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
1 other identifier
interventional
65
1 country
5
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2023
Typical duration for not_applicable
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2023
CompletedFirst Posted
Study publicly available on registry
August 21, 2023
CompletedStudy Start
First participant enrolled
October 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedJune 17, 2025
June 1, 2025
2.5 years
August 11, 2023
June 13, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
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
Mean Change in DIOP from baseline on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications
12 Months
Study Arms (1)
ELIOS Procedure
EXPERIMENTALELIOS Procedure
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Elios Vision Clinical Site
Glendale, Arizona, 85306, United States
Elios Vision Clinical Site
Largo, Florida, 33770, United States
Elios Vision Clinical Site
Rock Island, Illinois, 61201, United States
Elios Vision Clinical Site
Oklahoma City, Oklahoma, 73112, United States
Elios Vision Clinical Site
Kenosha, Wisconsin, 53142, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Iqbal (Ike) Ahmed, MD
Prism Eye Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 11, 2023
First Posted
August 21, 2023
Study Start
October 18, 2023
Primary Completion
April 1, 2026
Study Completion
April 1, 2026
Last Updated
June 17, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share