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UnknownNCT04586738

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

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

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
120 (estimated)
Sponsor
Germans Trias i Pujol Hospital · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREnon-perforating deep sclerectomy surgeryNon-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.

Timeline

Start date
2020-09-01
Primary completion
2021-11-01
Completion
2021-12-01
First posted
2020-10-14
Last updated
2021-02-18

Locations

2 sites across 1 country: Spain

Source: ClinicalTrials.gov record NCT04586738. Inclusion in this directory is not an endorsement.