Reprinted with permission from www.fdaweb.com
05/07/2010

Former CDRH chief of ophthalmic devices Morris Waxler, who was in charge of evaluation LASIK devices approved between 1996 and 2000, told the American Society of Cataract and Refractive Surgeons (ASCRS) 5/7 its proposed Phase 2 keratectasia trial on LASIK effects is unethical and “I will do everything I can to block approval of such a study.” Waxler, who has recently said the agency’s approval of LASIK devices was a mistake, defined keratectasia as “a rare but serious complication of laser vision correction of any refractive errors.”

Waxler’s criticism came in a three-page letter to ASCRS president Doyle Stulting, in which he said keratectasia affects at least 1% of LASIK patients. “In addition,” he wrote, there is a high probability of many other permanent vision and ocular health problems. LASIK eye surgery complications are already a major public health problem. Hundreds of thousands of eyes are permanently injured each year for a 60% chance of a couple of years free from glasses and contact lenses, and a 40% chance of little or no freedom from spectacles or contact lenses at all. Fifteen to thirty per cent of LASIK patients suffer from eye pain, glare, halos, dry eyes, night vision and other problems, even if their visual acuity is normal.”

Waxler told Stulting that FDA is “complicit” with LASIK manufacturer, ASCRS and others in minimizing the seriousness of multiple permanent vision complications. He asked for Stulting’s cooperation in helping to eliminate unnecessary LASIK through more transparency about the short-term “wow” effects versus the reality of permanent eye injury and achieving “clear and complete informed consent documents comparing percentage risks and benefits of LASIK versus glasses or contact lenses.”

Waxler said he planned to publish an open letter to FDA commissioner Margaret Hamburg in major U.S. newspapers this summer, urging specific actions by the agency to “stem the tide of unnecessary LASIK eye injuries.”