Supraciliary Micro-stent Implantation for Open-Angle Glaucoma Failing Topical Therapy: 1-Year Results of a Multicenter Study

PURPOSE: To evaluate the safety and efficacy of a supraciliary micro-stent (CyPass Micro-Stent; Transcend Medical, Menlo Park, California, USA) for surgical treatment of glaucoma in patients refractory to topical medications. DESIGN: Multicenter, single-arm interventional study. METHODS: Patients with open-angle glaucoma (Shaffer Grade 3 and 4) and uncontrolled medicated intraocular pressure (TOP) >21 mm Hg at baseline and candidates for conventional glaucoma surgery were enrolled. Glaucoma medications were discontinued at surgery and resumed at investigator discretion. CyPass Micro-Stent implantation was completed in all patients using a standard clear corneal approach. Adverse events, postoperative TOP changes, and need for TOP-lowering medications during the first 12 postoperative months (12M) were monitored. RESULTS: Sixty-five eyes were enrolled, and 55 were available at 12M, accounting for loss to follow-up and early termination. Baseline TOP was 24.5 +/- 2.8 mm Hg, and the mean number of medications recorded was 2.2 +/- 1.1. There were no serious intraoperative events or major adverse events (eg, retinal or choroidal detachment, persistent uveitis, persistent hypheina, hypotony maculopathy). The most common adverse events included TOP increases >30 mm Hg beyond 1 month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean TOP was 16.4 +/- 5.5 mm Hg at 12 months a 34.7% reduction (P <.0001). Mean medication usage also decreased from baseline to a mean of 1.4 +/- 1.3 medications at 12M (P =.002). In eyes originally indicated for conventional glaucoma surgery, no secondary surgery was performed in 83% (53/64). CONCLUSION: Supraciliary stenting with the CyPass Micro-Stent effectively lowers TOP as a surgical treatment for glaucoma, precluding the need for more invasive glaucoma surgery in > 80% of patients at 1 year, thereby reducing postoperative glaucoma surgical complications. (C) 2015 by Elsevier Inc. All rights reserved.