eyeTube in Combination With the eyeWatch Implant

NCT05912790 | Unknown

• 1 other identifier: SEN-CL
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Aqueous Humor Drainage

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Treated with the eyeTube

EXPERIMENTAL

Device: eyeTube

Interventions

eyeTube DEVICE

Implantation of a drainage device in the eye, in combination with the eyeWatch implant

Treated with the eyeTube

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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

Sponsors & Collaborators

• Rheon Medical SA: lead

Study Sites (1)

Senghor Centre

Mbour, Senegal

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2023
• First Posted: June 22, 2023
• Study Start: June 6, 2023
• Primary Completion: June 20, 2024
• Study Completion: September 30, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)