- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04323930
eyeWatch vs. Trabeculectomy RCT (evT) (evT)
May 4, 2022 updated by: Dr. Kaweh Mansouri
Randomized Control Trial of the eyeWatch System as a First-Line Surgical Treatment of Glaucoma vs. MMC-Trabeculectomy
The confirm the performance and safety of the eyeWatch System as first-line filtering surgery and compare its outcomes to trabeculectomy
Study Overview
Status
Enrolling by invitation
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Vaud
-
Lausanne, Vaud, Switzerland, 1006
- SwissVisio Montchoisi
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 95 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: 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.
Other Names:
|
EXPERIMENTAL: Trabeculectomy
|
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.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Intraocular pressure (mmHg)
Time Frame: pre-op to month 12
|
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
Time Frame: pre-op to month 12
|
The number of anti-glaucoma medications will be reported for each visit and compared to the baseline.
|
pre-op to month 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual acuity
Time Frame: baseline to month 12
|
Visual acuity will be measured at each visit and compared to the baseline measurement.
|
baseline to month 12
|
visual field mean deviation
Time Frame: baseline to month 12
|
Visual field mean deviation will be measured at each visit and compared to the baseline measurement.
|
baseline to month 12
|
endothelial cell density
Time Frame: baseline to month 12
|
the number of endothelial cells will be measured at each visit and compared to the baseline measurement.
|
baseline to month 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 30, 2021
Primary Completion (ANTICIPATED)
June 30, 2022
Study Completion (ANTICIPATED)
December 31, 2023
Study Registration Dates
First Submitted
March 20, 2020
First Submitted That Met QC Criteria
March 24, 2020
First Posted (ACTUAL)
March 27, 2020
Study Record Updates
Last Update Posted (ACTUAL)
May 10, 2022
Last Update Submitted That Met QC Criteria
May 4, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- evT-2020
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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