Wall Street Journal, July 23, 1999:

HEALTH

A Laser Surgery Procedure for Eyes

 Clears Hurdle With Federal Panel

By Otesa Middleton

Dow Jones Newswires

WASHINGTON-A federal advisory panel gave a conditional thumbs-up to a laser surgery procedure for eyes called LASIK, which is already commonly performed nationwide.

In the procedure, formally known as laser in-situ keratomileusis, a laser is used to make a flap in the cornea. Tissue under the flap is removed to change the eye surface and alter vision.

CRS Clinical Research Inc., a nonprofit doctors' group in Scottsdale, Ariz., that studied the procedure, asked to have a laser from VISX Inc. approved for LASIK in nearsighted patients with or without astig­matism. The laser had already been cleared for another form of laser eye surgery, photorefractive keratectomy, or PRK, in which tissue is removed directly from the cornea's surface.

Because the laser already is approved for PRK, doctors with the proper equipment can perform the LASIK procedure, but the manufacturer can't promote the device for LASIK until it is specifically approved for that use. If the Food and Drug Adminis­tration grants CRS's request, the group will transfer the approval to Visx, a Santa Clara,

Calif, developer of refractive laser technology. The FDA usually follows the advice of its advisory panels.

The panel's recommended conditions for approval include a caution for patients who have had previous incisional eye surgery and a notice on the device's label stating that a small percentage of patients may see glare or a halo after surgery. The panel also said the procedure shouldn't be performed on severely nearsighted patients and noted that the outcome isn't as good with patients with larger pupils.

Several panel members urged the FDA to approve LASIK so the agency would have a hand in the data distributed on the proce­dure.

Currently, doctors who perform the procedure advertise without FDA oversight and sometimes play down the possible side effects, said A. Ralph Rosenthal, director of the FDA's Division of Ophthalmic Devices. "The agency regulates companies -- we don't regulate doctors or what they advertise," he said. "This procedure is performed about 400,000 times a year in this country, and there is no information being provided by a government agency."