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The aim of the study is to evaluate and compare the hypotensive efficacy at 24 months between non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
The aim of this study is to evaluate and compare the hypotensive efficacy at 24 months between two implants in glaucoma surgery. Non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix versus non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-resorbable uveoscleral implant associated with absorbable collagen matrix | Other | non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix |
|
| Isolated absorbable collagen matrix implant | Other | non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| non-perforating deep sclerectomy surgery | Procedure | Non-penetrating deep sclerectomy is a non-perforating filtration procedure used for the surgical treatment of medically uncontrolled open angle glaucoma.This surgery is performed to facilitate the outflow of aqueous humour from the anterior chamber to the subconjunctival space through a natural membrane (trabeculo-Descemet's window). This enables a more physiological reduction of intraocular pressure to be achieved. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Intraocular pressure | Comparison of intraocular pressure measurements | 24 hours after surgery, 3 months, 12 months, 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of adverse events | Adverse events spontaneous by subject (Safety and tolerability) | 24 hours after surgery, 3 months, 12 months, 24 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jéssica Botella García, MD | Contact | +34691801518 | Jessicabotga@gmail.com | |
| Jordi Loscos, MD | Contact | +34691801518 | jordiloscos4@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Jéssica Botella García, MD | Germans Trias i Pujol Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jéssica Botella García | Recruiting | Barcelona | 08391 | Spain |
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| ID | Term |
|---|---|
| D005901 | Glaucoma |
| ID | Term |
|---|---|
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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Evaluations will be done an outcome assessor that do not know the intervention group
|
| Hospital Universitario Germans Trias i Pujol | Recruiting | Barcelona | Spain |
|