Two year outcomes with second generation stents in subjects with mild– moderate open-angle glaucoma

Session Details

Session Title: Glaucoma I

Session Date/Time: Sunday 14/09/2014 | 08:00-09:30

Paper Time: 08:24

Venue: Auditorium

First Author: : M.Tetz GERMANY

Co Author(s): :                  

Abstract Details

Purpose:

The purpose of this presentation is to describe experience by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group through two years postoperative following implantation of two second generation trabecular micro-bypass stents with a single injector in eyes with mild to moderate open angle glaucoma (OAG).

Setting:

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

Methods:

The second generation trabecular micro-bypass GTS400 single-piece heparin-coated titanium stent (Glaukos Corporation) is implanted ab internally in Schlemm’s canal. The G2-M-IS injector was designed to deliver two GTS400 stents using one insertion instrument through a clear corneal incision. A study by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group (S.V. Malayan Ophthalmological Center, Yerevan, Armenia) evaluated 55 qualified phakic eyes with OAG and IOP not controlled on one ocular hypotensive medication who underwent implantation of two GTS400 stents as the sole procedure. 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 follow-up through 2 years.

Results:

Fifty-five qualified eyes underwent uncomplicated stent implantation. In this phakic population, 34.5% of eyes had pre-existing cataract. Mean preoperative IOP was 20.9 ± 1.0 mmHg on 1 medication and 25.0 ± 1.5 mmHg after preoperative medication washout. Subjects were taking one ocular hypotensive medication at the screening visit and underwent a one-month medication washout period prior to surgery. At two years postoperative, mean IOP in 54 available eyes was 14.6 ± 1.1 mmHg. Two eyes were on a regimen of one ocular hypotensive medication at two years postoperative, and the remaining 52 eyes were not on medication. Postoperative ocular adverse events included 19 eyes with progression of pre-existing cataract, of whom 17 underwent cataract surgery. One subject presented with IOP = 25 mmHg following their 12 month exam, was treated with trabeculectomy, and has had an uneventful course since then. One subject experienced intermittent BCVA loss that resolved without intervention.

Conclusions:

In this study of 55 eyes with open-angle glaucoma implanted with two GTS400 stents as a sole procedure, only one subject required surgical intervention for control of IOP. The preoperative demographic status that includes 34.5% of subjects with pre-existing cataract is to be expected given this older population. These findings show a high safety profile over two years postoperative with sustained reduction in IOP and medication.

Financial Interest:

NONE