Glaucoma
Conditions
Brief summary
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).
Interventions
DEVICEPaul glaucoma drainage device (GDD)
Implantation of the GDD
Sponsors
Oogziekenhuis Rotterdam
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
Inclusion criteria
* Age \> 18 years * Informed consent * Pseudophakic * Open angle glaucoma, pseudoexfoliation glaucoma, pigment dispersion glaucoma or angle closure glaucoma with sufficiently deep anterior chamber * Endothelial image at baseline of fair or good quality
Exclusion criteria
* Iridocorneal endothelial syndrome or posterior polymorphous dystrophy * Eyes with a history of penetrating trauma * Eyes with a history of (intra)ocular surgery other than uncomplicated cataract surgery * Eyes with corneal disease * Synechiae posterior * Pregnant and lactating women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of endothelial cell density (ECD) | Baseline and 2 years | ECD will be assessed at the center of the cornea and close to the tube |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ECD | Baseline, 6, 12 and 24 months | ECD will be assessed at the center of the cornea and close to the tube |
| Intraocular pressure | Baseline, 1, 3, 6, 12 and 24 months | Intraocular pressure |
| Position of the tube | Baseline, 6, 12 and 24 months | Position of the tube on anterior segment OCT |
| Adverse events | Time of surgery, 1, 3, 6, 12, 24 months | Complications at the time of surgery, postoperative adverse events |
Countries
Netherlands
Contacts
Primary ContactRene Wubbels
Backup ContactSusan Marinissen
Outcome results
None listed