Laser Eye Surgery: Is It Worth Looking Into?

By Lewis, Carol | FDA Consumer, July-August 1998 | Go to article overview

Laser Eye Surgery: Is It Worth Looking Into?


Lewis, Carol, FDA Consumer


For Jeri Goldstein everything was a blur. Without her contact lenses she couldn't distinguish people, the scenes on television, the stars at night, and, generally, the world at large. Then, in March 1998, the 49-year-old California resident had eye surgery, and all that changed.

"After wearing contact lenses for 35 years, you can't imagine the freedom I felt," says Goldstein.

Goldstein underwent refractive eye surgery, an elective procedure intended to correct common eye disorders, known as refractive errors, such as myopia (nearsightedness), hyperopia (farsightedness), and astigmatism (distorted vision). Although there are several types of surgical techniques being performed today to correct refractive errors, laser refractive correction is fast becoming the most technologically advanced method available, according to the American Academy of Ophthalmology in San Francisco. Doctors say it allows for an unparalleled degree of precision and predictability.

"Laser surgery is the most exciting advancement in ophthalmology," says James J. Salz, M.D., clinical professor of ophthalmology at the University of Southern California in Los Angeles and the doctor who performed Goldstein's surgery. But surprisingly, he says, despite its sudden popularity, "only 20 percent of ophthalmologists in the United States today are trained in its operation."

The Food and Drug Administration first approved the excimer laser in October 1995 for correcting mild to moderate nearsightedness. With that approval, the agency also restricted use of the laser to practitioners trained both in laser refractive surgery and in the calibration and operation of the laser. Currently, the excimer laser is only approved for use in a procedure called photorefractive keratectomy (PRK).

Precision Surgery

PRK is an outpatient procedure generally performed with local anesthetic eye drops. This type of refractive surgery gently reshapes the cornea by removing microscopic amounts of tissue from the outer surface with a cool, computer-controlled ultraviolet beam of light. The beam is so precise it can cut notches in a strand of human hair without breaking it, and each pulse can remove 39 millionths of an inch of tissue in 12 billionths of a second. The procedure itself takes only a few minutes, and patients are typically back to daily routines in one to three days.

Before the procedure begins, the patient's eye is measured to determine the degree of visual problem, and a map of the eye's surface is constructed. The required corneal change is calculated based on this information, and then entered into the laser's computer.

Since 1995, two laser systems have been approved by FDA to treat mild to moderate nearsightedness and mild to moderate astigmatism with PRK: The SVX Apex excimer laser, manufactured by Summit Technology of Waltham, Mass., and the VISX excimer laser, manufactured by VISX Inc., of Santa Clara, Calif. FDA also has approved the VISX system to treat high myopia.

According to FDA's Center for Devices and Radiological Health, clinical studies showed that about 5 percent of patients continued to always need glasses following PRK for distance, and up to 15 percent needed glasses occasionally, such as when driving. In addition, many patients experienced mild corneal haze following surgery, which is part of the normal healing process. The haze appeared to have little or no effect on final vision, and could only be seen by a doctor with a microscope. Some patients experienced glare and halos around lights. These conditions, however, diminished or disappeared in most patients in six months. For about 5 percent of patients, however, best-corrected vision without corrective lenses was slightly worse after surgery than before. In view of these findings, FDA and the Federal Trade Commission (which oversees advertising) issued a letter to the eye-care community in May 1996 warning that unrealistic advertising claims, such as "throw away your eyeglasses," and unsubstantiated claims about success rates could be misleading to consumers. …

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