ClinicalTrials.gg
Active, not recruitingNCT07480603eV-SENUpdated Mar 18, 2026

Pilot Study on a New Self Adjustable Glaucoma Drainage Device

A Phase 1 interventional study of eyeValve in Glaucoma, sponsored by Rheon Medical SA. Active, not recruiting at 1 site in Senegal. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-03-18.

Sponsored by Rheon Medical SA · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Registered 9 months after the study started (first participant enrolled Jun 2025, registered Mar 2026).
Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Non-randomized
Ages
18 Years to 90 Years
Sex
All
01

Study summary

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

02

Conditions studied

  • Glaucoma

Browse trials for

Keywords

  • glaucoma, drainage device, filtering surgery
03

In context

Glaucoma

1,419 studies on the registry are indexed under Glaucoma; 223 are open to participants now.

This study's planned enrollment of 10 is below the median of 61 across 964 interventional studies indexed under Glaucoma.

Browse Glaucoma studies →

Lead sponsor

Rheon Medical SA is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

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

Exclusion Criteria:

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

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

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

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

Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (estimated)

Study arms

  • Experimental
    eyeValve

    Patient treated with the device

    Device: eyeValve

Interventions

  • DeviceeyeValve

    Implantation of a self adjustable glaucoma drainage device

06

What researchers measure

Primary outcomes

  1. Safety

    Type and rate of complications post-surgery

    Time frame: 3 months

  2. IOP reduction

    IOP reduction by \>20%

    Time frame: Baseline versus every visit, up to 1 year

07

Study locations

1 site
  • SwissVisio
    Sali, Senegal
08

References and documents

Publications

  • Rafiei S, Gerber JM, Bigler S, Villamarin A, Stergiopulos C, Ndoye C, Ngom EM, Mermoud A, Stergiopulos N. First-in-human implantation of a self-adjustable glaucoma drainage device (eyeValve): safety and performance in blind eyes. Graefes Arch Clin Exp Ophthalmol. 2026 May 29. doi: 10.1007/s00417-026-07278-1. Online ahead of print. PubMed 42213132 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2025 to primary completion in Sep 2025, 3 months.

Of 18 phase 1 interventional studies under Glaucoma, half reached primary completion within 8 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 23. This study's 3 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 13, 2026
First posted
Mar 18, 2026
StartActual
Jun 1, 2025
Primary completionActual
Sep 1, 2025
CompletionEst.
Jul 2026
Last update
Mar 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07480603
Lead sponsor
Rheon Medical SA
Responsible party
Sponsor
First posted
Mar 18, 2026
Start date
Jun 1, 2025
Primary completion
Sep 1, 2025
Completion
Jul 2026 (estimated)
Last update
Mar 18, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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