eyeTube in Combination With the eyeWatch Implant

• Sponsor: Rheon Medical SA (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT05912790
• Collaborator: (none)
• Enrollment: 15
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 15.8
• Patients Per Site Per Month: 0.9

Study Details

Study Description

Brief Summary

In this study, we investigate the success of aqueous humor shunting in the retrobulbar space, using the eyeTube in combination with the eyeWatch implant. We 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.

Condition or Disease	Intervention/Treatment	Phase
Aqueous Humor Drainage	Device: eyeTube	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 15 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: eyeTube in Combination With the eyeWatch Implant
• Actual Study Start Date: Jun 6, 2023
• Anticipated Primary Completion Date: Jun 20, 2024
• Anticipated Study Completion Date: Sep 30, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. IOP reduction [12 months]

   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.

2. Adverse events [12 months]

   The incidence and severity of adverse events in the study eye (overall and related to the eyeWatch system) throughout the follow-up period.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Senghor Centre	Mbour		Senegal

Sponsors and Collaborators

• Rheon Medical SA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Rheon Medical SA
• ClinicalTrials.gov Identifier: NCT05912790
• Other Study ID Numbers: SEN-CL
• First Posted: Jun 22, 2023
• Last Update Posted: Jun 22, 2023
• Last Verified: Jun 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jun 22, 2023