FDA Panel Meeting On LASIK Not All Negative
Data support LASIK benefits, safety
Negative opinions and LASIK complication horror stories were not the only component to the public testimony at the meeting. Several speakers presented a large body of scientific evidence that showed the benefits of LASIK and high patient satisfaction rates.
OSN Refractive Surgery Section Member Kerry D. Solomon, MD, spoke about the worldwide retrospective literature review of LASIK that found a 95.4% patient satisfaction rate from post-LASIK patients. Dr. Solomon and OSN Chief Medical Editor Richard L. Lindstrom, MD, who was not present at the panel meeting, are co-chairs of the ASCRS task force on LASIK.
OSN Cornea/External Disease Section Editor Eric D. Donnenfeld, MD, presented for the first time a separate worldwide retrospective review that the task force conducted analyzing dry eye after LASIK.
In a meta-analysis of more than 1,000 articles, the task force found reviewable data from 46 peer-review articles published in 13 journals from 15 countries and covering more than 32,000 eyes. Dr. Donnenfeld and colleagues found that although dry eye is common after LASIK (35% of patients), 32% of those same patients had pre-existing dry eye before surgery.
“The great majority of patients had complete resolution of their dry eye symptoms over a 2- to 4-week period following surgery,” Dr. Donnenfeld said. “Severe dry eye following LASIK is extremely rare.”
The military experience
Some of the strongest evidence and testimony in support of LASIK came from reports from the U.S. military’s experience with LASIK.
Previously trained in the Special Forces before becoming an eye surgeon, Lt. Col. Scott Barnes, MD, from Fort Bragg, N.C., described how commanders in the Special Forces asked him to evaluate LASIK specifically for those Special Forces soldiers.
“I said, ‘Well the Army has decided it’s a good thing.’ They said, ‘We don’t care what the Army says. We want to know from one of our guys who used to be out there doing the sorts of things that we’re doing: jumping out of planes, diving and flying helicopters. We need to know is this safe for us,’” Dr. Barnes said.
Since that time, Dr. Barnes said, the Special Forces troops have come to rely on LASIK to help them on the battlefield.
“It’s a significant issue for these guys,” he said. “They’re not talking about cosmetic needs. They’re saying, ‘I can’t do my job as well in glasses or contacts as I can after refractive surgery.’”
Cmdr. David Tanzer, MD, of the Navy, who was invited to speak by the FDA panel, cited a number of studies such as the flap stability study that found no flap dislocations occurred in either halo jumps, which are freefall parachute jumps from airplanes at high altitude, or forced ejections of pilots from airplanes, which occur with great force.
“There have been 45 studies performed to date by the Department of Defense,” he said. “Our goal is the constant, independent evaluation of the safety and efficacy of laser vision correction.”
Quoting a study published last year in Archives of Ophthalmology, Dr. Tanzer said the risk of infection from contact lens wear was 0.18%, whereas infection from LASIK was 0.05%.
To date, there has only been one medical disability retirement due to complications related to laser vision correction, which would equate with a 0.0009% incidence in the military, Dr. Tanzer said.
The FDA panel commented on the diversity of opinions represented at the forum.
“I think we have heard here today there are two different animals here,” Dr. Weiss 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 starbursts and halos. I think we need to start, if we are not already, distinguishing between the side effects that disappear and the complications.”
According to Dr. Weiss, there were a number of disturbing issues raised during the meeting that fell outside of the purview of the FDA that should be addressed in other forums, including overly aggressive marketing, use of LASIK as a commodity, the lack of informed consent in some cases and inadequate patient screening procedures.
Recommended labeling changes
The panel made a number of recommendations for changes to patient labeling as well as for the FDA Web site page on LASIK.
The panel agreed that post-LASIK patients who go on to have cataract surgery should have IOP monitoring. There should also be an indication that LASIK affects IOL implant measurements. Several photos should be used to distinguish how vision appears when affected by halos, starbursts or glare. The panel also recommended, if not present already, there be sufficiently strongly worded caution for patients with keratoconus and other ecstatic disorders.
The panel also advocated distinguishing between those with collagen vascular disease vs. those with collagen vascular disease with dry eye. Dr. Weiss said some wording should be included to point out possible psychological implications of adverse LASIK outcomes.
Surgeons recognize warning
Drs. Solomon and Donnenfeld discussed with Ocular Surgery News what they took away from this meeting and how it would impact refractive practices.
“I think it’s important that we make absolutely certain we have a good discussion about the motivations and expectations a particular patient has in terms of why they want to be less dependent on their glasses and contacts,” Dr. Solomon said. “I think it’s incredibly important because in my own experience, assuming that the eye is healthy and a good exam has been done, if someone’s goals, expectations and motivations are in line with what these procedures can provide, and I have had a good informed consent discussion with them, the vast majority of patients do incredibly well.
“If that rare occasional thing should occur where someone is dissatisfied, we as physicians need to spend the time with that patient to make them understand we are in this together. … What I did hear [at the panel] was that some of these patients felt like they were abandoned.”
Dr. Donnenfeld also stressed the need to care for dissatisfied patients.
“While LASIK is the safest elective procedure ever, we as ophthalmologists cannot rest until every patient has as good a result as possible and every complication is eliminated,” he said.
“We also have to be sensitive to the needs of unhappy patients,” he said. “These patients require more time and empathy, and we really have to go out of our way to make sure they achieve the best results they can possibly achieve.”