Session Title: Special Issues
Session Date/Time: Friday 15/02/2013 | 08:30-10:00
Paper Time: 08:48
Venue: Hall 2
First Author: : M.Tetz GERMANY
Co Author(s): :
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; 2010 ARVO). The G2-M-IS injector was designed to deliver two GTS400 stents using one insertion instrument through a clear corneal incision. A series of 100 eyes with moderate to advanced glaucoma underwent implantation with two GTS400 stents using the G2-M-IS injector by surgeons involved in the MIGS studies. The intent of these series was to evaluate the intraoperative performance of the G2-M-IS injector, and postoperative outcomes. This report includes preoperative and operative data on 100 eyes, and data through 12 months postoperative on 50 eyes.
Results:
Ninety eyes underwent stent implantation only and ten eyes underwent stent implantation during cataract surgery. Mean preoperative IOP was 23.9 (SD 1.6) mmHg on 1.8 (SD 0.6) medications. The mean C/D ratio was 0.8 (SD 0.1); 77% had a C/D ratio of 0.7 or worse. Nine eyes had undergone 11 prior glaucoma surgeries including 7 trabeculectomies and 4 laser trabeculoplasties. Mean IOP decreased from preoperative IOP of 23.9 mmHg to 14.8 mmHg or less at all postoperative time periods. There were no reports of IOP increase (defined as ≥ 10 mmHg vs. preoperative IOP). In the subset of 50 eyes with data available at 12 months postoperative, mean IOP was 14.5 mmHg (SD 2.1). The mean number of ocular hypotensive medications decreased from an average of 1.8 medications preoperatively to 0.3 medications or less at all postoperative time periods. In subjects with data through 12 months, the mean number of medications was 0.2 (SD 0.6); 41 subjects were not taking any ocular hypotensive medication, 6 were on 1 medication and 3 were on 2 medications. Following surgery on a dense cataract, one subject reported with corneal edema. No other adverse events were reported.
Conclusions:
Operative and postoperative findings following GTS400 stent implantation with the G2-M-IS injector showed significant postoperative decrease in IOP and medications with a favorable safety outcome.
Financial Disclosure:
None
