Status:
RECRUITING
Safety and Feasibility of the ELIOS System in POAG Patients
Lead Sponsor:
Elios Vision, Inc.
Conditions:
Glaucoma, Primary Open Angle
Eligibility:
All Genders
45+ years
Phase:
NA
Brief 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 Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 18 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2026
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT05999006
Start Date
October 18 2023
End Date
April 1 2026
Last Update
June 17 2025
Active Locations (5)
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1
Elios Vision Clinical Site
Glendale, Arizona, United States, 85306
2
Elios Vision Clinical Site
Largo, Florida, United States, 33770
3
Elios Vision Clinical Site
Rock Island, Illinois, United States, 61201
4
Elios Vision Clinical Site
Oklahoma City, Oklahoma, United States, 73112