r i n g s

FDA Approves Laser Vision Correction

The Food and Drug Adminis t ra t ion (FDA) has

approved the first system for photorefractive keratec­tomy (PRK), a laser procedure that corrects nearsighted­ness (see January 1995 OPN). The approval has unleashed a nationwide surge to offer the procedure to nearsighted individuals. It remains to be seen, however, whether PRK will live up to its proponents' expectations.

"This is a great day for nearsighted people," says Gary Jonas, CEO of 20/20 Laser Centers, about the approval. Before the FDA approved the procedure in the U.S., Jonas's company sent people to Canada to establish itself as a PRK provider and to get the jump on the U.S. mar­ket. Marketing efforts now include testimonials from 20/20 clients, radio commercials touting the procedure, and a toll-free number to call for a free screening.

The FDA approved a system made by Summit Tech­nology Inc. for performing PRK on patients with up to -7 diopters of myopia (nearsightedness), which is con­sidered moderate. PRK corrects nearsightedness by ablating layers of the cornea with successive blasts from an excimer laser beam. Taking advantage of an absorp­tion peak in corneal tissue at 193 nm, each laser blast ablates a layer of the cornea without damaging sur­rounding tissue. Each ablation flattens the cornea's shape and corrects its focus. The treatment reduces, and sometimes eliminates, the need for eyeglasses and con­tact lenses.

Three kinds of centers are opening up to offer PRK. Because of the system's $500,000 price tag, the least common PRK provider is individual practitioners. More common are hospital-based centers, where the hospital buys the system and affiliated doctors perform the procedure. The third and most prolific are corporate groups, which have various arrangements of limited partnership (20/20 Laser Centers falls into this catego­ry). Some analysts expect about 500 centers to open nationwide in the first year after the FDA approval.

Competition, cost, and questionable demand make PRK a high-risk venture. It costs about $1 million to open a center, according to Jonas. The procedure costs $1,500-$2,000 per eye. Analysts say that a center needs to serve 500-700 patients per instrument per year to break even. One survey says that 39% of nearsighted people are somewhat or very interested in PRK.

Over 60 million nearsighted people in the U.S. pre­sent a large potential market. But PRK isn't for every­one, according to Stephen McLeod, director of refrac­tive surgery services at the I l l inois Eye and Ear

Infirmary. McLeod characterizes the range of ophthal­mological opinion this way: "The most conservative camp says that there should never be surgery on eyes that can be corrected with glasses or contact lenses. On the other end, there are those that say if you're over 21, nearsighted, and your parents haven't bought you PRK, then you have mean parents."

McLeod says that risks need to be kept in mind as PRK becomes a more popular procedure. Although these risks are low, the number of complications goes up with the number of people getting the procedure. McLeod concludes that a prospective PRK patient should anticipate significant benefit to boost the risk-benefit ratio.

As insurance reimbursements for ophthalmological work has gone down, doctors have had to explore surgi­cal areas outside of managed care plans to remain prof­itable. "You wind up in the more cosmetic realm," says McLeod. PRK is currently an out-of-pocket procedure that isn't covered by most insurance plans. As managed care plans proliferate and compete, they may include more cosmetic procedures like PRK. If this happens, it will undercut the price of the procedure.

New players are already getting into the field, accord­ing to McLeod. Cheaper systems can be designed with solid state lasers, which will result in wider distribution of PRK systems among ophthalmologists and greater accessibility for nearsighted people.

—EK

Side view of cornea after PRK treatment. The dashed line represents tissue ablated by the procedure.

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