Abstract
Purpose :
The purpose of the COMPASS Trial was to evaluate the safety and effectiveness of the CyPass Micro-Stent in lowering IOP in glaucomatous eyes in conjunction with cataract surgery, as compared to eyes treated with cataract surgery alone.
Methods :
Prospective, randomized, comparative, multicenter investigation. 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). The primary effectiveness endpoint was defined as the proportion of eyes with a ≥ 20% decrease in mean unmedicated diurnal intraocular pressure (DIOP) from Baseline to Month 24. Additional analyses included changes in best-corrected visual acuity (BCVA).
Results :
In the Micro-Stent group, 72.5% of patients (compared to 58.0% of patients in the Control group) had a ≥20% decrease in unmedicated DIOP from Baseline at Month 24 (P = .003). At baseline, 20% (75/374) of subjects in the Micro-Stent group had BCVA 20/25 or better, compared to 19% (25/131) of subjects in the control group. The proportions increased to 64% (240/374) and 79% (297/374) at week 1 and Month 1 respectively, for the Micro-Stent group, and to 79% (103/131) and 83% (109/131) at week 1 and Month 1 respectively for the control group. At Month 3, the proportion of subjects with BCVA 20/25 or better was 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% of subjects in the control group).
Conclusions :
Supraciliary microstent implantation demonstrates safe and sustained IOP reduction in POAG patients undergoing cataract surgery. Long-term visual acuity outcomes were similar between Micro-Stent and control groups, and a trend is evident as early as Month 1. By Month 3 the proportions are similar and remain similar through the end of the study.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.