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Pilot Study on a New Self Adjustable Glaucoma Drainage Device | Clinical Trials | Clareo Health

ACTIVE_NOT_RECRUITINGPHASE1

Pilot Study on a New Self Adjustable Glaucoma Drainage Device

Pilot Study eyeValve

NCT07480603•Rheon Medical SA

Summary

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

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

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.

Locations (1)

SwissVisio

Sali, Senegal

Key Dates

Start Date

June 1, 2025

Primary Completion Date

September 1, 2025

Completion Date

July 1, 2026

Last Updated

March 18, 2026

Enrollment

ESTIMATED participants

Conditions

Glaucoma

Interventions

eyeValve

DEVICE

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

NCT04354545

GlaucomaOcular Surface Disease

View study

RECRUITINGNA

Automated Applanation Tonometry - Updated

NCT07298356

GlaucomaGlaucoma, Suspect

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 18, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Pilot Study on a New Self Adjustable Glaucoma Drainage Device

Inclusion Criteria

Exclusion Criteria

Treatment of Ocular Discomfort in Glaucoma Patients Using Multiple Topical Medications

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