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

Abstract

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. Multicenter, single-arm interventional study. Patients with open-angle glaucoma (Shaffer Grade 3 and 4) and uncontrolled medicated intraocular pressure (IOP) >21mm 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 IOP changes, and need for IOP-lowering medications during the first 12 postoperative months (12M) were monitored. Sixty-five eyes were enrolled, and 55 were available at 12M, accounting for loss to follow-up and early termination. Baseline IOP was 24.5 ± 2.8mm 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 hyphema, hypotony maculopathy). The most common adverse events included IOP increases >30mm Hg beyond 1month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean IOP was 16.4 ± 5.5mm Hg at 12months-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). Supraciliary stenting with the CyPass Micro-Stent effectively lowers IOP as a surgical treatment for glaucoma, precluding the need for more invasive glaucoma surgery in >80% of patients at 1 year, therebyreducing postoperative glaucoma surgical complications.