THE RING OF CHANGE: EMORY INTRODUCES POTENTIALLY REVERSIBLE SURGERY FOR NEARSIGHTEDNESS

A tiny, transparent ring that is changing the face of vision recently received recommendation for FDA approval by the agency's ophthalmic devices panel.

Available at the Emory Vision Correction Center in north Atlanta, the ring reshapes the eye's cornea, eliminating nearsightedness. It can be inserted into the cornea during a 15-minute surgical procedure using a topical anesthetic drop. The patient can be back to his or her regular activities in a few days with minimal discomfort. A surgeon can remove the ring if eyesight changes with age or if the eye requires a different sized ring. After removal, the eye returns to its pre-surgical state in the vast majority of cases.

"The ring restores vision without glasses or contact lenses for many mildly nearsighted individuals," says George O. Waring III, M.D., professor of ophthalmology at the Emory University School of Medicine and a founding director of the Emory Vision Correction Center. "It alters the curve of the cornea without the need for operating in the central cornea zone, the critical area for clear vision, and is especially designed to treat patients who have -1.0 to ­3.5 diopters of myopia, mild to moderate nearsightedness." An estimated 22 million adult Americans fall within this range of nearsightedness.

Dr. Waring and his colleagues R. Doyle Stulting, M.D., Ph.D., and Keith P. Thompson, M.D., conducted Phase III clinical trials of the ring to test its effectiveness and safety. Dr. Waring presented the results of a 12-center national clinical trial at the American Academy of Ophthalmology meeting in November 1998. Research shows that after surgery, 98% of patients achieved 20/40 vision or better, 78% of patients achieved 20/20 or better, and 56% achieved 20/16 or better without optical correction.

Henry F. Edelhauser, Ph.D., director of research at the Emory Eye Center, conducted important laboratory research on the ring and helped analyze data collected by centers involved in the national clinical trial. He found that the ring was safe and had no significant impact on the corneal endothelium.

Emory is currently conducting Phase III clinical trials of the corneal ring for individuals who have less than ­1.00 diopters or who have ­4.00 diopters of myopia. The intrastromal ring is not designed for treatment of higher amounts of nearsightedness. Within this clinical trial, the surgery is free of charge for about 20 eligible participants. After final FDA approval, the cost of the surgery will be approximately $2,000 for each eye. The procedure is rarely covered by medical insurance.

Made by KeraVision, Inc., the ring is marketed as the Intacs intrastromal corneal ring segment. It is composed of a polymer material that surgeons have used in the eye for more than 40 years. The ring was first used in nearsighted patients in 1991. Although the FDA is not bound by the recommendations of its ophthalmic devices panel, the federal agency generally follows panel recommendations, and final approval of the ring is expected in the spring of 1999.

"We are especially excited to offer a surgical procedure that is adjustable and reversible," says Dr. Waring. "If vision changes or if side-effects like night glare are too bothersome, the ring can be removed."

For more information, call 1-800-SEE-MORE or go to the Emory Vision Correction Center's web site at www.emoryvision.com or KeraVision's web site at www.keravision.com.