Reduced IOP and medication burden through 30 months: prospective, randomized, comparative study in OAG patients of implantation of 1, 2 or 3 trabecular micro-bypass stents as a sole procedure

Session Details

Session Title: Glaucoma II

Session Date/Time: Monday 12/09/2016 | 08:00-10:30

Paper Time: 08:00

Venue: Hall C4

First Author: : A.Fea ITALY

Co Author(s): :                        

Abstract Details

Purpose:

Previous clinical work has demonstrated benefit of multiple vs. single trabecular bypass as a standalone procedure for additive intraocular pressure (IOP) lowering through 18 months. In this same study by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group, we evaluated outcomes through 30 months (M30) 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:

This prospective, randomized study enrolled subjects with OAG on preoperative medication who were willing and able to be followed through 5 years postoperative. Subjects were required to have medicated IOP ≥ 18 mmHg and ≤ 30 mmHg, discontinue their medications, and return for evaluation of unmedicated IOP. Eyes with unmedicated IOP ≥ 22 mmHg and ≤ 38 mmHg were then randomized (1:1:1) to implantation of 1 stent (n=38), 2 stent (n=41) or 3 stent (n=40). Of 119 subjects, 117 have been followed 30 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 1.2), 25.0 mmHg (SD 1.7) and 24.9 mmHg (SD 2.2) in the 3 respective groups. Mean IOP was 15.2 mmHg (SD 2.6), 15.0 mmHg (SD 1.3) and 13.4 (SD 1.4) mmHg at M30 in the 3 groups; 10 of the 1-stent eyes, 4 of 2-stent and 3 of 3-stent eyes required medication. Five eyes among the groups underwent cataract surgery.

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 30 months, with safe outcomes using 1 or multiple stents.

Financial Disclosure:

NONE