OAG not controlled by trabeculectomy and medication treated with two trabecular micro-bypass stents, one suprachoroidal stent and travoprost: long-term outcomes

Session Details

Session Title: Glaucoma I

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

Paper Time: 09:06

Venue: Auditorium

First Author: : A.Fea ITALY

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 25 months postoperative following implantation of two trabecular micro-bypass stents and one suprachoroidal stent in eyes with mild to moderate open angle glaucoma (OAG) previously not controlled with trabeculectomy and medications

Setting:

The investigational site is the S.V. Malayan Ophthalmological Center in Yerevan, Armenia. The MIGS Study Group, comprised of visiting surgeons and staff surgeons from nine countries worldwide, has performed surgeries at the investigational

Methods:

In this prospective study, phakic or pseudophakic subjects with OAG and IOP between 18 mmHg and 45 mmHg following trabeculectomy and use of 1 to 3 ocular hypotensive medications were enrolled. After medication washout, 80 eligible subjects with unmedicated IOP ≥ 21 mmHg and ≤ 45 mmHg underwent implantation of two iStents and one iStent supra (Glaukos). Postoperatively, all subjects were prescribed Travoprost. One year efficacy endpoints were IOP reduction ≥ 20% and IOP ≤ 15 mmHg. Slit-lamp and optic nerve evaluation, BCVA and adverse events will comprise the safety evaluation through five years

Results:

To date, 80 subjects have been enrolled and have undergone uncomplicated implantation of two iStents and one iStent supra, and 34 subjects have presented at 25 months. Mean medicated IOP at screening was 22.0 (SD 3.1) mmHg. Mean baseline IOP after medication washout was 26.4 (SD 2.4) mmHg. Month 12 IOP was 13.6 (SD 1.5) mmHg. Post-medication washout IOP was 17.1 mmHg at both Month 13 and Month 25. At Month 12, all eyes achieved the primary efficacy endpoint of ≥ 20% IOP reduction, and 84.8% achieved the secondary efficacy endpoint of IOP ≤ 15 mmHg. In eyes followed through Month 24, all eyes achieved ≥ 20% IOP reduction 93.9% had IOP ≤ 15 mmHg; and 2 remaining eyes reported with IOP ≤ 16 mmHg. Postoperative adverse events included six eyes with BCVA loss ≥ 1 line from baseline BCVA due to cataract progression. After cataract surgery in one eye, BCVA returned to preoperative status. Last reported BCVA in 5 remaining (cataractous) eyes was 20/66, 20/200, 20/29, 20/40 and 20/100.

Conclusions:

Results through 25 months in this study of two trabecular bypass stents, one suprachoroidal stent and one postoperative medication in refractory OAG subjects uncontrolled after trabeculectomy showed long-term significant IOP reduction, reduction in drug burden, and an overall favorable safety profile.

Financial Interest:

NONE