Prospective, randomized comparison of one vs two trabecular micro-bypass stents implanted during cataract surgery in subjects with cataract and open-angle glaucoma on one preoperative ocular hypotensive medication: results through month 18

Session Details

Session Title: Glaucoma II

Session Date/Time: Tuesday 08/09/2015 | 08:00-10:30

Paper Time: 08:30

Venue: Room 17

First Author: : G.Auffarth GERMANY

Co Author(s): :                        

Abstract Details

Purpose:

The purpose of this presentation is to describe experience by the Micro-Invasive Glaucoma Surgery (MIGS) Study Group through 18 months following implantation of one vs. two trabecular micro-bypass stents during cataract surgery in eyes with cataract and mild to moderate open angle glaucoma (OAG) treated with one preoperative ocular hypotensive medication.

Setting:

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

Methods:

Eighty cataractous eyes with OAG and on one ocular hypotensive medication were randomized to implantation of one vs. two stents (iStent® Trabecular Micro-Bypass, Glaukos Corporation) during cataract surgery. Inclusion criteria also included C/D ratio ≤ 0.8, preoperative medicated IOP 18 - 24 mmHg, and preoperative IOP 22 - 38 mmHg after medication washout. Assessment of postoperative IOP, medication use, BCVA, C/D ratio, visual field and ocular adverse events (AEs) through five years is continuing in 77 qualified eyes implanted with 1 (n=37) or 2 stents (n=40). All 77 eyes have been followed through Month 18 (M18).

Results:

Mean preoperative IOP was 20.4 ± 1.2 mmHg vs. 20.5 ± 1.5 mmHg in the 1- and 2-stent groups, respectively, while on medication, and 26.1 ± 1.7 mmHg vs. 26.4 ± 1.4 mmHg after medication washout. At M18, mean IOP was 14.5 ± 1.5 mmHg in the 1-stent group, with 1 subject on 3 medications and 2 subjects were on 2 medications. Mean M18 IOP in the 2-stent group was 12.7 ± 1.2 mmHg, with 1 subject each on 1 and 2 medications. Corneal edema in 9 eyes, 1 of whom also had hyphema, resolved ≤ 1 month postoperative.

Conclusions:

In this prospective, randomized comparison study of 77 cataractous eyes with OAG implanted with 1 vs. 2 trabecular micro-bypass stents during cataract surgery, M18 IOP reduction was greater and medication burden was lower in eyes implanted with 2 stents vs. a single stent, thus showing additional efficacy afforded by a second stent. A high safety profile was shown in both groups through 18 months postoperative.

Financial Interest:

One of the authors research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented