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

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ClinicalTrials.gov Identifier: NCT03077789
Recruitment Status : Recruiting
First Posted : March 13, 2017
Last Update Posted : October 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Congenital Glaucoma Procedure: TRABECULOTOMY Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France
Actual Study Start Date : April 2013
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: TRABECULOTOMY Procedure: TRABECULOTOMY
Evaluation of the prognosis of different surgery in congenital glaucoma
Other Name: sclerectomy needling trabeculectomy




Primary Outcome Measures :
  1. Visual acuity by logarithmic scale of Sander-Zanlonghi [ Time Frame: 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 :
  1. Intraocular pressure [ Time Frame: 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



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Ages Eligible for Study:   up to 4 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077789


Contacts
Contact: Jean-François ROULAND, MD,PhD jf.rouland@chru-lille.fr

Locations
France
CHRU, Hôpital Claude Huriez Recruiting
Lille, France
Principal Investigator: Jean-François ROULAND, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
Principal Investigator: Jean-François ROULAND, MD, PhD University Hospital, Lille

Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT03077789     History of Changes
Other Study ID Numbers: 2011_32
2012-A00929-34 ( Other Identifier: ID-RCB number, ANSM )
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: October 15, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by University Hospital, Lille:
visual acuity
prognosis epidemiology

Additional relevant MeSH terms:
Glaucoma
Hydrophthalmos
Ocular Hypertension
Eye Diseases
Eye Abnormalities
Glaucoma, Open-Angle
Congenital Abnormalities
Infant, Newborn, Diseases