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| Name | Class |
|---|---|
| University Hospital, Bonn | OTHER |
| Hospital de Santa Maria, Lisbon | UNKNOWN |
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The goal of this randomized controlled clinical trial is to learn whether two minimally invasive bleb-forming glaucoma implants can effectively treat adult patients with open-angle glaucoma who require surgical lowering of intraocular pressure (IOP). Specifically, the study evaluates whether the PRESERFLO™ MicroShunt is at least as effective as the XEN®-63 Gel Stent in reducing IOP after surgery. 
The main questions it aims to answer are:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRESERFLO MicroShunt | Experimental | The PFMS is a SIBS-polymer microshunt. |
|
| XEN 63 Gelstent | Active Comparator | The XEN 63 Gelstent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XEN®-63 Gel Stent | Device | The XEN®-63 Gel Stent is a hydrophilic gel implant made of cross-linked, purified collagen (gelatin). This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark. |
| Measure | Description | Time Frame |
|---|---|---|
| Intraocular pressure | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Number of medications | Number of topical glaucoma medications | 2 year |
| adverse events | 2 years | |
| secundary pressure-lowering surgery |
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Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingeborg Stalmans, MD, PhD | Contact | +3216340391 | oogziekten.glaucoomstudies@uzleuven.be | |
| Thomas Jacobs, MD | Contact | +16346108 | thomas.jacobs@uzleuven.be |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals UZ Leuven | Recruiting | Leuven | Vlaams-brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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|
| PRESERFLO™ MicroShunt | Device | The PRESERFLO™ MicroShunt is a SIBS-polymer microshunt. This devices bypasses the trabecular meshwork and lower eye pressure via a subconjunctival filtering bleb, aided by intra-operative mitomycin C to reduce scarring. It has already been approved for the European market and therefore bear the CE mark. |
|
| 2 years |
| Mean Deviation changes on the visual field | 2 years |
| Retinal Nerve Fibre Layer Thickness changes on Optical Coherence Tomography | 2 years |
| Endothelial Cell Count | 2 years |
| Best Corrected Visual Acuity | 2 years |
| Universitätsklinikum Bonn | Recruiting | Bonn | North Rhine-Westphalia | D-53127 | Germany |
|
| ULS Santa Maria | Not yet recruiting | Lisbon | Lisbon District | 1649-028 | Portugal |
|