Copenhagen 2016 Registration Programme Exhibitor Information Virtual Exhibition Satellite Meetings Glaucoma Day 2016 Hotel Star Alliance
title

10 - 14 Sept. 2016, Bella Center, Copenhagen, Denmark

This Meeting has been awarded 27 CME credits

 

escrs app advert yo advert

Clinical impact after implantation of non-refractive transparent corneal inlay: US IDE clinical trial update

Search Title by author or title

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

Back to previous