FDA APPROVES EYE IMPLANTS.

Byline: Lauran Neergaard Associated Press

Millions of mildly nearsighted Americans won a radically new way to improve their vision without glasses or contact lenses Friday: The government approved tiny, transparent rings that are implanted directly onto the cornea.

KeraVision Inc.'s Intacs implants offer an alternative for some patients to popular but irreversible laser eye surgery, at about the same price.

Nearly three out of four patients who tried the implants in clinical trials achieved 20/20 vision. But if patients don't like their Intacs, or suffer a side effect such as glare, doctors can remove the rings with a good chance of returning the eyes to presurgery condition.

The Food and Drug Administration warned that the implants are only for mildly nearsighted people, whose vision is formally diagnosed as ``minus 1 diopters to minus 3 diopters.'' That roughly translates to vision ranging from 20/40 - where it's OK to drive but a movie is blurry without glasses - to about 20/300, where you can barely see the big ``E'' at the top of eye charts.

In contrast, laser surgery can sharpen the vision of people with much more severe nearsightedness.

Still, the implants are ``really an interesting approach,'' said Dr. Susan Alpert, FDA's medical device evaluation chief. ``It is a simple procedure. . . . These can remain in permanently, but if there's a problem, they can be removed.''

Patients say that's the feature that makes Intacs attractive.

``We'd considered laser surgery, but one of the biggest things that scared us . . . is that if it didn't work, there's no way to change that,'' said Fran Palek. So he, his wife, his neighbor and his neighbor's sister all tried the implants instead and liked them. ``It's amazing,'' said Palek, 30, describing seeing with perfect vision immediately after the 15-minute surgery.

Nearsightedness occurs when the cornea, the membrane covering the front of the eye, is too steeply curved. Flattening the cornea helps correct nearsightedness. Hundreds of thousands of Americans have sought radial keratotomy, in which surgeons slice the cornea with a knife, or surgery with a laser that shaves the cornea to flatten it.

But those surgeries can be risky, sometimes causing problems with night vision, glare, seeing halos or blurry vision. Patients occasionally cannot see as well after surgery as before. Thus, most patients who choose these operations have fairly severe nearsightedness.

Intacs are two crescents about the thickness of a contact lens that form a ring around the cornea's edge. Their slight weight flattens the cornea without permanently destroying tissue.

During about a 15-minute operation, the doctor uses eye drops to numb the eye and cuts a tiny pocket into the cornea. A special device slips the crescents onto the cornea. A single stitch closes the wound.

In a yearlong study of 448 eyes, 97 percent saw 20/40 or better without glasses or contact lenses after the implant. About 74 percent had 20/20 or better vision without glasses, and 53 percent could see 20/16 - the sharper vision required of combat pilots.

Most patients achieved good vision in the implanted eye a day after surgery. One eye is implanted at a time, in case patients have problems.

The implants are not risk-free: Some 7 percent to 17 percent of patients suffered side effects similar to laser surgery, including glare, halos and problems with night vision.

Thirty-nine patients had their implants removed, including 15 who were dissatisfied with their vision correction and 19 who had visual side effects. Removing the implant corrected more than 80 percent of those side effects, the company said.

As nearsighted people age, they also frequently need reading glasses, and Intacs won't help with that, Alpert warned. Also, the FDA ordered KeraVision to study Intacs' long-term benefit.

Intacs will cost between $2,000 and $2,500 per eye, about the same as laser surgery. They are available immediately in Washington; Tampa, Fla.; Fayettesville, Ark.; St. Louis; Kansas City; New York City; Minneapolis; Portland, Ore.; Los Angeles; San Francisco; San Diego; and Atlanta. KeraVision is training doctors in other areas to implant Intacs, so they will be available nationwide later in the year.