Safety and Feasibility of the ELIOS System in POAG Patients

June 13, 2026 updated by: Elios Vision, Inc.

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

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • ELIOS Vision Clinical Site
    • Illinois
      • Rock Island, Illinois, United States, 61201
        • ELIOS Vision Clinical Site
    • Missouri
      • St Louis, Missouri, United States, 63108
        • ELIOS Vision Clinical Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • ELIOS Vision Clinical Site
    • Texas
      • El Paso, Texas, United States, 79902
        • ELIOS Vision Clinical Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • ELIOS Vision Clinical Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
12 Months
Mean Change in DIOP from baseline on the same or fewer medications
Time Frame: 12 Months
Mean Change in DIOP from baseline on the same or fewer medications
12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Elios Vision, Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2023

Primary Completion (Actual)

April 28, 2026

Study Completion (Actual)

April 28, 2026

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 (Actual)

June 16, 2026

Last Update Submitted That Met QC Criteria

June 13, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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