Comparative Effectiveness and Safety of ELIOS in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

November 24, 2025 updated by: Elios Vision, Inc.

A Prospective, Multicenter, Randomized Clinical Trial to Evaluate the Safety and Effectiveness of ELIOS vs Competitor in Patients With Open-Angle Glaucoma Undergoing Cataract Surgery

The primary study objective is to compare the effectiveness of the combination of phacoemulsification with intraocular lens implant with ELIOS or competitor device in reducing IOP at 12 months postoperatively.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

194

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 Contact

Study Locations

  • Belgium
      • Leuven, Belgium
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +32 16 33 23 70
  • France
      • Avranches, France
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 0033 233686000
      • Bordeaux, France
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 0033 556795679
      • Paris, France
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 0033 148036565
  • Germany
      • Bochum, Germany
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +49 234 299 0
      • Bonn, Germany
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +49 228 28715505
      • Heidelberg, Germany
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +49 6221 56 6999
  • Netherlands
      • Maastricht, Netherlands
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 31 43 387 6800
  • Spain
      • Barcelona, Spain
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +34 936 11 80 24
      • Madrid, Spain
        • Recruiting
        • ELIOS Clincal Site
        • Contact:
          • Phone Number: +34 915 42 60 10
      • Madrid, Spain
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +34 913 30 30 00
  • United Kingdom
      • East Grinstead, United Kingdom
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +44 1342 414000
      • Edinburgh, United Kingdom
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +44 131 537 1340
      • Guildford, United Kingdom
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: +44 1483 571122
      • London, United Kingdom
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 00442072533411
      • Manchester, United Kingdom
        • Recruiting
        • ELIOS Clinical Site
        • Contact:
          • Phone Number: 44 161 276 5522

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:

  1. Male or female subjects.
  2. 40 years old or older.
  3. Diagnosis of mild to moderate primary open-angle glaucoma, pseudoexfoliation glaucoma or pigmentary glaucoma:
  4. Visually significant cataract eligible for phacoemulsification.

Exclusion Criteria:

  1. All forms of angle closure glaucoma
  2. Secondary glaucoma, including traumatic, neovascular, uveitic, lens-induced, steroid-induced, angle-recession, glaucoma associated with vascular disorders, and glaucoma associated with increased episcleral venous pressure
  3. Congenital or developmental glaucoma
  4. Prior incisional glaucoma surgery, intraocular surgery or ocular laser treatment of any type with the exception of selective laser trabeculoplasty (SLT) occurring a minimum of 6 months prior to the Screening visit

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Arm 1
ELIOS
Procedure: ELIOS
Following cataract surgery, surgeon will proceed to ELIOS treatment.
Active Comparator: Arm 2
Competitor Device
Procedure: Competitor Device
Following cataract surgery, surgeon will proceed to Competitor treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PRIMARY EFFECTIVENESS ENDPOINTS : IOP
Time Frame: 12 months
Mean change in post-washout diurnal IOP from baseline to 12 months.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
SECONDARY EFFECTIVENESS ENDPOINTS : Post-washout diurnal IOP
Time Frame: 24 months
Proportion of patients achieving 20% reduction in post-washout diurnal IOP from baseline.
24 months
SECONDARY EFFECTIVENESS ENDPOINTS : Number of hypotensive medications
Time Frame: 12 months
change in number of hypotensive medications from screening to 12 months
12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Treated IOP
Time Frame: 12 months
Mean change in treated IOP from screening to 12 months
12 months
SECONDARY EFFECTIVENESS ENDPOINTS : Medications
Time Frame: 12 months
Proportion of patients Medication free at 12 months
12 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
SAFETY ENDPOINTS : adverse events
Time Frame: 24 months
Rates of ocular adverse events
24 months
Safety endpoints: Retinal nerve fiber layer thickness
Time Frame: 12 months (with a planned extension of analysis at 24 months)
measurement of Retinal nerve fiber layer thickness
12 months (with a planned extension of analysis at 24 months)

Collaborators and Investigators

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

Sponsor

Elios Vision, Inc.

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)

December 5, 2023

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

March 31, 2028

Study Registration Dates

First Submitted

January 30, 2024

First Submitted That Met QC Criteria

January 30, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

November 26, 2025

Last Update Submitted That Met QC Criteria

November 24, 2025

Last Verified

November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ELIOS-RCT STERLING

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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