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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
194

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 5, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 30, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 30, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 26, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 24, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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