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

Not Applicable

• Conditions: Congenital Glaucoma
• Interventions: Procedure: TRABECULOTOMY

• Registration Number: NCT03077789
• Lead Sponsor: University Hospital, Lille

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

Study Timeline

• Study Start: 2013-04
• Study First Submitted: 2017-03-08
• Study First Submitted QC: 2017-03-08
• Study First Posted: 2017-03-13
• Status Verified: 2020-11
• Last Update Submitted: 2022-06-30
• Last Update Posted: 2022-07-01
• Primary Completion: 2023-04
• Study Completion: 2023-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 250

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
TRABECULOTOMY	TRABECULOTOMY	-

Primary Outcome Measures

Name	Time	Method
Visual acuity by logarithmic scale of Sander-Zanlonghi	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

Secondary Outcome Measures

Name	Time	Method
Intraocular pressure	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

Trial Locations

Locations (24)

Hopital Civil / Nouvel Hopital Civil - Strasbourg; 🇫🇷 Strasbourg, France

Chru Rennes Site Pontchaillou; 🇫🇷 Rennes, France

CHU Dijon Bourgogne; 🇫🇷 Dijon, France

Chu de Grenoble Alpes; 🇫🇷 Grenoble, France

Aphm Hopital Nord; 🇫🇷 Marseille, France

Centre Hospitalier Universitaire; 🇫🇷 Nantes, France

CHU Bordeaux; 🇫🇷 Bordeaux, France

CHRU de Montpellier; 🇫🇷 Montpellier, France

Chu de Nice Hopital de L'Archet; 🇫🇷 Nice, France

Hopital Charles Nicolle Chu Rouen; 🇫🇷 Rouen, France

Hopital Edouard Herriot - Hcl - Lyon 03; 🇫🇷 Lyon, France

CHU de Toulouse; 🇫🇷 Toulouse, France

Chu Amiens Picardie - Amiens 1; 🇫🇷 Amiens, France

Chu Amiens Picardie; 🇫🇷 Amiens, France

CHRU Besançon; 🇫🇷 Besançon, France

Centre Hospitalier Regional D' Angers; 🇫🇷 Angers, France

CHU de Clermont-Ferrand; 🇫🇷 Clermont-Ferrand, France

CHRU, Hôpital Claude Huriez; 🇫🇷 Lille, France

CHU de Montpellier; 🇫🇷 Montpellier, France

Hu Necker Enfants Malades Aphp - Paris 15; 🇫🇷 Paris, France

Fondation de Rothschild - Paris; 🇫🇷 Paris, France

Hopital Robert Debre Chu Reims; 🇫🇷 Reims, France

CHRU de Tours; 🇫🇷 Tours, France

Chu de Tours; 🇫🇷 Tours, France