Clinical impact after implantation of non-refractive transparent corneal inlay: US IDE clinical trial update
Session Details
Session Title: Corneal Inlays for Presbyopia Correction
Session Date/Time: Sunday 11/09/2016 | 16:30-18:00
Paper Time: 17:00
Venue: Hall C1
First Author: : D.Koch USA
Co Author(s): : R. Steinert
Abstract Details
Purpose:
To evaluate the change in safety parameters from baseline to 18M postoperatively in subjects implanted with the Raindrop® Near Vision Inlay. Post-explant visual recovery will also be evaluated in complicated cases.
Setting:
Cullen Eye Institute, Baylor College of Medicine, Houston, TX, USA; Gavin Herbert Eye Institute, University of California, Irvine, CA, USA
Methods:
Emmetropic presbyopes were implanted with the Raindrop Inlay in their non-dominant eye to corrected for presbyopia as part of a multicenter prospective FDA study. Safety parameters including: best-corrected distance visual acuity (BCDVA), refractive stability, and endothelial cell density (ECD) will be evaluated at 18M postoperatively compared to baseline. Adverse events and post explant visual recovery will be analyzed.
Results:
At 18M (n=351), 99% of subjects were 20/25 or better (BCDVA) in their inlay eye with 0% of subjects losing more than 2 lines from baseline. Refractive stability was achieved between 3M to 6M with greater than 98% of subjects within 1.0 D MRSE (3M to 18M) from baseline. No subjects lost more than 10% of ECD and most subjects (97%) had less than 5% ECD loss from baseline. Explants were minimal (4%) with all subjects returning to 20/25 or better (BCDVA) by 6M after removal.
Conclusions:
Subjects implanted with the Raindrop Inlay appeared to have minimal change in best-corrected vision, endothelial cell density, and manifest refraction at the 18M postoperative time point. Complications were manageable with all subjects returning to near baseline by 6M post explantation.
Financial Disclosure:
... receives consulting fees, retainer, or contract payments from a competing company
