Safety and Feasibility of the ELIOS System in POAG Patients
Not Applicable
Recruiting
- Conditions
- Glaucoma, Primary Open Angle
- Interventions
- Device: ELIOS Procedure
- Registration Number
- NCT05999006
- Lead Sponsor
- Elios Vision, Inc.
- 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 65
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ELIOS Procedure ELIOS Procedure ELIOS Procedure
- Primary Outcome Measures
Name Time Method Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications 12 Months Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications 12 Months Mean Change in DIOP from baseline on the same or fewer medications
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Elios Vision Clinical Site
🇺🇸Kenosha, Wisconsin, United States