eyeWatch vs. Trabeculectomy RCT (evT)

NCT04323930 | Unknown

• 1 other identifier: evT-2020
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Primary Glaucoma

Outcome Measures

Primary Outcomes (2)

• Intraocular pressure (mmHg)

  The primary endpoint will be the change in intraocular pressure (mmHg) from pre-operative baseline to 12-month post-operatively. Intraocular pressure will be measure at each visit using Goldmann tonometry. Baseline intraocular pressure will be defined as the mean of the last two pre-operative measurements.

  pre-op to month 12

• number of anti glaucoma medications

  The number of anti-glaucoma medications will be reported for each visit and compared to the baseline.

  pre-op to month 12

Secondary Outcomes (3)

• Visual acuity

  baseline to month 12

• visual field mean deviation

  baseline to month 12

• endothelial cell density

  baseline to month 12

Study Arms (2)

eyeWatch

EXPERIMENTAL

Device: eyeWatch

Trabeculectomy

EXPERIMENTAL

Device: eyeWatch

Interventions

eyeWatch 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.

Also known as: Trabeculectomy

Trabeculectomy; eyeWatch

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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),
• 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),
• Pregnancy or breast-feeding,
• Inability to give informed consent to participate to a clinical investigation.

Sponsors & Collaborators

• Dr. Kaweh Mansouri: lead
• Manchester Royal Eye Hospital: collaborator

Study Sites (1)

SwissVisio Montchoisi

Lausanne, Canton of Vaud, 1006, Switzerland

Location

MeSH Terms

Interventions

Trabeculectomy

Intervention Hierarchy (Ancestors)

Filtering Surgery; Ophthalmologic Surgical Procedures; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD MPH

Study Record Dates

• First Submitted: March 20, 2020
• First Posted: March 27, 2020
• Study Start: June 30, 2021
• Primary Completion: June 30, 2022
• Study Completion: December 31, 2023
• Last Updated: May 10, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)