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

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)

Study Overview

• Status: Recruiting
• Conditions: Glaucoma, Primary Open Angle
• Intervention / Treatment: Device: ELIOS Procedure

• Study Type: Interventional
• Enrollment (Estimated): 65
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rupali Nangia; Phone Number: 714-227-6151; Email: rupali@eliosvision.com

Study Locations

• United States
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Recruiting
      • Elios Vision Clinical Site
  • Florida
    • Largo, Florida, United States, 33770
      • Recruiting
      • Elios Vision Clinical Site
  • Illinois
    • Rock Island, Illinois, United States, 61201
      • Recruiting
      • Elios Vision Clinical Site
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Recruiting
      • Elios Vision Clinical Site
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Recruiting
      • Elios Vision Clinical Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Elios Vision, Inc.
• Investigators: Study Director: Iqbal (Ike) Ahmed, MD, Prism Eye Institute

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2023
• Primary Completion (Estimated): October 1, 2025
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: August 11, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: March 2, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: EP-02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes