Latest system used in Europe improves the outcomes, precision and consistency of scleral implant surgery for presbyopia

Session Details

Session Title: Corneal and Scleral Treatment

Session Date/Time: Wednesday 09/09/2015 | 08:00-09:30

Paper Time: 09:00

Venue: Room 13

First Author: : K.Stonecipher USA

Co Author(s): :                        

Abstract Details

Purpose:

To report on advancements in the instrumentation and technique of the VisAbility Implant System™ (Refocus Ocular Europe, BV) for the treatment of presbyopia and to compare the EU results utilizing the VisAbility Implant System™ (VIS) to results of earlier surgical methods and instrumentation used in the US IDE clinical trials.

Setting:

Comparison of advancements in the device, instrumentation and technique in the US IDE and international clinical trials for presbyopia.

Methods:

Since the commencement of US IDE clinical trials, there have been numerous modifications to the instrumentation used. The latest innovation, the VIS System is a fixation, docking and incision system designed to create scleral tunnels of consistent length, depth and location; it is currently being used at all EU sites. In the US IDE, 631 eyes had surgery with previous technology. To date in the EU, 66 eyes have had VIS System surgery and 12 month post-op measurements (DCNVA). All patients reported here have had DCNVA evaluated under uniform conditions pre-op and at regular intervals post-op to monitor efficacy.

Results:

In the US IDE, eyes having surgery with previous technology, improvement in DCNVA to J3 (20/40) or better at 1, 3, 6, 12, 18, and 24 months post-op was found in 63% (n=631), 62% (n=519), 70% (n=620), 81% (n=598), 85% (n=606), and 88% (n=535) of the eyes respectively. In the EU, where the VisAbility Implant System is being used, improvement of DCNVA to J3 (20/40) or better at 1, 3, 6, and 12 month post-op visits was found in 70% (n=48), 85% (n=54), 92% (n=48) and 93% (n=14) of the eyes respectively.

Conclusions:

The VisAbility Implant System™ now used in the EU has standardized and simplified scleral implant surgery for presbyopia. Early results from the EU show a more rapid improvement in DCNVA as compared to the immediately prior instrumentation and surgical technique used in the US IDE study. The consistent scleral tunnel architecture generated by the VIS Docking Station and Scleratome improved precision in position of the VisAbility Implant may account for this improvement.

Financial Interest:

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