NCT07480603

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for phase_1

Timeline
0mo left

Started Jun 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress96%
Jun 2025Jul 2026

Study Start

First participant enrolled

June 1, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 13, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 18, 2026

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Expected
Last Updated

March 18, 2026

Status Verified

March 1, 2026

Enrollment Period

3 months

First QC Date

March 13, 2026

Last Update Submit

March 13, 2026

Conditions

Glaucoma

Keywords

glaucoma, drainage device, filtering surgery

Outcome Measures

Primary Outcomes (2)

  • Safety

    Type and rate of complications post-surgery

    3 months

  • IOP reduction

    IOP reduction by \>20%

    Baseline versus every visit, up to 1 year

Study Arms (1)

eyeValve

EXPERIMENTAL

Patient treated with the device

Device: eyeValve

Interventions

eyeValveDEVICE

Implantation of a self adjustable glaucoma drainage device

eyeValve

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SwissVisio

Sali, Senegal

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2026

First Posted

March 18, 2026

Study Start

June 1, 2025

Primary Completion

September 1, 2025

Study Completion (Estimated)

July 1, 2026

Last Updated

March 18, 2026

Record last verified: 2026-03

Locations

SE(1)