Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy
NCT ID: NCT04586738
Last Updated: 2021-02-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2020-09-01
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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Non-resorbable uveoscleral implant associated with absorbable collagen matrix
non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix
non-perforating deep sclerectomy surgery
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.
Isolated absorbable collagen matrix implant
non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant
non-perforating deep sclerectomy surgery
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.
Interventions
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non-perforating deep sclerectomy surgery
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.
Eligibility Criteria
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Inclusion Criteria
* Primary or secondary open-angle glaucoma
* High intraocular pressure (greater than or equal to 18mmHg) despite using maximum medical treatment
* Intolerance to medication.
Exclusion Criteria
* Previous ocular surgery in the last 6 months
* Previous history of Laser trabeculoplasty in the last 12 months
* Moderate or severe diabetic retinopathy
* Active or recurrent eye disease (uveitis)
* Plateau iris
* Ocular neovascularization
* Aphakia
* Neovascular angle-closure glaucoma
* Previous history of intraocular or extraocular malignant neoplasm
* Pregnancy or lactation period, axial length\> 26mm and \<20mm
* Unwillingness for participating
18 Years
ALL
No
Sponsors
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Germans Trias i Pujol Hospital
OTHER
Responsible Party
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Principal Investigators
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Jéssica Botella García, MD
Role: PRINCIPAL_INVESTIGATOR
Germans Trias i Pujol Hospital
Locations
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Jéssica Botella García
Barcelona, , Spain
Hospital Universitario Germans Trias i Pujol
Barcelona, , Spain
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Implants in deep sclerectomy
Identifier Type: -
Identifier Source: org_study_id
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