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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

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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


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.


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.


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).


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.


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

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