Actively Recruiting
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
Led by Oogziekenhuis Rotterdam · Updated on 2022-12-13
200
Participants Needed
1
Research Sites
197 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Rationale: Glaucoma is a group of diseases characterized by progressive neuropathy of the optic nerve associated with visual field loss. Current glaucoma management aims to preserve visual function throughout life by reducing the intraocular pressure. This can be achieved by medical therapy or by surgical procedures such as implantation of a glaucoma drainage device (GDD). Conventionally, the tube of such a device is positioned in the anterior chamber (AC). Unfortunately, the presence of the tube in the AC may have a significant negative impact on the number of endothelial cells of the cornea and may even lead to corneal decompensation. Alternatively, the tube can be positioned in the posterior chamber (i.e. behind the iris). In this study, both procedures will be compared. Objective: Primary: to determine the loss of corneal endothelial cells after implantation of a Paul GDD with its tube either anterior or posterior of the iris. Secondary: to compare efficacy and safety of both procedures. Study design: Prospective, randomised, treatment controlled clinical trial. Study population: Pseudophakic patients with glaucoma who need a GDD. Intervention: Implantation of a Paul GDD with its tube anterior/posterior of the iris. Main study parameters/endpoints: Endothelial cell loss of the cornea. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: At present potential benefits and drawbacks of positioning the Paul tube behind the iris are insufficiently known, successful positioning of the tube may require slightly more surgery time and the risk of hyphaema may be higher. It is expected, that in the long run damage to the corneal endothelium is less. Risks of study-related assessments are negligible, burden is low, extra time is about 35+15+35+35 minutes (total 2h).
CONDITIONS
Official Title
Endothelial Cell Loss in Pseudophakic Patients Receiving a Paul Glaucoma Drainage Device With Its Tube Inserted in the Anterior Versus Posterior Chamber: a Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age > 18 years
- Provided informed consent
- Pseudophakic (have an artificial lens after cataract surgery)
- Diagnosed with open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma, or angle closure glaucoma with a sufficiently deep anterior chamber
- Baseline endothelial cell image of fair or good quality
You will not qualify if you...
- Iridocorneal endothelial syndrome or posterior polymorphous dystrophy
- History of penetrating trauma to the eye
- History of eye surgery other than uncomplicated cataract surgery
- Presence of corneal disease
- Presence of posterior synechiae
- Pregnant or lactating women
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 Wubbels
CONTACT
S
Susan Marinissen
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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