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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


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.


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.


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.


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.


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.

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