Evaluating the ELIOS System for treating glaucoma
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
NA · Elios Vision, Inc. · NCT05999006
This study is testing a new procedure called the ELIOS System to see if it can safely lower eye pressure in adults with mild to moderate glaucoma.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 65 (estimated) |
| Ages | 45 Years and up |
| Sex | All |
| Sponsor | Elios Vision, Inc. (industry) |
| Locations | 5 sites (Glendale, Arizona and 4 other locations) |
| Trial ID | NCT05999006 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and effectiveness of the ELIOS System procedure aimed at reducing intraocular pressure in adults diagnosed with mild to moderate primary open-angle glaucoma. Participants will undergo the ELIOS procedure, which is designed to provide a new treatment option for managing this condition. The study focuses on patients with specific eligibility criteria, including controlled intraocular pressure and certain anatomical characteristics of the eye. The trial aims to gather data on the procedure's feasibility and safety profile.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 45 and older with mild to moderate primary open-angle glaucoma and controlled intraocular pressure.
Not a fit: Patients with closed-angle or secondary glaucomas, or those who have had prior glaucoma surgeries, may not benefit from this study.
Why it matters
Potential benefit: If successful, this procedure could offer a new, effective treatment option for patients with primary open-angle glaucoma.
How similar studies have performed: While this specific approach is novel, similar studies evaluating new glaucoma treatments have shown promise in the past.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Glendale, Arizona and 4 other locations
- Elios Vision Clinical Site — Glendale, Arizona, United States (RECRUITING)
- Elios Vision Clinical Site — Largo, Florida, United States (RECRUITING)
- Elios Vision Clinical Site — Rock Island, Illinois, United States (RECRUITING)
- Elios Vision Clinical Site — Oklahoma City, Oklahoma, United States (RECRUITING)
- Elios Vision Clinical Site — Kenosha, Wisconsin, United States (RECRUITING)
Study contacts
- Study coordinator: Rupali Nangia
- Email: rupali@eliosvision.com
- Phone: 714-227-6151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Glaucoma, Primary Open Angle