Congenital GlaucomaConglauNCT03077789
Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France
A study testing TRABECULOTOMY in people with Congenital Glaucoma, run by University Hospital, Lille at 24 sites in France.
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… Read more about this study
- Who is it for?
- Ages Up to 4 years
- Conditions the study is for
- Congenital Glaucoma
- What is being tested?
- TRABECULOTOMY
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 24 sitesFrance
- Study dates
- Apr 2013to Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 4 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Boys or girls under the age of 4, without antecedent, French or resident in France, Suspected Glaucoma
Who cannot join
- Antecedent of surgery for glaucoma
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Chu Amiens Picardie - Amiens 1
Amiens
Chu Amiens Picardie
Amiens
Centre Hospitalier Regional D' Angers
Angers
CHRU Besançon
Besançon
CHU Bordeaux
Bordeaux
CHU de Clermont-Ferrand
Clermont-Ferrand
CHU Dijon Bourgogne
Dijon
Chu de Grenoble Alpes
Grenoble
CHRU, Hôpital Claude Huriez
Lille
Hopital Edouard Herriot - Hcl - Lyon 03
Lyon, 69008
Aphm Hopital Nord
Marseille
CHRU de Montpellier
Montpellier
CHU de Montpellier
Montpellier
Centre Hospitalier Universitaire
Nantes
Chu de Nice Hopital de L'Archet
Nice
Fondation de Rothschild - Paris
Paris
Hu Necker Enfants Malades Aphp - Paris 15
Paris
Hopital Robert Debre Chu Reims
Reims
Chru Rennes Site Pontchaillou
Rennes
Hopital Charles Nicolle Chu Rouen
Rouen
Hopital Civil / Nouvel Hopital Civil - Strasbourg
Strasbourg, 67091
CHU de Toulouse
Toulouse
CHRU de Tours
Tours
Chu de Tours
Tours
About this study
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.
Read the 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
- Conditions
- Congenital Glaucoma
- Being tested
- TRABECULOTOMY
- Keywords
- visual acuity, prognosis epidemiology
- Medical subject headings
- Hydrophthalmos
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRABECULOTOMYProcedure or surgery
Also called sclerectomy needling trabeculectomy
Evaluation of the prognosis of different surgery in congenital glaucoma
| Study group | Role | What they receive |
|---|---|---|
| TRABECULOTOMY | Experimental | Not described Receives: Procedure: TRABECULOTOMY |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 4 years of the child
Secondary outcomes (1)
Intraocular pressure
measure intraocular pressure (Tonopen or Perkins initially, air tonometer or Goldman as soon as possible) for prognosis of congenital glaucoma
Measured: at 4 years of the child
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2017
- Study startApr 2013
- Primary completionNov 2021
- Study completionNov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital GlaucomaStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-François ROULAND, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03077789
- Sponsor's protocol ID
- 2011_32
- Other IDs
- 2012-A00929-34
- Acronym
- Conglau
- Status last verified
- Dec 2025
- First submitted
- 8 Mar 2017
- Last updated
- 3 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study of the Diagnostic and Therapeutic Management of Congenital Glaucoma in France
- ClinicalTrials.gov ID
- NCT03077789
- Acronym / sponsor ID
- Conglau / 2011_32
- Conditions
- Congenital Glaucoma
- Keywords
- visual acuity, prognosis epidemiology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Apr 2013 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 13 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRABECULOTOMY | Experimental | Procedure: TRABECULOTOMY |
Who may qualify
- Ages
- Up to 4 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Boys or girls under the age of 4, without antecedent, French or resident in France, Suspected Glaucoma
Key exclusion criteria (1 listed)
- Antecedent of surgery for glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRABECULOTOMYAlso: sclerectomy needling trabeculectomyEvaluation of the prognosis of different surgery in congenital glaucoma | Procedure or surgery | TRABECULOTOMY |
Primary outcome
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
1 secondary outcome
Intraocular pressure
Time frame: at 4 years of the child
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean-François ROULAND, MD, PhD principal investigator
University Hospital, Lille
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRABECULOTOMY in people with Congenital Glaucoma, run by University Hospital, Lille at 24 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity by logarithmic scale of Sander-Zanlonghi (time frame: at 4 years of the child). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Dec 2025.