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

• Published in: American journal of ophthalmology Vol. 159; no. 6; pp. 1075 - 1081.e1
• Main Authors: García-Feijoo, Julian, Rau, Magda, Grisanti, Swaantje, Grisanti, Salvatore, Höh, Helmut, Erb, Carl, Guguchkova, Pravoslava, Ahmed, Iqbal, Grabner, Günther, Reitsamer, Herbert, Shaarawy, Tarek, Ianchulev, Tsontcho
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2015; Elsevier Limited
• Subjects: Advisors; Aged; Antihypertensive Agents - therapeutic use; Cataracts; Ciliary Body - surgery; Female; Glaucoma; Glaucoma Drainage Implants; Glaucoma, Open-Angle - drug therapy; Glaucoma, Open-Angle - physiopathology; Glaucoma, Open-Angle - surgery; Gonioscopy; Humans; Intraocular Pressure - drug effects; Intraocular Pressure - physiology; Male; Middle Aged; Ophthalmology; Prognosis; Prospective Studies; Prosthesis Implantation; Single-Blind Method; Stents; Surgery; Tonometry, Ocular; Treatment Failure; Visual Acuity - physiology; California
• ISSN: 0002-9394; 1879-1891
• DOI: 10.1016/j.ajo.2015.02.018

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 (IOP) >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 IOP changes, and need for IOP-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 IOP 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 hyphema, hypotony maculopathy). The most common adverse events included IOP increases >30 mm Hg beyond 1 month (11%, 7/65), transient hyphema (6%, 4/65), and cataract progression (12%, 5/41 phakic eyes). Mean IOP 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 IOP 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.