FDA panel hears public testimony for, against LASIK

GAITHERSBURG, Maryland – The FDA Ophthalmic Devices Panel heard public testimony both in favor of and sometimes vehemently opposed to LASIK at a post-market LASIK meeting here.

The Ophthalmic Devices Panel heard a number of impassioned presentations opposing LASIK. The testimony ranged from individuals who had suffered adverse LASIK-related complications, therapists and other specialists who had treated patients for depression following adverse complications, optometrists, ophthalmologists and attorneys representing those patients with significant post-LASIK complications.

Gerard Dorrian, whose son Colin committed suicide after suffering painful complications from LASIK, said, “A patient satisfaction survey does not address issues faced by patients deformed by LASIK.”

Some called upon the FDA to impose a moratorium on LASIK procedures until more is known about the alleged psychological damage inflicted upon those who have experienced debilitating complications. However, there was a large body of evidence presented that showed the benefits of LASIK and high-patient satisfaction.

Kerry D. Solomon, MD, presented a worldwide retrospective literature review of LASIK that found 95.4% of patients were satisfied with their post-LASIK results.

Eric D. Donnenfeld, MD, presented a worldwide retrospective review analyzing the incidence of dry eye after LASIK and said the “great majority of cases resolve after 2 weeks.”

“I think we have heard here today there are two different animals here,” committee chairperson Jayne S. Weiss, MD, said. “We have those patients who come in the next day who are filled with elation … and they are very happy patients, and then we have those people who have been reported to us today, who have visually disabling problems, and I think we need to start … distinguishing between the side effects that disappear and the complications.”

Jayne S. Weiss

Despite the often dramatic testimony, the FDA panel was not convened as a referendum on LASIK, according to Dr. Weiss. “I think some of you came here today, and I know that some of the press had touted this meeting as a referendum on LASIK,” Dr. Weiss said. “It appears to me from hearing what was said today that this really has been a referendum on the performance of LASIK by some surgeons who should be doing a better job. And I hope and feel that in general will help you get the answers to some of this, and the FDA and the organizations will help in terms of getting further information to try to make things better for future patients, so your testimony here has been of value, and we thank you.”

The purpose of the panel meeting according to an FDA executive summary was to present regulatory background and history of refractive lasers, evaluate the American National Standards Institute refractive laser standard, review the Post-market Issue Action Team’s assessment of quality of life for LASIK patients, explore cost-effective means of executing patient reported outcomes in clinical trials and discuss the feasibility of a large multicenter clinical trial of LASIK and quality of life.