Laser to Correct Myopia Gets Qualified OK From Scientists
Scientific advisers to the government are recommending approval of the nation’s first laser device to correct nearsightedness but only if it meets strict safety guidelines.
“We have a technology that has enormous potential,” said Dr. Olivia Serdarevic, one of the experts who recommended Food and Drug Administration approval of the laser Thursday night. “Our dilemma tonight . . . is that the data presented is not sufficient to say it’s totally safe.”
By a 13-1 vote, the panel told the FDA that the laser, sold under the brand name OmniMed, should be approved as soon as its maker, Summit Technology Inc., proves that:
* Seventy-five percent of its patients have their vision improve to 20/25 or better without glasses.
* Fewer than 5% of patients have their vision worsen as result of the surgery.
Summit says 78% of its patients abandon their glasses--but many of those do so with vision worse than 20/25. And estimates of vision problems from the laser range from 3% to 7%, a number the panel insisted be pinned down.
The panel said doctors must be properly trained to use the lasers. Also patient brochures must warn that it only helps mild-to-moderate nearsightedness and that it poses some risk of vision loss and glare problems.
The FDA is not obliged to accept the recommendations of its outside advisers, but it usually does.
At issue is a surgical technique called photo-refractive keratectomy, or PRK, which some doctors say is safer and more precise than the current eye surgery that 250,000 Americans undergo each year. That surgery is radial keratotomy, or RK.
In RK, a surgeon uses a knife to make tiny cuts on the cornea, the clear tissue covering the iris and pupil. The cuts flatten misshapen corneas to bring vision closer to normal. PRK also flattens the cornea, using a cold beam of ultraviolet light to vaporize corneal cells. But it has some risks similar to RK, including a tendency for some patients to over-correct and thus require reading glasses.
Researchers for Summit Technology of Waltham, Mass., presented data on 700 patients treated with the laser over the past two years. About 78% of the patients no longer needed corrective lenses.
