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Efficacy and safety outcomes through 18 months from prospective, randomized, comparative study in OAG patients of implantation of 1, 2 or 3 trabecular micro-bypass stents as a sole procedure

Poster Details

First Author: A.Fea ITALY

Co Author(s):                        

Abstract Details

Purpose:

Pre-clinical work has demonstrated benefit of multiple vs. single trabecular bypass for additive intraocular pressure (IOP) lowering. Non-comparative clinical studies have shown significant IOP and medication reduction from micro-invasive glaucoma surgery (MIGS) using multiple trabecular micro-bypass stents with cataract surgery or as a sole procedure. This study by the MIGS study group compared efficacy and safety through 18 months following implantation of 1, 2 or 3 stents as a sole procedure in open angle glaucoma (OAG) subjects preoperative ocular hypotensive medications.

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:

In this prospective, randomized study, subjects with OAG on preoperative medication who were willing and able to be followed through 5 years postoperative were required to present with medicated IOP ≥ 18 mmHg and ≤ 30 mmHg, discontinue medications, and return for evaluation of unmedicated IOP. Eyes with unmedicated IOP ≥ 22 mmHg and ≤ 38 mmHg were randomized (1:1:1) to implantation of 1 stent (n=38), 2 stent (n=41) or 3 stent (n=40). All 119 subjects have been followed 18 months. Medication burden, IOP, CD ratio, visual field, BCVA, pachymetry, and intraoperative/postoperative adverse events were evaluated.

Results:

Preoperative mean medicated IOP was 19.8 mmHg (SD 1.3), 20.1 mmHg (SD 1.6) and 20.4 mmHg (SD 1.8) in 1, 2 and 3-stent eyes, respectively. After medication washout, mean preoperative IOP was 25.0 mmHg (SD 1.1), 25.0 mmHg (SD 1.7) and 25.1 mmHg (SD 2.2) in the 3 respective groups. Mean IOP was 15.5 mmHg (SD 1.6), 13.8 mmHg (SD 1.3) and 12.1 (SD 1.2) mmH at 18 months in the 3 respective groups; 7 of the 1-stent eyes, 4 of 2-stent and 3 of 3-stent eyes required medication. Four eyes required cataract surgery over the 18-month period.

Conclusions:

Both IOP and medication use were reduced after implantation of a single trabecular micro-bypass stent as a sole procedure in OAG. Additional IOP reduction to ≤ 15 mmHg has been shown with multiple stents. Favorable safety was reported in all eyes. These findings demonstrate sustained titratable efficacy of trabecular micro-bypass through 18 months, with safe outcomes using 1 or multiple stents.

Financial Disclosure:

NONE

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