ReVision Optics today released results from a trial of its Raindrop near vision inlay, touting significantly improved near and immediate vision and no loss of distance binocular acuity in subjects with presbyopia.
The study was published in the journal Investigative Ophthalmology and Visual Science, the company said.
“This newly published study shows that changes in the eye’s structure were greatest in regions where the Raindrop Near Vision Inlay induces the most pronounced changes to the surface curvature, thus leading to the outstanding improvement in near and intermediate visual acuity which we have repeatedly demonstrated in our clinical trials. This study further showed no adverse corneal conditions associated with epithelial thinning that can occur with other refractive procedures or corneal pathologies. We extend thanks to the clinicians who participated in this study for elucidating these important insights regarding the mechanism of epithelial remodeling with the Raindrop Near Vision Inlay,” CEO John Kilcoyne said in prepared remarks.
The Raindrop is a microscopic hydrogel inlay for treating presbyopia, which the Lake Forest, Calif.-based company said could reduce or eliminate the need for reading glasses. The inlay is placed in the cornea of the patient’s non-dominant eye during a 10-minute procedure to gently reshape the anterior curvature of the cornea to provide near and intermediate vision, ReVision said.
The 30-patient prospective clinical study examined changes to the eye’s connective tissue at 1-year post procedure and found that the tissue “predominately takes on the curvature shape of the inlay,” according to the company.
In June, ReVision Optics said it won pre-market approval from the FDA for its Raindrop near vision inlay, a corneal implant designed to treat presbyopia.
The FDA said the Raindrop inlay is the 2nd such device it’s approved for treating presbyopia, following the April 2015 green light for the Kamra inlay made byAcuFocus.
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