eyeWatch vs. Trabeculectomy RCT (evT)

NCT ID: NCT04323930

Last Updated: 2022-05-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-06-30
• Study Completion Date: 2023-12-31

Brief Summary

The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy

Detailed Description

Open-angle glaucoma is an ophthalmic disease often characterised by high intraocular pressures. Traditionally, glaucoma is treated using medication, however, more advanced or refractory glaucoma requires surgical treatment. In terms of surgery, the current gold-standard is trabeculectomy. Despite good efficacy, the technique carries relatively high rates of complications. The eyeWatch system has recently received CE-marking for the treatment of open-angle glaucoma. During its initial clinical trial, the eyeWatch system demonstrated good safety and efficacy profile. The present randomized control trial will assess its safety and efficacy against the current gold-standard: trabeculectomy.

Conditions

Primary Glaucoma

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

eyeWatch

Group Type: EXPERIMENTAL

eyeWatch

Intervention Type: DEVICE

The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.

Trabeculectomy

Group Type: EXPERIMENTAL

eyeWatch

Intervention Type: DEVICE

The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.

Interventions

eyeWatch

The eyeWatch system will be implanted as per the manufacturer's instruction, and trabeculectomy will be performed using mitomycin C as per standard surgical protocols.

Intervention Type: DEVICE

Other Intervention Names

Trabeculectomy

Eligibility Criteria

Inclusion Criteria

• Aged between 18 and 95 years,
• Diagnosis of primary open-angle glaucoma, pseudo-exfoliative glaucoma or pigmentary glaucoma in the study eye (based on [1] glaucomatous optic neuropathy and [2] visual field defects in keeping with optic disc appearance),
• Phakic or pseudophakic study eye,
• Indication for primary filtering surgery (defined as a corrected IOP ≥ 20 mmHg in the study eye, under maximally tolerated therapy on 2 consecutive measurements made on different days prior to surgery),
• Undergoing surgery and post-operative follow-up at one of the investigations centres: Montchoisi Clinic, Swiss Visio, Lausanne, Switzerland OR Manchester Royal Eye Hospital, Manchester, United-Kingdom,
• Patient agreed to sign the written inform consent prior to entering the study,
• Patient is able and willing to complete post-operative follow-up requirements.

Exclusion Criteria

• Diagnosis of secondary glaucoma except for pseudo-exfoliative or pigmentary glaucoma (neovascular glaucoma, congenital glaucoma, uveitic glaucoma…),
• Previous filtering or tube surgery in the same eye (including trabeculectomy, deep-sclerectomy and all GDDs / excluding XEN gel stents, angle surgery, cataract surgery and all MIGS),
• Recent ophthalmic surgery (less than 3 months prior to inclusion) or indication for a combined procedure (no combined surgeries will be performed),
• Narrow iridocorneal angles defined as a Shaffer grade ≤ 2 or presence of iris bombé,
• Endothelial cell density < 1500 cells/mm²,
• Presence of other significant pathologies in the study eye (including extensive conjunctival thinning or scarring, optic neuropathy of non-glaucomatous etiology, retinal vein occlusion, retinal artery occlusion, corneal opacification or irregularities, ocular malformations such as microphthalmia, concurrent inflammation/infection),
• Proliferative or severe non-proliferative retinopathy in either eye,
• Any sign of past or present uveitis,
• Severe systemic disease or disabling conditions (including chronic renal failure, history of organ transplantation),
• Current or recent participation in another clinical trial (less than 3 months prior to inclusion),
• Pregnancy or breast-feeding,
• Inability to give informed consent to participate to a clinical investigation.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Manchester Royal Eye Hospital

OTHER

Sponsor Role: collaborator

Dr. Kaweh Mansouri

OTHER

Sponsor Role: lead

Responsible Party

Dr. Kaweh Mansouri

MD MPH

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

SwissVisio Montchoisi

Lausanne, Canton of Vaud, Switzerland

Countries

Switzerland

Other Identifiers

evT-2020

Identifier Type: -

Identifier Source: org_study_id