Back to resultsSafety and Feasibility of the ELIOS System in POAG Patients
Primary Purpose
Glaucoma, Primary Open Angle
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
ELIOS Procedure
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Primary Open Angle
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ELIOS Procedure
Arm Description
ELIOS Procedure
Outcomes
Primary Outcome Measures
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
Mean Change in DIOP from baseline on the same or fewer medications
Mean Change in DIOP from baseline on the same or fewer medications
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05999006
Brief Title
Safety and Feasibility of the ELIOS System in POAG Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
September 2025 (Anticipated)
Study Completion Date
September 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Elios Vision, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Primary Open Angle
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ELIOS Procedure
Arm Type
Experimental
Arm Description
ELIOS Procedure
Intervention Type
Device
Intervention Name(s)
ELIOS Procedure
Intervention Description
Treatment with the ELIOS System
Primary Outcome Measure Information:
Title
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
Description
Proportion of subjects who achieve a decrease in mean diurnal IOP (DIOP) from baseline of at least 20% on the same or fewer medications
Time Frame
12 Months
Title
Mean Change in DIOP from baseline on the same or fewer medications
Description
Mean Change in DIOP from baseline on the same or fewer medications
Time Frame
12 Months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rupali Nangia
Phone
714-227-6151
Email
rupali@eliosvision.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Iqbal (Ike) Ahmed, MD
Organizational Affiliation
Prism Eye Institute
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Safety and Feasibility of the ELIOS System in POAG Patients
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