Improvement in near visual acuity persists 2 and 3 years following surgery in the VisAbility multicenter clinical trial

Session Details

Session Title: Presbyopia Correction

Session Date/Time: Tuesday 13/09/2016 | 16:00-18:00

Paper Time: 16:06

Venue: Auditorium A

First Author: : J.Katz USA

Co Author(s): :                        

Abstract Details

Purpose:

To report on 24- and 36-month follow-up of patients receiving VisAbility Implants (Refocus, Dallas, TX) in a prospective, multicenter FDA IDE clinical trial.

Setting:

The Midwest Center for Sight, Chicago IL, USA

Methods:

A total 330 patients from 11 sites were enrolled in the study. Patients were eligible for the study if they were 50 to 60 years, had best-corrected distance and near visual acuity (BCDVA and BCNVA, respectively) at 40 cm of 20/20 in either eye, distance corrected near visual acuity (DCNVA) at 40 cm of 20/50 to 20/100, manifest refraction spherical equivalent (MRSE) of -0.50D to +0.75D, and astigmatism ≤1.00D. Near visual acuity was assessed at 12, 18, 24 and 36 month follow-up visits.

Results:

Binocular DCNVA (Sloan) at 40 cm of 20/40 or better was achieved by 92%, 93%, 95%, and 96% of bilaterally implanted subjects at 12, 18, 24, and 36 months, respectively. Mean binocular DCNVA preferred viewing distance was 54.2 cm at baseline and improved to 39.4, 39.4, 38.2, and 38.6 cm at 12, 18, 24, and 36 months, respectively, in bilaterally implanted subjects.

Conclusions:

Long-term follow-up of bilaterally implanted patients demonstrates that near visual acuity improves over time and remains stable at 24 and 36 months of follow-up.

Financial Disclosure:

... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented