Safety and Feasibility of the ELIOS System in POAG Patients

• Sponsor: Elios Vision, Inc. (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05999006
• Collaborator: (none)
• Enrollment: 65
• Arm: 1
• Anticipated Duration (Months): 24

Study Details

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)

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Primary Open Angle	Device: ELIOS Procedure	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 65 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Sep 1, 2023
• Anticipated Primary Completion Date: Sep 1, 2025
• Anticipated Study Completion Date: Sep 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ELIOS Procedure ELIOS Procedure	Device: ELIOS Procedure; Treatment with the ELIOS System

Outcome Measures

Primary Outcome Measures

1. 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

2. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 45 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Elios Vision, Inc.

Investigators

• Study Director: Iqbal (Ike) Ahmed, MD, Prism Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Elios Vision, Inc.
• ClinicalTrials.gov Identifier: NCT05999006
• Other Study ID Numbers: EP-02
• First Posted: Aug 21, 2023
• Last Update Posted: Aug 21, 2023
• Last Verified: Aug 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 21, 2023