NCT03077789

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
250

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

24 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2013

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 13, 2017

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

December 3, 2025

Status Verified

December 1, 2025

Enrollment Period

8.6 years

First QC Date

March 8, 2017

Last Update Submit

December 2, 2025

Conditions

Keywords

visual acuityprognosis epidemiology

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Intraocular pressure

    at 4 years of the child

Study Arms (1)

TRABECULOTOMY

EXPERIMENTAL
Procedure: TRABECULOTOMY

Interventions

TRABECULOTOMYPROCEDURE

Evaluation of the prognosis of different surgery in congenital glaucoma

Also known as: sclerectomy needling trabeculectomy
TRABECULOTOMY

Eligibility Criteria

AgeUp to 4 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

  • Antecedent of surgery for glaucoma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (24)

Chu Amiens Picardie - Amiens 1

Amiens, France

Location

Chu Amiens Picardie

Amiens, France

Location

Centre Hospitalier Regional D' Angers

Angers, France

Location

CHRU Besançon

Besançon, France

Location

CHU Bordeaux

Bordeaux, France

Location

CHU de Clermont-Ferrand

Clermont-Ferrand, France

Location

CHU Dijon Bourgogne

Dijon, France

Location

Chu de Grenoble Alpes

Grenoble, France

Location

CHRU, Hôpital Claude Huriez

Lille, France

Location

Hopital Edouard Herriot - Hcl - Lyon 03

Lyon, 69008, France

Location

Aphm Hopital Nord

Marseille, France

Location

CHRU de Montpellier

Montpellier, France

Location

CHU de Montpellier

Montpellier, France

Location

Centre Hospitalier Universitaire

Nantes, France

Location

Chu de Nice Hopital de L'Archet

Nice, France

Location

Fondation de Rothschild - Paris

Paris, France

Location

Hu Necker Enfants Malades Aphp - Paris 15

Paris, France

Location

Hopital Robert Debre Chu Reims

Reims, France

Location

Chru Rennes Site Pontchaillou

Rennes, France

Location

Hopital Charles Nicolle Chu Rouen

Rouen, France

Location

Hopital Civil / Nouvel Hopital Civil - Strasbourg

Strasbourg, 67091, France

Location

CHU de Toulouse

Toulouse, France

Location

CHRU de Tours

Tours, France

Location

Chu de Tours

Tours, France

Location

MeSH Terms

Conditions

Hydrophthalmos

Interventions

Trabeculectomy

Condition Hierarchy (Ancestors)

Eye AbnormalitiesEye DiseasesGlaucoma, Open-AngleGlaucomaOcular HypertensionCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Filtering SurgeryOphthalmologic Surgical ProceduresSurgical Procedures, Operative

Study Officials

  • Jean-François ROULAND, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 8, 2017

First Posted

March 13, 2017

Study Start

April 1, 2013

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

December 3, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations