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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Glaucoma
- Sponsor
- Germans Trias i Pujol Hospital
- Enrollment
- 120
- Locations
- 2
- Primary Endpoint
- Number of Intraocular pressure
- Last Updated
- 5 years ago
Overview
Brief Summary
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
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.
Investigators
Eligibility Criteria
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
- •Neovascular angle-closure glaucoma
- •Previous history of intraocular or extraocular malignant neoplasm
- •Pregnancy or lactation period, axial length\> 26mm and \<20mm
Outcomes
Primary Outcomes
Number of Intraocular pressure
Time Frame: 24 hours after surgery, 3 months, 12 months, 24 months
Comparison of intraocular pressure measurements
Secondary Outcomes
- Number of adverse events(24 hours after surgery, 3 months, 12 months, 24 months)