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| ID | Type | Description | Link |
|---|---|---|---|
| NL80518.078.22 | Other Identifier | Centrale Commissie Mensgebonden Onderzoek | |
| MEC-2022-0069 | Other Identifier | Medical Ethical Committe of the Erasmus Medical Center |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baerveldt glaucoma drainage device | Active Comparator |
| |
| Paul glaucoma drainage device | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery/implantation | Device | The 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 quadrant of the eye. The tube is positioned in the anterior chamber. |
| 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 |
|---|---|---|
| Endothelial cell density (ECD). | ECD will be assessed at the center of the cornea and close to the tube. | Baseline, 3, 6, 12, 24 months. |
| Intraocular pressure. | Intraocular pressure. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rene J 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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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
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| Baseline, 1, 3, 6, 12, 24 months. |
| Orthoptic assessment. | Prism cover test: total deviation at 30 cm; Goldmann: monocular ductions in 8 directions starting from primary position, binocular field of single vision. | Baseline, 3, 6, 12, 24 months. |