An interventional study of Paul glaucoma drainage device (GDD) in Glaucoma, sponsored by Oogziekenhuis Rotterdam. Recruiting at 1 site in Netherlands. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-12-13.
Sponsored by Oogziekenhuis Rotterdam · Not applicable, Interventional, and Treatment
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).
1,818 studies on the registry are indexed under Glaucoma; 231 are open to participants now.
This study's planned enrollment of 200 is above the median of 65 across 1,272 interventional studies indexed under Glaucoma.
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Exclusion Criteria:
The Paul 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 or nasal quadrant of the eye. The tube is positioned in the anterior chamber.
Device: Paul glaucoma drainage device (GDD)
The Paul 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 or nasal quadrant of the eye. The tube is positioned in the posterior chamber.
Device: Paul glaucoma drainage device (GDD)
Implantation of the GDD
Change of endothelial cell density (ECD)
ECD will be assessed at the center of the cornea and close to the tube
Time frame: Baseline and 2 years
ECD
ECD will be assessed at the center of the cornea and close to the tube
Time frame: Baseline, 6, 12 and 24 months
Intraocular pressure
Intraocular pressure
Time frame: Baseline, 1, 3, 6, 12 and 24 months
Position of the tube
Position of the tube on anterior segment OCT
Time frame: Baseline, 6, 12 and 24 months
Adverse events
Complications at the time of surgery, postoperative adverse events
Time frame: Time of surgery, 1, 3, 6, 12, 24 months
Plan to share: No
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Oogziekenhuis Rotterdam