Nonrefractive Corneal Inlay Implantation After Cataract Surgery: U.S. Clinical Study Experience
To assess the feasibility of implanting a hydrogel corneal inlay in patients that previously underwent cataract surgery with IOL implantation, as part of the Raindrop Near Vision Inlay U.S. study.
Prospective non-randomized multicenter clinical study. Twenty-five (n=25) subjects implanted with Raindrop Near Vision Inlay in the non-dominant eye of pseudophakic eyes (minimum three months after IOL implantation). Visual acuities (uncorrected and best-distance corrected), quality of life and patient satisfaction at 1, 3 and 6 months are being evaluated.
At the time of abstract submission, six eyes have been implanted, with 5 seen at the 1-month follow-up visit. The other 19 subject’s eyes will be enrolled and the abstract updated with more comprehensive data. Uncorrected distance vision at 1 month is 20/32 or better, and uncorrected near is 20/25 or better in all eyes. There are no complications at this point. Uncorrected visual acuities (mean, SD), percentage of patients that are satisfied with their near vision, bright and dim light tasks and safety profile will be reported.
Options for surgical correction of presbyopia after cataract surgery are limited because this population (as it grows older) has the potential for age-related diseases like increasing rates of retinal/macular diseases and others. Raindrop is a removable corneal inlay, which provides a reversible alternative for this group of patients.
* CAUTION: Investigational device. Limited by Federal United States law to investigational use.