RECRUITINGINTERVENTIONAL
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
About This Trial
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)
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DEVICE
ELIOS Procedure
Treatment with the ELIOS System
Locations (5)
Elios Vision Clinical Site
Glendale, Arizona, United States
Elios Vision Clinical Site
Largo, Florida, United States
Elios Vision Clinical Site
Rock Island, Illinois, United States
Elios Vision Clinical Site
Oklahoma City, Oklahoma, United States
Elios Vision Clinical Site
Kenosha, Wisconsin, United States