RecruitingNot ApplicableNCT05999006
Safety and Feasibility of the ELIOS System in POAG Patients
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
Sponsor
Elios Vision, Inc.
Enrollment
65 participants
Start Date
Oct 18, 2023
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 45 Years
Inclusion Criteria5
- 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 Criteria4
- 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)
View Full Details on ClinicalTrials.gov
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NCT05999006