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). Per the study protocol, ocular hypotensive medication was to be introduced at 1 month postoperatively or later to any subject with IOP ≥ 21.0 mmHg at 2 consecutive visits within a 2-week period. Administration of glaucoma medication to subjects with IOP < 21.0 mmHg was to be considered on a case-by-case basis by the study investigator and the Medical Monitor.
Results :
The mean number of ocular hypotensive medications used at screening was 1.4 (SD 0.9) in the Micro-Stent group and 1.3 (SD 1.0) in the Control group and mean unmedicated diurnal IOP (DIOP) was 24.4±2.77 mmHg for the Micro-Stent group, and 24.5±2.95 mm Hg for the Control group. Mean unmedicated DIOP at 24 months was 17.5±4.79 mmHg for the Micro-Stent group and 19.2±4.87 mmHg for the Control group. At 24 months, the mean number of ocular hypotensive medications used was 0.2 (SD 0.6) in the Micro-Stent group and 0.6 (SD 0.8) in the Control group, and 84.8% of subjects in the Micro-stent group and 59.1% of subjects in the Control group were ocular hypotensive medication-free. In the Micro-Stent group, 72.5% of patients (compared to 58.0% of patients in the Control group) achieved the primary endpoint, which was ≥20% decrease in unmedicated mean DIOP 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 :
At 24 Months, the Micro-Stent group had a higher proportion of patients who achieved a clinically significant reduction in IOP and who were medication-free. Supraciliary microstent implantation demonstrates safe and sustained IOP reduction in POAG patients undergoing cataract surgery.
This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.