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

Not Applicable

• Conditions: Glaucoma
• Interventions: Procedure: non-perforating deep sclerectomy surgery

• Registration Number: NCT04586738
• Lead Sponsor: Germans Trias i Pujol Hospital

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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2020-10-07
• Study First Submitted QC: 2020-10-07
• Study First Posted: 2020-10-14
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-16
• Last Update Posted: 2021-02-18
• Primary Completion: 2021-11
• Study Completion: 2021-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Non-resorbable uveoscleral implant associated with absorbable collagen matrix	non-perforating deep sclerectomy surgery	non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix
Isolated absorbable collagen matrix implant	non-perforating deep sclerectomy surgery	non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant

Primary Outcome Measures

Name	Time	Method
Number of Intraocular pressure	24 hours after surgery, 3 months, 12 months, 24 months	Comparison of intraocular pressure measurements

Secondary Outcome Measures

Name	Time	Method
Number of adverse events	24 hours after surgery, 3 months, 12 months, 24 months	Adverse events spontaneous by subject (Safety and tolerability)

Trial Locations

Locations (2)

Hospital Universitario Germans Trias i Pujol; 🇪🇸 Barcelona, Spain

Jéssica Botella García; 🇪🇸 Barcelona, Spain