Visual outcomes after implantation of a non-refractive transparent corneal inlay for the treatment of presbyopia: US FDA 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: 17:24

Venue: Hall C1

First Author: : G.Parkhurst USA

Co Author(s): :    R. Steinert   D. Koch                 

Abstract Details

Purpose:

To evaluate visual outcomes in emmetropic presbyopes implanted with the Raindrop® Near Vision Inlay (ReVision Optics, Inc., Lake Forest, CA, USA) as part of the US FDA IDE study.

Setting:

Gavin Herbert Eye Institute, University of California Irvine, CA USA, Cullen Eye Institute, Baylor College of Medicine, Houston, TX, USA (20/50)

Methods:

Emmetropic presbyopes were implanted with the Raindrop Inlay in the non-dominant eye to correct for presbyopia as part of a multi-center, non-randomized, prospective FDA study. Monocular and binocular ETDRS visual acuities were collected at various viewing distances throughout the study. The latest results at 18M will be presented and compared to pre-operative as well as other post-operative values. Subjects were evaluated with a NEI quality of life assessment to evaluate post-operative satisfaction.

Results:

At 18M (n=351), subjects on average gain 5 lines of near vision in the treated eye. Nearly all subjects (92%) achieved 20/25 or better monocular uncorrected near visual acuity. 20/32 or better visual acuity was achieved in 93% of subjects at intermediate and 85% of subjects at distance. Binocularly, more than 90% of subjects had a visual acuity of 20/32 or better at all viewing distances (near, intermediate and distance). 90% of subjects were satisfied with their inlay corrected vision and 98.5% of subjects were satisfied with their appearance.

Conclusions:

Raindrop Inlay improves near and intermediate vision in the treated eye while maintaining good binocular function at all viewing distances. Subjects were satisfied with their vision and appearance 18 months after inlay implantation when compared to pre-operative results.

Financial Disclosure:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented