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

Primary Purpose

Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
non-perforating deep sclerectomy surgery
Sponsored by
Germans Trias i Pujol Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Jéssica Botella GarcíaRecruiting
  • Hospital Universitario Germans Trias i PujolRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Non-resorbable uveoscleral implant associated with absorbable collagen matrix

Isolated absorbable collagen matrix implant

Arm Description

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

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

Outcomes

Primary Outcome Measures

Number of Intraocular pressure
Comparison of intraocular pressure measurements

Secondary Outcome Measures

Number of adverse events
Adverse events spontaneous by subject (Safety and tolerability)

Full Information

First Posted
October 7, 2020
Last Updated
February 16, 2021
Sponsor
Germans Trias i Pujol Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04586738
Brief Title
Efficacy and Safety of Non-resorbable Uveoscleral Implant Versus Absorbable Collagen Matrix in Non-perforating Deep Sclerectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
November 2021 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Germans Trias i Pujol Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Evaluations will be done an outcome assessor that do not know the intervention group
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-resorbable uveoscleral implant associated with absorbable collagen matrix
Arm Type
Other
Arm Description
non-perforating deep sclerectomy surgery with non-resorbable uveoscleral implant associated with absorbable collagen matrix
Arm Title
Isolated absorbable collagen matrix implant
Arm Type
Other
Arm Description
non-perforating deep sclerectomy surgery with isolated absorbable collagen matrix implant
Intervention Type
Procedure
Intervention Name(s)
non-perforating deep sclerectomy surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Intraocular pressure
Description
Comparison of intraocular pressure measurements
Time Frame
24 hours after surgery, 3 months, 12 months, 24 months
Secondary Outcome Measure Information:
Title
Number of adverse events
Description
Adverse events spontaneous by subject (Safety and tolerability)
Time Frame
24 hours after surgery, 3 months, 12 months, 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jéssica Botella García, MD
Phone
+34691801518
Email
Jessicabotga@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jordi Loscos, MD
Phone
+34691801518
Email
jordiloscos4@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jéssica Botella García, MD
Organizational Affiliation
Germans Trias i Pujol Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jéssica Botella García
City
Barcelona
ZIP/Postal Code
08391
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jéssica Botella
Phone
691801518
Email
Jessicabotga@gmail.com
Facility Name
Hospital Universitario Germans Trias i Pujol
City
Barcelona
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jéssica B García
Phone
691801518
Email
Jessicabotga@gmail.com

12. IPD Sharing Statement

Learn more about this trial

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

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