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Abstract #59317 Published in IGR 16-3
Initial Clinical Experience With the CyPass Micro-Stent: Safety and Surgical Outcomes of a Novel Supraciliary Microstent
Hoeh H; Vold SD; Ahmed IK; Anton A; Rau M; Singh K; Chang DF; Shingleton BJ; Ianchulev TJournal of Glaucoma 2016; 25: 106-112
PURPOSE: To evaluate safety and clinical outcomes of a novel supraciliary device, the CyPass Micro-Stent, for surgical treatment of open-angle glaucoma when implanted in conjunction with cataract surgery. PATIENTS AND METHODS: Subjects (n=142) with open-angle glaucoma and cataract underwent combined phacoemulsification, with intraocular lens insertion, and microstent implantation into the supraciliary space of study eyes (n=167). Two analysis cohorts were prespecified based upon medicated baseline intraocular pressure (IOP): ≥21 mm Hg (cohort 1, n=65) or <21 mm Hg (cohort 2, n=102). Glaucoma medications were discontinued or tapered at surgery, and restarted at investigator discretion. The main postoperative outcome measures were adverse events, IOP changes, and number of IOP-lowering medications. RESULTS: Mean±SD follow-up was 294±121 days. No major intraoperative or postoperative complications occurred. Preoperative baseline mean IOP was 20.2±6.0 mm Hg and mean number of IOP-lowering medications was 2.0±1.1. Cohort 1 showed a 35% decrease in mean IOP and a 49% reduction in mean glaucoma medication usage; cohort 2 demonstrated a 75% reduction in mean medication usage while maintaining mean IOP<21 mm Hg. For all eyes, mean IOP at 12 months was 15.9±3.1 mm Hg (14% reduction from baseline). Early and late postoperative IOP elevation occurred in 1.2% and 1.8% of eyes, respectively. Two subjects developed mild transient hyphema, and none exhibited prolonged inflammation, persistent hypotony, or hypotony maculopathy. CONCLUSIONS: CyPass Micro-Stent implantation, combined with cataract surgery, resulted in minimal complications and reduced IOP and IOP-lowering medication use at 12 months postoperatively.
*Eye Hospital at the Dietrich-Bonhoeffer-Klinikum, Neubrandenburg †Teaching Hospital of the Ernst-Moritz-Arndt, University Greifswald, Greifswald ¶Eye Clinic, Cham, Germany ‡Vold Vision, Fayetteville, AK §Department of Ophthalmology, University of Toronto, Toronto, ON, Canada ∥Institut Catala de Retina, Universidad Internacional de Cataluña, Barcelona, Spain #Department of Ophthalmology, Stanford University, Palo Alto, CA **Department of Ophthalmology, University of California San Francisco, San Francisco, CA ††Ophthalmic Consultants of Boston, Boston, MA.
Full articleClassification:
12.8.2 With tube implant or other drainage devices (Part of: 12 Surgical treatment > 12.8 Filtering surgery)
12.14.3 Phacoemulsification (Part of: 12 Surgical treatment > 12.14 Combined cataract extraction and glaucoma surgery)