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10 - 14 Sept. 2016, Bella Center, Copenhagen, Denmark

This Meeting has been awarded 27 CME credits

 

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Scleral implants for presbyopia: an early analysis of a single site in a multicenter clinical trial

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Session Details

Session Title: Presented Poster Session: Presbyopia

Session Date/Time: Tuesday 13/09/2016 | 09:30-11:00

Paper Time: 10:20

Venue: Poster Village: Pod 2

First Author: : B. Soloway UNITED STATES

Co Author(s): :    R. Chu              

Abstract Details

Purpose:

To evaluate improvements in near visual acuity outcomes of the first 10 patients’ primary eyes receiving VisAbility™ Implants (Refocus, Dallas, TX) at a single center participating in a prospective, multi-center FDA monitored IDE clinical trial with a primary effectiveness endpoint of distance corrected near visual acuity (DCNVA) of 20/40 or better at 40 cm and at least 10 letters (ETDRS) improvement in DCNVA in the primary eye.

Setting:

Private clinic, Bloomington, Minnesota

Methods:

A prospective randomized control FDA monitored IDE clinical trial (G140205) to evaluate the effectiveness of VisAbility™ Implants to improve unaided near vision in naturally emmetropic presbyopes in a cohort of 360 patients at 14 sites is underway. At one site, ten patients have been implanted bilaterally with VisAbility™ Implants using the VisAbility™ Implant System and have been followed for at least 6 months. The Optec 6500 (Stereo Optical, Chicago, IL) was used for all acuity measurements to ensure uniform lighting and distance.

Results:

100% (10/10) of the primary eyes in this study achieved DCNVA of 20/40 or better at 40cm and 80% (8/10) of these eyes had an improvement of at least 10 ETDRS letters at 40cm with distance correction at 6 months postop. The amount of add needed to achieve the best corrected near visual acuity at 40cm decreased from a mean of 1.55 D at baseline (range, 1.25 to 2.00 D) to a mean of 0.625 D (range, 0.25 to 1.00 D) at 6 months. There were no reported serious adverse events in the 10 patients in this study sample.

Conclusions:

This evaluation of patients at a single center participating in a multicenter clinical trial suggests that the VisAbility™ Implant System may provides correction of near vision with corresponding reduction in the amount of refractive add needed to achieve optimal DCNVA.

Financial Disclosure:

One or more of the authors receives consulting fees, retainer, or contract payments from 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, One or more of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented

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