FDA Plans to Examine Scope of Complaints About Lasik

By Rob Stein
Washington Post Staff Writer
Friday, April 25, 2008

In response to complaints of double vision, blurry vision and other complications following popular laser surgery to improve eyesight, the Food and Drug Administration is looking for ways to better educate patients about the possible risks and to assess the scope of the problems, an official said yesterday.

"Our sense is that most of the patients who are having the procedures are reasonably satisfied and are doing fairly well," Daniel G. Schultz, director of the FDA's Center for Devices and Radiological Health, told reporters during a telephone briefing. "But clearly there is a group that is not satisfied and do not get the kind of results that they expect. What we're really trying to do is figure out what that number is."

The FDA is convening a panel of outside advisers for a day-long meeting today to hear from patients who have experienced problems and to make recommendations about whether those considering the procedures should receive better information about the risks.

"We want to provide people with accurate, timely information to help people make decisions," Schultz said. About 700,000 Americans each year undergo the procedure, known as Lasik (laser-assisted in situ keratomileusis). About 7.6 million Americans have received Lasik, which costs about $2,500 per eye.

The operations involve cutting a flap on the surface of the cornea and zapping the underlying corneal tissue with a laser to reshape it to correct nearsightedness, farsightedness or astigmatism.

About 95 percent of patients report being satisfied with the outcome, according to the American Society of Cataract and Refractive Surgery, which represents doctors who perform the procedures. But critics estimate that a much higher proportion of patients have problems, including excessively dry eyes, "starbursts" and "halos" that make it difficult to see.

"I have no night vision. I can't drive at night. When I look across my living room, it's like looking through used wax paper," said Barbara Berney, who underwent the procedure in 2001 and now is president of the Vision Surgery Rehab Network, which helps patients who have experienced complications. "I deal with people every day who are miserable and depressed after Lasik surgery."

After receiving such complaints, the FDA began trying to get an accurate assessment of the scope of the problems. The agency determined that existing data were insufficient and that there was no reliable method for assessing patients' quality of life after the procedures, Schultz said.

"There really is a need to develop better-quality information," he said.

The agency plans to collect information about the complications from a national network of 350 medical facilities already organized to alert the agency about problems with other medical treatments.

"This should really help to give us a better view of how ophthalmic devices are performing in the real world," Schultz said.

The panel will also advise the agency about how to conduct a $1.2 million study that the agency is planning with the National Eye Institute and the American Society of Cataract and Refractive Surgery to better assess the quality of life of patients after the operations.

Critics expressed skepticism about the effort, given the involvement of the organization representing doctors who perform the procedures.

"I don't think anything is going to come out of it," said David Hartzok, a Chambersburg, Pa., optometrist who treats patients who have had problems after Lasik and is executive director of Berney's group.

"The industry is going to design the study. We were hoping we'd finally get some light shed on the subject. Unfortunately, that doesn't look like it's the way it's evolving," he said.

Kerry D. Solomon, a professor of ophthalmology at the Medical University of South Carolina who works with the eye doctors' group, said the study would provide valuable information.

"This study will give us invaluable insight on the many and diverse factors that make up quality of life," he said. "This new knowledge will ultimately be a great benefit to patients and doctors alike."

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