Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France (Conglau)

June 30, 2022 updated by: University Hospital, Lille

Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age.

The delay in diagnosis is a factor of poor visual acuity. Will justify the implementation of information programs with health and education professionals in order to improve the functional prognosis of patients with congenital glaucoma.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Prospective multicentre prospective cohort Enabling the identification and follow-up of an almost exhaustive population of incidents of congenital glaucoma in 23 ophthalmology centers in France Inclusion over 4 years Epidemiological data, all reports of consultation, medical and surgical procedures collected in an E-CRF.

Database for gene research related to congenital glaucoma to provide screening, genetic counseling and personalized care

Study Type

Interventional

Enrollment (Anticipated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Amiens, France
        • CHU Amiens Picardie
      • Amiens, France
        • Chu Amiens Picardie - Amiens 1
      • Angers, France
        • Centre Hospitalier Regional D' Angers
      • Besançon, France
        • CHRU Besançon
      • Bordeaux, France
        • CHU Bordeaux
      • Clermont-Ferrand, France
        • CHU de Clermont-Ferrand
      • Dijon, France
        • Chu Dijon Bourgogne
      • Grenoble, France
        • CHU de Grenoble Alpes
      • Lille, France
        • CHRU, Hôpital Claude HURIEZ
      • Lyon, France, 69008
        • Hopital Edouard Herriot - Hcl - Lyon 03
      • Marseille, France
        • APHM Hôpital Nord
      • Montpellier, France
        • CHU de Montpellier
      • Montpellier, France
        • CHRU de Montpellier
      • Nantes, France
        • Centre Hospitalier Universitaire
      • Nice, France
        • Chu de Nice Hopital de L'Archet
      • Paris, France
        • Fondation de Rothschild - Paris
      • Paris, France
        • Hu Necker Enfants Malades Aphp - Paris 15
      • Reims, France
        • Hopital Robert Debre Chu Reims
      • Rennes, France
        • Chru Rennes Site Pontchaillou
      • Rouen, France
        • Hopital Charles Nicolle Chu Rouen
      • Strasbourg, France, 67091
        • Hopital Civil / Nouvel Hopital Civil - Strasbourg
      • Toulouse, France
        • CHU de Toulouse
      • Tours, France
        • CHU de Tours
      • Tours, France
        • CHRU de Tours

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Boys or girls under the age of 4, without antecedent, French or resident in France, Suspected Glaucoma

Exclusion Criteria:

  • Antecedent of surgery for glaucoma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: TRABECULOTOMY
Procedure: TRABECULOTOMY
Evaluation of the prognosis of different surgery in congenital glaucoma
Other Names:
  • sclerectomy needling trabeculectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity by logarithmic scale of Sander-Zanlonghi
Time Frame: at 4 years of the child
Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age
at 4 years of the child

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure
Time Frame: at 4 years of the child
measure intraocular pressure (Tonopen or Perkins initially, air tonometer or Goldman as soon as possible) for prognosis of congenital glaucoma
at 4 years of the child

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Lille

Investigators

  • Principal Investigator: Jean-François ROULAND, MD, PhD, University Hospital, Lille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2013

Primary Completion (Anticipated)

April 1, 2023

Study Completion (Anticipated)

April 1, 2023

Study Registration Dates

First Submitted

March 8, 2017

First Submitted That Met QC Criteria

March 8, 2017

First Posted (Actual)

March 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 1, 2022

Last Update Submitted That Met QC Criteria

June 30, 2022

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011_32
  • 2012-A00929-34 (Other Identifier: ID-RCB number, ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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