Posters

Long-term titrated IOP control and medication reduction following implantation of one, two, or three trabecular micro-bypass stents

Poster Details

First Author: L.Voskanyan ARMENIA

Co Author(s):                        

Abstract Details

Purpose:

Prior reports have demonstrated incremental reductions in IOP and medications with 1, 2, or 3 trabecular micro-bypass stents when implanted as a sole procedure in open-angle glaucoma (OAG) patients on ocular hypotensive medication. The current work presents data through 42 months (42M) from this prospective study of 119 qualified subjects (109 with 42M follow-up) randomized to implantation of 1, 2, or 3 trabecular micro-bypass stents in a standalone procedure.

Setting:

Tertiary-care, high-volume ophthalmology facility (S.V. Malayan Opthalmology Centre) in Yerevan, Armenia.

Methods:

This was a prospective, randomized, single-site study designed to enroll 120 subjects with OAG uncontrolled on 1 to 3 ocular hypotensive medications. Qualified subjects were randomized in a 1:1:1 ratio to 1, 2, or 3 trabecular micro-bypass stents implanted in a sole procedure (i.e., without concomitant cataract surgery). We recorded patient history and preop/postop IOP, medications, visual field, cup to disc (C:D) ratio, complications/interventions, and proportional analyses of IOP reduction �â�‰�¥20% in the three groups. In addition, preoperative and annual postoperative medication washouts were completed in order to measure unmedicated IOP.

Results:

Sustained IOP reduction and favorable safety were demonstrated in the 1-, 2-, and 3-stent groups through 42 months. Mean 42M IOP was 15.0 �Â�± 2.8 mmHg in 1-stent eyes (versus 19.8 �Â�± 1.3 preoperatively), 15.7 �Â�± 1.0 mmHg in 2-stent eyes (versus 20.1 �Â�± 1.6 preoperatively), and 14.8 �Â�± 1.3 mmHg in 3-stent eyes (versus 20.4 �Â�± 1.8 preoperatively). At 42M, 61%, 94%, and 91% of 1-, 2-, and 3-stent eyes, respectively, had IOP reduction �â�‰�¥ 20% while eliminating medications. Eighteen one-stent eyes, 4 two-stent eyes, and 3 three-stent eyes needed additional medication, but no eyes required additional IOP-lowering surgery.

Conclusions:

In this cohort of OAG subjects on ocular hypotensive medication randomized to standalone implantation of 1, 2, or 3 trabecular micro-bypass stents, data through 42 months showed meaningful IOP and medication reductions in all groups and incrementally greater IOP reduction in multiple-stent eyes, with no additional IOP-lowering surgeries nor significant safety events in any group. Through 42 months, a higher proportion of multiple-stent eyes had IOP reduction �â�‰�¥ 20% without medication vs. single-stent eyes, and fewer multiple-stent eyes required medication due to elevated IOP.

Financial Disclosure:

receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented