Safety and Effectiveness of CyPass Supraciliary Micro-Stent in Primary Open-Angle Glaucoma: Five-Year Results from the COMPASS XT Study

Abstract Purpose To characterize the long-term (up to five years) safety and effectiveness of the supraciliary micro-stent implanted at the time of phacoemulsification in eyes with coexisting open-angle glaucoma (OAG) and visually significant cataract Design Three-year safety extension of a two-year randomized clinical trial. Methods Patients from the multicenter COMPASS trial who underwent micro-stent implantation plus phacoemulsification (n=215) or phacoemulsification alone (n=67) were evaluated 36, 48, and 60 months postoperatively. The primary outcome measure was the occurrence of sight-threatening ocular serious adverse events. Evaluations at each time point included best-corrected visual acuity (BCVA), anterior and posterior segment examinations, tonometry, gonioscopy, pachymetry, perimetry, specular microscopy, and assessment of adverse events. Results Three sight-threatening ocular adverse events occurred, two in the micro-stent and one in the control group, but none of these events was related to the micro-stent device. Ocular adverse events were of similar frequencies in both groups, the most common of which were BCVA loss > 2 lines compared with best BCVA in COMPASS and worsening of visual field mean defect (VFMD) > 2.5 dB compared with Month 24. Changes from baseline in mean BCVA, clinical examinations, pachymetry and VFMD were similar in the two groups. At 60 months, a higher proportion of subjects in the micro-stent (46%; 95% CI 38.9% –53.2%) than in the control (32.1%; 95% CI 19.9%–46.3%) group achieved ≥ 20% IOP reduction without using hypotensive medication. Conclusions Few sight-threatening serious ocular adverse events occurred following micro-stent implantation, and clinical evidence of corneal decompensation was minimal.