Surgical refinement of scleral spacing procedure (SSP) with PMMA implants and improvement of near acuity in emmetropic presbyopes

Poster Details

First Author: B.Soloway USA

Co Author(s):                  

Abstract Details

Purpose:

To discuss advancements of the PresViewTM Scleral Implant (PSI) device, surgical instrumentation and techniques used on the resulting improvement in cohort near vision during all phases of the FDA monitored investigational device exemption (IDE) US clinical trial for presbyopia

Setting:

Sixteen private practice sites in the USA of the principal investigators in an FDA monitored IDE study

Methods:

Protocols for randomized, controlled, multicenter clinical trials of PSI and SSP for presbyopia have been granted by the US FDA since 2000. During this time, an evolution of the device, instrumentation and subsequent technique has occurred. Changes to a two piece locking PSI implant device, Oculock and DockTM instrument location of the PSI position and shuttle placement of the PSI have all standardized the surgery making it more repeatable and reliable

Results:

With current surgical technique and devices, 174 primary (average baseline DCNVA of 20/70) and 146 fellow eyes (average baseline DCNVA of 20/72) have received SSP (average baseline DCNVA of 20/71, combined). At 6, 12, 18 and 24 months, the percentage of eyes reaching 20/40 or better DCNVA were 71% (n=114), 94% (n=53), 82% (n=33), and 94% (n=18), respectively. These results show significant improvement over previously reported results of earlier modifications. Current techniques meet or exceed FDA hurdles at 24 month endpoints. Current device, instrumentation and technique will be discussed along with the improvements in near acuity over the course of the IDE clinical trial during phase I, II and III

Conclusions:

Improvements in implant stability, accurate positioning and subsequent facilitation of surgical technique has resulted in earlier and longer lasting improvement in near acuity after SSP with PSI FINANCIAL DISCLOSURE?: ... receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, ... travel has been funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, ... research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented