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

Primary Purpose

Congenital Glaucoma

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
TRABECULOTOMY
Sponsored by
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Congenital Glaucoma focused on measuring visual acuity, prognosis epidemiology

Eligibility Criteria

undefined - 4 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

TRABECULOTOMY

Arm Description

Outcomes

Primary Outcome Measures

Visual acuity by logarithmic scale of Sander-Zanlonghi
Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age

Secondary Outcome Measures

Intraocular pressure
measure intraocular pressure (Tonopen or Perkins initially, air tonometer or Goldman as soon as possible) for prognosis of congenital glaucoma

Full Information

First Posted
March 8, 2017
Last Updated
June 30, 2022
Sponsor
University Hospital, Lille
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1. Study Identification

Unique Protocol Identification Number
NCT03077789
Brief Title
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France
Acronym
Conglau
Official Title
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France
Study Type
Interventional

2. Study Status

Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 2013 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille

4. Oversight

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

5. Study Description

Brief Summary
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Congenital Glaucoma
Keywords
visual acuity, prognosis epidemiology

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TRABECULOTOMY
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
TRABECULOTOMY
Other Intervention Name(s)
sclerectomy needling trabeculectomy
Intervention Description
Evaluation of the prognosis of different surgery in congenital glaucoma
Primary Outcome Measure Information:
Title
Visual acuity by logarithmic scale of Sander-Zanlonghi
Description
Evidence of a relationship between age at discovery of congenital glaucoma and visual acuity at 4 years of age
Time Frame
at 4 years of the child
Secondary Outcome Measure Information:
Title
Intraocular pressure
Description
measure intraocular pressure (Tonopen or Perkins initially, air tonometer or Goldman as soon as possible) for prognosis of congenital glaucoma
Time Frame
at 4 years of the child

10. Eligibility

Sex
All
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-François ROULAND, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chu Amiens Picardie - Amiens 1
City
Amiens
Country
France
Facility Name
Chu Amiens Picardie
City
Amiens
Country
France
Facility Name
Centre Hospitalier Regional D' Angers
City
Angers
Country
France
Facility Name
CHRU Besançon
City
Besançon
Country
France
Facility Name
CHU Bordeaux
City
Bordeaux
Country
France
Facility Name
CHU de Clermont-Ferrand
City
Clermont-Ferrand
Country
France
Facility Name
CHU Dijon Bourgogne
City
Dijon
Country
France
Facility Name
Chu de Grenoble Alpes
City
Grenoble
Country
France
Facility Name
CHRU, Hôpital Claude Huriez
City
Lille
Country
France
Facility Name
Hopital Edouard Herriot - Hcl - Lyon 03
City
Lyon
ZIP/Postal Code
69008
Country
France
Facility Name
Aphm Hopital Nord
City
Marseille
Country
France
Facility Name
CHRU de Montpellier
City
Montpellier
Country
France
Facility Name
CHU de Montpellier
City
Montpellier
Country
France
Facility Name
Centre Hospitalier Universitaire
City
Nantes
Country
France
Facility Name
Chu de Nice Hopital de L'Archet
City
Nice
Country
France
Facility Name
Fondation de Rothschild - Paris
City
Paris
Country
France
Facility Name
Hu Necker Enfants Malades Aphp - Paris 15
City
Paris
Country
France
Facility Name
Hopital Robert Debre Chu Reims
City
Reims
Country
France
Facility Name
Chru Rennes Site Pontchaillou
City
Rennes
Country
France
Facility Name
Hopital Charles Nicolle Chu Rouen
City
Rouen
Country
France
Facility Name
Hopital Civil / Nouvel Hopital Civil - Strasbourg
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
CHU de Toulouse
City
Toulouse
Country
France
Facility Name
CHRU de Tours
City
Tours
Country
France
Facility Name
Chu de Tours
City
Tours
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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