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Results through 25 month postoperative ab interno suprachoroidal stent implantation and postoperative travoprost for the treatment of open-angle glaucoma

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Session Details

Session Title: Glaucoma I

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

Paper Time: 08:42

Venue: Auditorium

First Author: : J.Belda SPAIN

Co Author(s): :    K. Schargel              

Abstract Details

Purpose:

The intraocular pressure (IOP) lowering effect of an ab interno suprachoroidal stent in conjunction with postoperative Travoprost was assessed through 25 months postoperative in eyes with open angle glaucoma (OAG) and IOP previously not controlled on two topical hypotensive medications.

Setting:

This prospective study was conducted by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group, comprised of visiting surgeons and staff surgeons at the S.V. Malayan Ophthalmological Center in Yerevan, Armenia. The MIGS Study Group is evaluating iStent technology as titratable ab interno therapy in multiple studies that involve over 2000 subjects.

Methods:

A suprachoroidal stent (Model G3) was developed by Glaukos to create a patent lumen from the anterior chamber into the suprachoroidal space to enhance aqueous outflow and reduce IOP in moderate to advanced OAG. In this study, preoperative medicated IOP was required to be between 18 mmHg and 30 mmHg on two medications. Preoperative IOP after medication washout was to be between 22 mmHg and 38 mmHg. Seventy-three qualified subjects underwent implantation of a single stent through a 1 mm temporal clear corneal incision under topical anesthesia. Travoprost was prescribed postoperatively and discontinued if IOP measured below 6 mmHg. Medication washouts were scheduled at annual visits. Postoperative evaluations occurred at Day 1, Week 1, and Month 1, 3, 6, 12, 13, 18, 24 and 25.

Results:

Mean preoperative medicated diurnal IOP was 20.4 mmHg (SD 2.4), and unmedicated (baseline) IOP was 24.8 mmHg (SD 1.7). To date, 41 subjects have been followed through 25 months postoperative. Following uncomplicated implantation of a Model G3 suprachoroidal stent and administration of postoperative Travoprost, medicated IOP decreased to 13.2 mmHg or less through the two year timeframe. Mean IOP following Month 12 medication washout was 16.7 mmHg (SD 2.1), and mean IOP following Month 24 medication washout was 17.0 mmHg (SD 2.1). The primary efficacy endpoint of Month 12 IOP reduction ≥ 20% with reduction in one medication was met in 98.6% of eyes. The secondary efficacy endpoint of IOP ≤ 18 mmHg with reduction of one medication was met in 91.4% of eyes. Two eyes had transient hypotony at 1 week that resolved by 1 month. One eye underwent trabeculectomy for worsening glaucoma and increased IOP. Five eyes had BCVA loss ≥ 1 line due to progression of pre-existing cataract; BCVA in two eyes returned to preoperative BCVA following cataract surgery; BCVA in 3 eyes with no cataract surgery was 20/25, 20/50 and 20/66, respectively.

Conclusions:

These data through 25 months postoperative suggest that MIGS implantation of a suprachoroidal stent in OAG subjects previously uncontrolled on two topical hypotensive medications is feasible, safe and capable of significant and sustained reduction in IOP and medication burden.

Financial Interest:

NONE

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