A Prospective, Multicenter, Clinical Trial Designed to Evaluate the Safety and Feasibility of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma as a Standalone Procedure
Elios Vision, Inc.
Summary
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG)
Eligibility
- Age range
- 45+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Diagnosis of mild to moderate POAG * Medicated IOP of \<=24 mmHg * Shaffer angle grade of III or IV * CD ratio \<=0.8 * At least 45 years old Exclusion Criteria: * Closed-angle and secondary glaucomas * Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery * Cannot undergo medication washout in the study eye * Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control
Interventions
- DeviceELIOS Procedure
Treatment with the ELIOS System
Locations (5)
- Elios Vision Clinical SiteGlendale, Arizona
- Elios Vision Clinical SiteLargo, Florida
- Elios Vision Clinical SiteRock Island, Illinois
- Elios Vision Clinical SiteOklahoma City, Oklahoma
- Elios Vision Clinical SiteKenosha, Wisconsin