A controversial technique to correct nearsightedness with eye surgery -- tiny slashes of the cornea -- is a relatively safe and effective alternative to eyeglasses, the first national study of the procedure concludes.
Results from the first year of the planned five-year study confirm similar findings in Tennessee and Kansas and in the Soviet Union, which pioneered the technique, called radial keratotomy.
They also confirm the experiences of American ophthalmologists, who have performed more than 63,000 of the operations since 1978.
The $2.5 million study -- the Prospective Evaluation of Radial Keratotomy, or PERK -- was funded by the National Eye Institute, part of the National Institutes of Health. Results were announced here at the annual meeting of the American Academy of Ophthalmology.
Both the technique and the study have been the subjects of occasionally acrimonious debate among ophthalmologists. In a suit now being heard in U.S. District Court here, several private ophthalmologists have argued that the study was a waste of time and public funding.
In the PERK study, 413 patients underwent the procedure on one eye at one of nine centers. More than half had 20/200 vision or worse -- which means that the only letter they could read on an eye chart was the big E.
After surgery, 78 percent of the patients had 20/40 vision or better, the quality of vision needed in most states to get a driver's license without glasses.
While the statistical results seem encouraging, study director Dr. George O. Waring III, professor of ophthalmology at Emory University, said "the outcome cannot be precisely predicted for an individual patient."
To perform the procedure, a surgeon makes eight to 16 tiny slashes in the eye's cornea -- a clear, dime-sized covering about as thick as a credit card. The slashes run from a point near the center of the cornea to the edge, like the spokes of a wheel.
The cuts weaken the cornea, allowing the eye's internal pressure to form bulges at the cornea's edges and flatten its center. That flattening refocuses the light entering the eye, eliminating myopia, or nearsightedness.
Surgery takes about 15 minutes, costs $1,000 to $2,000 and can be performed in a doctor's office. Although side effects seem minor -- fluctuations in vision and glare -- PERK researchers stressed that long-term problems might not show up for 10 to 30 years.
Patient satisfaction also may become an issue, since the surgery fails to free about 20 percent of the patients from their glasses. More than 70 percent of the patients who asked for the surgery wanted it to be rid of their glasses. Only 6 percent, such as airline pilots, had a job-related need.
About 120 million Americans wear corrective lenses, half of them for nearsightedness, according to the National Center for Health Statistics.
Whether the PERK findings will increase the numbers of such operations is unclear. Unlike drugs or medical devices, new surgical techniques do not have to be approved by the Food and Drug Administration before their use becomes widespread.
The PERK results have not ended a controversy over the study itself.
Last weekend, Dr. Robert Marmer, an Atlanta ophthalmologist and a leader in the Radial Keratotomy Society (RKS), released a review of his group's study of 63,000 Americans who have had the surgery performed by members of the society. Marmer said that 85 percent of the patients received near-normal sight. But the RKS study has not yet been reviewed by other experts to ensure that proper scientific procedures were followed.
In 1982, frustrated by warnings from the American Academy of Ophthalmology that the surgery had not been proved safe or effective and by calls for a surgical moratorium by state ophthalmological societies until the PERK study was completed, Marmer and other RKS members filed an antitrust suit against Waring and other members of the PERK study, claiming that they were trying to restrain trade. No settlement has been reached.