NCT04586738

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 7, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 14, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

February 18, 2021

Status Verified

February 1, 2021

Enrollment Period

1.2 years

First QC Date

October 7, 2020

Last Update Submit

February 16, 2021

Conditions

Glaucoma

Outcome Measures

Primary Outcomes (1)

  • Number of Intraocular pressure

    Comparison of intraocular pressure measurements

    24 hours after surgery, 3 months, 12 months, 24 months

Secondary Outcomes (1)

  • Number of adverse events

    24 hours after surgery, 3 months, 12 months, 24 months

Study Arms (2)

Non-resorbable uveoscleral implant associated with absorbable collagen matrix

OTHER

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

Procedure: non-perforating deep sclerectomy surgery

Isolated absorbable collagen matrix implant

OTHER

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

Procedure: non-perforating deep sclerectomy surgery

Interventions

non-perforating deep sclerectomy surgeryPROCEDURE

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 implantNon-resorbable uveoscleral implant associated with absorbable collagen matrix

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Jéssica Botella García

Barcelona, 08391, Spain

RECRUITING

Hospital Universitario Germans Trias i Pujol

Barcelona, Spain

RECRUITING

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular HypertensionEye Diseases

Study Officials

  • Jéssica Botella García, MD

    Germans Trias i Pujol Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jéssica Botella García, MD

CONTACT

+34691801518Jessicabotga@gmail.com

Jordi Loscos, MD

CONTACT

+34691801518jordiloscos4@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Evaluations will be done an outcome assessor that do not know the intervention group
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2020

First Posted

October 14, 2020

Study Start

September 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

February 18, 2021

Record last verified: 2021-02

Locations

ES(2)