Scleral implants for the treatment of presbyopia demonstrate improved near visual acuity
Session Details
Session Title: Corneal, Scleral and Pharmaceutical Treatment of Presbyopia
Session Date/Time: Monday 09/10/2017 | 16:30-18:00
Paper Time: 17:14
Venue: Meeting Center Room I
First Author: : F.Bucci USA
Co Author(s): :
Abstract Details
Purpose:
To evaluate the visual acuity outcomes of eyes receiving scleral implants from a two-site subsample of patients participating in an FDA multicenter prospective clinical trial.
Setting:
Bucci Laser Vision Institute, Wilkes-Barre, PA-USA
Methods:
The multicenter clinical study enrolled 360 subjects at 13 sites ranging in age between 45 and 60 years with distance corrected near visual acuity (DCNVA) and uncorrected near visual acuity (UCNVA) of 20/50 to 20/80 (inclusive). The primary endpoint is DCNVA of Snellen equivalent 20/40 or better at 40 cm and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye at 12 months. Two centers, with a total of 105 surgical subjects were selected for analysis. A subsample of 10 consecutive bilaterally implanted patients (patients 6-15 from both sites) was analyzed for near preliminary visual acuity results
Results:
20 patients were implanted with VisAbility™ Implants and at 12 months 95% of all eyes improved at least 10 EDTRS letters for DCNVA. Bilateral UCNVA at 40 cm was J3 for 100% of patients, J2 for 95%, and J1 or better for 90%. DCNVA for all primary eyes (unilateral) at 40cm was 100% J3, 95% J2, and 63% J1 or better at 12 months. The refractive add needed to achieve optimal DCNVA improved from a mean of 1.65 D at baseline to 0.63 D and 0.46 D at 6 months and 12 months respectively. No serious adverse events were reported.
Conclusions:
The results of this subsample evaluation of patients from a two-center analysis suggest that the VisAbility™ Implant System may provide clinically significant improvement in near visual acuity, both with and without distance correction.
Financial Disclosure:
NONE
