Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparative Clinical Trial on the Efficacy and Safety of Non-resorbable Uveoscleral Implant Associated With Absorbable Collagen Matrix vs Isolated Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy in Glaucoma Surgery

Conditions
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Glaucoma

Intervention / Treatment
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* Procedure: non-perforating deep sclerectomy surgery


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients older than 18 years of age 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: Patients with previous glaucoma surgery 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-resorbable uveoscleral implant associated with absorbable collagen matrix<br>non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix | Procedure: non-perforating deep sclerectomy surgery<br>* 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.<br>|
| Other: Isolated absorbable collagen matrix implant<br>non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant | Procedure: non-perforating deep sclerectomy surgery<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Intraocular pressure | Comparison of intraocular pressure measurements | 24 hours after surgery, 3 months, 12 months, 24 months | 

Secondary Outcome Measures

| Outcome Measure | 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 |