmology

Confocal image of rat RPE layer two weeks after laser. A well-defined neovascular membrane labeled with Isolectin Ib4 (red) is detected below proliferating RPE cells (Phalloidin in green). New vessels are growing toward the subretinal space

neuron. If additional tinkering increases the yield further it would appear that a practically unlimited source of RPE cells could be made available for therapeutic transplantation. With such a goal in mind the researchers looked to the literature in embryology where studies with chick embryos had shown that Activin and other factors from the TGF-beta superfamily of proteins played a key role in patterning the optic vesicle into RPE. To test a potential augmenting role for Activin the researchers added the component to their cultures in the presence of NIC and found a dosedependent effect on RPE differentiation.

In an elegant reference to the logical use of Activin and the chance finding of NIC, Drs Barbara Corneo and Sally Temple, at the New York Neural Stem Cell Institute, described the breakthrough in a Cell Press commentary entitled “Sense and serendipity aid RPE generation”.

Follow-up analysis Analysis of the new cells in vitro showed that the RPE derived cells had RPE-like morphology and immuno-staining of the mature pigmented cells revealed the expression of markers such as RPE-65, CRALBP and bestrophin. Of course, morphology and markers are of little use without function and so the research team tested the phagocytic abilities of the cell by incubating RPE-derived cultures with latex beads and mouse purified photoreceptor outer segments. Confocal microscopy showed that the RPEs in the dish could engulf and digest both beads and outer segments which provided sufficient

motivation for the research team to test the hESC derived cells in a live animal model.

Drs Idelson and Alper chose the RCS rat as the appropriate animal model to test their freshly minted RPE cells. The RCS rat has a primary mutation in the receptor tyrosine kinase gene (Mertk) resulting in a severe disruption of the RPE cells in which they fail to phagocytose the shed photoreceptor outer segments. This failure of the RPE subsequently results in secondary degeneration and loss of photoreceptors within eight to 12 weeks. Having produced RPE batches of cells expressing several markers of RPE biology the research team sub-retinally transplanted the stem cell-derived RPE cells into the three-week-old animal models of impaired retinal function (RCS Mertk rat). Within six weeks of treatment researchers observed an improved ERG and preservation of retinal function compared to controls.

Follow-up analysis out to 13 weeks of age confirmed a significant functional rescue in addition to the encouraging finding that transplanted RPE cells appeared to be functioning healthily in respect of rod photoreceptor outer segment phagocytosis. Importantly, confocal microscopy was capable of showing that transplanted RPE cells contained ingested rhodopsin from shed photoreceptor outer segments while the native RPE cells from the RCS rat contained only minimal traces of rhodopsin. Clearly, rescue of the RCS phenotype was been mediated through the transplanted hESC derived RPE cells.

39

JCRS Highlights

JCRS Highlights

by Thomas Kohnen

Journal of Cataract and Refractive Surgery jointly published by the ESCRS and ASCRS

Negative dysphotopsia Despite many years of study and

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discussion, the issue of negative dysphotopsia following cataract surgery remains an enigma, notes JCRS editor

Nick Mamalis MD in an editorial. He reviews the current understanding of dysphotopsia, noting that significant negative dysphotopsia symptoms have now been reported with virtually all IOL materials. In a related study, VĂĄmosi and colleagues evaluated the results of IOL exchange in cases of severe negative dysphotopsia, and measured the distance between the iris and the IOL optic using ultrasound biomicroscopy. Čą ČąĹ&#x;Ĺ&#x2013;Ĺ&#x2013;Č&#x203A; They reported five eyes of four patients among 3,806 cataract procedures had severe negative dysphotopsia symptoms. Intraocular lens exchange was performed in three cases. In one case, the secondary IOL was implanted in the reopened capsular bag and the symptoms persisted. In two cases, the secondary IOL was implanted in the ciliary sulcus and the symptoms resolved.

Ultrasound revealed a mean 7KH DOO LQ RQH %LRPHWHU iris-optic distance of 0.45mm .HUDWRPHWHU 3DFK\ Âą 0.07 in the symptomatic PHWHU 3XSLOORPHWHU group, compared with 0.59 DQG ,2/ FDOFXODWRU Âą 0.29mm in a control group, and 0.00mm in the *HW XS WR QLQH PHDVXUHPHQWV sulcus-fixated group. The LQ RQH VKRW LQFOXGLQJ OHQV reduction of the iris-IOL WKLFNQHVV distance following IOL exchange appeared to be $OO PHDVXUHPHQWV XVLQJ related to resolution of the ODVHU RSWLFDO WHFKQRORJ\ severe negative dysphotopsia $OLJQ RQFH JHW DOO UHVXOWV symptoms.

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N Mamalis, JCRS, â&#x20AC;&#x153;Negative dysphotopsia following cataract surgeryâ&#x20AC;?, March 2010, Volume 36, Issue 3, 371-372.

P VĂĄmosi et al., JCRS, â&#x20AC;&#x153;Intraocular lens exchange in patients with negative dysphotopsia symptomsâ&#x20AC;?, March 2010, Volume 36, Issue 3, 418424.

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40

Accommodating IOLs â&#x20AC;&#x201C; meta-analysis Despite many studies seeking to characterise the function and effectiveness of accommodating IOLs, it remains unclear whether accommodating IOLs truly restore accommodation in cataract surgery patients.

Takakura and colleagues performed a meta-analysis of 12 randomised controlled trials to characterise the functional performance of accommodating IOLs versus that of standard monofocal IOLs. Lenses included the 1CU accommodating IOL, the BioComFold, the Crystalens AT-45, and the KH-3500 (Lenstec).

There was no clear evidence of near acuity improvement despite statistically significant pilocarpine-induced anterior lens displacement in some studies.

With regard to adverse effects, PCO consistently emerged as an important complication of accommodating IOLs. The researchers urged caution in interpretation of the results, noting substantial heterogeneity between the studies.

A Takakura et al., JCRS, â&#x20AC;&#x153;Functional assessment of accommodating intraocular lenses versus monofocal intraocular lenses in cataract surgery: Metaanalysisâ&#x20AC;?, March 2010, Volume 36, Issue 3, pages 380-388.

Black pen vs. computer Cyclotorsional errors are a concern when using LASIK to treat myopic astigmatism. Researchers in Taiwan compared the efficacy and safety of manual limbal markings and wavefrontguided treatment with iris-registration software in conjunction with LASIK. This retrospective study included 118 eyes treated from July 2004 to June 2005.

They found that manual limbal reference markings and wavefront-guided ablation with iris-registration software were both safe and effective. There were no statistically significant differences in vector analysis results between the two groups. They suggest that limbal markings be routinely used in all LASIK procedures for astigmatic correction to ensure the least errors and provide the best postoperative outcomes.

EP Shen et al., JCRS, â&#x20AC;&#x153;Manual limbal markings versus iris-registration software for correction of myopic astigmatism by laser in situ keratomileusisâ&#x20AC;?, March 2010, Volume 36, Issue 3, 431-436.

Feature

EU Matters New code of recruiting practice to deter EU from poaching ophthalmologists from developing countries

A

proposed international code of practice could restrict health systems in EU countries from recruiting ophthalmologists and other health professionals in developing countries in a manner that unfairly deprives those countries of their services.

In drafting the code, the World Health Organization (WHO) says it hopes to preserve fragile health systems in developing counties, where ophthalmologists and other specialists are in short supply.

The code, formally known as the “WHO code of practice on the international recruitment of health personnel,” is scheduled for discussion and adoption by the WHO’s governing body – the World Health Assembly – at its next annual meeting in May in Geneva.

Although the code will not have the force of law, the WHO hopes all 193 countries that belong to the organisation will introduce their own national laws and guidelines to enforce the code’s principles, standards and practices for the international recruitment of doctors and other health professionals.

“Acute shortages, and the uneven distribution of health workers within and between countries amount to a global health workforce crisis,” according to the WHO. Managing international migration In addition to the code, the WHO is attempting to manage international migration and motivate physicians and other health professionals to remain in their workplaces through a number of initiatives and networks, including its Vision 20/20 programme.

There is little doubt that ophthalmology services in the developing world could be assisted by such a code. WHO statistics indicate that more than 87 per cent of the world’s 314 million visually impaired persons live in developing countries. In many of those countries there is only one ophthalmologist for every 100,000 or more persons. One tragic result of such an imbalance is that cataracts are the leading cause of blindness in the developing world.

In dozens of developing countries, fewer than 500 persons per million of population undergo cataract surgery each year. By contrast, the annual rates of cataract surgery in many EU countries surpasses 5,000 per million of population.

Against that background, the proposed WHO code of practice hopes to correct the worldwide imbalance of ophthalmologists and other specialists to help correct the unequal distribution of healthcare services.

“Addressing present and anticipated shortages in the health workforce is of critical importance to protecting global 42

by Paul McGinn

the adoption of appropriate measures.

Such measures may include the provision of targeted technical and developmental assistance, access to specialised training, technology and skills transfers, and the support of return migration, whether temporary or permanent.

In addition, the code encourages countries to engage in professional exchanges.

“Member States in both source and destination countries should encourage and support health workers to utilise work experience gained abroad for the benefit of their home country.”

More than 87 per cent of the world’s 314 million visually impaired persons live in developing countries

“Acute shortages, and the uneven distribution of health workers within and between countries amount to a global health workforce crisis,” according to the WHO health,” the code states. “International recruitment can make a legitimate contribution to the development and strengthening of a national health workforce.

However, the development of voluntary international standards and the coordination of national policies on international health worker recruitment are desirable in order to maximise the benefits to and mitigate the potential negative impact on countries and to safeguard the rights of health workers.”

Ethical recruitment practices The draft code provides that “ethical recruitment practices should also promote equality of treatment of migrant health workers with the domestically trained health workforce by ensuring that migrant health workers are not subjected to improper or fraudulent conduct.”

Any employer that hires migrant health workers should also ensure that they are treated fairly once they take up their employment. “In all terms of employment and conditions of work, migrant health personnel should enjoy the same legal rights and responsibilities as the domestically trained health workforce, without discrimination.”

The WHO code also stresses that countries have a responsibility to run their own health services in a manner that does not rely on migrant doctors and healthcare professionals from poorer countries. “Member states should work towards establishing effective health

workforce planning that will reduce their need to recruit migrant health personnel.

Policies and measures to develop the health workforce should be appropriate for the specific conditions of each country and should be integrated with national development programmes,” the code provides. “The specific needs and special circumstances of countries, especially those developing countries and countries with economies in transition that are particularly vulnerable to health workforce shortages and/or have limited capacity to implement the recommendations of this code, should be considered.”

Relevant and accurate disclosure Under the WHO code, each country should ensure that: a) migrant health workers enjoy the same legal rights and responsibilities as the domestically trained health workforce in all terms of employment and conditions of work; b) recruiters and employers provide migrant health workers with relevant and accurate disclosure about any health worker position that they are offered; c) recruiters and employers observe fair contractual practices to mitigate the potential negative impact of international recruitment of health workers through

Regulation of recruiters and employers The code also calls on all countries to regulate and monitor recruiters and employers “to ensure that the services performed by recruiters and employers in connection with the recruitment and placement of migrant health workers are rendered free of charge to health workers.” The code adds that migrant health professionals should be offered all appropriate induction and orientation programmes once they take up their posts.

The code also calls for an international information exchange on migrant health workers.

To promote and facilitate the exchange of such information, every country should: i. keep and update data on the recruiting and migration of health workers; ii. establish and maintain a database of the laws and regulations related to health personnel recruitment and migration; iii. provide such data to the WHO every two years.

The code also recommends that each country designate a national authority responsible for the health worker migration and the code. “The designated national authority should be authorised to communicate directly or, as provided by national law or regulation, with designated national authorities of other Member States and with WHO and other regional and international organisations concerned, and to submit reports and other information to WHO,” the code provides.

To ensure that the code is implemented as broadly as possible, the WHO recommends that all stakeholders in the recruitment of health workers – recruiters, employers, health professional organisations, regional, and international governmental and non-governmental organisations – be consulted about all decisions affecting the international recruitment of health personnel.

For more information about the “WHO code of practice on the international recruitment of health personnel,” visit the World Health Organization’s website at www.who.int.

Industry News

Industry News

Recent developments in the vision care industry

Regulatory Update Uveitis treatment Lux Biosciences has announced a twopronged regulatory campaign in which it will submit simultaneous regulatory filings to both the US FDA and European Medicines Agency (EMEA) seeking marketing approval for its investigational drug Luveniq™ (LX211; oral voclosporin) for the treatment of non-infectious uveitis involving the intermediate or posterior segments of the eye. The company cites two controlled, randomised, multi-centre trials including data from 450 patients at 56 sites in seven countries to bolster its case. The safety data include a total of 2,110 subjects who received voclosporin during its clinical development in uveitis and psoriasis, about 500 of whom were treated for at least 36 weeks and about 200 for at least 52 weeks. LX211 had previously received orphan drug status from FDA and EMEA, and fast track status from FDA. Based on the latter, Lux Biosciences has requested priority review from FDA. The drug is the oral form of a next-generation calcineurin inhibitor, voclosporin. Like other molecules of this class, the compound reversibly inhibits immunocompetent lymphocytes, particularly T-lymphocytes, and it also inhibits lymphokine production and release.

Lux Biosciences has exclusive worldwide rights to voclosporin for ophthalmic use and is cooperating with the team at Isotechnika Pharma who discovered the molecule and are developing for psoriasis and organ transplantation. www.luxbio.com

Stem cell advance THE US FDA granted orphan status to Advanced Cell Technology’s MA09-hRPE cells for use in the treatment of Stargardt’s Macular Dystrophy. This status brings a number of benefits, including tax credits, access to grant funding for clinical trials, accelerated FDA approval and allowance for marketing exclusivity after drug approval for a period of as long as seven years. Orphan drug designation is granted to companies with products aimed at treatment of a rare disease or condition that affects fewer than 200,000 Americans. The National Institutes of Health recently proposed broadening the definition of a human embryonic stem cell to include ACT’s “single blastomere technology platform” which was used to derive ACT’s MA09-hRPE cells. The novel treatment for eye disease uses stem cells to re-create RPE cells. In earlier studies the cells restored vision in animal models of macular degeneration.

New laser for retinal therapy The OD-OS company reported receiving FDA 510k Clearance to market its Navilas system for retina laser therapy. The company also recently received the CE mark for the system. The new navigated laser system incorporates advanced imaging with retinal laser therapy in a planned and controlled way using the image registration in one device with integrated workflow to improve the safety, accuracy, speed, comfort and transparency of retina laser photocoagulation, the company says. The Navilas system produces a live image of the fundus in true colour, IR and red-free as well as fluorescein angiography (FA) with 50-degree field-of-view on a monitor panable across the fundus.

Company News

Staar approval The Japanese Ministry of Health, Labour and Welfare approved Staar Surgical’s application to market the Visian Implantable Collamer Lens (ICL) in Japan. The agency approved marketing the Visian ICL for the treatment of myopia. Staar announced it intends to file a partial change application for approval of the Visian Toric ICL in Japan as soon as practicable following discussions with the Pharmaceuticals and Medical Device Agency (PMDA).

EyeDock app

Anyone who prescribes contact lenses

might want to check out a new iPhone application called EyeDock. The application provides a searchable contact lens database according to name, manufacturer or specific parameters and includes tables for keratometry to base curve conversion and for vertexing lens power. Free to download, EyeDock’s contact lens application requires either a no-cost 30-day trial subscription or a paid annual subscription from EyeDock. com, allowing access to the contact lens database. The app is available for download from the Apple iTunes store.

Revenue down but mood up at Carl Zeiss Meditec In the first three months of financial year 2009/2010, Carl Zeiss Meditec generated revenue of €156.2m (previous year: €177.9m). The yearMichael Kaschke on-year decline of 12.2 per cent is mainly due to the previous year’s quarter, which was influenced by the negative effect of exchange rate fluctuations totalling €8.3m. The gross margin, on the other hand, increased from 50.3 per cent to 50.7 per cent.

Earnings before interest and tax decreased by 13.1 per cent year-on-year to €18.7m (previous year: €21.5m). The EBIT margin, however, remained almost stable at 12.0 per cent (previous year: 12.1 per cent), despite a decline in revenue. Cash flow from operating activities increased year-on-year and amounts to €7.7m (previous year: €4.0m).

“We consider ourselves well equipped – if markets continue to stabilise and recover – to be able to continue on our growth course of the past year, with corresponding increases in profitability,” says Dr Michael Kaschke, president and CEO of Carl Zeiss Meditec AG. * Since this announcement was made Dr Ludwin Monz has taken over as CEO of Carl Zeiss Meditec with Dr Kaschke returning to his former position as chairman of the company’s Supervisory Board. (See Outlook on Industry, EuroTimes, March 2010).

www.staar.com

www.apple.com/itunes/

www.meditec.zeiss.com

www.advancedcell.com

Journal Watch

www.od-os.com

Online

by Sean Henahan

Ocular herpes, stroke link

Neuron transplants reopen eyes

Patients with herpes zoster ophthalmicus appear to have an increased risk of stroke, a new study suggests. Researchers identified 658 people diagnosed with ocular shingles and 1974 without the infection. None of these people had a history of stroke at the beginning of the study.

During the one-year study, stroke developed in 8.1 per cent of the people with shingles and 1.7 per cent of the people without shingles. The results held true regardless of age, gender, high blood pressure, diabetes, heart disease and medications.

Transplanting foetal neurons into the brains of young mice renewed plasticity in visual development, report biological researchers. For a specific period, shortly after birth, if one eye is constantly covered, the brain’s visual cortex can rewire itself so that the neurons formerly devoted to receiving information from the covered eye are instead controlled by the working eye. Researchers transplanted immature neurons (from shortly before birth) into the brains of slightly older, newborn mice. As the mice developed, their visual cortex went through the normal critical period. However, the transplanted cells then initiated a new critical period at a later time that corresponded to the out-of-step age of the transplanted neurons. The transplanted neurons were inhibitory neurons, meaning they dampen signals, as opposed to amplifying them. The researchers propose that inhibitory neuron transplantation may offer a means to repair damaged brain circuits.

The study also found the people with shingles were more likely to have ischemic stroke, and less likely to have hemorrhagic stroke. The researchers found that there was no difference in the risk of stroke between people who received antiviral drugs and those who did not. The researchers believe that shingles could be a marker for stroke. However, they caution that further research is needed because the study did not account for stroke risk factors such as cigarette smoking.

Also, the results are based on people in Taiwan, and there may be differences in stroke risk compared to other populations.

DG Southwell et al., Science, “Cortical Plasticity Induced by Inhibitory Neuron Transplantation”, 26 February 2010: 1145-1148.

Jau-Der Ho et al, Neurology, Volume 74, Issue 9, March 3, 2010, online issue 43

April 2010

Calendar April

7-9

Boston, ma, USA World Cornea Congress VI

Web: www.corneacongress.org

9-14

Boston, ma, USA ASCRS/ASOA Symposium and Congress

Web: www.ascrs.org

May 2010 19-22 NATAL, BRAZIL XI International Congress of Cataract and

Refractive Surgery

Web: www.catarata-refrativa.com.br/2010

19-22

ROME, ITALY 8th SOI International Congress

Web: www.soiweb.com

June 2010 5-9

BERLIN, GERMANY World Ophthalmology Congress

June 2010

Web: www.woc2010.de

VENICE, ITALY

VENICE, ITALY 1st EuCornea Congress

17-19

17-19

Web: www.eucornea.org

1st EuCornea Congress Web: www.eucornea.org

July 2010 2

Brighton, East Sussex, UK Contact Lens Basics and Laser Refractive Surgery Complications Course

Email: richard.lee@bsuh.nhs.uk

9-11

Web: www.aegeancornea.gr

18-23

MONTREAL, CANADA ISER 2010 XIX Biennial Meeting of the International Society for Eye Research

16-19

Web: www.aao.org/annual_meeting

21-24

Hamburg, germany 23rd International Congress of German Ophthalmic Surgeons

2-5

CRETE, GREECE Aegean Cornea X

September 2010

4-8

9-11

7

12-16

GENEVA, SWITZERLAND PRESBYMANIA 2010

Web: www.presbymania.com

16-20 13-15

MUMBAI, INDIA EyeAdvance 2010

Web: www.eyeadvance.com

20-22

Web: www.euretina.org

XXVIII Congress of the ESCRS

Web: www.escrs.org

MUNICH, GERMANY 28th Annual ESOPRS Meeting

Vilnius, Lithuania XIII Baltic Ophthalmologicum Balticum

9-12

EDINBURGH, SCOTLAND SIDUO XXIII Congress (International Soc. of Ophthalmic Ultrasound)

Web: www.siduo2010.org

Beijing, China 25th Congress of the Asia-Pacific Academy of Ophthalmology (APAO) in combination with the 15th National Congress of the Chinese Ophthalmological Society (COS) Website: www.apao2010beijing.org

11

BELGRADE, SERBIA 3rd International Symposium on Macular Disease

Web: www.ever.be

ISTANBUL, TURKEY 15th ESCRS Winter Meeting

Web: www.escrs.org

September 2011 17-21

vienna, austria XVIX Congress of the ESCRS

Advertising Directory

Web: www.milosklinika.com

February 2011

crete, greece European Assocation for Vision and Eye Research 2010

MACAU, CHINA The International Symposium on Ocular Pharmacology and Therapeutics – ISOPT ASIA

Web: www.isopt.net

October 2010 6-9

Web: www.doc-nuernberg.de

18-20

Web: www.fob2010.com

chicago, IL, usa American Academy of Ophthalmology

December 2010

Web: www.esoprs2010.org

Web: www.kenes.com/iser

August 2010

Paris, France 10th EURETINA Congress

Web: www.escrs.org

Abbott Medical Optics

Bausch & Lomb

Croma

Katena

Oculus

Reichert

Wills Eye Institute

Tel: +49 7243 501 610 Fax: +49 7243 501 100 www.abbottmedicaloptics.com Page: IFC

Tel: + 44 134 438 0406 Fax: + 44 134 445 4570 www.bausch.com Page: 17

Tel: +43 2262 / 68468 -0 Fax: +43 2262 / 68468 -165 www.croma.at Page: 24

Tel: + 1 9739891600 Fax: + 1 9739898175 www.katena.com Page: 12

Tel: + 49 64120050 Fax: + 49 6412005295 www.oculus.de Page: 10

Tel: +1 7166864500 www.cornealhysteresis.com Page: 30

www.willseyeonline.org Page: 8

Alcon Tel: +1 817 293 0450 Fax: +1 817 551 8968 www.alconlabs.com Pages: 15, OBC

ASCRS / Eyeworld Tel: + 1 703 591 2220 Fax: + 1 703 591 0614 www.ascrs.org Pages: 33, 41

Benz Research and Development www.benzrd.com Page: 3

Carl Zeiss Tel: +49 3641 220 333 Fax: +49 3641 220 332 www.meditec.zeiss.com Page: 24

D.O.R.C International BV

NIDEK

Tel: +31 181 45 80 80 Fax: +31 181 45 80 90 www.dorc.nl Page: 28

Tel: +81 3 5844 2641 Fax: +81 3 5844 2642 www.nidek.com Page: 18

Haag Streit

Novamed Orbtex

Tel: +49 4103 709 02 www.haag-streit.com Pages: 11, 40

Tel: +44 1382-774777 Fax: +44 1382-775777 www.orbtex.com Pages: 19

Oertli Instrumente AG Tel: + 41 71 7474 200 Fax: + 41 71 7474 290 www.oertli-instruments.com Pages: 35, 37

Rayner Intraocular Lenses Limited Tel: +44 1273 205401 Fax: +44 1273 324623 www.rayner.com Page: IBC

Rumex Tel: + 1 7275680909 Fax: + 1 7275680919 Page: 21

VSY Tel: +90 216 455 96 96 Fax: +90 216 455 96 90 www.vsybiotechnology.com Page: 5

WOC www.woc2010.org Page: 13

Zeimer Tel: +41 323327050 www.ziemergroup.com Page: 16

Please visit us on booth 2734 at the ASCRS Boston 2010

RAYNER Toric IOL experts, the world over.

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