Unrealistic claims for eye surgery concern FDA, FTC - photorefractive keratectomy, Food and Drug Administration, Federal Trade Commission - Brief Article

In response to inquiries and complaints about misleading promotion of photorefractive keratectomy (PRK), a laser treatment for nearsightedness, FDA and the Federal Trade Commission recently notified the eye-care community that advertising and promotion for the procedure should be truthful and substantiated.

In a joint letter sent May 7, 1996, the agencies said advertising or promotion should contain enough information about the risks and limitations of PRK to prevent deception, and consumers should be given enough information about the surgery to make an informed decision. Unrealistic claims such as "throw away your eye glasses" and unsubstantiated claims about success rates could be misleading to consumers.

In clinical studies, about 5 percent of patients who had PRK continued to need glasses all the time for distance, and up to 15 percent needed glasses occasionally, such as for driving. Best corrected vision (vision with glasses) was slightly worse after surgery in about 5 percent of patients.

In PRK, an excimer laser is used to reshape the cornea to improve mild to moderate nearsightedness. The surgery is not reversible. Excimer lasers have not been shown safe and effective for severe nearsightedness (more than -7 diopters), farsightedness or astigmatism. People who need reading glasses continue to need them after PRK. Also, PRK does not prevent farsightedness associated with aging, so people may require reading glasses as they age even if they have had the laser surgery. Risks of PRK to the cornea beyond three years have not been studied.

Some doctors perform PRK on both eyes without a waiting period between. Patient brochures developed by the laser manufacturers and reviewed by FDA, however, recommend a three-month wait between eye surgeries to allow vision to stabilize.

In addition, some surgeons perform a laser procedure called LASIK to improve nearsightedness. FDA has not cleared lasers for this use, however, and the devices cannot be promoted or advertised for it.

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