Advanced scleral implant system and technique for the treatment of presbyopia

Session Details

Session Title: Corneal and Scleral Treatment

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

Paper Time: 09:06

Venue: Room 13

First Author: : B.Soloway USA

Co Author(s): :                        

Abstract Details

Purpose:

To describe the latest techniques and improvements in scleral implant surgery for the treatment of presbyopia and to compare the results in the EU utilizing the VisAbility Implant System™ (Refocus Ocular Europe, BV) to results of earlier surgical methods and instrumentation used in the US IDE clinical trials.

Setting:

A total of 18 investigators at 18 private clinics in the United States and Europe participated in clinical trials of scleral implant surgery for presbyopia

Methods:

The latest innovation, the VisAbility Implant System™ (VIS) is a fixation, docking and incision system designed to create scleral tunnels of consistent length, depth and location; it is currently being used in the EU. 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 prior instrumentation and surgical technique used in the US IDE study. The consistent scleral tunnel architecture generated by the VIS Docking Station and Scleratome may account for this improvement. Additionally, the use of fibrin glue for hemostasis improves patient comfort recovery and decrease surgical time.

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 travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented