January - March Issue

VOLUME 4 ISSUE1 JANUARY-MARCH 2009 AA PPuubblliiccaattiioonn bbyy tthhee EEuurrooppeeaann SSoocciieettyy ooff CCaattaarraacctt && RReeffrraaccttiivvee SSuurrggeeoonnss

14–17 May 2009 Nice Acropolis Centre, Nice, France 99TTHHEEUURREETTIINNAA CCOONNGGRREESSSS EEUURREETTIINNAA 22000099 European Society of Retina Specialists NNiiccee,, FFrraannccee Tel: +353 1 210 0092 Fax: +353 1 209 1112 Email: euretina@euretina.org Web: www.euretina.org Preliminary Programme now available online www.euretina.org

1 The 67th All India Ophthalmological Conference will be held in Jaipur at the B M Birla Auditorium from the 5-8 of February.This will be the largest meeting of 2009 in India and may well cross 8000 delegates. Jaipur,the capital of Rajasthan,is known as the Pink City as there are many buildings built of pink sandstone.There will be free papers, instructional courses,symposia,a video competition session among other scientific and cultural events.Included in the scientific sessions are topics such as lacrimal disorders,diabetic retinopathy,complicated situations in cataract,microincision cataract surgery,sleeveless phaco, glaucoma filtration and strabismus updates,and many more. Some of the new advances covered will be amniotic membrane transplantation,advances in VEGF therapy,accommodating lenses, techniques to manage subluxed cataracts,wavefront-guided LASIK and DSEK. Topics such as phaco with increasingly smaller incisions,newer advances in non-penetrating glaucoma surgery and advances in machine and lens technology are bound to occupy centre stage at the meeting. There is a perennial shortage of corneas in India.Sessions on artificial cornea will be well attended as they offer an alternative when donor tissue is not available. Oculoplasty will be covered in this meeting with topics like orbitotomy,advances in squint surgery,dacryocystorhinostomy by laser and the diagnosis and treatment of intraocular tumours. Aesthetic plastic surgery is gaining acceptance among ophthalmologists and this trend is reflected in the course available on esthetic oculofacial and eyelid surgeries. A large percentage of Indian ophthalmologists in smaller towns and in rural settings handle high volumes of very hard cataracts using manual small-incision non-phaco techniques which when practised well are not only extremely cost effective,but very efficient in dealing with rock hard nuclei.These techniques do not need expensive machinery or expensive instrumentation.These SICS courses are being taught by masters and will run to packed houses. Basic training sessions like conjunctival surgeries,perimetry, refraction in children,phaco basics,inflammations of the eye, endophthalmitis,ocular surface disorders will appeal to postgraduates and ophthalmologists fresh out of medical school. Training opportunities for diagnostic modalities like B Scan,OCT (3D) and Electrophysiology will present themselves at the meeting. Founded in 1991,the European Society of Cataract and Refractive Surgeons (ESCRS) is Europe's leading organisation for cataract and refractive surgeons and is at the forefront of developments in anterior segment surgery.The society currently has over 4,000 members from over 90 different countries worldwide.The ESCRS offers a unique forum for discussion and learning which ensures that international expertise is shared by ophthalmologists all over Europe. EuroTimesis the leading news magazine for ophthalmic surgeons published in Europe.It is circulated to over 27,000 ophthalmologists in over 120 countries. EuroTimesis pleased to announce that the Indian edition has now changed from the A4 format to international EuroTimesfull-size format,which will include more articles per page.We have been reaching 10,000 ophthalmologists with every issue and from the next issue we aim to increase that reach to 11,000.When we launched the Indian edition we received the wholehearted support of the trade and the warm acceptance from our colleagues.We will continue to bring you the latest developments in ophthalmology in our easily recognisable format. Once again EuroTimesthanks you all for your interest and continued support. From the Editor Cyres Mehta MD José GüellIoannis Pallikaris Clive PeckarPaul Rosen MMeeddiiccaall EEddiittoorrss Advances in machine and lens technology will feature at All India Conference Editorial January-March Cyres MehtaMUMBAI- Editor Indian Edition Mahipal SachdevDELHI Amar AgarwalCHENNAI Ashok GargHISAR S.Natarajan MUMBAI Mohan RajanCHENNAI Keiki Mehta MUMBAI IInnddiiaann EEddiittoorriiaall BBooaarrdd Contributors Devon Schuyler Eisele Nick Lane Howard Larkin Dermot McGrath Robert Henahan 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 / 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. Publisher Carol Fitzpatrick Executive Editor Colin Kerr Editors Sean Henahan Paul McGinn Managing Editor Caroline Brick Assistant Editor Angela Sweetman Senior Designer Patrick Dunne Assistant Designer Janice Robb EEddiittoorriiaall SSttaaffff Cover Image: GDxTM (Carl Zeiss Meditec) showing progressive retinal nerve fibre loss

2 Newsmaker Interview Ocular Trauma Ocular trauma remains one of the most common causes of monocular blindness worldwide.Household accidents,chemical injuries,sports injuries,terrorism,war and road accidents threaten the sight of millions of people every year.While prevention is always better than cure,not all eye injuries can be avoided.In this interview with EuroTimescontributing editor Dermot McGrath,Ferenc Kuhn MD, PhD,discusses recent advances in ocular trauma treatments,the importance of proper data collection and the need for more specialised trauma centres. ET:The field of ocular trauma has undergone rapid change in recent years. What do you consider the more significant of these advances in surgical techniques and technology? Dr Kuhn:If we have an injured eye today, one in which the macula or retina has not been destroyed and which retains the capability of anatomy and function,there are two main threats to the eye's long- term health.The first is a dysfunctional ciliary body and the second is proliferative vitreoretinopathy (PVR).Apart from these two issues,we are very good today at preserving visual function.However,we have also made a lot of progress in recent years in dealing with both the PVR and the ciliary body issues and saving eyes that have suffered a serious posterior trauma. ET:Why is the ciliary body so important to the prognosis of a trauma patient and what can be done to help save vision in these cases? Dr Kuhn:The ciliary body is critical because even if you have normal function in the retina,eventually the lack of aqueous production leads to loss of function and then the globe starts to shrink and the eyeball will eventually be lost.However,we have a couple of weapons today that we did not have,or perhaps did not fully appreciate,in the past. If the eye starts to lose pressure,UBM or similar imaging devices can alert us if there is an anatomical problem such as ciliary body detachment that can be subsequently fixed.An eye that has a normal anatomy but partial loss of ciliary body function may be helped by injecting viscoelastic into the eye,which will help to maintain pressure for a while.There are also situations in which fibrin and scar tissue may grow over the ciliary body and there are various types of surgeries that enable us to debulk these and restore function.The endoscope has also become more popular in recent years.It allows us to image the ciliary body intraoperatively without the distortion caused by indentation,which is a major plus.With all of these tools we can at least give a fighting chance to the tissue,which by regaining its own function will help the eye to survive. ET:What measures can be taken to reduce the risk of proliferative vitreoretinopathy in trauma cases? Dr Kuhn:There are several risk factors for PVR,such as an open globe injury or the presence of vitreous haemorrhage; these two almost always go together.We have decent surgical approaches today to PVR and it is no longer synonymous with the death of the eyeball.But in trauma cases,PVR has a tendency to recur and the pharmacological approaches that have been tried to date have not been very successful.So,the ideal method is to prevent PVR in the first place.We know that PVR usually comes from two main sources:retinal pigment epithelial cells and/or fibroblasts produced during the healing of a scleral wound. It occurred to me some years ago that if we perform surgery for malignant melanoma,we do a fairly drastic surgery that involves removal of the retina and the choroid in the area of the tumour. And while you would reasonably expect a fairly high PVR rate as a result of this,the PVR rate is actually very low.So I decided to try removing the choroid around the wound,thereby destroying the RPE cells in that area,and much to my surprise there was no PVR development.I subsequently performed several such surgeries ("prophylactic chorioretinectomy") and had the same outcome. ET:What does the preventive PVR surgery involve and what kind of clinical results have been achieved to date? Dr Kuhn:Prophylactic chorioretinectomy is rather simple.Essentially we use a diathermy probe to burn the tissue around the scleral wound.By doing this, we remove the risk of haemorrhage during the procedure,and leave a fairly clean ring,1mm wide,of retina/choroid- free sclera.We aspirate the debris that forms during the diathermy but never excise the scar itself. We now have more than 20 eyes in our series in a prospective international study involving several centres and have seen no severe PVR after a follow-up of six months or more.The expected PVR rate for such cases should be around 70 per cent or even higher,so we're very encouraged by the results so far. ET:You have been a strong advocate for better data collection relating to ocular trauma injuries.Are things improving in that respect? Dr Kuhn:Yes,I think there is now much greater recognition of the need for data collection.Comparisons are vital and we need data to improve our outcomes and help our patients.The ocular trauma score (OTS) that I helped to develop was part of that process.Based upon data from the United States Eye Injury Registry (USEIR), the OTS helps surgeons to predict the functional outcome of a serious eye injury, and does it with a 70 per cent accuracy rate,which is pretty good.The OTS system is very valuable for counselling and helps to give the patient a clear and objective measure of their likely functional outcome. ET:How important is patient counselling in dealing with such sight-threatening injuries? Dr Kuhn:I really believe that we need to improve on this issue.My philosophy is that we treat not the eye but the person. I started talking about this issue about 20 years ago but you still will not find other traumatology books apart from mine detailing the importance of counselling.It is a very complex process but the essence of it is that the patient is involved in the entire process.He is not a target or a spectator,but an active participant at all stages of the treatment.We still have a lot of work to do in that regard. ET:Different centres have different approaches to dealing with serious eye injuries.Is there an ideal model for how ocular trauma cases should be treated? Dr Kuhn:One of the sad things today is that in a lot of places,it is the resident surgeon who is assigned to treat these eyes – in other words,the person with the least experience.Furthermore,trauma is rarely part of the curriculum when residents receive training and so there is clearly room for improvement there.For serious ocular injuries where intervention matters so much,I used to consider any ophthalmologist who is interested in trauma to be an expert capable of functioning as his very own trauma centre.I would now add to this that the person has to be truly dedicated and has to have a facility that provides all the necessary support. So rather than focusing on one designated 'expert' it is more important for the centre to draw up clear guidelines and protocols to be followed for dealing with both any individual trauma cases or mass casualties such as after a terror attack.Dedicated trauma centres are one approach to the problem,but we also should not forget the individual surgeon who needs proper support and back-up to do his or her job properly. ET:You have argued for more rapid surgical intervention in certain ocular trauma cases.Why is timing so important? Dr Kuhn:Surgeons traditionally waited seven days or more to perform vitrectomy because the classic studies from the 1970s showed no significant difference between early and late intervention.Other arguments against early intervention were the risk of expulsive haemorrhage and also to allow time for posterior vitreous detachment to occur spontaneously,which we now know is completely false.Spontaneous posterior vitreous detachment is not a valid reason to defer an intervention.While haemorrhage is an issue and every surgeon who performs primary vitrectomy for an injured eye must realise that there is a risk of losing the eye,we now have better instrumentation and better equipment to minimise the risk. fkuhn@mindspring.com Ferenc Kuhn Newsmaker Interview…Ferenc Kuhn Saving sight against the odds “Yes, I think there is now much greater recognition of the need for data collection. Comparisons are vital and we need data to improve our outcomes and help our patients” Contact information: US Eye Injury Registry www.useironline.org World Eye Injury Registry www.weironline.org/ Dr Kuhn www.eyeinjury.com/_The International Society of Ocular Trauma www.isotonline.org/about.html

3 Multiple screening strategies aim to reduce burden of diabetic retinopathy Special Focus Diabetes and the Eye Jonathan WalkerCatherine Creuzot-Garcher Cheryl Guttman in Fort Lauderdale Researchers around the world are developing screening modalities to reduce the burden of diabetic eye disease.In a series of reports presented at the annual meeting of the Association for Research in Vision and Ophthalmology,investigators described new screening programmes and strategies to contain costs and improve the efficiencies of fundus image acquisition and analysis. Automated pre-screening Michael K Smolek PhD,Louisiana State University Eye Centre,New Orleans described an expert system for mass screening of diabetic retinopathy based on the use of a non-mydriatic,operator-free fundus camera and artificial intelligence image analysis software.Patient positioning in front of the camera is achieved by automated instructions from the machine,and five overlapping fundus fields are recorded and combined into a single 45-degree mosaic image.The mosaic image undergoes contrast enhancement, analysis of suspected pathology,and expert system grading. Dr Smolek believes that this device could be installed at sites frequented by diabetic patients,such as in the offices of general practitioners or endocrinologists, or at optical shops. The artificial intelligence software has performed well in initial validation testing. A pilot study included 11 cases with vision-threatening diabetic retinopathy and 130 controls (normal subjects and diabetics with normal retinas or non- visually threatening disease).When screening for vision-threatening diabetic retinopathy on non-dilated eyes,the expert camera system had a sensitivity, specificity,and overall accuracy of 91 per cent,99 per cent,and 98 per cent, respectively. “Currently the programme is designed only to identify diabetic retinopathy and differentiate between vision-threatening and non-vision-threatening pathology. Ultimately we hope to refine the grading system so that it provides a report equivalent to that generated by a human expert grader,” Dr Smolek told EuroTimes. Reaching the uninsured via a telemedicine approach In the US,retinal specialists in a group practice in Fort Wayne,Indiana,worked with a local free medical clinic to design a cost-effective system for diabetic retinopathy screening based on telemedicine. “In the US,many patients with diabetes are uninsured and have to depend on free medical clinics for their care.This results in a lack of systematic follow-up,and retina specialists often see the result of this when patients present for the first time with severe,progressive retinopathy,” said Jonathan Walker,MD. Clinic volunteers with no prior ophthalmology experience were trained to operate the camera,and the pictures are sent via an electronic medical records system to the retinal specialists who volunteer their time to review the images on their personal computers. After a short learning period,the staff at the clinic became adept at taking readable photographs,and the programme has been successful in achieving rapid screening of a large number of diabetic patients at a low cost.Of 339 patients screened during the initial 15-month period,51 (11 per cent) were determined to have non-urgent pathology and were recommended for closer surveillance, while 27 (six per cent) patients had potentially urgent pathology and were referred to the retinal practice for further evaluation. Experience in England In England,a national community-based diabetic screening programme was introduced in 2006.Gilli Vafidis MD, consultant ophthalmic surgeon,Central Middlesex Hospital,London,and John Bladen MD,specialist registrar,undertook an analysis of the programme's early success in recruiting patients in an ethnically diverse London suburb and appraised its system for arbitration. They found a disappointing patient uptake rate of 61 per cent among patients scheduled for screening. “This issue will be addressed with strategies to raise education and awareness within the community in order to improve patient recruitment and by adjusting screening schedules in anticipation of no-shows,” Dr Vafidis told EuroTimes. Their appraisal of the arbitration protocol suggested it could be safely revised to reduce drastically the number of images sent for arbitration grading. “The original fail-safe method of arbitration grading for discrepancies results in an unnecessarily high number of images being sent to the arbitration grader.Based on our findings,we propose that the arbitration rate can be reduced to 10 per cent of cases where both graders agree the referral outcome.This would offer advantages to the healthcare system of improved efficiency and cost- effectiveness without compromising patient care,” Dr Vafidis said. As originally described,all screening photos are reviewed and graded by a primary grader.Of those considered normal,10 per cent are sent to a secondary grader for the purpose of quality assurance.Outcome of screening is either a return to annual screening or referral to Hospital Eye Service (HES).All abnormal photos are also sent to the secondary grader,and if there is any disagreement in the retinopathy grade,the image set is sent to an arbitration grader. Primary and secondary graders can differ on the retinopathy grade,but may agree on screening outcome,explained Dr Bladen. The review showed that in the majority of arbitrated cases,there was an agreed outcome despite retinopathy grade disagreement.Where the outcome was agreed,0.17 per cent (1/594) false negative and 0.80 per cent (1/124) false positive referral outcomes were found. Reaching the French rural population with a mobile unit In France,an annual mobile diabetic retinopathy screening campaign programme was launched in 2004 to target residents in rural areas of Burgundy.The screening is performed using a non-mydriatic camera and is administered by a trained orthoptist.The images acquired were interpreted by trained fellows in the Department of Ophthalmology,University Hospital,Dijon. Analyses of data collected during successive campaigns indicate the programme seems to be successful in recruiting patients and improving ophthalmic and general care of screened diabetic patients.However,it appears to have had less of a positive impact on general practitioners in encouraging their recommendations for ophthalmic follow- up in their diabetic patient populations. Over the three annual campaigns,the total number of patients screened nearly doubled from 676 in 2004 to1369 in 2006.The overall proportion of eyes diagnosed with diabetic retinopathy also increased from 8.6 per cent in the first year to 10.5 per cent in the third year. Encouragingly,there was an almost fourfold increase in the proportion of patients who had an ophthalmic consultation within the year before their screening,4.5 per cent in 2004 versus 16.4 per cent in 2006. About 80 per cent of screened patients who were diagnosed with diabetic retinopathy in the screening programme went on to consult an ophthalmologist, providing further evidence that the screening programme is successful in improving care of diabetic patients. However,the findings were less encouraging from analyses evaluating the impact of the diabetic retinopathy screening programme on the quality of the ophthalmic follow-up by the general practitioners. “One of the primary goals of the screening campaign is to improve the rate of annual ophthalmic examination among patients with diabetes,and we expected that educational programmes,media campaigns,and questions from the patients themselves might raise awareness among the general practitioners that would increase their ophthalmic referral rate,” noted Catherine Creuzot-Garcher, MD,PhD,professor of ophthalmology, University Hospital Dijon. msmole@lsuhsc.edu jonwalker22@gmail.com catherine.creuzot-garcher@chu-dijon.fr gillivafidis@blueyonder.co.uk “Ultimately we hope to refine the grading system so that it provides a report equivalent to that generated by a human expert grader” Michael K Smolek PhD EUROTIMES ESCRSPODCAST Listen to our podcasts at www.eurotimes.org Podcasts are also available on

4 Special Focus Pat Phillips SPORTS-RELATED eye injuries,especially in children,can be more dangerous than generally recognised and present significant ocular hazards internationally. The US National Eye Institute finds eye injuries are the leading cause of blindness in children in the US.The majority of eye injuries occurring in school-aged children are sports-related.Children under age 15 account for 43 per cent of sports and recreational eye injuries. “Ophthalmologists should raise their level of awareness about the devastating effects of sports-related eye injuries from a public health standpoint,” said Vikram D Durairaj MD,associate professor of ophthalmology and otolaryngology,University of Colorado School of Medicine,Denver.He is the lead author of a recent study of paediatric golf injuries to the eye,which appeared in the September 2008 issue of Archives of Ophthalmology. Dr Durairaj pointed out that paediatric golf injuries are rare,but can be devastating to the eye and visual system.In his own series of 11 children treated for ophthalmic trauma,three had permanent deficits, including blindness,decreased vision,and anophthalmia. Anita Agarwal MD,associate professor of ophthalmology at the Vanderbilt Eye Institute,Vanderbilt University Medical Center,Nashville,Tennessee is in accord with Dr Durairaj on the importance of raising awareness about the potential hazards of sports for children. She emphasised the need for prevention of eye injuries,particularly the use of protective eyewear. “Sports are part of growing up for children,but parents need to have a vigilant attitude toward protecting children against sports-related eye injuries,” she said. Overall,the NEI finds sports-related eye injuries account for more than 100,000 physician visits yearly at a cost of $175,000 in the US.Sports-related eye injuries are often more severe and cause more vision problems than other eye injuries.About 42,000 of these sports-related injuries are treated each year,a number that appears to be increasing.About 1.5 per cent to 5.6 per cent are golf-related. In his series of golf-related injuries,Dr Durairaj studied 11 paediatric patients treated for eye injuries at two institutions over 15 years.The six boys and five girls had an average age of 10.2 and were followed for an average of one year. Injuries included orbital fracture in all 11 eyes;hyphaema in four eyes,36 per cent; damage to the optic nerve in three eyes,27 per cent.Nine of 11 children required surgery.At the final follow-up visit,two eyes, 18 per cent,had no light perception;visual acuity was 20/70 in one eye,nine per cent; and 20/20 or better in eight eyes,73 per cent. “Orbital fractures are common and can be significant and vision threatening,” he emphasised. Golf clubs do more damage than balls Dr Durairaj noted that most paediatric golf- related injuries occur when children are injured by other children wielding a golf club while at play away from the golf course.In his series,10 patients were injured by golf clubs,while only one patient was injured by a golf ball. These injuries do not occur on the golf course or during supervised play,according to Dr Durairaj.These observations led him to recommend close adult supervision, adequate separation between children as they swing a club,and protective eyewear for children learning to play golf. “Supervision and a controlled environment are the most important points to help prevent an injury as well as education about the potential risk of injury,” he said. Sports-related eye injuries can be classified according to risk,although there are different approaches to risk classification.The NEI classification of high risk includes:BB gun,baseball,basketball,cricket,hockey, lacrosse,paintball,racquetball,softball,and squash. Moderate risk of eye injury includes: badminton,fishing,football,golf,soccer, tennis,and volleyball. High-risk sports involve the use of a ball, puck,bat,stick,club or racquet and no body contact,according to Dr Agarwal.She cited basketball,hockey,lacrosse,racquet sports, tennis,fencing and golf as examples. Racquet sports are among the top three sports responsible for the greatest number of eye injuries,according to the NEI. Baseball remains the leading cause of eye injuries in children aged 14 and under. Blunt trauma causes most sports-related eye injuries.Penetrating injuries are less common as are radiation injuries, primarily related to snow and ice sports. Examples of blunt trauma injuries are: orbital blowout fracture, ruptured globe, and detached retina. Eye injuries range from mild to serious. Common eye injuries include scratches on the cornea,inflamed iris,fracture of the eye socket, detached retina, and traumatic cataract. “One great danger in sports injuries is when the ball is coming straight at the eye,” Dr Agarwal said. Surprisingly, she finds the shuttlecock in badminton is the fastest ball in all racquet sports. The shuttlecock speeds at about 180 mph,while a tennis ball speeds at about 135 mph. “The shuttlecock is faster than the tennis ball,faster than the cricket ball,and faster than the baseball,” she said.“At the speed of the shuttlecock,when it hits the eye,it can cause serious injury. She points out that playing squash,with the ball coming directly at you,has significant potential for eye injury.She advises wearing goggles for protection in all racquet sports. BB gun injuries pose a serious threat to children,according to Dr Agarwal.“BB gun injuries are common among children.If the BB gets inside the eye,the eye is lost – 100 per cent.If the BB shoots by the eye,there's a 50 per cent chance there will be a serious injury.” She estimates it is likely 25 to 30 per cent of children who experience eye injuries will have vision that is poorer than 20/200. In India,and other former Commonwealth countries,cricket has been the most popular of all games.The spinning ball or the pace ball,much harder and heavier than a baseball, can jump up and hit the eye,according to Dr Agarwal who played for a girls' cricket team, and in high school and middle school before attending medical school at Mangalore University,Mangalore,India. She recommends protective goggles and other protective gear for racquet sports.She agrees with medical organisations that estimate about 90 per cent of ocular injuries can be prevented with the proper use of protective eyewear. Dr Agarwal now has become a runner, while Dr Durairaj describes himself as an “avid tennis player”. Dr Agarwal is an advocate of banning the very high-risk sports of BB guns and paintball. The potential severity of sports-related eye injuries in children has led the American Academy of Pediatrics and the American Academy of Ophthalmology to issue a joint policy statement recommending appropriate eye protection for appropriate youth sports. Vikram.Durairaj@UCHSC.edu anita.agarwal@vanderbilt.edu Devastating eye injuries can result from children playing golf and racquet sports Ocular Trauma Vikram D Durairaj “Supervision and a controlled environment are the most important points to help prevent an injury as well as education about the potential risk of injury” Vikram D Durairaj MD

Cheryl Guttman in Chicago THE WHITESTAR Signature system with Fusion Fluidics (AMO) offers surgeons state-of-the art phaco technology for enhanced surgical safety and efficiency, according to users who discussed their experiences at the annual conference of the ASCRS. The Signature system is equipped with dual-pump technology so that surgeons can enjoy the responsiveness and holding power of a Venturi pump plus the control of a peristaltic flow-based pump and with the opportunity to switch pump technology on-the-fly using a single cassette,explained Burkhard Dick MD,Ruhr University Eye Clinic,Bochum,Germany. The Signature’s features include an intuitive touch screen interface,wireless Bluetooth accessories,an onscreen animated help system,multilingual user interface,one-step,auto-loading tubing pack,single-step surgeon programming,and a faster prime cycle to minimise wait time. The Fusion Fluidics system also enhances safety through its ability to recognise occlusion and proactively adjust vacuum before occlusion break,he said. “When the vacuum level increases and reaches a preset up-threshold,the Signature fluidics system reverses the pump with a reaction time of as little as 20 milliseconds,actively stepping down the vacuum before the occlusion breaks,” said Dr Dick. To illustrate its performance in maintaining anterior chamber stability,Dr Dick presented a video of a surgical case where capsular rupture was avoided even when the phaco tip approached the posterior capsule after penetrating through a hard,thick nucleus concealing a thin cortex. He also presented outcomes for the first 50 eyes he operated on using the Signature system.The procedures were all performed under topical anaesthesia using the same equipment and settings. One day postoperatively the eyes achieved clear corneas and excellent visual outcomes with a mean BCVA of better than 0.8.At six weeks after surgery,there was minimal endothelial cell loss with a mean change from baseline of about 100 cells/mm2. “In a comparator group of eyes operated on with the Sovereign system using the same pulsed ultrasound technique,similar outcomes were achieved with respect to midterm visual rehabilitation and mean endothelial cell loss.However,vision recovered faster in the Signature group and the range of endothelial cell loss was less, perhaps because the Signature procedures were associated with less total phaco power and time,especially in eyes with hard nuclei,” said Dr Dick. Ekkehard Fabian MD concurred with Dr Dick regarding the benefits of the new pump system on the Signature. “The rapidly responding vacuum pump of this platform permits surgeons to use higher fluidics parameters for increased efficiency without compromising chamber stability and safety.The Signature offers users an advance over the entire range of surgical cases,but the ability to operate safely with a higher vacuum is especially valuable for improving efficient and complete cortex removal,” said Dr Fabian, Rosenheim,Germany. Archiving and teaching tools Researchers also delivered enthusiastic reviews for the new Surgical Media Center (SMC),praising its learning,teaching,and documentation capabilities. In their talks,Dr Fabian and Ann Haustermans MD,AZ Klina,Brasschaat, Belgium,also showcased the SMC,an advanced video overlay system that utilises specialised media software for intraoperative video capture and to allow customisable playback.With its high storage capacity,the ability to create DVD quality recordings,and extensive playback and editing options,the SMC is a valuable tool that surgeons can use for quality assurance documentation purposes and teaching. The SMC performs continuous taping of cataract surgery procedures and blends real-time operating data from the phaco system with the video image from the surgical microscope.It consists of a video control module that represents a simple user interface for manual control of the recording plus a Windows-based laptop computer for offline viewing and editing. Videos are recorded in a DVD quality format (MPEG-2),and the system has a high storage capacity with a minimum recording time of 25 hours.The laptop computer is used for video playback in a customisable format and with the option for frame-by- frame review.Since the overlay graphics on the SMC are maintained in a separate file from the video rather than embedded in it, surgeons can tailor the data appearing as an overlay in the playback to their own preference.The custom-designed layout can then be stored for future use. Options for displaying aspiration,vacuum, and ultrasound power data include bar graphs and speedometers.However,a data plot format that displays a simultaneous, colour-coded,real-time tracking of changes in each parameter throughout the procedure is particularly useful in allowing surgeons to appreciate interactions between their settings and the performance of the phaco system,Dr Haustermans said. She illustrated her point with a video that showed the performance of the Signature Fusion Fluidics system for anticipating vacuum breaks to prevent surge and maintain anterior chamber stability. Dr Fabian agreed that the time curves of the phaco parameters represent a valuable tool for surgeons. “Until now,intraoperative video systems only displayed a single point in time.With the SMC,the data are displayed as a sequence that allows much greater insight as to what is happening during the procedure,” he explained. The SMC can also be used with AMO’s Sovereign and Sovereign Compact phacoemulsification units.However, considering the enhanced capabilities and options available on the Signature,the SMC is a particularly welcome aid for surgeons wishing to optimise their use of this sophisticated new platform,observed Kenneth Rosenthal,MD,FACS,associate professor of ophthalmology,The John A Moran Eye Center,University of Utah Medical Center and in private practice in New York. Dr Rosenthal moderated the session and noted he has been using the Signature system with the SMC since November 2007.He observed that compared with the Sovereign,the Signature system has about three times as many potential settings.While its increased sophistication provides opportunities to improve surgical safety and efficiency,the SMC facilitates the surgeon’s ability to harness the potential of the Signature by allowing careful monitoring and analysis of each procedure in real-time. “The SMC is wonderful technology for surgeons in the learning curve and those who are highly experienced,and I believe that with the ability to view intraoperative video in sync with their surgical settings and as a time sequence,surgeons will find they can revolutionise their performance in the OR,” Dr Rosenthal said. Dr Rosenthal noted that when the Signature system was first installed at his centre,the manufacturer’s representative had programmed it with parameters that were slightly modified compared with the settings that were being used on the Sovereign.Relative to prior outcomes,Dr Rosenthal noted an increase in total phaco time per case,even when operating on softer lenses.Using the SMC,he was able to identify that the phaco power was now coming on earlier at the bottom of foot pedal position 2. “While we might have intuited this to be the reason for the increase in our phaco time,using the SMC we could quickly document it as the cause,and this is just one of many situations where it has proven helpful,” Dr Rosenthal said. burkhard.dick@kk-bochum.de kr@eyesurgery.org dr.fabian@augencentrum.de annhaustermans@skynet.be 5 Cataract Update Burkhard DickAnn HaustermansKenneth Rosenthal Latest AMO phaco platform garners favourable reviews Data plots Speedometers Laptop & VCM Bar Graphs Courtesy of Ann Haustermans MD

Cataract Update Dermot McGrath in Berlin THE Tecnis 1-Piece IOL (AMO) is safe and effective for IOL implantation and offers biomechanical and biomaterial advantages over the AcrySof lens (Alcon Inc) with over two years of follow-up,according to Donald R Nixon MD,FRCSC. “The Tecnis IOL has all the benefits of the one-piece design for easy injection and in-the-bag placement with less risk of posterior capsular opacification compared to the AcrySof lens.This difference may be explained by the features incorporated in the Tecnis 1-Piece to enhance the barrier to lens epithelial migration,” Dr Nixon told delegates attending the XXVI Congress of the ESCRS. Dr Nixon,senior staff ophthalmologist at Royal Victoria Hospital in Barrie,Ontario, Canada,said that the purpose of the study was to evaluate high-resolution digital images of the two different lenses in individual patients two years after implantation,including observation and measurement of the amount and density of lens epithelial cell migration and lens optic glistenings. As part of a larger study,14 patients ranging from 63 to 82 years were implanted with the Tecnis ZCB00 1-Piece lens in one eye and the single-piece AcrySof IOL in the fellow eye.These patients were called back at the two-year interval for examination and evaluation using high-resolution digital photographs of the intraocular lenses. The digital images were then compared using specialised EPCO software for PCO analysis to determine the overall score of the individual lenses.A smaller subset was also evaluated using the Pentacam system (Oculus) to compare the degree of glistenings between the two lenses,said Dr Nixon.Dr Nixon noted that the EPCO software rates the level of PCO on a graded scale of 1 to 4. “Grade 1 is minimal wrinkling of the capsule,and a fine layer of epithelial cells on the optic.Grade 2 denotes mild honeycomb PCO and a thicker layer of cells and dense fibrosis.Grade 3 is evidence of classic Elschnig's pearls,very thick on the lens and grade 4 denotes severe opacity with a discernable 'darkening effect.” Looking at the overall results,Dr Nixon said that there was a statistically significant greater EPCO score for the AcrySof intraocular lens group compared to the Tecnis 1-Piece group. “This result also carried over into the individual comparative grades,which showed that after two years the AcrySof IOL had a higher grade of PCO compared to the Tecnis 1-Piece lens.In fact,at grade 3 and grade 4,the Tecnis IOL had no involvement at all at those particular grades,” he said. Dr Nixon then used some high- resolution digital images of the AcrySof lens to show how the lens epithelial cells utilise the haptic-optic junction as a staging point for migration onto the posterior surface of the IOL. “This weakness has been well documented and discussed by Dr David Apple,among others,as being the Achilles heel of this particular lens.By contrast,the digital images of the Tecnis 1-Piece show minimal cellular ingrowth at two years, which shows just how effective this lens is at minimising PCO,” he said. Pentacam Scheimpflug imaging is another useful means of evaluating capsular bag and lens dynamics,said Dr Nixon.Scheimpflug images of the AcrySof clearly revealed the presence of vacuole water glistenings in the lens material,while those taken of the Tecnis IOL showed the ability of the lens to remain optically clear over the same time frame. Discussing the design and material issues that may account for the difference in PCO scores in his study,Dr Nixon said that the Tecnis 1-Piece IOL had been created specifically to address perceived weaknesses in existing hydrophobic acrylic lenses. “The biomechanical design of the Tecnis enhances the barrier to lens epithelial cell migration.The IOL has a 360-degree square-edge and offset optics and these features optimise centration and posterior compression.Furthermore,the biomaterial of the second-generation hydrophobic acrylic in the Tecnis resists compression to a greater extent across all dioptic powers than that of the AcrySof both before and after a saline bath at 35˚C for 24 hours. This resistance to compression further optimises centration and the barrier effect of the 360-degree square edge.The design and the material also facilitate easy insertion into the capsular bag,” he said. By contrast,Dr Nixon noted that the technology and material on which the single-piece AcrySof lens is based is now between 10 to 15 years old.“The AcrySof biomechanical design is planar and without a continuous 360-degree posterior square edge.The lens also has less resistance to compression and hence no effective posterior forces and the first-generation hydrophobic acrylic is predisposed to progressive glistening,” he said.He notes with capsular bag shrinkage the low resistance to compression and lack of posterior forces allow for a potential space between the optic and posterior capsule which may explain the higher EPCO scores. Focusing on the haptic-optic junction,Dr Nixon said that the Tecnis lens incorporates a feature called ProTec to prevent lens epithelial cells from migrating along the posterior capsule by continuing the square edge along the haptic.“The Protec design offers uninterrupted contact of a square edge with the posterior capsular bag even at the haptic-optic junction and unlike traditional single-piece designs;it is designed to prevent cell migration along the haptic,“he said. Dr Nixon went on to discuss that another important feature of the Tecnis lens is the Tri-Fix system,which is characterised by an offset haptic design. “It provides a three-point fixation of the lens in the capsule with constant pressure outwards and backwards allowing for excellent early centration and long-term stability.The contact of the sharp optic edge against the posterior capsule is designed to limit epithelial cell migration and minimise PCO,” he said.The role of haptic compression,which shows greater resistance in the Tecnis than the AcrySof lens,should also not be underestimated. “The ability of the Tecnis lens to resist compression forces combined with the offset design effectively generates greater posterior pressure,further exemplifying and magnifying the effect of the 360-degree square edge.The net effect is to reduce the potential space between the optic and the posterior capsule and this may help to explain why there is a statistically significant difference in EPCO scoring in favour of the Tecnis lens,” he concluded. trimedeyedoc@rogers.com 6 Donald Nixon Tecnis I-Piece IOL has the edge for PCO resistance, study finds 34 Months12 MonthsAMOTecnis I-Piece at 3 Months Courtesy of Donald R Nixon MD

7 Refractive Laser Cheryl Guttman in Hong Kong REFRACTIVE laser surgery represents a viable long-term solution for the treatment of refractive errors in appropriately selected paediatric patients,reported William F Astle MD at the 2008 World Ophthalmology Congress. Dr Astle,professor of surgery (ophthalmology),University of Calgary, Alberta,Canada,together with Peter T Huang MD,began performing laser surgery to treat anisometropia and congenital high myopia in children more than nine years ago.Their experience over that time encompasses 287 eyes of 188 patients who ranged in age from 10 months to over 17 years at the time of surgery. Initially,treatment was performed using PRK and was limited to children who had large refractive errors and associated developmental/health issues that made it impossible for them to wear glasses and/or contact lenses.Subsequently,they transitioned to LASEK and expanded the candidate pool to include normal children with anisometropic amblyopia who failed previous traditional treatment. Dr Astle presented analyses of long-term follow-up (3.5 years or more) based on 56 eyes of 39 patients.He also reviewed one- year outcomes of 56 children treated for anisometropia.The results showed reasonable stability of refractive outcomes, no safety concerns,and benefits that included gains in vision,stereopsis,and binocular fusion accompanied by improved psychosocial functioning. “We have been very excited by the outcomes achieved through our innovative work performing laser surgery in children who could not use or had failed traditional methods of refractive correction. Furthermore,over a lifetime,laser surgery may be less expensive than glasses,contact lenses,and other treatments.Based on our experience,we believe laser refractive surgery is something that all clinicians should consider for paediatric patients who cannot be managed with traditional therapies,” commented Dr Astle,who is also director of the vision clinic,Alberta Children’s Hospital,Calgary. Dr Astle,Dr Huang and colleagues have published five papers in the Journal of Cataract & Refractive Surgerydescribing their experience with paediatric laser refractive surgery.All procedures were performed under general anaesthesia in a non-hospital surgical facility using either a laryngeal mask or nasopharyngeal airway for airway maintenance. “Initially,we received a lot of criticism for performing this surgery.However,based on our large experience,we can conclude the anaesthesia technique is standard and safe,” Dr Astle told EuroTimes. The 39 patients included in the long-term analysis had a mean age of 6.5 years at the time of surgery (range 10 months to 17.4 years) and were followed for a mean of 5.15 years (range 3.5 to 7.8 years).Of the 56 eyes,27 were treated with PRK and 29 with LASEK. In all eyes,preoperative SE ranged from +1.75 D to -27.0 D with a mean of -10.4 D. Mean SE at last follow-up was -1.73 D (range -9.50 to +2.25 D). Among patients treated with PRK,mean SE was reduced from -11.9 D preoperatively to -3.20 D at last visit.In the LASEK cohort,mean SE was -9.01 D preoperatively and -1.37 D at the last visit. Refraction was relatively stable,although a little better after LASEK than PRK. However,there was some myopic shift over time,and 43 per cent of eyes received a second laser treatment for myopic regression at a mean of 26 months postoperatively. “There is still some room for improvement in outcomes,but the second surgery was effective in achieving refractive stability over time.Still,these data highlight the importance of informing families of the possibility of needing additional surgery in the future,” Dr Astle said. At last follow-up,SE was within 3 D of the refractive target in 77 per cent of eyes, while achieved SE was within 1.0 D in 45 per cent of eyes and within 2.0 D in 66 per cent of eyes. Vision outcomes were favourable, although Dr Astle noted that in this population including many children who are very young and/or have disabilities, obtaining an objective measure of vision is difficult.Among 28 evaluable eyes,there were no losses of BCVA,and 12 eyes had an improvement ranging from 1 to 7 lines (mean 1.6). Stereopsis also improved with an increase of 31 per cent in the proportion of patients with measurable stereopsis from seven patients (18 per cent) preoperatively to 19 patients (49 per cent) postoperatively.There were no cases of loss of binocular fusion. Trace haze developed in 10 eyes,was less common after LASEK compared with PRK, but resolved in all cases. “When we were performing PRK originally,corneal haze was our only ‘major’ complication.In terms of severity,it was relatively minor,but we switched to LASEK and now perform LASEK exclusively,” Dr Astle said. LASEK was performed in all 53 patients who were included in the analysis of one- year outcomes after treatment for anisometropia.These patients were no longer responding to traditional therapy and were selected for laser surgery based on evidence-based guidelines for amblyogenic risk factors published in 2006. The patients ranged in age from 10 months to 16 years.Preoperatively they had a mean refractive difference between eyes of about 7.0 D that was reduced to 1.81 D at one year.Subgroup analyses showed the refractive difference between eyes was reduced from 9.48 D to 2.43 D in 31 patients treated for myopic anisometropia, 3.13 D to 0.74 D in 19 patients with astigmatic anisometropia,and from 6.98 D to 1.81 D in three patients with hyperopic anisometropia.At one year,80 per cent of patients maintained a refractive difference between eyes within 3 D,and in about two- thirds of patients,the LASEK-treated eye was within 2 D of the fellow eye. “Preoperatively,these patients were stuck at a point where vision was in the 20/60 to 20/80 range.Theoretically,the treatment brought them to a situation where their vision could start to improve,” Dr Astle said. Consistent with that concept,in 33 eyes that could be evaluated for vision,64 per cent had improved BCVA at one year while none showed worsening.In addition, whereas 58 per cent of children had no stereopsis of any kind pre-LASEK,the majority were seeing better and had improved fusion.At last visit,stereopsis was absent in only 12 per cent of children. In the anisomyopic group,there was some myopic shift between two months and one year;the mean refractive difference was 1.09 D at two months and increased to 2.43 D at one year.In the anisoastigmatic group,there was only a 0.1 D mean change in refractive difference comparing the month two and month 12 results. “The greater shift in the anisomyopic group probably relates more to the fact that these children’s eyes are still growing rather than being a true myopic shift after laser treatment.Therefore,it makes inherent sense that the anisoastigmatic group showed better refractive stability,” Dr Astle said. In order to gain additional insight into the benefits of the treatment,parents were asked to complete a quality of life questionnaire.Their responses showed significant improvement overall in the children’s behaviour and ability to function in their environment.The majority of parents noted improvements in posture, frustration/stress level,self-confidence, walking/mobility,and balance in sitting and standing.There were no reports of any negative changes. “Parents indicated their children started feeding independently and autistic-like behaviours improved.Almost all families,92 per cent,said they would recommend LASEK for other children,” said Dr Astle. william.astle@calgaryhealthregion.ca “Based on our large experience, we can conclude the anaesthesia technique is standard and safe” Long-term experience supports value of laser refractive surgery in children

8 Refractive Lens Dermot McGrath in Berlin ANGLE-SUPPORTED anterior chamber phakic IOLs may still have a viable future so long as surgeons adhere to careful selection criteria and respect the anatomical dimensions of the anterior chamber,according to Roberto Bellucci MD and Simonetta Morselli MD. “The distance between the corneal endothelium and the lens material seems to be the most critical factor for IOL safety in our study comparing the performance of two angle-supported anterior chamber phakic IOLs,” Dr Bellucci told delegates attending a special session on phakic IOLs held during the XXVI Congress of the ESCRS. Dr Bellucci's and Dr Morselli's study included 22 eyes of 11 patients who underwent simultaneous bilateral implantation with the AcrySof Phakic IOL (Alcon) in one eye (Figure 1) and the Icare (Cornéal) lens in the contralateral eye (Figure 2),with a follow-up of 24 to 42 months. “We wanted to have a closer look at the safety of these angle-supported lenses. In Italy we are compelled by the Ministry of Health to check the endothelial cell count in implanted patients twice a year,” he said. Discussing the properties of the two lenses in more detail,Dr Bellucci said that the Icare lens is made of hydrophilic acrylic material with an optic diameter of 5.75mm,an overall diameter of 12.0mm to 13.5mm and a power range from -5 D to -20 D.Later versions of the IOL had reduced vaulting and smaller footplates,he said. The AcrySof Phakic IOL,which is currently undergoing multicentre clinical trials in Europe,is a single-piece hydrophobic lens,with an optic size of 6.0mm and an overall length of 12.5mm to 14.0mm and a dioptric power range from -6.0 D to -16.5 D. The outcomes for both IOLs were very satisfactory in the early postoperative period,noted Dr Bellucci.All of the patients were satisfied and they did not perceive any differences in the performance of the respective IOLs,he said. Between 24 and 42 months,however, two cases of pupil ovalisation were reported with the Icare lens,compared to none in the AcrySof Phakic IOL eyes. “At this point in time out of hundreds of eyes implanted with the AcrySof Phakic IOL,not one case of pupil ovalisation has occurred,” Dr Bellucci said. Looking at the data for endothelial cell counts,Dr Bellucci said that acute loss at the time of surgery was about four per cent for both IOLs.However,the rate was markedly different for the yearly endothelial cell loss and was directly related to the corneal clearance distance between the IOL and the endothelium,he said. “When the distance was greater than 2.0mm the loss was 1.1 per cent yearly in the AcrySof and 2.0 per cent in the Icare lens.However,if the distance between the IOL and the endothelium was less than 2.0mm,the loss was up to 20 per cent in the Icare lens.There was no AcrySof lens in this group because the design of the lens is such that it maintains a good clearance between the optic and the endothelium,” Dr Bellucci said. Two Icare lenses were subsequently explanted to avoid corneal decompensation and these patients received an aphakic IOL implant,he explained. Using Visante (Carl Zeiss Meditec) imaging,Dr Bellucci and colleagues observed that the vaulting of the Icare lens was too high,especially in earlier versions of the IOL (Figure 3). “This is not exclusively related to the length of the lens,even though the vaulting is higher if the lens is too long. But at the beginning,the perception was that we could pay slightly less attention to the corneal clearance because the material was hydrophilic acrylic and was considered to be very biocompatible with the corneal tissues,” he said. By contrast,the Visante images of the AcrySof Phakic IOL showed that there was a very safe clearance between the optic and the corneal endothelium (Figure 4). Further investigation also ruled out the haptics on the Icare lens as a possible source of the endothelial loss. “We could study the effect of the haptics onto the chamber angle and with either IOL it was clear that the haptics were not impairing the angle.So this was not an issue and neither was elevated IOP a problem with either IOL,” he said. The Visante images clearly showed, however,the close proximity of the Icare lens to the endothelium. “We could observe the lens as close as 1.25mm in the centre which may lead to endothelial touch in the periphery.But I believe that the corneal endothelial cell loss also happens when no endothelial touch occurs.The standard deviation was much higher with the Icare lens than the AcrySof lens,so this probably comes from the haptics which are better designed in the AcrySof lens than the Icare IOL,” Dr Bellucci said. Putting the results into perspective,Dr Bellucci said it was important to use Visante or similar imaging technology to try to ensure correct anatomical measurements of the anterior segment, including anterior chamber length and depth for accurate sizing and positioning of the phakic implant. “The distance between the corneal endothelium and the lens material seems to be the most critical factor for IOL safety.After four years' experience,it seems that the hydrophilic material of the Icare offered no advantage in case of lens- endothelium proximity,” he concluded. Dr Bellucci's study is not the first reported problem for the Icare lens in terms of endothelial cell loss.The lens has been under increased scrutiny since the decision in 2007 of the French health authority to withdraw the Icare from the market because of problems associated with endothelial cell loss.Two other lenses – the Vivarte and NewLife angle- supported phakic IOLs (both IOLTech/Carl Zeiss Meditec) – were also withdrawn in 2007. roberto.bellucci@azosp.vr.it simonetta.morselli@gmail.com Figure 4Figure 3 Figure 1Figure 2 Courtesy of Roberto Bellucci MD Roberto BellucciSimonetta Morselli Corneal clearance critical for angle-supported phakic lens safety

9 Cornea Update Cheryl Guttman in Berlin SEVERE inflammation of the cornea leads to angiogenesis that can result in significant visual impairment but also represents a major risk factor for immune graft rejection after penetrating keratoplasty. While the exact mechanisms underlying loss of the normal cornea's “angiogenic privilege” and the development of pathologic neovascularisation have yet to be completely defined,researchers are investigating the therapeutic potential of various agents targeting known pro- angiogenic mediators. At the XXVI Congress of the ESCRS, Claus Cursiefen MD,department of ophthalmology,University of Erlangen- Nuerenberg,Germany,reported encouraging interim results from a Phase II, European multicentre study investigating topical treatment with GS-101.The investigational compound is an antisense oligonucleotide against insulin receptor substrate-1 (IRS-1) being developed by Gene Signal,France. “Based on the positive interim data from the Phase II trial,a Phase III multicentre, European study will be launched soon. Currently,however,in Germany,France,and Switzerland,the countries where the Phase II study was performed,it is possible to obtain GS-101 drops in a compassionate use programme for patients with progressive corneal neovascularisation not amenable to other forms of treatment,” Dr Cursiefen told attendees. Dr Cursiefen explained that IRS-1 is an important mediator for new vessel formation and growth,perhaps acting as a regulator in the production of other proangiogenic compounds.GS-101 is a specific inhibitor of IRS-1 synthesis,but in preclinical testing it has also been associated with reduced expression of VEGF and interleukin-1.In animal models of experimentally induced corneal neovascularisation,GS-101 inhibited new vessel growth,and it was found to be well- tolerated in a Phase I clinical study. The Phase II trial has a double-blind randomised design and enrolled 40 patients with progressive corneal neovascularisation due to a variety of underlying diseases, including,herpetic or bacterial keratitis, chemical burns,or contact lens-induced trauma. “It is known that only fresh blood vessels need VEGF so there is no point in giving angiogenic inhibitors in eyes with old established vessels.For this reason,the study protocol inclusion criteria required that patients enrolled have documented active,progressive growth of new vessels,” Dr Cursiefen said. The patients were randomised into four groups to receive treatment with placebo or GS-101 43,86,or 172 mcg/day.The assigned drops were instilled twice daily. The results showed GS-101 was a potent inhibitor of angiogenesis and induced regression of existing neovascularisation. The benefit of the treatment was most pronounced with the intermediate dose. “Of the patients treated with GS-101 86 mcg/day,only one showed any increase in blood vessel area whereas regression was observed in all other eyes in this group,and there was also a trend for improvement of visual acuity.In the placebo group,all eyes demonstrated an increase in the area of neovascularisation after three months,” Dr Cursiefen reported. As in the Phase I study, the GS-101 drops were well tolerated.A total of 57 adverse reactions were reported in 21 patients,but the incidence of events considered possibly related to the treatment was only five per cent,and none of those reactions were severe or serious. “The few possibly related adverse events involved minor ocular surface discomfort, which might also be associated with the underlying disease,” Dr Cursiefen said. Bevacizumab benefits more modest Speaking on behalf of colleagues from the Eye Clinic,Catholic University of Sacro Cuore,Rome,Romina Fasciani MD, presented outcomes from 30 eyes of 30 patients treated with subconjunctival injection of bevacizumab (Avastin). For Dr Fasciani and colleagues, knowledge of the success with intravitreal injection of anti-VEGF agents in the treatment of retinal neovascularisation and of the central role of VEGF in the development of corneal neovascularisation led them to explore the potential of subconjunctival bevacizumab injection to inhibit the proliferation of new corneal vessels. Patients were treated with bevacizumab 1.25mg/0.1ml,and an effort was made to deliver the injection closest to the site of greatest vessel involvement.All patients had at least six months of available follow-up, and the mean follow-up duration was 7.69 months. The eyes were evaluated at the slit-lamp and with confocal corneal microscopy,and the investigators also used software analysis of digitised photographs to quantify the area of vascularisation at baseline and during follow-up.The assessments showed the treatment was safe and particularly effective for reducing ocular inflammation. However,its effects on preventing progression of corneal neovascular- isation and inducing regression were variable,partial at most,and transient.A second injection was often administered to treat vessel recurrence after a mean of 3.51 months. “Long-term follow-up in controlled randomised trials is necessary to more precisely determine the efficacy,dose and duration of effect of bevacizumab in the treatment of corneal neovascularisation,” concluded Dr Fasciani. Post-infective leucoma was the underlying pathology for the majority of the treated eyes (77 per cent).Six eyes (20 per cent) were penetrating keratoplasty failures and one eye had severe limbus deficiency. In general,all patients benefited from the anti-VEGF treatment with improvement in inflammation and reduced congestion of small vessels.The digital analysis showed the area of corneal neovascularisation was reduced from baseline by a mean of 22 per cent,but the change was not statistically significant,and visual acuity remained unchanged as vessel involvement and scarring of the visual axis persisted. “Eyes with post-infective leucoma seemed to respond best.In this subgroup, there was a 28 per cent reduction in the area of neovascularisation,and that change from baseline was statistically significant,” noted Dr Fasciani. There were no systemic complications or ocular adverse events associated with the treatment aside from mild subconjunctival haemorrhage. ccursiefen@yahoo.com romina.fasciani@tiscali.it Claus CursiefenRomina Fasciani The search for effective treatments for corneal neovascularisation Comparison of the effects of pre- vs post-subconjunctival Bevacizumab injection in a postherpetic neovascularised leucoma A comparison of the Bevacizumab subconjunctival injection results during the follow-up in a post-traumatic leucoma. Courtesy of Romina Fasciani a) A postherpetic neovascularised leucoma before the injection; b) the reduction of new vessels one month after the subconjunctival injection of Bevacizumab; c) the same case at 3rd month of follow-up.

10 Glaucoma Update Ananth C Viswanathan New diagnostic technologies have an evolving role in the clinical management of glaucoma Roibeard O’hEineachain GLAUCOMA is the leading cause of irreversible blindness worldwide but several landmark studies over the past decade have demonstrated that it may be possible in a high proportion of cases to prevent early disease from becoming symptomatic and to prevent symptomatic cases from progressing to total blindness. There is,therefore,now an urgent effort under way to find ways of detecting the disease at its earliest stages,when there are structural changes to the optic nerve but no detectable loss of vision,and to track the progression of disease in order to assess the effectiveness of a given treatment in a given patient and determine whether further intervention may be required. Among the means under investigation include new imaging technologies for visualising the optic nerve head and new types of perimetry that detect subtle changes in the functioning of a patient’s retinal ganglion cells not detectable with standard automated perimetry (SAP). But these new technologies raise many questions.For example,do the new imaging technologies genuinely represent what is physically occurring in the optic nerve head and retinal nerve fibre layer? And are the new perimetry technologies more sensitive than standard automated perimetry? And in lieu of long follow-ups of large numbers of patients,how is it possible to prove that either type of new technology is superior to the current gold standards for structural and functional testing? Moreover,given that,according to most epidemiological studies,half of glaucoma patients are undiagnosed,what role may these new technologies have in screening for glaucoma? Do they have enough sensitivity and specificity to provide a cost- effective means of population screening,or will they miss some cases or will they lead to false diagnoses and extensive unnecessary investigations? The need for objective measurements Stereo optic disc photographs are the current gold standard for detecting glaucomatous structural changes.They are ideal in the sense that ‘the camera does not lie’.The difficulty arises in their interpretation,which can vary not only between different glaucoma specialists,but between different viewings by the same glaucoma specialist,noted Ananth C Viswanathan FRCOphth MD Moorfields Eye Hospital,London UK. Speaking at a special session of the 20th Anniversary Congress of the Royal College of Ophthalmology in Liverpool,Dr Viswanathan cited a study carried out by the AGIS investigators where 14 glaucoma specialists viewed a series of 26 optic nerve stereophotographs with varying degrees of glaucomatous disease.The specialists were asked to determine the degree of notching of the optic disc.The researchers found that the specialists disagreed substantially in 58 per cent of cases. Furthermore,when 10 of the glaucoma specialists were asked to view the same disc stereophotographs again,all classified some of the cases differently than they had previously and over half reclassified at least four cases. Disagreement between specialists may also prevail with regards to the use of stereophotographs for determining glaucoma progression,Dr Viswanathan noted.In a study carried out at the Wilmer Eye Institute (Jampel et al.Am J Ophthalmol.2008 Sep 12;:18790472), three glaucoma specialists were presented with two stereophotographs from 164 glaucoma patients taken a median of 26 months apart and asked to judge whether the eyes were getting worse. The proportion deemed to have progressed by the three observers ranged from seven per cent to 38 per cent.All three expert observers reached a consensus that just two of the discs were definitely getting worse,while two out of three agreed that 10 were getting worse. However,the specialists were masked regarding the actual sequence of the stereophotographs and,in fact,50 per cent of those discs for which a consensus had been reached by two or three specialists as having progressed were actually taken at the beginning of the study. “So I think we need some help here from the machines.We need to try and reduce observer variation.” Diagnosis dependent on normative databases The three main diagnostic imaging devices in use today are the Heidelberg Retinal Tomographer (HRT,Heidelberg Engineering),the GDx,and the Stratus OCT (Carl Zeiss Meditec).All three are designed to provide objective measurements of the optic nerve and or the peripapillary region and all have accompanying software for comparing their measurements with normative databases. “The current machines do work in different ways but produce similar results and single test diagnostics with these devices are really dependent on good quality normal database,” said Stephen A Vernon DM FRCS FRCOphth,Department of Ophthalmology,University Hospital, Nottingham,UK,who also spoke at the Liverpool congress. The HRT is a confocal scanning laser ophthalmoscope.Using a rapid scanning 670 nm diode laser,the computer creates,point by point and layer by layer,a three- dimensional image of the optic disc region. The HRT also provides reflectance images from the light reflected from the surface of the optic disc,and converts the image into a topographic map. In early models of the HRT,the computer software required the operator to manually determine the outline of the disc so that it could calculate whether or not the disc was abnormal,using the Moorfields regression analysis algorithm. To reduce inter-operator variability in defining the disc margins,the HRT III has software that can automatically analyse the profile of the disc and define its outline.The software also compares the disc profile with a normative database specific to three ethnic groups (Caucasian,African and Asian) and arrives at a glaucoma probability score. “But all of these things depend on a normal database.As a result the glaucoma probability score and Moorfields regression analysis seems to suffer from the same problem.They’re not very accurate in small and large discs.That is because if you do a large study of normal people as we did in the Bridlington study of over 3500 elderly people,the norm spreads out as the optic disc gets bigger,” Dr Vernon noted. The GDx VCC uses confocal laser scanning in a different way,based on the principle of birefringence.The microtubules of the retinal nerve fibre layer (RNFL) have birefringent properties because they are thinner than some wavelengths of light and have a polar structure. The GDx VCC exploits this by polarising a laser’s light into two components perpendicular to each other so that they proceed at different velocities through the birefringent RNFL.The difference in velocity between the two components of the polarised light is directly proportional to the thickness of the RNFL. The GDx uses its measurements to produce reflectance and retardation maps of the optic disc and the peripapillary and macular regions.The reflectance image comes from the light reflected directly back from the surface of the retina,and appears as the fundus image on the monitor and printouts.The retardation image is a map of the retardation values converted to RNFL thickness. The GDx also facilitates interpretation of the images by comparing them with a normative database and uses neural network analysis to calculate a score that indicates the likelihood of the optic disc being abnormal. “Like every other machine using a normal database there will be normal people outside the normal range,” Dr Vernon noted. Optical Coherence Tomography,or ‘OCT’,is often described as ‘optical ultrasound’,because like ultrasound it depends on interface “echoes” for its functioning.But instead of ultrasonic vibrations it uses an infrared laser.As with ultrasound,the delay of the reflected light correlates with the thickness of the structure being measured. The Stratus OCT obtains RNFL measurement of the peripapillary region and its software compares it with a normative database,graphed in a TSNIT (temporal,superior,Nasal Inferior and temporal) orientation.The Stratus OCT now also has glaucoma progression analysis that plots RNFL thickness over time and reports any statistically significant change and the rate of change. “You can use it as a quantitative and qualitative scan but although the analysis does correct for age,it does not correct for the normal variations of RNFL thickness that occur with increased axial length and optic disc size.So what we need are individual databases for these various types of eyes,” Dr Vernon added. Practical considerations of diagnostic imaging Achieving the best results with diagnostic imaging technology requires a considerable investment of money and time,said Prof Peter Shah MD,Birmingham & Midland Eye Centre,Birmingham UK. “I have an HRT in my practice and a GDx in my research practice and I can tell you that without good technical back-up they have the potential to produce poor quality data.Are you going to invest in that technical back-up if you have many competing needs in your department? That’s a decision you need to make if you are clinical director,” he added In addition,with currently available diagnostic imaging technology it is difficult and time consuming,and sometimes impossible,to produce useful results in a significant proportion of glaucoma patients, including those with small pupils,any media opacity,or any difficulty keeping still.In some of the more difficult patients a good scan can take the most experienced operator up to 20 minutes,Prof Shah said. “In my practice,I have a lot of elderly patients who are unwell,on multiple systemic and topical medications,they may be wheelchair bound,they may have a tremor,they may not be able to get their neck into the machine because they have cervical spondylosis.In the real world it can be very difficult to get good pictures,” he added. No gold standard for glaucoma progression One of the difficulties in assessing the accuracy of a diagnostic imaging technology and the various forms of visual field testing

11 Glaucoma Update is the absence of a defensible criterion for glaucoma progression that they can be measured against,said Balwantray Chauhan PhD,Dalhousie University,Halifax,Canada. “There isn’t an external gold standard for progression,so progression is therefore necessarily criterion dependent.I suppose at the most fundamental level if you could image and test the function of the individual retinal ganglion cell you would find parity in the relationship between the structural and functional change.But what we measure clinically are surrogates for what we really want to measure,” he said at the Eighth Congress of the European Glaucoma Society in Berlin. As a result of the indirect nature of the measurements,there is generally a poor concordance between findings of structural and functional change in most studies where glaucoma patients have been monitored over several years,Dr Chauhan noted. Furthermore,in large randomised studies like the Ocular Hypertension Treatment Study (OHTS) and the Early Manifest Glaucoma Trial (EMGT),visual field and optic disc change have variously been shown to occur first.But those studies each had their own criteria for disease progression and findings from different studies may not be comparable. “I think from a clinical perspective it is better to talk about a disc change or field change rather than glaucoma progression. Glaucoma progression is really a complex issue to define so we should probably stick with simpler definitions that have a more solid basis,” Dr Chauhan added. Newer perimetry may be more sensitive Several new types of perimetry have become available over the past decade that are designed to more closely reflect visual field changes more sensitively than does SAP,currently the gold standard for visual field testing.However,validation of those technologies will require long follow-up, said Augusto Azuara-Blanco MD PhD,who also spoke at the Berlin EGS congress. ‘I think that standard automated perimetry will be with us for many years to come,” he commented. However,SAP uses a white background and white stimuli and provides a measure of overall visual performance and may therefore conceal the loss of certain types of retinal ganglion cells.Newer types of perimetry such as short wave automated perimetry (SWAP) and frequency-doubling technology (FDT) appear to detect loss of more specific classes of retinal ganglion cells.They may therefore,in theory,detect structural damage to the optic nerve earlier than SAP. Shortwave automated perimetry (SWAP) is similar to SAP except that it uses a yellow background and blue stimuli.It tests the activity of the blue-yellow ganglion cells and the konicellular layers of the lateral geniculate nucleus.In numerous hospital- based studies SWAP has shown greater sensitivity in detecting glaucomatous damage than SAP. However,SWAP requires a longer test time,has more variability,lower specificity and does not work well in patients with lens opacities,Dr Azuara-Blanco said. “I think that the original high expectations for SWAP have not been fulfilled,” he added. Frequency doubling perimetry appears to be showing more promise.Based on the frequency doubling illusion,FDT tests the activity of large parasol ganglion cells.The results of both hospital-based and population studies indicate that FDT can detect visual field loss with greater sensitivity and specificity than standard white-on-white perimetry. On that basis,FDT could have advantages over SAP for monitoring progression of visual field loss.However,long-term studies will be necessary to prove whether or not that is true. There are also a range of other new technologies under investigation for visual field testing such as flicker perimetry and motion perimetry,which measure the activity of the same set of retinal ganglion cells as FDT,and high-pass resolution perimetry,which measures the activity of the parvocellular ganglion cells.But research with those devices is still in the pilot stages,Dr Azuara-Blanco added. "SAP has evolved,and current fast strategies such as SITA and TOP are more accurate than the older ones." Consensus meeting finds population screening unjustified Despite the enormous costs of glaucoma to patients and society,there is insufficient evidence to justify population screening for glaucoma with currently available diagnostic technologies.That was the conclusion of a consensus meeting about screening for glaucoma organised by the World Glaucoma Association in April 2008,said Thierry Zeyen MD PhD who was a participant at the meeting. “When we want to screen for open- angle glaucoma we have four questions to ask.First,is open-angle glaucoma an important health problem? Second,is there an effective treatment? Third,is there an accurate screening test? And lastly,is the cost of screening economically balanced?” said Dr Zeyen,Leuven University Hospital, Leuven,Belgium. That glaucoma is an important health problem seems pretty clear,he noted.The prevalence of glaucoma is roughly one per cent among people aged 40 years,four per cent among people aged 80 years.Roughly 70 million are affected by glaucoma worldwide and according to most epidemiological studies,50 per cent are undiagnosed. Furthermore,according to the World Health Organization,glaucoma is the leading cause of preventable irreversible blindness worldwide.Population studies like Olmsted study and the St Lucia Eye Study indicate that around 10 per cent of patients diagnosed with glaucoma will go blind bilaterally and 20 per cent will go blind unilaterally after 20 years.Glaucoma also has an impact on the quality of life.It can contribute to falls and traffic accidents. Healthcare costs increase with the severity of the disease. Moreover,there is effective treatment for glaucoma;numerous randomised clinical trials have shown that IOP lowering medication can delay the onset and progression of primary open-angle glaucoma. On the other hand,it is much less clear whether there is an accurate screening test for glaucoma,since the sensitivity and specificity for population-based tests are unknown.Most studies have involved selected groups mostly hospital patients with a disproportio-nately higher rate of severe disease and involving clinicians with a lot of experience in identifying patients with the disease. As a result,mass population screening for the disease might yield a high proportion of false positives,which would in turn make it not very cost effective. A better approach might be to use opportunistic screening,taking IOP measurements,performing visual field tests and diagnostic imaging in patients aged 40- 45 years who are at risk for developing glaucoma,during routine eye exams when they seek consultation regarding reading glasses,Dr Zeyen suggested.Another opportunistic screening strategy is to incorporate glaucoma case findings into already existing programmes (e.g.eye examination related to the driver licence). “Glaucoma screening may be more cost effective when the initial assessment is supervised by known medical technicians screening for multiple diseases.For example if you set up a programme screening for diabetes with fundus photographs you can take that opportunity to also look at the optic disc,” he said. a.viswanathan@ucl.ac.uk stephen.vernon@nuh.nhs.uk Shah.Peter@swbh.nhs.uk bal@dal.ca aazblanco@aol.com thierry.zeyen@uz.kuleuven.ac.be EUROTIMES ESCRS PODCAST www.eurotimes.org VViissiittwww.eurotimes.orgttoo rreeaadd tthhee llaatteesstt iissssuuee aanndd aacccceessss oouurr ccoommpplleettee rraannggee ooff oonnlliinnee sseerrvviicceess TThhee llaatteesstt oopphhtthhaallmmoollooggyy nneewwss aanndd vviieewwss oonnlliinnee ffrroomm EuroTimes

BARCELONA 2009 XXVIICongress of the ESCRS 12 – 16 September 2009 CCIB Congress Centre Barcelona Spain www.escrs.org Abstract submission deadline: 15 April 2009 EUROPEANSOCIETYOFCATARACT& REFRACTIVESURGEONS INCLUDING First World Congress of Paediatric Ophthalmology and Strabismus 12 – 13 September 2009 www.wcpos.org Abstract submission deadline: 15 April 2009 SYMPOSIA TOPICS: Cataract and Macular Disease Cross-Linking Paediatric Cataract and Refractive Surgery Managing Subluxated Lenses Surgical Solutions for High Refractive Errors

Sustained IOP reductions seen with canaloplasty, new study suggests 13 Glaucoma Update Sean Henahan CANALOPLASTY provides sustained reductions in IOP in primary open-angle glaucoma patients,with far fewer complications than trabeculectomy,a new study suggests. Researchers reported the three-year results of canaloplasty in 97 eyes of patients, along with a comparison group of 120 eyes that underwent viscocanalostomy. Canaloplasty produced a mean lowering of IOP from 27 to 14 mmHg,a mean drop of 48 per cent (Table 1).The investigators also report a reduction in adjunctive medications used (Table 2).Some 96 per cent of canaloplasty patients achieved an IOP of 21 mmHg or lower,55 per cent without additional drops.A comparison with patients who underwent viscocanalostomy showed statistically significant differences in favour of the canaloplasty group in the number of patients achieving a postoperative IOP of 17 mmHg or less,and in medication requirements (Table 3). “We conducted this study in primary open-angle glaucoma patients because we felt it was important that we establish whether it works in normal open-angle glaucoma before making recommendations for other cases. Viscocanalostomy and canaloplasty are both excellent procedures.We wanted to see if we could get better results with canaloplasty, meaning greater lowering of intraocular tension,and prevention of the failure of viscocanalostomy from ostial closure,the one problem that does occur with time in that procedure.We wanted to establish a benchmark for future studies,” said Clive Peckar MSc(Oxford) FRCS FRCSEd FRCOphth,consultant ophthalmic surgeon, Warrington,UK. Both canaloplasty and viscocanalostomy have similar low complication rates (Table 4). The only marked difference in complications was an increased incidence of transient hyphaema postoperatively in the canaloplasty patients. “We are not overly concerned about the hyphaema.This is a physiological effect of holding the canal wide open and putting tension on the meshwork,” Dr Peckar commented. There are cases where the catheter will not pass in canaloplasty.He noted that even though catheters have been improved,even with latest designs and experience,there are a proportion of patients who can't pass the catheter for anatomical reasons.Those patients still experience the benefits of viscocanalostomy. None of the patients developed visual loss or cataract during the duration of the study. The low rate of complications with these procedures compares favourably against MMC-trabeculectomy,for which published studies report endophthalmitis rates approaching 3.0 per cent,as well as other serious complications including hypotony maculopathy1. Moreover,a UK national study of trabeculectomy2 reported early complications in 47 per cent of cases and late complications in 43 per cent.The most frequent early complications,of trabeculectomy,were hyphaema (25 per cent), shallow anterior chamber (24 per cent),hypotony (24 per cent),wound leak (18 per cent) and choroidal detachment (14 per cent).The most frequent late complications reported for trabeculectomy were cataract in 20 per cent and visual loss in 19 per cent. New age of Schlemm's canal surgery “Up until the end of the last century, fistularising surgery,most recently trabeculectomy,was the operation of choice for the majority of ophthalmologists worldwide.With viscocanalostomy we entered into the new age of Schlemm's canal surgery,allowing our patients to have comfortable 'bleb free' eyes without the devastating complications of gross hypotony and endophthalmitis,and allowing their surgeons to sleep better at night.With canaloplasty we have advanced one step nearer to the goal of 'bleb-independent,safe glaucoma surgery,” Dr Peckar told EuroTimes. The data thus far suggest that the benefits of canaloplasty persist over time,with no diminution of effect.There is no change in appearance of the tension sutures over time. Indeed,there are anecdotal reports where pressure continues to drop as the months go by,he noted. Dr Peckar explained that a potential limitation of current medical treatment with prostaglandin analogues is that these agents work by increasing uveo-scleral outflow, bypassing Schlemm's canal and the collector channels and that in time this may contribute to Collector Channel Collapse.The advantage of these newer procedures is that they re-establish flow through Schlemm's canal,re-establishing the normal physiological state within the eye,he said. Surgical technique “With viscocanalostomy we mark an area on the sclera,usually at 12:00 position,about 5.0mm from the limbus.We make a parabolic opening through the sclera,and produce a superficial sclerectomy flap that is designed to be watertight.Inside that we make a secondary sclerectomy flap,and cut down until we can just see the choroid.We cross the scleral spur to Schlemm's canal,de-roof the canal,and create a 'Descemet's window'.We then remove the block of sclera,creating a scleral lake.Next we dilate the two ends of Schlemm's canal with viscoelastic,producing direct access into the canal and the collector channels.We then suture the flap,having achieved internal bleb- independent surgery.Postoperative care includes topical steroids,anti- prostaglandins,and antibiotics. The advantage of this approach is that you produce a deep sclerotomy with a Descemet's window.This prevents gross hypotony.You have no direct fistula through the sclera,and therefore no flat anterior chambers or choroidal detachments.As these procedures produce internal drainage through Schlemm's canal,we have no problem with late bleb failure or infection,since there is no bleb. Canaloplasty evolved from viscocanalostomy,a procedure developed by pioneering surgeon Prof Robert Stegmann. Dr Jack Kearney worked with iScience to develop a 250µmicrocatheter to viscodilate the whole of Schlemm's canal.Dr Stegmann then took the new technique a step further by using the microcatheter to place a 360°circumferential tension suture within Schlemm's canal to hold the canal and ostia open and place the canal under tension. During catheterisation of the canal Collector Channel Microangiography (CCMA) may be carried out through the microcatheter,in order to document the distribution and patency of the collector channel network,using trypan blue,which illustrates the high concentration of collector channel vessels draining the superior nasal quadrant of Schlemm's canal. The current study,conducted by Clive Peckar and Norbert Körber MD,appears in the journal Spektrum der Augenheilkunde3. clivepeckar@yahoo.co.uk References: 1: Wishart PK. Trabeculectomy is not the best surgical option for glaucoma. Eye 2008; 22: 603-606 2: Edmunds B, Thompson JR, Salmon JF, Wormald RP. The National Survey of Trabeculectomy. III. Early and late complications. Eye 2002; 16: 297-303. 3: Peckar C O, Körber N. Canaloplasty for open angle glaucoma: a three years critical evaluation and comparison with viscocanalostomy Spektrum der Augenheilkunde (2008) 22/4: 240-246. Hyphaema (transient)2 (1.7%)10 (10%) Descemet's split > PI2 (1.7%)1 (1%) Converted to trabeculectomy00 Choroidal detachment1 (0.8%)0 Pressure spike (1 day post-op >30mmHg)01(1%) Laser Trabeculoplasty (post-op)3 (2.5%)0 Resuturing of sclerectomy/conjunctiva02(2%) Bleb revision (post-op)1 (0.8%)0 Flat Anterior Chamber00 Failed: Surgical Revision2 (1.7%)0 Trabeculectomy00 Ahmed Valve™01(1%) Prolene Tension Suture: No Suture: microcatheter did not pass 360°-9 (9%) Microcatheter Suprachoroidal-1 (1%) Sub-Descemet's Healon-3(3%) Suture 'Cheese-wired' post-op-1(1%) ComplicationsViscocanalostomy n=121Canaloplasty n=97 Table 3: Success: Viscocanalostomy and Canaloplasty Table 2: Mean Medications: Viscocanalostomy & CanaloplastyTable 1: Mean Intraocular Pressures: Viscocanalostomy & Canaloplasty Table 4: Complications: Viscocanalostomy & Canaloplasty

14 Retina Update Devon Schuyler WHICH people with AMD are at greatest risk for vision loss? Two recent studies tackled that question. The first study,called the Complications of Age-Related Macular Degeneration Prevention Trial (CAPT),found that people with extensive drusen were most likely to progress to advanced AMD if they were older,had focal hyperpigmentation or retinal pigment epithelium depigmentation,smoked cigarettes,or had a greater retinal area covered by drusen. “This confirms the findings of previous studies,” said Emily Chew MD,director of epidemiology at the National Eye Institute. The second study,performed in Baltimore, found that people with dry AMD who had the worst vision under low-light conditions were most likely to experience a rapid loss in visual acuity.Dr Chew said that she would be interested in seeing this finding replicated in future studies with longer follow-up. The importance of risk factors Learning who is at greatest risk for vision loss is important for giving patients an accurate prognosis,and for determining which patients need more-frequent monitoring.Enrolling patients who are most likely to progress in clinical trials may also allow for smaller,faster trials.Finally, identifying risk factors can also provide clues about the progression of AMD that may lead to a better understanding of the condition and improved treatment. “The fact that multiple drusen was a known risk factor for progression to late AMD,and that laser treatment reduced the number of drusen,led to the clinical trial of CAPT,” said Maureen G Maguire PhD,a professor of ophthalmology at the University of Pennsylvania and corresponding author on the risk factors study.Unfortunately,the trial found laser treatment to be ineffective in this population. “It may be that drusen are a product of the disease process that causes CNV and geographic atrophy,but are not themselves in the causal chain – so that reducing their number has no effect,” she hypothesised. The CAPT study CAPT was designed to investigate whether low-intensity laser treatment could prevent loss of vision in people with extensive drusen.Researchers enrolled more than 1,000 people aged 50 and older with 10 or more large drusen (greater than 125 micrometers) and visual acuity of 20/40 or better in each eye. Each participant received laser treatment in one eye and observation for the other eye.Over the next five or six years, researchers identified choroidal neovascularisation and geographic atrophy based on colour photographs and annual fluorescein angiograms. Low-intensity laser treatment failed to decrease the risk of developing CNV or geographic atrophy.The study did,however, shed light on the factors associated with AMD progression.After adjusting for confounders,the researchers found that increased age and focal hyperpigmentation were risk factors for the development of CNV and geographic atrophy.Cigarette smoking was associated with CNV only, whereas the retinal area covered by drusen and RPE depigmentation were associated with geographic atrophy only. Largest drusen size,number of drusen within 500 micrometers of the foveal centre, percentage of global area covered by drusen, and RPE depigmentation were not significantly associated with the development of CNV. “It may be that once an eye has 10 or more drusen,there are sufficient changes throughout the retina and Bruch's membrane (the layer between the choroid and the retina) that the risk of CNV is elevated,” said Dr Maguire. Dr Maguire said that female gender,regular aspirin use,and diabetes were not associated with geographic atrophy. Baltimore study The second study,which took place in Baltimore,included 91 people with geographic atrophy resulting from AMD in one or both eyes without CNV.Geographic atrophy was defined as one or more discrete areas of loss of retinal pigment epithelium, measuring 500 micrometers or more.The low-luminance deficit was measured by determining how much the ETDRS visual acuity worsened when a 2.0-log unit neutral density filter (similar to a dark sunglass) was placed over the best correction for that eye. The researchers found that among people with baseline visual acuity of at least 20/50, 55 per cent of those with worse low- luminance deficit (LLD) (a four line or greater loss of acuity with the filter) experienced at least moderate vision loss.By contrast,only 19 per cent of those with better LLD (less than four lines of loss of acuity with the filter) had moderate vision loss.What's more,40 per cent of participants with a baseline acuity of 20/50 or better lost three or more lines of visual acuity, compared with 13 per cent of those who had worse visual acuity at baseline. The researchers said that LLD was able to predict vision loss because it measures cone function in reduced illumination.The ability of the cones to adapt to dark conditions is impaired in advanced AMD. “Even though we normally think of rods as being responsible for night vision,the cones also have to adapt to the dark as well,and this reduced dark-adapted cone function is what we are gauging by the low luminance test,” said Dr Sunness. The other factors that predicted which people with good baseline visual acuity would lose vision were foveal dark-adapted sensitivity and reduced reading rate.People with geographic atrophy in 25 per cent to 75 per cent of the central 10.2 mm2had a higher rate of visual loss than did those with geographic atrophy in less than 25 per cent or more than 75 per cent of the central 10.2 mm2- a surprising finding. “I expected that eyes with 75 per cent or more of the central area being atrophic would have been at the highest risk,but this was not the case.My hypothesis is that some eyes have better foveal preservation capabilities,so that you may have very large areas of geographic atrophy surrounding a small central spared area that remains spared over time,” said Dr Sunness. Age,gender,fellow eye diagnosis,fellow eye visual acuity,baseline geographic atrophy area,and geographic atrophy enlargement rate all failed to predict later loss of visual acuity. Dr Sunness said that it's important for patients and their families to better understand that people with good visual acuity could still have problems with reading and recognising faces because of blind spots and a reduction in low luminance vision.She added that nursing homes and retirement communities are often poorly lit,and that “much more attention should be paid to lighting and contrast.” Dr Sunness also pointed out that low luminance visual function might be able to serve as an early indicator of whether a treatment for geographic atrophy is effective. “It is possible that a treatment that improves foveal survival will affect function in dim illumination much earlier.Testing low luminance function would then allow rapid screening of potential treatments for geographic atrophy,” she said. Future directions Dr Maguire said that even though anti-VEGF treatments have had a huge impact on the treatment of CNV,and several drugs are under evaluation for the treatment of geographic atrophy,prevention of the late stages is generally more beneficial and cost- effective than treatment of the late stages. Possible preventive strategies included lutein and omega-3 and -6 fatty acids,which Dr Chew and her team are currently evaluating in the Age-Related Eye Disease Study 2,and the possibility of delivering sustained low doses of anti-VEGF agents to the eye as researchers develop novel drug delivery systems. Dr Sunness also pointed to work on genetic modifications targeting the inflammatory and immune response systems that might reduce the risk of developing advanced geographic atrophy.She added that “one other area to investigate are the genetic variations in people who retain foveal function for years compared to people who lose foveal function early”. maguirem@mail.med.upenn.edu jsunness@gbmc.org echew@nei.nih.gov Emily ChewMaureen G Maguire CChheecckk iitt oouutt oonn hhttttpp::////mmyyeeuurroottiimmeess..bbllooggssppoott..ccoomm ffoorr aa uunniiqquuee oonnlliinnee vviieeww oonn tthhee wwoorrlldd ooff oopphhtthhaallmmoollooggyy EEuurrooTTiimmeessnnooww hhaass iittss oowwnn BBlloogg!! New studies shed light on risk factors for AMD progression

15 Cheryl Guttman in Hong Kong FEMTOSECOND laser refractive surgery first entered the clinic in 2001 with the FDA approval of the IntraLase system.That system is now in its fifth iteration,and has since been joined by three other femtosecond laser platforms.EuroTimesgot an update on the features,performance,and applications of the individual lasers at a refractive surgery session at the WOC. Holger Lubatschowski PhD,Hannover Laser Centre,Germany,provided an overview of basic principles of femtosecond laser performance and a side-by-side comparison of the technical features of each of the four commercial platforms.All of the femtosecond lasers use photodisruption to cut through corneal tissue,and they all operate at a wavelength of about 1040 nm,but they differ in a number of technical respects. The Femtec (20/10 Perfect Vision) and IntraLase have a high pulse energy,the LDV (Ziemer) has a very low pulse energy,and the VisuMax (Zeiss) lies somewhere in between.With the IntraLase,Femtec,and VisuMax,the cutting process is directly visible to the operator,whereas it is seen only on the monitor using the LDV.The Femtec and VisuMax have a spherical contact interface to the cornea,while the VisuMax has a contact glass for corneal fixation. The LDV delivers its laser beam through a mirror arm that fits under all excimer lasers and consists of just an oscillator without an amplifier.Therefore,the LDV can be used without moving patients during the surgical process,and it is also the smallest of the devices. The four femtosecond lasers also differ in pulse width,which ranges from 250 femtoseconds for the LDV to more than 500 femtoseconds for the IntraLase and Femtec.The repetition rate is in the MHz range for the LDV and in the kHz range for the other platforms,while pulse energy is in the nanoJ range for the LDV and in the microJ range for the others. IntraLase Perry S Binder MS,MD,San Diego, California,US,presented worldwide clinical experience with the IntraLase femtosecond laser.Since the introduction of the first- generation system in 2001,the IntraLase platform has been used to perform more than two million procedures,including over 500 IntraLase-enabled keratoplasties.Other uses have included astigmatic keratotomy, wedge resection,lamellar keratoplasty, penetrating keratoplasty,creation of INTACS channels,and corneal biopsies. The recently introduced 5th generation device provides a number of important features and benefits.This 150 kHz femtosecond laser allows reductions in time for flap creation and total energy delivery.It also permits unique methods of flap customisation,including a bevel-in sidecut angle up to 150 degrees and the creation of oval flaps,which have been shown in various studies to result in stronger flap healing. The newest IntraLase laser also offers a high resolution video microscope for increased depth of focus during surgery,a touchscreen user interface,and digital video output. “We think the 5th generation IntraLase laser enables most of the idealised goals of LASIK surgery better than any currently existing femtosecond laser while placing all the tools necessary for customising the flap within the hands of the surgeon,” Dr Binder said. Femtec The Femtec is a highly capable workstation that is also able to perform roles beyond LASIK flap creation,said Julian Stevens, Moorfields Eye Hospital,London,UK. A key feature of this platform is that it has a curved patient interface that is important because it translates into less distortion of the cornea and less compression of the eye.Therefore,IOP is minimally increased. The Femtec also features excellent diagnostic graphics on the video screen that are particularly useful for monitoring shape when cutting corneal grafts,a torque feature that detects patient head movement,and a direct diagnostic link with customised treatments. In addition to having proven itself as a capable flapmaker,the Femtec laser has been used for astigmatic keratotomy, intrastromal astigmatic keratotomy,and cutting corneal grafts. However,the capability that most distinguishes it from other existing platforms is its potential to be used to perform intrastromal refractive surgery with no flap. “The Femtec laser is a very capable workstation with excellent software.It is one of the most sophisticated and advanced systems available today and may bring us to the Holy Grail of femtosecond lasers,which is to use this technology to put energy into the cornea in order to achieve a shape change without cutting a flap,” Dr Stevens said. LDV Theo Seiler MD,PhD,IROC,Zurich, Switzerland,discussed the Ziemer LDV based on his experience over the last two years.His presentation delivered three messages relating to precision,safety,and platform dependability. After proposing that a femtosecond laser has a role in refractive surgery for procedures where flap dimension precision truly matters,Dr Seiler reported that in a series of 92 eyes undergoing creation of flaps with an attempted thickness of 110 microns,the mean ±SD thickness was 109 ±3.7 microns with a range from 101 to 116 microns.Flap diameter outcomes also showed sufficient precision and reproducibility,although Dr Seiler noted that the desired flap diameter is obtained only if the suction is complete. Safety has been excellent.Complications encountered in the last 200 patients consisted of strong adhesion necessitating manual cut in two eyes,failure of the scan in one eye,too small flap diameter in one eye,and inability to perform two treatments because of a small eye and deep orbit.There were no air bubbles in the anterior chamber or eyes with transient light sensitivity,and eyes with Sands of Sahara have been very infrequent. The LDV has also proven itself to be an easy-to-use and dependable workhorse,he noted. “We have had to cancel only one surgery session over the last two years and consider this platform a Volkswagen,not a Ferrari.There is no need for a technician, no calibration,and no extra temperature and humidity controls.We know that with the LDV,we can just turn it on,and it goes,” Dr Seiler said. VisuMax As described by Marcus Blum MD,Helios Clinic,Erfurt,Germany,the VisuMax platform (Zeiss) is an integrated solution combining a femtosecond laser and excimer laser.It uses a spherical contact interface system to the cornea with low suction pressure so there is no vision loss during suction,and treatment positioning is precise as the patient fixates on a blinking light within the system. A study using high-frequency digital ultrasound to measure flap thickness showed it performs reliably and precisely for flap creation.In a series of eyes with an attempted thickness of 110 microns,the mean achieved was 112 microns,25 per cent of eyes were within two microns of intended,and 88 per cent were within 10 microns. However,ongoing research using the VisuMax femtosecond laser for femtosecond lenticule extraction (FLEx) as a new method of refractive surgery is what is distinguishing this platform,said Dr Blum. He presented data from six months of follow-up of more than 100 eyes showing good safety,refractive stability,and reasonable accuracy but with slight overcorrections in lower myopes. “We have been very grateful to use this system because it works perfectly for LASIK flap creation.However,we have tried to take the VisuMax beyond the point where it is only a flap maker.Obviously there is a learning curve,but we expect the outcomes with FLEx will become more precise as the technique is refined,and this approach would have the advantage of eliminating the need for two lasers,” said Dr Blum. h.lubatschowski@lzh.de garrett23@aol.com julianstevens@compuserve.com theo.seiler@iroc.ch Update on features, performance and applications of femtosecond lasers Conference Report WOC – World Ophthalmology Congress,Hong Kong Courtesy of Julian Stevens MD

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17 T he next time you get a chance, stand in an unobtrusive corner of your reception area and watch what happens when patients enter or call. Do your staff members greet long-time patients by name? Do they smile when they talk to patients? Do they even look up from their work when a patient approaches? When the phone rings,do they pick it up? Do they answer questions fully,or transfer the call to someone who can? If the answer to any of these questions is “no”,you may be losing revenue and referrals. Your front-line staff,whether in the office or on the phone,are the public face of your practice.If that face is not welcoming – or,worse yet,is unresponsive or outright hostile – it will drive patients away. This is especially deadly for refractive practices that rely on word-of-mouth referrals to survive.But it doesn't do a cataract practice much good either.If you let your staff give you a reputation for ignoring patients,referrals from other physicians could suffer,too. Train and establish a positive practice culture If your staff have problems treating patients right,your first move should be to train them,Walter Pfeifer of Colana Consulting,Berlin,Germany told a EuroTimes Practice Management Workshop at the XXVI Congress of the ESCRS.You might also try treating them with respect and making sure they feel valued and secure.This will help create a positive practice culture that will be reflected in the way your staff treat patients.It can be done using performance incentives,company outings and regular staff meetings to build morale,and to set and reinforce performance expectations. “You are your practice team's coach,” said Mr Pfeifer,who was a top administrator for 16 years at three of Germany's largest ophthalmic practices before becoming a consultant.By meeting your employees' human needs for money, recognition,and community,and training them in the skills they need to do their work,you encourage them to work together as professionals. But not every employee responds to training,respectful treatment,or even monetary incentives.Those who don't should be replaced.This should be done quickly to avoid conflict that drags down staff morale and interferes with teamwork,Mr Pfeifer said.“Your staff is like a bicycle chain.Don't work with a chain that is not oiled,or old,or lacks tension.You need a good running chain to have a good running practice.” Finding service-oriented employees Traditionally,ophthalmic practices mostly have hired candidates with training as nurses or medical assistants to staff their offices.But people with clinical backgrounds do not always have the strong customer service orientation that practices need to compete for refractive patients,said Eckhard Weingäertner,MD, medical director of the EuroEyes Clinic, Stuttgart,Germany.In fact,he has found it can be easier to train someone who has good people skills to be a good clinical assistant than to try to teach someone with years of experience to be friendlier to patients. “Most of the time we train nurses and doctors' assistants,but we also found out it is good to hire people out of the hotel and retail industries,” Dr Weingäertner said.“Sometimes the nurse with 20 years in the business doesn't want to move.If they have been working long in the public hospital sometimes they are not so much patient-oriented and friendly and nice,like someone who has been in the hotel business for a long time.Sometimes,it is better if you get new people and train them to do things the way you want them to be done.” So Dr Weingäertner is very open- minded when hiring new employees.What he really wants are people with potential “Their background can be anything.We take people who have worked in call centres and nurses and other trained professionals.The important thing is they have social skills and fit in with the team.” Of course,new hires without a medical background require extensive training.But so do experienced clinicians when it comes to satisfying demanding patients, Dr Weingäertner explained.“We have engineers from Daimler and Siemens and they know everything about the technology.They want to see the invoice for your laser to make sure you have the latest one.” Recognising the need for highly educated staff to provide this level of information and service,EuroEyes created the position of “refractive coordinator” in 2005.These employees go through a one- year training course in how to handle every patient need.They are extensively trained on how to talk to patients on the phone,how to educate them on refractive procedures,how to workup patients,and screen them as candidates.They are also taught the fundamentals of eye anatomy and physiology,and all of the technical details of every kind of cataract and refractive surgery. EuroEyes also offers employees a free LASIK procedure after one year.Dr Weingäertner believes this helps staff members better appreciate the surgery and makes them more effective in conveying its value to patients.“Those who have had LASIK talk totally differently to the patient.It is very important that your staff understand refractive surgery and understand the value of it.” These coordinators become the face of the practice,answering patient questions and advising them on available procedures and lenses.They even present at patient education events.They are also paid more than other staff. “The staff is much more motivated now that we have created this position,” Dr Weingäertner says.“Everyone wants to be a coordinator now.We have even created a coordinator II position with even more training to counsel patients over the phone.” There are one to three of these coordinators working in each EuroEyes centre.Many were nurses to begin with, but some have been hired for their people skills and trained in clinical skills from the ground up. “It's good to have people with different service backgrounds,from the hotel industry or call centres,” Dr Weingäertner said.“They are very service oriented and that helps set a good example for the other staff members.” Practice Management When looking for staff, consider candidates with non-clinical backgrounds It may be easier to train a service-oriented worker in clinical skills than vice-versa bbyy HHoowwaarrdd LLaarrkkiinn Feature

18 World medical body tightens restrictions on placebo-controlled clinical trials Researchers should test new drugs and medical devices only against effective therapies Ophthalmologists could lose out in patient care to opticians and optometrists in economic crisis Feature T he World Medical Association (WMA) has tightened its policy on placebo-controlled trials.The revision follows fears by a number of physicians that pharmaceutical and medical device companies would attempt to save money by withholding effective therapies from patients in developing countries when carrying out clinical studies of their new products. In its latest revision of its policy,known as the “Declaration of Helsinki,” the WMA has stated that clinical researchers should test new devices and drugs only against proven treatments.The only exceptions for allowing placebo-controlled trials are where such trials are absolutely necessary and where patients who receive placebo treatment do so without risking any serious or irreversible harm. The new revision reads: “The benefits,risks,burdens,and effectiveness of a new intervention must be tested against those of the best current proven intervention,except in the following circumstances: The use of placebo,or no treatment,is acceptable in studies where no current proven intervention exists;or Where for compelling and scientifically sound methodological reasons the use of placebo is necessary to determine the efficacy or safety of an intervention and the patients who receive placebo or no treatment will not be subject to any risk of serious or irreversible harm.Extreme care must be taken to avoid abuse of this option.” The policy on placebo-controlled trials replaced a somewhat more terse policy, most recently updated in 2002. “The benefits,risks,burdens,and effectiveness of a new method should be tested against those of the best current prophylactic,diagnostic,and therapeutic methods.This does not exclude the use of placebo,or no treatment,in studies where no proven prophylactic,diagnostic,or therapeutic method exists.” After many physicians raised concern about loopholes in the wording of the 2002 version,the WMA issued a clarification in October of 2004,which laid the basis for the changes in the 2008 document.That clarification read: “The WMA hereby reaffirms its position that extreme care must be taken in making use of a placebo-controlled trial and that in general this methodology should only be used in the absence of existing proven therapy.However,a placebo-controlled trial may be ethically acceptable,even if proven therapy is available,under the following circumstances: Where for compelling and scientifically sound methodological reasons its use is necessary to determine the efficacy or safety of a prophylactic,diagnostic or therapeutic method;or Where a prophylactic,diagnostic,or therapeutic method is being investigated for a minor condition and the patients who receive placebo will not be subject to any additional risk of serious or irreversible harm.” The newest version of the declaration, which WMA approved at its annual meeting in Seoul,South Korea last October,also states that patients who participate in clinical trials have a right to share in any benefits that might accrue from the research. “At the conclusion of the study,patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it,for example,access to interventions identified as beneficial in the study or to other appropriate care or benefits,” the newly revised declaration reads. Like the WMA's previous policy on placebo-controlled trials,the previous policy on post-trial treatment likewise worried some physicians who believed that pharmaceutical companies and medical device manufacturers might take unfair advantage of patients in developing countries. The previous policy read:“At the conclusion of the study,every patient entered into the study should be assured of access to the best proven prophylactic, diagnostic,and therapeutic methods identified by the study.” That policy,too,led to the issuing of a clarification by the WMA in October of 2004: “The WMA hereby reaffirms its position that it is necessary during the study planning process to identify post-trial access by study participants to prophylactic,diagnostic,and therapeutic procedures identified as beneficial in the study or access to other appropriate care. Post-trial access arrangements or other care must be described in the study protocol so the ethical review committee may consider such arrangements during its review.” In addition to its updated policy on placebo-controlled trials and rights to post-trial treatment,the newest version of the Declaration also strengthens patient rights to consent to the use by researchers of not only their blood, tissue,and DNA,but also of the data produced by such trials.In addition,the latest declaration also requires researchers to register clinical trials in a publicly accessible database. “Authors,editors and publishers all have ethical obligations with regard to the publication of the results of research,” the new revision reads.“Authors have a duty to make publicly available the results of their research on human subjects and are accountable for the completeness and accuracy of their reports.They should adhere to accepted guidelines for ethical reporting.” The declaration also requires researchers to publish or make publicly available negative and inconclusive results as well as positive results.Researchers should also declare in any publication their sources of funding,institutional affiliations,and conflicts of interest.Also, journals should accept for publication reports of any studies that fail to comply with the principles of the declaration. The adoption of the new revisions followed extensive consultation with national medical associations,researchers, government officials,and industry representatives. Dr Eva Bågenholm,who chaired the WMA working group that drafted the revision,said the consultation process helped cement protections for research subjects.“The WMA now looks to other stakeholders,especially governments,to raise their standards to the declaration's level,” Dr Bågenholm said at the WMA General Assembly. The Declaration of Helsinki,which was first promulgated by the WMA in the Finnish capital in 1964,is the world's leading policy document on the ethics of clinical research.Although not ethically or legally binding in itself,scores of countries and medical regulatory bodies around the world have adopted the declaration into their own laws and rules,thus making the declaration legally and ethically binding on doctors within their respective jurisdictions.The WMA is an independent confederation of national medical associations from more than 90 countries that collectively represent more than eight million physicians. World Matters bbyy PPaauull MMccGGiinnnn T he ongoing world economic crisis will hasten the shift of care away from ophthalmologists and other physicians to cheaper health professionals, the outgoing president of the World Medical Association (WMA) has warned. Dr Jon Snaedal,who stepped down in October at the WMA's General Assembly in Seoul,South Korea, predicted that the current economic turmoil will accelerate the move towards shifting doctors' responsibilities to other health professionals. “Many of the other health professionals are willing to take over tasks that we have traditionally provided.These tasks include,for example,prescribing of drugs,diagnostic work and even treatment,and follow-up of patients,” Dr Snaedal said. Dr Snaedal,a geriatrician who practises in Reykjavik, Iceland,noted that despite the allure of saving money by using non-physicians,the replacement of physicians lacks appropriate evidence to underpin such change.He added that there was often a lack of regulation,education,and training for such non-medical professions. Dr Snaedal acknowledged that the shift from physicians to non-doctors has not occurred in a vacuum.Allied health professionals have long been willing to provide expanded roles at a cheaper price than doctors.In addition,doctors have often failed to respond to patients' needs,particularly where patients had chronic conditions and were in need of continuous and easy access to medical services and medical help.Where this occurred, pressure arose from nurses,pharmacists,and technicians to step in. In response to such pressures,Dr Snaedal advised that doctors should organise their medical services better and lead patient care from within teams of health professionals.

19 Feature R esearchers in the field of retinal degeneration have reported an association between a cell surface receptor – which helps the immune system recognise foreign pathogens – and the dry form of age-related macular degeneration (AMD). The finding adds a further candidate to a previously established list of immune players that appear to play a significant role in AMD. In addition,the report may prove to have significant implications for the promise of using siRNA to inhibit angiogenesis in wet AMD. The researchers,Dr Zhenglin Yang MD,Ms Charity Stratton BS,Dr Peter Francis MD, PhD,Dr Mark Kleinman MD,and Prof Kang Zhang MD,PhD reported their findings in the New England Journal of Medicinein October.(N Engl J Med 2008;359;1456- 1463).Their report followed an extensive collaboration between two research institutes in China and three institutes in the US. A significant risk factor for developing AMD has been the presence of cellular debris – known as “drusen” – underneath the retinal pigment epithelium (RPE) in the macula.Drusen are now known to consist of extracellular deposits of material which aggregate between the RPE and Bruch's membrane.Components of the drusen “complement” include serum proteins that mediate one of the immune system's antibody-mediated disposal mechanisms.This process is known as “complement fixation”. It is the number and size of drusen observed under ophthalmic examination that aids in categorising a patient with “early-to- intermediate AMD”,when the drusen are few and small;or with “advanced AMD”, when the drusen are many and large. Geographic atrophy is generally a term reserved for the advanced stages of AMD. Despite its prevalence,the cause of such retinal cell death remains largely unknown. There have been many recent genetic association studies showing statistical links between certain genetic loci and AMD,but there is,as yet,no clear molecular understanding of the path from gene to disease. Several immune system components and regulators have been postulated to overlap in the pathogenesis of AMD.Such speculation led the current collaborating research team to take a close look at a cell surface receptor known as “toll-like receptor 3” or “TLR3”.Toll-like receptors are a well known class of single membrane spanning receptors that recognise conserved molecules from invading micro-organisms and facilitate activation of an immune response. As with all genes in the human body, TLR3 can come in slightly different flavours or “variants”,technically known as “SNPs”, short for “single nucleotide polymorphisms”.Often,such variants have little or no impact on the biological function of a given gene product;however, on occasion,these variants may represent the difference between having a disease or not. In their research,Prof Kang Zhang's team examined a number of TLR3 variants and their association with AMD.In essence,the research group found that a variant of TLR3 – known as the “Phe variant” – was associated with protection from geographic atrophy.In other words,if you had a TLR3 gene that encoded the Phe variant,then you were less likely to suffer geographic atrophy of the retina. The researchers looked at 441 patients with choroidal neovascularisation,232 with geographic atrophy,152 with soft confluent drusen,and 359 unaffected controls.The clinical presentation was compared against variants of the TLR3 gene genotyped from each of the patients.The statistical analysis that followed clearly indicated that the Phe variant tended to be associated with protection against geographic atrophy. According to Prof Zhang's analysis,patients with this protective form of TLR3 have a 30 per cent to 70 per cent lower risk of developing geographic atrophy.This same TLR3 variant was not found to have any significant association with either choroidal neovascularisation or with soft confluent drusen,however. Such a finding in itself represents a major milestone and allows for the future categorisation of “at risk” populations through either a gene-based SNP test or potentially some other biomarker-based technology.Such testing would allow clinicians to quickly screen individuals into one or other category and allow them to advise those individuals appropriately about adjusting any risk factors.Such individuals might also be candidates for new drug treatments currently progressing to the clinic.Such new treatments,as it turns out, include the highly promising field of RNAi and,in particular,the use of siRNA as a treatment strategy against choroidal neovascularisation found in wet AMD patients. The interaction of RNAi therapy with TLR3 comes about – in part – because of an earlier provocative publication last April in the journal Science(Science 2008;452:591).According to that report, researchers demonstrated that the effects of siRNA in the retina appeared to be independent of their genetic sequence and dependent on TLR3.Building on this knowledge,Prof Zhang and his research colleagues used double stranded RNA, known to activate TLR3,to infect cultures of human retinal pigment epithelial (RPE) cells with the protective TLR3 Phe variant and these cells survived on average 50 per cent more than when the TLR3 Phe variant was absent. The significance of this finding may be appreciated in the context of several therapeutic strategies currently in progress using double stranded RNA (or other RNAi approaches) to target angiogenesis in wet AMD patients.If such patients have the Phe variant of TLR3, then they may survive significant cell death compared to patients with a different variant of TLR3,such as the “Leu” variant.On a practical level,it may be therefore necessary for genotype patients prior to RNAi therapy to determine their risk status as mediated through the presence or absence of particular TLR3 variants.This additional requirement will be likely requested by regulatory authorities monitoring the clinical trials of experimental drugs based on RNAi biology. Understandably,a number of the companies involved in conducting clinical trials with siRNA targeting VEGF or its receptor in the eye have come out strongly against the significance of the finding.A number of company sources argue that they have conducted testing on hundreds of patients with no ill effects in comparison to the current single paper. Such companies claim that the weight of evidence clearly demonstrates the safety of siRNAs in the eye.However,several leading scientists are not yet convinced.In particular,Prof Zhang expressed serious concerns that in efforts to cure wet AMD, there may be a significant possibility of causing geographic atrophy. In summary,the findings by Prof Zhang and colleagues clearly show an association between variants of TLR3 and AMD and their extension of these findings into siRNA therapeutics will have significant impact for future treatment strategies employing RNAi.The design of current clinical trials using siRNA to target either VEGF or its receptor may need to accommodate this new information,most specifically with regard to choosing patients with the more protective TLR3 variant. Bio-Ophthalmology Researchers report that new dry AMD gene highlights immune system regulationbbyy GGeeaarrooiidd TTuuoohhyy eTIMES is EuroTimes’ bimonthly newsletter with the latest breaking news from the ESCRS and the world of ophthalmology. We offer exclusive access to upcoming EuroTimescontent where subscribers can read our stories first online. To subscribe to this exciting new service log on to the EuroTimeswebsite at www.eurotimes.org. Such a finding in itself represents a major milestone and allows for the future categorisation of “at risk” populations through either a gene-based SNP test or potentially some other biomarker-based technology

News from Berlin The annual ESCRS Congress is often a launching pad for new products from industry.This year was no exception,as delegates were introduced to innovations in all areas of ophthalmology. ReSTOR +3.0 Add Power IOL launch Alcon announced the commercial launch outside the U.S.of the new +3.0 Add Power AcrySof®ReSTOR®Aspheric IOL during the 2008 ESCRS annual meeting in Berlin,Germany.The lens maintains the original optical design of the +4.0 Add Power AcrySof®ReSTOR®Aspheric IOL, while the new add power gives flexibility to tailor the surgery to patients’ vision needs and lifestyle,noted José F Alfonso, MD,PhD,head of the Refractive Surgery Department at the Instituto Oftalmológico Fernández-Vega,in Oviedo,Spain.In clinical studies,at the three-month follow-up exam,95 per cent of patients had combined distance corrected visual acuities (near,intermediate and distance) of 20/40 or better.The clinical studies also showed a patient satisfaction rate of 96 per cent.Alcon completed its CE Mark of the new iteration in the third quarter of 2007.The IOL is now available in most major markets outside the US.The company filed a Pre-Market Application for the lens in June of 2008 with the US FDA. Alcon also introduced its AcrySof phakic IOL,which received the CE mark this summer.The angle-supported phakic lens is intended for the correction of stable high myopia.The lens is foldable,and comes in a variety of lengths and refractive power ranges. www.alcon.com Schwind and Ziemer form all-laser alliance Schwind and Ziemer reported that they will work together to create an all-laser LASIK platform combining Schwind's Amaris excimer laser and Ziemer's Femto LDV femtosecond surgical laser.The companies will share distribution channels where possible,although they say they will also continue to market their products independently. www.eye-tech-solutions.com www.ziemergroup.ch Dry eye monitoring system OcuSense launched its TearLab Osmolarity System,a system that measures and monitors tear osmolarity to diagnose dry eye disease.The TearLab system determines osmolarity through the measurement of electrical impedance of tear samples.The System includes the TearLab Osmolarity Test Card,the TearLab Reader and the TearLab Pen.The test requires only 0.05 µL tear film samples, takes about 30 seconds from start to finish,and can be performed by a technician.Once the tears are collected, the pen is docked into the TearLab Reader to provide the osmolarity reading.The "lab-on-a-chip" approach used by the device mitigates the risk of evaporation from altering the osmolarity of the tear sample,an issue that is of particular concern with techniques involving small tear samples. www.ocusense.com CO-MICS 2 from Oertli Oertli demonstrated its latest instrument for coaxial microincision cataract surgery: the CO-MICS 2 tip.The company says that the new tip is fully compatible with its OS3,SwissTech and CataRhex platforms. The tip allows microincision surgery to be performed through a 1.6mm incision. www.oertli-instruments.com New biometry instrument WaveLight debuted the Allegro BioGraph,a biometry device that utilises optical low coherence reflectometry.The contact-free device provides axial eye dimensions and the complete anterior segment in a single,one- click measurement.It is intended for use with both cataract and refractive surgery. www.wavelight.com Optiflex Surgery Assistant and H-R Wide Field Lenses Volk Optical featured two new products at its exhibit during the ESCRS Congress in Berlin.One of these was the Optiflex® non-contact surgical viewing system. During vitreoretinal surgical procedures, the Optiflex provides precision manoeuvring and instrument control to ensure the positioning of surgical lenses for the finest imaging,the company says. The company also displayed its High Resolution (H-R) Wide Field lens for pan- retinal diagnosis and treatment.The H-R Wide Field lens has a double aspheric design that delivers an unparalleled view all the way to the ora serrata with no distortion across the entire field. www.volk.com Moria introduces new product line Moria introduced a new line of single-use ophthalmic instruments dubbed “the One”. The new line includes instruments commonly used during cataract surgery, which are available separately or in packs. The company also makes a microkeratome with disposable heads and suction rings, the One Use-Plus SBK. www.moria-surgical.com Akreos approval by FDA Bausch & Lomb (B&L) announced during the ESCRS Congress that it had received FDA approval to market the Akreos™ Advanced Optics Aspheric Lens (model AO60) in the US.The Akreos AO Lens is a single-piece,foldable acrylic intraocular lens with a unique four-haptic design and aspheric optics designed to be aberration-free.The lens is implanted with Bausch & Lomb’s single-use AI-28 inserter,which enables single-handed insertion through an un-enlarged standard phaco incision.The company expects to begin shipping the Akreos AO Lens to surgical facilities in the US immediately. B&L also announced that it would form a joint venture with 20/10 Perfect Vision AG,a femtosecond laser developer.The joint venture will combine the refractive eye surgery assets of both businesses,in particular,20/10 Perfect Vision's technology for presbyopia correction and B&L's development network and worldwide commercial reach.B&L currently develops and manufactures refractive surgery products including the Zyoptix Personalized Laser Vision Correction System,the Zyoptix XP microkeratome and related diagnostic products.20/10 Perfect Vision develops and markets the FEMTEC femtosecond laser workstation for proprietary,non- invasive intrastromal refractive procedures.The transaction is expected to close by the end of 2008.Financial terms were not disclosed. www.bausch.com 20 Industry News Recent developments in the vision care industryIInndduussttrryyNews Spectralis upgrade Heidelberg Engineering has released a new software upgrade for the Spectralis®product line.The version 3.2 upgrade adds new capabilities to both the 2-mode Spectralis OCT and 6-mode Spectralis HRA+OCT versions of the company’s tracking laser tomographer which combines spectral-domain OCT and confocal scanning laser technologies.New features include dynamic selection of reference images for progression analysis,manual adjustment of the layer segmentation lines,improved display options,and expanded printing options. www.heidelbergengineering.com ASICO diamond knife ASICO introduced the Koch Double-Footplate LRI Diamond Knife (AE-8122).It features double- footplate to ensure consistent wound architecture.Trifacet blade facilitates controlled entry and side- cutting edges allow easy wound extension.Depths are adjustable to 500,550,and 600 microns. Canaloplasty microcatheter approval iScience Interventional announced that it has received expanded 510(k) clearance from the FDA to allow ophthalmic surgeons to use its microcatheters for canaloplasty procedures.The microcatheters are used to enlarge outflow passages to reduce IOP in the treatment of primary open-angle glaucoma (POAG).Canaloplasty has been performed worldwide for more than three years. www.iscienceinterventional.com Product Launches Regulatory Updates

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