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New laser eye surgery recommended

A panel of outside scientists advised the Food and Drug Administration on Thursday to approve the nation's first laser to correct nearsightedness, provided the maker can meet safety criteria.

Summit Technology Inc. must show the FDA that at least 75 percent of patients treated with the laser will have good enough vision to abandon their glasses or contact lenses and that only a tiny number could have their vision worsened because of the procedure.

The 13-1 vote by the panel came after 12{ hours of often-testy debate. At one point, the panel came within a single vote of rejecting the OmniMed laser.

The FDA is not obliged to accept the recommendations of its advisers, but it customarily does.

Some panel members expressed concern that the laser was already outmoded in the 40 countries that now permit this type of surgery. "Why are we advocating a technology that has been replaced everywhere else worldwide," said Dr. Olivia Serdarevic, a Cornell University ophthalmologist.

At issue is a surgery called photorefractive keratectomy or PRK, which some doctors say is safer and more precise than the current eye surgery that 250,000 Americans undergo every year. That surgery is radial keratotomy, or RK.

In RK, a surgeon makes tiny cuts on the cornea, the clear tissue covering the eye's iris and pupil. The cuts flatten the cornea to bring vision closer to normal.

PRK also flattens the cornea, using a cold beam of ultraviolent light to vaporize corneal cells. But it has some risks similar to RK, including a tendency for some patients to be overcorrected and thus require reading glasses.

In addition to occurrences of farsightedness, some RK patients have difficulties with glare and night vision.

Advocates project that 1.4-million Americans would make use of the new surgical procedure each year.

The new laser uses a cold beam of ultraviolet light to reshape the corneas of patients who are nearsighted _ unable to see clearly at a distance.

The FDA has been awaiting studies proving that the laser works before allowing it in this country, and some on the advisory panel questioned its safety.

"I am very, very concerned," said Dr. Alexander Brucker, who questioned whether the laser could actually cost some patients their vision or induce cataracts later in life.

Researchers for Summit Technology, of Waltham, Mass., presented data on 700 eyes treated with the laser over the past two years. About 78 percent of the patients no longer needed glasses.

But it was unclear whether the rest needed their glasses because they remained nearsighted or because the laser had overcorrected and made it difficult for them to read, a characteristic of farsightedness.

And 3 percent of the patients had worse vision with their glasses after the operation than had before.