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Early results with a hydrogel corneal inlay to improve near and intermediate vision in pseudophakic patients

Session Details

Session Title: Intracorneal inlays for correction of presbyopia

Session Date/Time: Tuesday 08/10/2013 | 08:00-10:30

Paper Time: 09:42

Venue: Main Lecture Hall (Ground Floor)

First Author: : D.Tran USA

Co Author(s): :    A. Chayet   E. Barragan           

Abstract Details

Purpose:

To assess visual performance of monofocal pseudophakic patients treated with the RaindropTM Near Vision Inlay* (ReVision Optics, Inc., Lake Forest, CA). The inlay is a 2 mm diameter hydrogel corneal inlay that creates central corneal steepening that may aid near and intermediate vision for pseudophakic patients.

Setting:

Private Practice in Southern California and Mexico

Methods:

The non-dominant eyes of a cohort of pseudophakic patients were implanted with Raindrop Near Vision Inlays. Pre-operatively, all subjects have uncorrected visual acuity (UVA) at near 20/50 (J5) or worse. Changes in near, intermediate and distance acuity at 3 months post-operation, uncorrected and best corrected, will be reported based on standard measurement methods while patient satisfaction, visual function and any visual symptoms will be assessed using a questionnaire.

Results:

Data from the pseudophakic cohort will be compared with 205 emmetropic eyes treated in an FDA prospective clinical trial. In that study, the mean uncorrected near visual acuity of the treated eye was 20/20 at 3 months, corresponding to 5 lines of improvement. Mean uncorrected intermediate visual acuity in the treated eye improved to 20/25, corresponding to 2 lines of improvement. Mean uncorrected distance visual acuity in the treated eye declined to 20/25, corresponding to 1 line of loss. No patient had worse than 20/25 BCNVA or BCDVA and both means were better than 20/20. The first three subjects (two at six months post-op and one at three months post-op) in the pseudophakic study report being Satisfied or Very Satisfied with their near vision (near UVAs: 20/32, 20/20, 20/25), intermediate vision (intermediate UVAs: 20/32, 20/32, 20/25), distance vision (distance UVAs: 20/25, 20/25, 20/32), and overall vision. Two patients could perform all 15 visual tasks on the questionnaire (5 each at near, intermediate and distance) "With Ease" and the third patient could perform 14 "With Ease" and one "With Difficulty." Visual symptoms were low.

Conclusions:

In this first series of pseudophakic patients, early outcomes with the Raindrop Near Vision Inlay appear to be similar to the results of a US multi-center trial. Marked improvement in near and intermediate vision, without significant compromise of functional distance vision, has been shown to occur in the first three subjects treated.

Financial Interest:

... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented