Sunday, August 06, 2006

eye laser surgery : Is Laser Surgery for You?

For some, like Goldstein, laser surgery has been the ultimate freedom from the everyday hassles of contact lenses, and a second chance at having normal eyesight. But can everyone expect such dramatic results?

"The answer is no," says Rosenthal. "It's not a foolproof procedure and people need to know that some can end up with worse eyesight than before they went in."

Mary Ann Duke, M.D., a general ophthalmologist practicing in Potomac, Md., adds that there are other reasons why the expectations for eye laser surgery vary from person to person.

"People who are slow healers or who have ongoing medical conditions [such as glaucoma or diabetes] are not good candidates for laser surgery," she says. "That's why it's so important for patients to undergo a thorough examination with their doctor."

Poor candidates for this surgery also include those with uncontrolled vascular disease, autoimmune disease, or people with certain eye diseases involving the cornea or retina. Pregnant women should not have refractive surgery of any kind because the refraction of the eye may change during pregnancy.

Looking Ahead

At present, a number of other lasers for eye surgery are currently being tested in FDA-sanctioned studies to determine their safety and effectiveness. Investigational Device Exemptions (IDEs) filed with FDA allow for clinical studies involving the excimer laser and the correction of farsightedness. The IDE process is designed to investigate the safety and effectiveness of a device, or a new procedure with an already approved device, either to obtain information for publication or to generate the data needed to obtain marketing approval from FDA.

"If the refractive surgery center says the laser is approved by FDA, it probably is," Waxler concludes. "Still, it is wise for consumers to check that the device being used for their surgery is FDA-approved," he says, or that they make sure they are being treated with a laser that is under study in an FDA-sanctioned clinical trial.

During the first few weeks immediately following laser surgery, Goldstein says, "Every week I kept thinking, 'this is as good as it gets'?" Then, she discovered by the sixth week, as predicted by her surgeon, that her eyesight was noticeably better and eventually stabilized.

"I would tell others to be patient about their expected outcome," she advises. "Even though with LASIK you can expect quicker results, I'm happy with the choice of PRK."

Carol Lewis is a staff writer for FDA Consumer.

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