Pilot Study on a New Self Adjustable Glaucoma Drainage De... | NCT07480603

Studies
Pilot Study on a New Self Adjustable Glaucoma Drainage Device

NCT07480603

Sponsor

Rheon Medical SA

Status

Active, not recruiting

Last Update Posted

Mar 18, 2026Actual

Enrollment

10Estimated

Phase

Phase 1

Conditions

Glaucoma

Interventions

eyeValve

Countries

Senegal

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Active, not recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2025Actual

Primary Completion Date

Sep 1, 2025Actual

Completion Date

Jul 2026Estimated

First Submitted Date

Mar 13, 2026

First Submission Date that Met QC Criteria

Mar 13, 2026

First Posted Date

Mar 18, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 13, 2026

Last Update Posted Date

Mar 18, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

10Estimated

Label	Type	Description	Intervention Names
eyeValve	Experimental	Patient treated with the device	Device: eyeValve

Name	Type	Description	Arm Group Labels	Other Names
eyeValve	Device	Implantation of a self adjustable glaucoma drainage device	eyeValve

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
42213132	Derived	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.

ID	Term
D009798	Ocular Hypertension
D005128	Eye Diseases