A proprietary clear corneal inlay (PresbyLens, ReVision Optics Inc.) has entered the final phase of its U.S. clinical trial under an investigational device exemption.
Lake Forest, CA-A proprietary clear corneal inlay (PresbyLens, ReVision Optics Inc.) has entered the final phase of its U.S. clinical trial under an investigational device exemption.
A prospective, multicenter, phase III study, to be conducted at several specialized ophthalmology centers across the United States, will evaluate the safety and effectiveness of the inlay in improving near vision in patients with presbyopia. The device will be implanted in non-dominant eyes.
“The [inlay] is designed to reduce or even eliminate the need for reading glasses by microscopically changing the shape of the surface of one eye,” said Roger F. Steinert, MD, medical monitor for the clinical trial.
In phase I and II of the trial, those who received the inlay saw average improvements of about 5 lines in near visual acuity and about 1 to 2 lines in intermediate visual acuity on a standard eye chart, added Dr. Steinert, who is chairman of the Department of Ophthalmology, director of the Gavin Herbert Eye Institute, the Irving H. Leopold Professor of ophthalmology, and a professor of biomedical engineering at the University of California, Irvine. The average loss in distance vision was about 1 line in the treated eye, he said, whereas patients’ distance vision binocularly remained at 20/20.
“Subjects in the phase I trial have now been followed for more than 2 years and are demonstrating sustained visual acuity improvement and corneal health,” he said.
The corneal inlay is made of medical-grade hydrogel similar to commercial contact lenses. The inlay is mostly water, as is the cornea, and has optical characteristics almost identical to the cornea, according to the company. The inlay is 2 mm in diameter, is bioengineered to facilitate transport of nutrients and fluid, and is as transparent as natural tears, according to the company. It is implanted in a 15-minute outpatient procedure.
The inlay has CE mark authorization and is approved for sale in Europe. The company is pursuing regulatory approvals and market opportunities for the inlay worldwide.
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