Posters

Eighteen-month postoperative outcomes following implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma not controlled by one preoperative medications

Poster Details

First Author: J. Belda SPAIN

Co Author(s):    K. Schargel                    

Abstract Details

Purpose:

The objective of this study by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group was to evaluate decrease in IOP and medication burden and safety parameters following stand-alone implantation of second generation trabecular micro-bypass stents in patients with open-angle glaucoma (OAG) not controlled on 1 preoperative topical ocular hypotensive medication.

Setting:

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

Methods:

The iStent inject (Glaukos) is a single-piece titanium stent inserted in Schlemm’s canal via ab interno implantation through a temporal corneal incision. This study enrolled 57 OAG subjects on 1 preoperative medication, medicated IOP ≥ 18 mmHg and ≤ 30 mmHg, and post-medication washout IOP ≥ 22 mmHg and ≤ 38 mmHg. Postoperative medication was prescribed for elevated IOP (e.g., > 21 mmHg) or optic nerve findings. Subjects returned at 1 day, 1 week, 1, 3, 6, 12 months and semi-annually through 60 months for evaluations of adverse events, BCVA, CD ratio, visual field, pachymetry, IOP and medication use.

Results:

Fifty-seven qualified OAG subjects underwent uncomplicated implantation of 2 iStent inject devices. Preoperative mean medicated IOP was 19.5 (SD 1.5) mmHg; IOP after washout was 24.4 (SD 1.3) mmHg. At 18 months, mean IOP on 0 medications was 14.4 (SD 2.1) mmHg, a 10 mmHg (41%) decrease from preoperative unmedicated IOP. One subject was placed on medication at M18 (IOP = 17.7 mmHg). One subject with pre-existing cataract and BCVA of 0.2 (decimal) had BCVA loss ≥ 1 line from cataract progression at Month 12, with BCVA of 0.09. Cataract surgery is pending. No other ocular adverse events were reported.

Conclusions:

Data from this series suggest second generation ab interno stents implanted as a stand-alone procedure in OAG patients on 1 preoperative medication can enable IOP reduction to ≤ 15 mmHg without postoperative medication through 18 months.

Financial Disclosure:

NONE