Pilot Study on a New Self Adjustable Glaucoma Drainage Device (eV-SEN)

March 13, 2026 updated by: Rheon Medical SA

Pilot Study eyeValve

A new self-adjustable glaucoma drainage device has been developed. And to test its efficacy and its safety, a pilot study is designed.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

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

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:

  • Men and women aged 18 to 90 years.

Diagnosis of primary open-angle glaucoma meeting the following criteria:

  • Intraocular pressure (IOP) not controlled by at least one (1) or more classes of topical IOP-lowering medications, and
  • Eye without visual acuity.

Patients must be able to understand the study requirements and provide written informed consent.

Patients must be willing to follow study instructions, agree to comply with all study procedures, and be able to attend all scheduled follow-up visits for at least 6 months after surgery.

Exclusion Criteria:

  • Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breastfeeding, or inability to understand or provide informed consent.

Pregnant or breastfeeding women, or women of childbearing potential who are not willing to use a medically acceptable method of contraception from the screening visit until the 12-month follow-up visit.

Known or suspected allergy or hypersensitivity to any component of the device (e.g., silicone).

Current participation, or participation within the last 30 days (from the screening visit), in another investigational drug or interventional device clinical trial.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: eyeValve
Patient treated with the device
Device: eyeValve
Implantation of a self adjustable glaucoma drainage device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: 3 months
Type and rate of complications post-surgery
3 months
IOP reduction
Time Frame: Baseline versus every visit, up to 1 year
IOP reduction by >20%
Baseline versus every visit, up to 1 year

Collaborators and Investigators

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

Sponsor

Rheon Medical SA

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)

June 1, 2025

Primary Completion (Actual)

September 1, 2025

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

March 13, 2026

First Submitted That Met QC Criteria

March 13, 2026

First Posted (Actual)

March 18, 2026

Study Record Updates

Last Update Posted (Actual)

March 18, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • eV-7007

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

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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