Actively Recruiting
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
Led by Oogziekenhuis Rotterdam · Updated on 2022-12-13
160
Participants Needed
1
Research Sites
188 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: The Baerveldt glaucoma drainage device (GDD) successfully reduces intraocular pressure but also involves a risk of corneal endothelial deterioration. Supposedly, the tip of a GDD tube with a thinner diameter, such as the Paul implant, will remain at a larger distance from the cornea and, thereby, cause less damage. 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.
CONDITIONS
Official Title
Comparing the Baerveldt and Paul Glaucoma Drainage Devices and Their Effects on the Corneal Endothelium
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Provided informed consent
- Caucasian ethnicity as self-reported or based on parents' origin
- Diagnosed with primary open-angle glaucoma, pseudoexfoliative glaucoma, or pigmentary glaucoma
You will not qualify if you...
- History of intraocular surgery such as vitrectomy, cataract surgery, or cyclodestructive procedures
- History of ocular comorbidities including active uveitis or proliferative diabetic retinopathy
- Presence of pseudophakia (artificial lens)
- Functionally monocular patients
- Need for glaucoma surgery combined with other eye surgeries like cataract surgery, keratoplasty, or retinal surgery
- Narrow anterior chamber angle
- Best corrected visual acuity less than 0.1
- Severe blepharitis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Oogziekenhuis Rotterdam
Rotterdam, Netherlands, 3011BH
Actively Recruiting
Research Team
R
Rene J Wubbels
CONTACT
S
Susan Marinissen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here