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

Glaucoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04586738
• Other study ID #: Implants in deep sclerectomy
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2020
• Est. completion date: December 2021

Study information

• Verified date: February 2021
• Source: Germans Trias i Pujol Hospital
• Contact: Jéssica Botella García, MD
• Phone: +34691801518
• Email: Jessicabotga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: December 2021
• Est. primary completion date: November 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Germans Trias i Pujol	Barcelona
Spain	Jéssica Botella García	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Germans Trias i Pujol Hospital

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Intraocular pressure	Comparison of intraocular pressure measurements	24 hours after surgery, 3 months, 12 months, 24 months
Secondary	Number of adverse events	Adverse events spontaneous by subject (Safety and tolerability)	24 hours after surgery, 3 months, 12 months, 24 months