LAKE FOREST, Calif.--(BUSINESS WIRE)--ReVision Optics, Inc., a leader in implantable presbyopia-correcting corneal inlay technology, announces that results from its ongoing Phase III U.S. FDA clinical study evaluating the Raindrop Near Vision Inlay for the treatment of presbyopia show significantly improved near visual performance and produced a 92% rate of satisfaction among study subjects one year following the procedure. The outcomes data were published in an article entitled “Treatment of Presbyopia in Emmetropes Using a Shape-Changing Corneal Inlay: One-Year Clinical Outcomes,” Whitman, et al., in the March 2016 issue of the peer-reviewed journal Ophthalmology (2016;123:466-475).
Highlights of the one-year post-treatment outcomes are as follows:
- Average uncorrected near visual acuity improved by 5 lines on a standard eye chart in the treated eye. There was no loss in binocular distance vision.
- 93% of subjects achieved uncorrected near visual acuity of 20/25 or better in the treated eye.
- The mean uncorrected visual acuity for both eyes exceeded 20/20 at all distances with no loss in contrast sensitivity.
“These clinical outcomes clearly show that subjects in this trial who had difficulty with near visual acuity due to presbyopia have excellent uncorrected vision at all distances one year after treatment with the Raindrop Near Vision Inlay. It is an honor to have the Raindrop clinical outcomes published in the Academy’s journal,” said John Kilcoyne, ReVision Optics President and Chief Executive Officer.
“Key to these results is the high rate of patient satisfaction, which is an indication of the improved quality of life that the Raindrop could provide to the millions of people impaired by age-related loss of near vision,” he added.
About the Raindrop Near Vision Inlay
The Raindrop Near Vision Inlay is placed in the cornea of the non-dominant eye during a 10-minute procedure. The Raindrop is comprised of approximately 80% water and has a refractive index very similar to the cornea. It is transparent and therefore does not restrict the amount of light reaching the retina. The reshaping of the anterior curvature of the cornea is designed to improve near and intermediate vision.
The Raindrop Inlay has received CE Mark approval. In November 2015 the U.S. Food and Drug Administration (FDA) accepted and deemed fileable the company’s premarket approval (PMA) submission for the Raindrop Near Vision Inlay.
About ReVision Optics
ReVision Optics, Inc. focuses on the development and commercialization of innovative optical solutions dedicated to presbyopic vision correction. The company’s Raindrop Near Vision Inlay offers a unique, patented refractive surgery solution. The Raindrop is designed to improve near vision that has been lost through the eye’s natural aging process called presbyopia. The Raindrop Near Vision Inlay provides an ideally suited surgical option for near vision enhancement.
CAUTION: Investigational device. Limited by Federal (United States) law to investigational use.
