This announcement comes on the heels of the FDA's approval of CK as the first procedure to improve near vision in patients with presbyopia. Affecting approximately 90 million Americans, presbyopia is a progressive condition that causes near vision to fade with age.
NearVision CK is indicated for the temporary improvement of near vision in emmetropic presbyopes (those who require only reading glasses) and hyperopic presbyopes (those who require reading and distance glasses). Generally, CK is performed on one eye to restore near vision without compromising the patient's binocular distance vision.
The FDA approved NearVision CK for use in presbyopes after reviewing clinical trial data from the 12-month follow-up data point. Mount Sinai participated in the clinical trials, in which 98 percent of patients could see J5 (magazine- and newspaper-size print) in the eye that was treated with CK and 87 percent could see 20/20 in the distance and read J3 (phone book-sized print; significantly smaller than newsprint).
No serious, sight-threatening or unanticipated safety events were reported, giving CK one of the highest safety profiles among refractive procedures. CK uses leading-edge radiofrequency energy, instead of a laser or scalpel, to restore near vision without cutting or removing corneal tissue.
In a three-minute procedure using topical (eye drop) anesthesia, CK uses a probe thinner than a strand of human hair to apply radio waves in a circular pattern on the outer cornea, shrinking small areas of tissue. This circular pattern creates a constrictive band (like the tightening of a belt), increasing the overall curvature of the cornea to improve the patient's near vision.
"The telltale symptom of aging for the baby boomer population is the need for reading glasses to perform everyday tasks, such as checking their watch for the time," said Penny Asbell, M.D., Director of the Cornea Service and Refractive Surgery Center at The Mount Sinai Hospital and a principal investigator of the Mount Sinai clinical trials for CK. "CK offers a safe, effective and minimally invasive procedure that helps people over 40 to overcome the aging of their eyes."
Mount Sinai Department of Ophthalmology
Led by Chairman Steven M. Podos, M.D., Mount Sinai's Department of Ophthalmology is a complete interdisciplinary center for the visual sciences that is considered one of the most influential vision care centers in the world. The department boasts a comprehensive program of patient care that exposes patients to the latest therapies in eye care, a cutting-edge team of investigators who carry out both clinical trials and laboratory research, and a robust educational program that spans both undergraduate- and graduate-level courses at The Mount Sinai School of Medicine and at affiliated institutions in the New York metropolitan area, as well as an acclaimed residency training program.
The department comprises a full-time faculty of over 23 clinicians and senior research scientists, and a voluntary faculty of over 100 ophthalmologists located throughout the greater New York area.