Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
NCT ID: NCT05344651
Last Updated: 2022-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
160 participants
INTERVENTIONAL
2022-10-19
2026-06-30
Brief Summary
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Objective: To determine whether the Paul tube induces less damage to the corneal endothelium than the Baerveldt GDD.
Study design: Randomized clinical trial. Study population: Phakic patients scheduled for surgical GDD implantation. Intervention: Either a Baerveldt or a Paul GDD implant. Main study parameters/endpoints: Endothelial cell density and tube position at 24 months.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness: The Paul GDD may have a less harmful effect on corneal endothelium. Otherwise, both GDDs will probably have a similar risk/benefit profile. The risks of study-related assessments are negligible, burden is low, extra time is about 5 x 1.5 h (total 7.5 h) in two years.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Baerveldt glaucoma drainage device
Surgery/implantation
The glaucoma drainage device consists of a plate and a tube. During surgery the plate is positioned underneath the conjunctiva and two extraocular muscles in the upper temporal quadrant of the eye. The tube is positioned in the anterior chamber.
Paul glaucoma drainage device
Surgery/implantation
The glaucoma drainage device consists of a plate and a tube. During surgery the plate is positioned underneath the conjunctiva and two extraocular muscles in the upper temporal quadrant of the eye. The tube is positioned in the anterior chamber.
Interventions
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Surgery/implantation
The glaucoma drainage device consists of a plate and a tube. During surgery the plate is positioned underneath the conjunctiva and two extraocular muscles in the upper temporal quadrant of the eye. The tube is positioned in the anterior chamber.
Eligibility Criteria
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Inclusion Criteria
* Informed consent.
* Caucasian ethnicity (to facilitate comparison of results with those of earlier work). Ethnicity will be based on self-reported origin of subject and/or parents.
* Primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma.
Exclusion Criteria
* History of ocular comorbidity (e.g. active uveitis, proliferative diabetic retinopathy).
* Pseudophakia.
* Functionally monocular patients.
* Need for glaucoma surgery combined with other ocular procedures (i.e. cataract surgery, keratoplasty, or retinal surgery) or an anticipated need for additional ocular surgery.
* Narrow anterior chamber angle.
* Best corrected visual acuity less than 0.1.
* Severe blepharitis.
18 Years
100 Years
ALL
No
Sponsors
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Oogziekenhuis Rotterdam
OTHER
Responsible Party
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Locations
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Oogziekenhuis Rotterdam
Rotterdam, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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Rene J Wubbels, PhD
Role: primary
Ionela Popescu-Giovanitsas, MD
Role: backup
Other Identifiers
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NL80518.078.22
Identifier Type: OTHER
Identifier Source: secondary_id
MEC-2022-0069
Identifier Type: OTHER
Identifier Source: secondary_id
OZR-2020-30
Identifier Type: -
Identifier Source: org_study_id