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

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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Procedure: non-perforating deep sclerectomy surgery

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 Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jéssica Botella García, MD; Phone Number: +34691801518; Email: Jessicabotga@gmail.com
• Study Contact Backup: Name: Jordi Loscos, MD; Phone Number: +34691801518; Email: jordiloscos4@hotmail.com

Study Locations

• Spain
  • Barcelona, Spain, 08391
    • Recruiting
    • Jéssica Botella García
    • Contact: Jéssica Botella; Phone Number: 691801518; Email: Jessicabotga@gmail.com
  • Barcelona, Spain
    • Recruiting
    • Hospital Universitario Germans Trias i Pujol
    • Contact: Jéssica B García; Phone Number: 691801518; Email: Jessicabotga@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Non-resorbable uveoscleral implant associated with absorbable collagen matrix; non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix	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.
Other: Isolated absorbable collagen matrix implant; non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Germans Trias i Pujol Hospital
• Investigators: Principal Investigator: Jéssica Botella García, MD, Germans Trias i Pujol Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Anticipated): November 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: October 7, 2020
• First Submitted That Met QC Criteria: October 7, 2020
• First Posted (Actual): October 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2021
• Last Update Submitted That Met QC Criteria: February 16, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Implants in deep sclerectomy

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No