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

NCT ID: NCT03077789

Last Updated: 2025-12-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

250 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2021-11-30

Brief Summary

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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

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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

Conditions

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Congenital Glaucoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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TRABECULOTOMY

Group Type EXPERIMENTAL

TRABECULOTOMY

Intervention Type PROCEDURE

Evaluation of the prognosis of different surgery in congenital glaucoma

Interventions

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TRABECULOTOMY

Evaluation of the prognosis of different surgery in congenital glaucoma

Intervention Type PROCEDURE

Other Intervention Names

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sclerectomy needling trabeculectomy

Eligibility Criteria

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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
Maximum Eligible Age

4 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jean-François ROULAND, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Chu Amiens Picardie - Amiens 1

Amiens, , France

Site Status

Chu Amiens Picardie

Amiens, , France

Site Status

Centre Hospitalier Regional D' Angers

Angers, , France

Site Status

CHRU Besançon

Besançon, , France

Site Status

CHU Bordeaux

Bordeaux, , France

Site Status

CHU de Clermont-Ferrand

Clermont-Ferrand, , France

Site Status

CHU Dijon Bourgogne

Dijon, , France

Site Status

Chu de Grenoble Alpes

Grenoble, , France

Site Status

CHRU, Hôpital Claude Huriez

Lille, , France

Site Status

Hopital Edouard Herriot - Hcl - Lyon 03

Lyon, , France

Site Status

Aphm Hopital Nord

Marseille, , France

Site Status

CHRU de Montpellier

Montpellier, , France

Site Status

CHU de Montpellier

Montpellier, , France

Site Status

Centre Hospitalier Universitaire

Nantes, , France

Site Status

Chu de Nice Hopital de L'Archet

Nice, , France

Site Status

Fondation de Rothschild - Paris

Paris, , France

Site Status

Hu Necker Enfants Malades Aphp - Paris 15

Paris, , France

Site Status

Hopital Robert Debre Chu Reims

Reims, , France

Site Status

Chru Rennes Site Pontchaillou

Rennes, , France

Site Status

Hopital Charles Nicolle Chu Rouen

Rouen, , France

Site Status

Hopital Civil / Nouvel Hopital Civil - Strasbourg

Strasbourg, , France

Site Status

CHU de Toulouse

Toulouse, , France

Site Status

CHRU de Tours

Tours, , France

Site Status

Chu de Tours

Tours, , France

Site Status

Countries

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France

Other Identifiers

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2012-A00929-34

Identifier Type: OTHER

Identifier Source: secondary_id

2011_32

Identifier Type: -

Identifier Source: org_study_id

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