eyeTube in Combination With the eyeWatch Implant

In this study, the investigators want to investigate the success of aqueous humor shunting in the retrobulbar space, using the eyeTube in combination with the eyeWatch implant. The investigators postulate that posterior aqueous humor shunting would be more effective, as this space offers a larger drainage area and a less aggressive local inflammatory environment than the subconjunctival space close to the limbus, resulting in lower and better-sustained IOP than in the more limited, fibroblast-promoting subconjunctival environment surrounding standard implants.

Study Overview

• Status: Active, not recruiting
• Conditions: Aqueous Humor Drainage
• Intervention / Treatment: Device: eyeTube

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Senegal
  • Mbour, Senegal
    • Senghor Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• - Men and women aged 18 to 85.
• Diagnosis of primary open-angle glaucoma meeting both of the following criteria:
• IOP uncontrolled by at least one (1) or more classes of topical IOP-lowering medical therapy, and
• Failure of at least one (1) conventional intraocular glaucoma surgery (e.g., glaucoma filter surgery or tube shunting) or cilioablative procedures (e.g., cryotherapy, cyclodiode therapy).
• Trabecular meshwork visible on gonioscopy, with a Shaffer angle ≥ 3 in the target quadrant.
• 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 examinations for at least 12 months after surgery.

Exclusion Criteria:

• - Previous filtering surgery, secondary glaucoma, severe systemic disease, pregnancy, breast-feeding, inability to understand or give informed consent.
• Choroidal detachment, choroidal effusion or any active choroidopathy.
• Diagnosis of acute angle-closure glaucoma or malignant glaucoma.
• History of glaucoma drainage/valve implant in target quadrant
• Presence of conjunctival scarring, previous conjunctival surgery or other conjunctival pathology (e.g. pterygium) in the target quadrant.
• Use of systemic (oral or intravenous) glaucoma medications
• History of corneal surgery (including LASIK and PRK), corneal opacities, corneal diseases or any corneal pathology likely to interfere with IOP measurement.
• Eyes with ocular malformations such as microphthalmia
• Eyes with concomitant inflammatory/infectious ocular disorders
• Aphakia
• Presence of an anterior chamber intraocular lens or implantable contact lens
• Previous complicated cataract surgery or presence of vitreous in the anterior chamber
• Cataract surgery performed less than 6 months before the start of the study
• Presence of intraocular silicone oil
• Previous diagnosis of chronic uveitis in either eye
• Active diabetic retinopathy, choroidal neovascularization, secondary retinal vein occlusion, central retinal vein occlusion, proliferative retinopathy or other ophthalmic disease or disorder likely to distort study results.
• Impaired episcleral venous drainage (e.g., Sturge-Weber or nanophthalmos or other evidence of elevated venous pressure)
• Uncontrolled systemic disease (e.g. diabetes, hypertension)
• History of dermatological keloid formation
• Use of ocular or systemic steroids in the last 30 days (chronic continuous use of systemic steroids is permitted) prior to the screening visit, or known response to corticosteroids.
• Pregnant or breast-feeding women, or women of childbearing age who do not wish to use medically acceptable contraception between the screening visit and 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 clinical trial of an investigational drug or interventional device.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treated with the eyeTube	Device: eyeTube; Implantation of a drainage device in the eye, in combination with the eyeWatch implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events	The incidence and severity of adverse events in the study eye (overall and related to the eyeWatch system) throughout the follow-up period.	12 months
Intraocular pressure (IOP) reduction	The proportion of subjects achieving a mean reduction in IOP of ≥ 20% compared with pre-operative pressure at 12 months with the same or fewer hypotensive drugs.	12 months

Collaborators and Investigators

• Sponsor: Rheon Medical SA

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2023
• Primary Completion (Estimated): June 20, 2024
• Study Completion (Estimated): September 30, 2024

Study Registration Dates

• First Submitted: June 12, 2023
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Estimated): August 31, 2023
• Last Update Submitted That Met QC Criteria: August 29, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: SEN-CL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No