Combined cataract surgery and supraciliary microstent implantation for open-angle glaucoma: BCVA outcomes from the COMPASS trial

Session Details

Session Title: Glaucoma

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

Paper Time: 09:36

Venue: Room 4.1

First Author: : T.Ianchulev USA

Co Author(s): :    T. Landry                    

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 (POAG) 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). The primary effectiveness endpoint was defined as the proportion of eyes with a ≥ 20% decrease in 24-month postoperative mean unmedicated diurnal intraocular pressure (DIOP) from baseline. Additional evaluations included post-operative visual recovery and incidence of adverse events (AEs).

Results:

Proportion of subjects with BCVA 20/25 or better at Month 1 was 79% (297/374) for the Micro-Stent group, and 83% (109/131) for the control group. At Month 3, the proportions were 86% (321/374) in the Micro-Stent group and 85% (111/130) for the control group. At the end of the study (Month 24) BCVA was 20/25 or better for 91% (323/355) of subjects in the Micro-Stent group and 88% (113/128) of subjects in the control group. A similar number of subjects in each group experienced postoperative ocular AEs (39% of subjects in the Micro-Stent group and 36% in the control group).

Conclusions:

Supraciliary micro-stent implantation demonstrates safe and sustained IOP reduction in POAG patients undergoing cataract surgery. By 1 month postoperatively, BCVA outcomes were similar, with no differences between groups through 24 months.

Financial Disclosure:

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