Eyeworld

EW NEWS & OPINION 12 claim, you cite, "P970053 Patient In- formation Booklet (p9 3rd bullet under #8)" and state, "This is a typi- cal value for refractive lasers and bet- ter than some." This document is attached as Appendix 3. First, it should be noted that the document you reference describes the results of treatment with a laser designed more than 20 years ago, tested more than 15 years ago, and approved by the FDA 12 years ago— a laser that is not commonly used in the United States today and one that does not incorporate numerous technological advances that have oc- curred in the last two decades. Sec- ond, the document you cite pertains to PRK, rather than LASIK. Finally, the actual statement you reference states, "PRK may reduce or eliminate dependency upon contact lenses or glasses (60.6% could see 20/20 or better without glasses or contacts at 6 months)." Clearly, the document that you reference bears no resem- blance to what you wrote in your letter. The very next statement in the document you reference states, "PRK should be considered a permanent surgical procedure," in absolute con- tradiction to your statement that the document labels LASIK as a "tempo- rary" procedure. Dr. Waxler, you also state, "This is a typical value for refractive lasers and better than some." That state- ment is simply false. For example, 93.4 percent of patients achieved 20/20 or better vision at 6 months post-operatively with the WaveLight Allegretto Wave Excimer Laser Sys- tem (see FDA, P020050/S004, page 34, Table 7, Study Cohort, Summary of Key Efficacy Variables Over Time), which was approved in 2003 (Ap- pendix 4). Your letter to me also contains a graph, which you claim was taken from an article published by Pal- likaris in 2001, showing what he says are visual complaints expressed by patients who have undergone LASIK. There are two major prob- lems with this claim. First, the arti- cle you reference does not contain the chart you included in your letter to me. Second, it is important to show that the incidence of visual complaints after LASIK is higher than it was before LASIK, in order to conclude that LASIK caused them. Omitting the preoperative symp- toms and claiming that LASIK is the cause of postoperative symptoms is misleading because many people no- tice visual symptoms with their glasses and contact lenses. I was unable to determine where you obtained the graph that was in- cluded in your letter to me; how- ever, the Summary of Safety and Effectiveness published by the FDA for the WaveLight Allegretto Wave Excimer Laser System, which was ap- proved on October 7, 2003, states, "Patient reports of glare from bright lights, light sensitivity, night driving glare and visual fluctuations all im- proved after LASIK. The percent of subjects reporting 'none' or 'mild' of these symptoms improved after treatment" (Appendix 4). If these and other objective data from FDA- supervised clinical trials of modern excimer lasers had been reviewed by you, Dr. Waxler, you should have concluded that modern LASIK does not increase the incidence of visual symptoms. In summary, your letter is filled with false statements, incorrect cita- tions of the published literature, ref- erences that do not fairly represent the existing literature, … incorrect reference to outcomes of PRK as if they were for LASIK, citation of re- sults for a laser designed two decades ago as if it were representative of modern lasers, mischaracterization of results from older lasers as "better than most," reference of a graph that does not exist in the reference you cite, and misrepresentations of the actual performance of modern excimer lasers for the correction of refractive errors. A recent review of the world's literature on LASIK led to the con- clusion that it is safe and effective, with outstanding results in the vast majority of patients 8 . Complex, visu- ally demanding activities like night firing range performance and mili- tary helicopter piloting is as good or better without glasses in soldiers who have had refractive surgery as it is with glasses before surgery 9, 10 . In fact, laser refractive surgery is now commonly performed on our mili- tary personnel, including aviators and members of Special Forces units, whose lives, performance, and oper- ation of multi-million dollar equip- ment depends on their ability to identify accurately and target the enemy in unfriendly environmental conditions. Based on this positive real-life military experience over the past decade, NASA approved LASIK for astronauts. LASIK has been shown to be a safe and effective procedure for the correction of refractive errors by nu- merous studies around the world. It has a low complication rate that is acceptable to many patients and comparable to that of contact lenses over a lifetime. It serves to reduce or eliminate dependency on glasses and contact lenses for millions of patients around the world and has been found by the U.S. government to be acceptable for use by military personnel and astronauts. Advances in technology and techniques based on scientifically based studies have allowed the profession continually to improve the safety of LASIK. This is clearly a procedure that should be made available to patients who are properly informed about its risks and benefits. Complications of LASIK still exist, and even their low rate is a concern to surgeons and ASCRS. The literature clearly shows that efforts of excimer laser manufacturers, physicians, ASCRS, and the FDA have improved LASIK outcomes over the years. We continue to work to produce better results for our pa- tients and will not be satisfied until the complication rate for this proce- dure is effectively zero. EW Sincerely, R. Doyle Stulting, M.D., Ph.D. President American Society of Cataract and Refractive Surgery References 1. Seiler T, Koufala K, Richter G. Iatrogenic keratectasia after laser in situ keratomileu- sis. J Refract Surg 1998; 14:312–317. 2. Randleman JB, Russell B, Ward MA, Thompson KP, Stulting RD. Risk factors and prognosis for corneal ectasia after LASIK. Ophthalmology 2003; 110:267–275. 3. Randleman JB. Post-laser in-situ ker- atomileusis ectasia: current understanding and future directions. Curr Opin Ophthalmol 2006; 17:406–412. 4. Randleman JB, Woodward M, Lynn MJ, Stulting RD. Risk assessment for ectasia after corneal refractive surgery. Ophthal- mology 2008; 115:37–50. 5. Randleman, JB, Trattler WB, Stulting RD. Validation of the Ectasia Risk Score System for preoperative laser in situ keratomileusis screening. Am J Ophthalmol 2008; 145:813–816. 6. Binder PS, Lindstrom RL, Stulting RD, Don- nenfeld E, Wu H, McDonnell P, Rabinowitz Y. Keratoconus and corneal ectasia after LASIK. J Refract Surg 2005; 21:749–752. 7. Wang JC, Hufnagel TJ, Buxton DF. Bilateral keratectasia after unilateral laser in situ keratomileusis: a retrospective diagnosis of ectatic corneal disorder. J Cataract Refract Surg 2003; 29:2015–2018. 8. Schallhorn SC, Farjo AA, Huang D, Boxer Wachler BS, Trattler WB, Tanzer DJ, Majmu- dar PA, Sugar A. Wavefront-guided LASIK for the correction of primary myopia and astigmatism; a report by the American Academy of Ophthalmology (Ophthalmic Technology Assessment). Ophthalmology 2008; 115:1249–1261. 9. Bower KS, Burka JM, Subramanian PS, Stutzman RD, Mines MJ, Rabin JC. Night firing range performance following photore- fractive keratectomy and laser in situ ker- atomileusis. Mil Med 2006; 171:468–471. 10. Van de Pol C, Greig JL, Estrada A, Bissette GM, Bower KS. Visual and flight perform- ance recovery after PRK or LASIK in heli- copter pilots. Aviat Space Environ Med 2007 78:547–553. Appendix 1. Letter from Dr. Waxler to Dr. Stulting dated May 7, 2010. Available at: http://www. lasiknewswire.com/MorrisWaxler_letter_to _DoyleStulting.pdf. Accessed September 9, 2010. 2. Maguen E, Rabinowitz YS, Regev L, Saghizadeh M, Sasaki T, Ljubimov AV. Alter- ations of extracellular matrix components and proteinases in human corneal buttons with INTACS for post-laser in situ ker- atomileusis keratectasia and keratoconus. Cornea 2008; 27:565–573. 3. Patient Information Book for P970053. 4. Summary of Safety and Effectiveness for Wavelight Allegretto Wave Excimer Laser System http://www.accessdata.fda.gov/ cdrh_docs/pdf2/P020050b.pdf. March 2011 ASCRS continued from page 11

• Cover