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

NCT ID: NCT04586738

Last Updated: 2021-02-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-01

Study Completion Date

2021-12-31

Brief Summary

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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

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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

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Glaucoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
Evaluations will be done an outcome assessor that do not know the intervention group

Study Groups

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Non-resorbable uveoscleral implant associated with absorbable collagen matrix

non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix

Group Type OTHER

non-perforating deep sclerectomy surgery

Intervention Type PROCEDURE

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.

Isolated absorbable collagen matrix implant

non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant

Group Type OTHER

non-perforating deep sclerectomy surgery

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Germans Trias i Pujol Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jéssica Botella García, MD

Role: PRINCIPAL_INVESTIGATOR

Germans Trias i Pujol Hospital

Locations

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Jéssica Botella García

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitario Germans Trias i Pujol

Barcelona, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Jéssica Botella García, MD

Role: CONTACT

+34691801518

Jordi Loscos, MD

Role: CONTACT

+34691801518

Facility Contacts

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Jéssica Botella

Role: primary

691801518

Jéssica B García

Role: primary

691801518

Other Identifiers

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Implants in deep sclerectomy

Identifier Type: -

Identifier Source: org_study_id

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