Ocular hypotensive medication use in patients undergoing combined cataract surgery and supraciliary micro-stent implantation for open-angle glaucoma in the COMPASS trial

Session Details

Session Title: Glaucoma

Session Date/Time: Monday 09/10/2017 | 08:00-10:30

Paper Time: 09:12

Venue: Room 4.1

First Author: : S.Sarkisian Jr. USA

Co Author(s): :    G. Clasby                    

Abstract Details

Purpose:

The purpose of the COMPASS Trial was to evaluate the safety and effectiveness of the CyPass Micro-Stent in lowering intraocular pressure (IOP) in glaucomatous eyes in conjunction with cataract surgery, as compared to eyes treated with cataract surgery alone.

Setting:

Prospective, randomized, comparative, multicenter investigation.

Methods:

Primary open-angle glaucoma subjects qualified for cataract surgery (N=505) had unmedicated IOP measured prior to randomization to either supraciliary stenting + phaco (Micro-Stent, n=374) or phaco (Control, n=131) groups (approximately 3:1 ratio). Per the study protocol, ocular hypotensive medication was to be introduced at 1 month postoperatively or later to any subject with IOP ≥ 21.0 mm Hg at 2 consecutive visits within a 2-week period. Administration of glaucoma medication to subjects with IOP < 21.0 mm Hg was to be considered on a case-by-case basis by the study investigator and the Medical Monitor.

Results:

Mean number of ocular hypotensive medications used at screening: 1.4 (SD 0.9) in the Micro-Stent group, 1.3 (SD 1.0) in the Control group. At 24 months, ocular hypotensive medications used was 0.2 (SD 0.6) and 0.6 (SD 0.8), respectively. In the Micro-Stent group, 72.5% of patients (compared to 58.0% of patients in the Control group) achieved the primary endpoint: ≥20% decrease in unmedicated mean diurnal IOP from baseline (P=.003). Of those patients who achieved the primary endpoint, 93.0% of subjects in the Micro-Stent group and 72.4% in the Control group were not using ocular hypotensive medication at 24 months.

Conclusions:

A statistically higher proportion of subjects in the micro-stent group achieved a clinically significant reduction in IOP at 24 months postoperative, with the majority of subjects being medication-free. Supraciliary micro-stent implantation results in safe and sustained IOP reduction in POAG patients undergoing cataract surgery.

Financial Disclosure:

is employed by a forNONEprofit company with an interest in the subject of the presentation, research is funded, fully or partially, by a company producing, developing or supplying the product or procedure presented, receives consulting fees, retainer, or contract payments from a company producing, developing or supplying the product or procedure presented