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| ID | Type | Description | Link |
|---|---|---|---|
| NL81305.078.22 | Other Identifier | CCMO | |
| MEC-2022-0364 | Other Identifier | MEC |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GDD-tube in anterior chamber | Active Comparator | 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. |
|
| GDD-tube in posterior chamber | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Paul glaucoma drainage device (GDD) | Device | Implantation of the GDD |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change of endothelial cell density (ECD) | ECD will be assessed at the center of the cornea and close to the tube | Baseline and 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| ECD | ECD will be assessed at the center of the cornea and close to the tube | Baseline, 6, 12 and 24 months |
| Intraocular pressure | Intraocular pressure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rene Wubbels | Contact | +31104023430 | r.wubbels@oogziekenhuis.nl | |
| Susan Marinissen | Contact | +31104023449 | S.Marinissen@oogziekenhuis.nl |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oogziekenhuis Rotterdam | Recruiting | Rotterdam | 3011BH | Netherlands |
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| Baseline, 1, 3, 6, 12 and 24 months |
| Position of the tube | Position of the tube on anterior segment OCT | Baseline, 6, 12 and 24 months |
| Adverse events | Complications at the time of surgery, postoperative adverse events | Time of surgery, 1, 3, 6, 12, 24 months |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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