Eyeworld

EW NEWS & OPINION 11 Over the past few months there has been some media coverage of criticisms of LASIK safety and effectiveness by the former U.S. Food and Drug Administra- tion's Center for Devices and Radiologi- cal Health (CDRH) chief of ophthalmic devices, Morris Waxler, Ph.D., who was in charge of evaluating LASIK devices approved between 1996 and 2000. In May of last year Dr. Waxler wrote to R. Doyle Stulting, M.D., Ph.D., presi- dent of ASCRS, to level his complaints. Dr. Stulting responded in September with a letter, partly quoted below. As members have expressed an interest in ASCRS's response to Dr. Waxler's claims, the salient sections of the letter are provided below. D uring my 10 years of serv- ice as a member of the FDA's Ophthalmic Devices Committee and three years as its Chairman, I came to know and respect you for your professionalism, knowledge, and dedication during your tenure with the FDA. However, your cur- rent view of LASIK is misinformed, unsupported by evidence, and lack- ing in balance and perspective. In your letter to me, you wrote that the U.S. Food and Drug Admin- istration (FDA), is "complicit" with LASIK manufacturers [manufacturers of ophthalmic excimer lasers], and the American Society of Cataract and Refractive Surgery (ASCRS) is trivializing complications. Nothing could be further from the truth. LASIK was first approved by the FDA on your watch, following all the required FDA protocols and guidance documents created to measure safety and effectiveness. In fact, laser vision correction is one of the most studied elective surgical procedures, with 7,830 patients rep- resenting 16,502 eyes in U.S. FDA clinical trials from 1993 to 2005— not to mention more recent submis- sions to the FDA and thousands of other patients reported in the pub- lished literature. The FDA review process is more stringent than that of any other country in the world. Your estimate of the keratectasia rate is inflated and inconsistent with existing data. In your letter you stated, "Keratectasia will occur in over 3,000 patients in 2010 (rate of 0.87 of about 700,000 LASIK surger- ies expected to be performed)." Your March 2011 Comparison between bilateral and monovision IOL Fuxiang Zhang, M.D., Alan Sugar, M.D., Gordon Jacobsen, M.S., Melissa Collins, C.O.A. In this study, investigators set out to compare how monovision pa- tients fared versus those receiving multifocal IOLs. For the study, 43 patients received either the AcrySof ReStor SN60D3 (Alcon, Fort Worth, Texas) multifocal IOL or the monofocal AcrySof SN60WF IOL (Alcon) as monovision. At the 3-month mark, investigators de- termined that while the multifocal IOL group did slightly better in terms of bilateral uncorrected distance and near vision, this differ- ence was not statistically significant. Intermediate vision was better in the monovision group, enabling these patients to use computers with significantly less difficulty than their multifocal counterparts. Satisfaction scores, complaints, and out-of-pocket costs also favored the monovision patients. Investigators concluded that pseudophakic monovision fared well, with comparable distance and near findings and significantly better intermediate vision. This enabled them to use computers more easily without glasses. The monovision patients also dodged the risk of disturbing visual symptoms that can be prob- lematic with multifocal IOLs. LASIK with and without iris registration Gaurav Prakash, M.D., Amar Agarwal, M.S., F.R.C.Ophth., Dhivya Ashok Kumar, M.D., Soosan Jacob, M.S., D.N.B., Athiya Agarwal, M.D., D.O. The aim here was to consider how myopic astigmatic patients who underwent LASIK with dynamic rotational eye tracking did in com- parison to those in which static pre-ablation iris registration or no iris registration was employed. Investigators determined that at 6 months with no iris registration, the mean spherical equivalent was −0.27 D, with static iris registration this was −0.12 D, and with dy- namic iris registration this was −0.02 D. Mean post-op cylinder at 6 months for the eyes with no registration was −0.37 D, was −0.29 D for those with static registration, and for those with dynamic iris registration was −0.20 D. Investigators concluded that iris registra- tion with dynamic rotational eye tracking offered better outcomes in myopic astigmatism than either static or no iris registration. For- going iris registration altogether resulted in the worst outcomes of the three. Review/update: Anatomy and physiology of the cornea Derek W. DelMonte, M.D., Terry Kim, M.D. The one vital structure of the visual system that is often overlooked is the cornea. While the eye would be unable to function without this transparent ocular component, the lens with its intricate move- ment and the retina with its neurobiological nature often garner the lion's share of attention. In this update, investigators delved into the components of the cornea that allow it to function with seem- ingly elegant simplicity. In the journal … March 2011 by John Ciccone ASCRS Director of Communications ASCRS responds to LASIK critic Morris Waxler support for this information is "Ezra Maguen, Yaron S. Rabinowitz, Lee Regev, Mehrnoosh Saghizadeh, Takako Sasaki, and Alexander V. Ljubimov. Alterations of Extracellu- lar Matrix Components and Pro- teinases in Human Corneal Buttons With INTACS for Post–Laser In Situ Keratomileusis Keratectasia and Ker- atoconus. Cornea. 2008 June; 27(5): 565–573." This article (Appendix 2) actu- ally deals with biochemical alter- ations related to INTACS, does not contain a discussion of keratectasia, and makes no mention of the rate of iatrogenic keratectasia. Thus, it pro- vides no support for the grossly in- flated keratectasia rate that you claim in your letter to me. Elsewhere in your letter, you wrote, "At least 1% of LASIK patients have keratectasia," referencing a re- port by Pallikaris et al., that actually gives the rate as 0.66% and is the highest estimate in the literature. Since the first report of keratec- tasia in 1998 1 , the profession has worked diligently to understand this complication and how to avoid it— and ASCRS has facilitated this work. Published estimates of its incidence actually range from 0.0004% to 0.66%. The later report is from out- side of the United States and is not reflective of the incidence of keratec- tasia in this country 2-3 . Another se- ries of papers not referenced by you now allows surgeons to identify and avoid operating on potential pa- tients who are likely to develop ecta- sia 1, 4-5 . My colleagues and I even published an editorial to bring these criteria to the attention of LASIK sur- geons and make certain that they know how to identify patients at risk for ectasia 6 . Application of these cri- teria is now well known and will un- doubtedly make the future incidence of ectasia lower than it has been in the past. It is also clear that some of the patients who developed ectasia after LASIK would have developed a related, ectatic, corneal condition called keratoconus, even in the ab- sence of corneal surgery 7 . Concerning LASIK, Dr. Waxler, you further wrote, "The benefit is ~60% chance of temporary reduc- tion in dependence on glasses or contact lenses." To support this continued on page 12

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