Posters
Patient satisfaction in presbyopia correction: single-site assessment of bilateral VisAbilityTM implanted patients in a multicenter clinical trial
Poster Details
First Author: K. Stonecipher UNITED STATES
Co Author(s):
Abstract Details
Purpose:
To assess patient satisfaction in subjects implanted bilaterally with VisAbilityTM Implants (Refocus, Dallas, TX).
Setting:
Single-center participating in a prospective, multicenter FDA IDE clinical trial.
Methods:
Twenty-six patients treated at a single-center participating in an FDA IDE clinical trial (G970152) were evaluated for analysis at 36 months. A subset of 79 eyes were evaluated at 24 months regarding Distance Corrected Near Visual Acuity (DCNVA). Eligibility criteria were identical to that of the multicenter study, which enrolled 330 subjects. A standardized quality of life survey was used to evaluate patient satisfaction at baseline and 3,12, 24, 30, and 36 months, post-operatively.
Results:
As early as 3-months post-operatively, ninety-six percent of patients reported improved ability to perform close up tasks without glasses, versus zero ability at baseline. At the 24 month visit the average DCNVA was 20/32 and 92.4% of eyes were 20/40 or better (N-79). Additionally, 95% (N-21) of the patients available for 36-month follow-up described their improvement in performing most close-up tasks without glasses as “Significantly Better” or “Better”, as compared to preoperative vision.
Conclusions:
This single-site analysis of patients participating in a multicenter clinical trial suggests that VisAbilityTM Implants may provide visual outcomes allowing patients to perform most near vision tasks without glasses. Subjects described their visual ability as “significantly better” or “better”, after receiving VisAbilityTM Implants, when compared to their vision prior to surgery.
Financial Disclosure:
One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One or more of the authors travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented