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Evaluation of second generation stent technology in subjects with mild–moderate open angle glaucoma

Session Details

Session Title: Glaucoma

Session Date/Time: Monday 07/10/2013 | 17:00-18:34

Paper Time: 18:02

Venue: Elicium 2 (First Floor)

First Author: : M.Tetz GERMANY

Co Author(s): :                  

Abstract Details

Purpose:

A second generation trabecular micro-bypass stent has been developed (Model GTS400; Glaukos Corporation). The purpose of this presentation is to describe the surgical experience by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group with these second generation trabecular micro-bypass stents implanted with an injector system in eyes with moderate to advanced open angle glaucoma (OAG).

Setting:

The MIGS Study Group includes visiting surgeons and staff surgeons from seven countries in North America and Europe. These surgeons have performed surgeries at one investigational site – the S.V. Malayan Ophthalmological Center in Yerevan, Armenia.

Methods:

The GTS400 single-piece heparin-coated titanium stent is implanted ab internally in Schlemm’s canal. Multiple outlet lateral lumens are designed to provide an exit route for aqueous from the anterior chamber. Outflow facility was shown to significantly increase after insertion of this device in pre-clinical testing. (Bahler, et al; 2012 AJO). The G2-M-IS injector was designed to deliver two GTS400 stents using one insertion instrument through a clear corneal incision. A recent study initiated in March, 2011 by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group (S.V. Malayan Ophthalmological Center, Yerevan, Armenia) evaluated implantation of two ab interno second generation stents (Model GTS400, iStent inject, Glaukos) stents, as the sole procedure, in 60 phakic eyes with OAG and IOP not controlled on one ocular hypotensive medication. Inclusion criteria also included C/D ratio ? 0.8, preoperative medicated IOP 18 - 30 mmHg, preoperative IOP 21 - 36 mmHg after medication washout, and ability to undergo a 25-month follow-up period.

Results:

Sixty phakic eyes underwent uncomplicated implantation of two GTS400 stents using the G2-M-IS injector. Mean preoperative IOP was 20.9 ± 1.0 mmHg on 1 medication and 25.2 mmHg after preoperative medication washout. In 59 eyes followed through 12 months, IOP was 14.1 ± 1.7 mmHg without medication. No adverse events were reported.

Conclusions:

Data through one year following GTS400 stent implantation were consistent with prior experience using this device and showed significant postoperative decrease in IOP and medications with a favorable safety outcome. Follow-up is ongoing.

Financial Interest:

NONE