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Study Comparing ELIOS and Another Device for Eye Pressure Control in Adults with Open-Angle Glaucoma Undergoing Cataract Surgery
Led by Elios Vision, Inc. · Updated on 2026-06-17
194
Participants Needed
16
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are comparing the effectiveness and safety of the ELIOS device versus a competitor device in patients with open-angle glaucoma who are undergoing cataract surgery. The study focuses on lowering intraocular pressure IOP at 12 months after surgery. This prospective, multicenter, randomized clinical trial aims to assess which device better reduces IOP in this patient group. Participants will receive cataract surgery followed by treatment with either the ELIOS device or the competitor device, assigned randomly. Both treatments are procedures performed by the surgeon immediately after cataract surgery. The trial compares these two active treatment groups in a parallel design. Participants will be monitored for intraocular pressure at 12 months and again at 24 months after washout. The study also tracks the number of hypotensive medications used and measures treated IOP at 12 months. Safety and effectiveness will be evaluated throughout the follow-up period, which extends until December 2028.
CONDITIONS
Brief Title
Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery
Research Team
C
Cameron Hudson
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