A long-needed independent forum for potential lasik customers to really understand some the potential risks and negative outcomes. Article from the Wall Street Journal:
FDA to Give Unhappy Patients Of Laser Eye Surgery a Forum
By RHONDA L. RUNDLE
April 24, 2008; Page D1
Laser vision surgery has helped millions of people see better without corrective lenses. But a small number of patients have experienced troubling aftereffects from the procedure, and the Food and Drug Administration has begun taking a closer look at their complaints.
Most people who have had their eyes zapped are thrilled with their vision. But some patients say that as a result of the surgery they developed such problems as painful dry eyes and fuzzy or double vision that can't be corrected with glasses. Such complaints have circulated on Internet sites, but have rarely drawn widespread public exposure.
A CLOSER LOOK
The FDA is paying greater attention to consumers' concerns about laser eye surgery.
• A small number of patients complain of problems such as chronic dry eyes and fuzzy vision after surgery.
• Prospective patients should discuss the risks of the procedure with a doctor.Now, the FDA has invited consumers to air their grievances at Friday's regular meeting of its ophthalmic devices division in Gaithersburg, Md. The full-day event will focus on laser-assisted in situ keratomileusis, or Lasik, the most common type of vision-correction surgery. While laser surgeons also are expected to testify, the session likely will be dominated by consumers critical of the procedure.
In a related move, the FDA recently recruited the National Eye Institute, part of the National Institutes of Health, to study how patients' quality of life has been affected by laser eye surgery, beyond helping to correct their vision. Eye doctors are hoping that the study will shed light on the incidence of dissatisfaction with laser eye surgery and lead to ways to shrink the risk of poor outcomes.
Past studies generally have found that 95% of Lasik patients are satisfied with their surgery. "We all have a lot of friends who say it's the best thing that ever happened to them," says Frederick Ferris III, the eye institute's clinical director. But, he says, that's no consolation when "the fickle finger of fate points to you," bringing negative consequences.
Matt Kotsovolos, of Raleigh, N.C., says he has had debilitating dry eye, facial pain and migraine headaches since undergoing Lasik nearly two years ago. He says he was until then a "completely healthy" 37-year-old working as director of finance at Duke University's eye center, which paid for his surgery. Like most people, he says, he expected Lasik to be "a piece of cake."
Mr. Kotsovolos now has a different administrative job at Duke, from which he is intermittently on leave because of his medical condition. He says he plans to testify at this week's FDA meeting.
The heightened focus on potential problems from laser eye surgery comes at a time when the industry is suffering a slowdown partly because of the weakening economy. Dave Harmon, president of research firm Market Scope LLC, forecasts a 17% decline in U.S. laser vision-correction procedures this year. Surgery volumes peaked in 2000 at about 1.4 million and have been flat in recent years, he says. The procedure costs on average about $2,000 per eye.
The FDA says its decision to invite Lasik critics to this week's meeting was spurred by patient complaints over the years. "There are people raising questions about the information" available to those who are deciding whether to have surgery, says Daniel Schultz, director of the FDA's Center for Devices and Radiological Health. The agency says its "Learning about Lasik" Internet site is one of the most frequently visited federal government sites, underscoring the large public interest in the procedure.
It's difficult to know before surgery whether a patient could experience negative results. Still, it's a subject worth discussing with your doctor. And there may be tests that can provide some guidance. For instance, a test that measures tear production could suggest whether a person may be prone to dry eye.
Malvina Eydelman, director of the FDA's ophthalmic and ear, nose and throat devices division, told a meeting of eye surgeons in Chicago this month that "the vast majority of patients are indeed satisfied with their outcome" from laser eye surgery. But, she added, few studies have focused on how patients' quality of life is affected.
To research this angle, the FDA enlisted the participation of the American Academy of Ophthalmology and the American Society of Cataract and Refractive Surgery, in addition to the National Eye Institute. Each of the two professional physician groups has agreed to contribute $500,000 of the estimated $1.2 million cost of the study. Such a joint government-physician study is unusual, says Dr. Ferris, the eye institute's clinical director. "This is very difficult research" that will require a large study of more than a thousand people, he says.
Lasik critics are upset about the collaboration because it includes surgeons who make their living from refractive surgery. A potentially contentious issue could be the choice of quality-of-life factors to be studied. Lasik surgeons tout the procedure's lifestyle benefits, such as freedom from glasses and improved sports performance. But Lasik critics say that past studies generally haven't measured such aftereffects as chronic dry eye and clinical depression that can lead to suicidal thoughts. Some patients complain that they have been abandoned by surgeons who refuse to believe their problems are real.
Refractive surgeons discount such criticisms. "Our goal is to put patient care first. As physicians we've taken the Hippocratic oath," says Kerry Solomon, director of cataract, refractive and cornea services at South Carolina's Storm Eye Institute and co-chair of the Lasik joint study task force.
Dr. Schultz of the FDA says the study "will be done with an eye toward objectivity to make sure we don't pre-specify any kind of outcome."
Meanwhile, laser makers are confident that demand for surgery will rebound along with consumer confidence. "We don't think anyone has changed their mind about Lasik, but people are holding off until they have a better sense of how their stock portfolios will do or what their mortgage interest rates will reset to," says Sheree Aronson, a vice president at Advanced Medical Optics Inc., a Santa Ana, Calif.-based device maker with the largest share of the U.S. Lasik market.
