Presbyopia treatment for near visual acuity improvement: a two-site subsample analysis of patients with scleral micro-inserts at 24 months postop

Session Details

Session Title: Vision & Accommodation Assessment

Session Date/Time: Monday 24/09/2018 | 14:00-16:00

Paper Time: 15:12

Venue: Room A3, Podium 2

First Author: : B.Soloway USA

Co Author(s): :                        

Abstract Details

Purpose:

To evaluate the visual outcomes of eyes after receiving scleral micro-inserts from a two-site subsample of consecutive patients participating in an FDA monitored multicenter prospective control clinical study

Setting:

Chu Vision Center, Bloomington, MN Bucci Vision Center, Wikes Barre, PA

Methods:

The FDA monitored multicenter prospective control clinical study enrolled 360 patients at 13 sites ranging in age from 45 to 60 years of age with distance corrected near visual acuity (DCNVA) and uncorrected near visual acuity (UCNVA) of 20/50 to 20/80 inclusive and followed them for 24 months. The primary endpoint set was DCNVA of Snellen Equivalent 20/40 or better at 40 cm and at least 10 letter (5 letters = 1 line) ETDRS improvement over baseline monocularly in the primary eye. A subsample of 10 early consecutive patients implanted bilaterally at each of two centers were selected for evaluation

Results:

The mean improvement from baseline for all 20 eyes monocular DCNVA was +17.2, +18.3, +17.4 and +19.1 EDTRS letters (5 letters = 1 line) at 6, 12, 18, and 24 months post-op respectively. The mean improvement in binocular UCNVA was greater at +19.2, +20.1, +18.8, and +19.8 lEDTRS letters at these same intervals. Ninety-five percent of eyes (38/40) maintained at least 20/20 uncorrected distance visual acuity (UCDVA) in each eye and 70% (28/40) had at least one line improvement in UCDVA at 24 months. No acute serious adverse events were reported for any of these patients at these two sites

Conclusions:

The results of this two-center subsample evaluation of patients suggest that the VisAbility TM Micro-Inserts can provide clinically significant improvement in near visual acuity without compromising distance vision

Financial Disclosure:

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