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

Congenital Glaucoma Clinical Trial

— Conglau  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03077789
• Other study ID #: 2011_32
• Secondary ID: 2012-A00929-34
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 2013
• Est. completion date: April 2023

Study information

• Verified date: November 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 250
• Est. completion date: April 2023
• Est. primary completion date: April 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Glaucoma
• Glaucoma

Intervention

Procedure:
• TRABECULOTOMY
Evaluation of the prognosis of different surgery in congenital glaucoma

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 4 years of the child
Secondary	Intraocular pressure	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