Implantation of Scharioth macula lens in patients with age-related macular degeneration: results of a prospective European multicentre clinical trial

Session Details

Session Title: Glaucoma & Posterior Segment

Session Date/Time: Monday 24/09/2018 | 08:00-10:30

Paper Time: 09:42

Venue: Room A3, Podium 1

First Author: : S.Srinivasan UK

Co Author(s): :    G. Scharioth   A. Riehl   I. Tanev   P. Rozsival   J. Nekolova   Z. Nagy     

Abstract Details

Purpose:

To report the twelve months visual outcomes following implantation of the Scharioth AddOn injectable macular lens (SML) in previously pseudophakic eyes with age related macular degeneration (AMD).

Setting:

Prospective European multicentre clinical trial. Study centres included Ayr, Scotland, Recklinghause, Germany, Keil, Germany, Sofia, Bulgaria, Hradec Kralove, Czech Republic, Budapest, Hungary.

Methods:

46 pseudophakic patients with dry or inactive wet AMD were recruited. The inclusion criteria were: age over 55, corrected distance visual acuity (CDVA) of 0.1 to 0.32 (decimal), improvement of at least three lines of corrected near visual acuity (CNVA) when tested with a +6.0 D reading addition at 15 cms, compared to a +2.5 D reading addition at 40 cms with a self illuminated ETDRS near vision chart. One eye of each patient was implanted with the SML. Patients were examined at 1 day, 1 week, 1 and 3, 6 months and 1 year post operatively.

Results:

There were no intraoperative or postoperative complications. The mean CDVA remained unchanged 0.18 decimal preoperatively compared to at 3, 6 months and 1 year postoperative visit. The CNVA at 15 cms improved from 0.25 decimal preoperatively to 0.55 at 3 months and to 0.68 and to 0.64 at 6 months and 0.62 at 1-year time gate.

Conclusions:

The injectable AddOn SML appears to be safe and effective in the short to medium term in improving the CNVA in patients with AMD. Data suggests that the CDVA remains unaffected following the implantation of SML. Testing of CNVA at 15 cms with a +6.0 D near addition seems to be effective screening tool in patient selection. Further data is needed to assess the long-term safety and efficacy of this implant.

Financial Disclosure:

... gains financially from product or procedure presented