NCT06928727

Brief Summary

Craniosynostosis are cranial deformations due to the premature closure of one or more cranial sutures. These deformations affect approximately one in 2.500 births. In most cases, craniosynostoses are isolated with unknown (non syndrome). On the other hand, 20% of these deformations are associated with other concentration (syndrome). Craniosynostosis has morphological (associated dysmorphism) and functional (growth conflict between the skull and the brain) repercussions. Ophthalmological disorders are frequent: refractive disorders, oculomotor disorders, optic nerve damage, sensory damage. This retrospective study aims to describe the ocular clinical characteristics associated with craniosynostosis in patients followed at the Amiens University Hospital.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
65

participants targeted

Target at P25-P50 for all trials

Timeline
6mo left

Started Apr 2025

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress69%
Apr 2025Nov 2026

Study Start

First participant enrolled

April 4, 2025

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

April 8, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 15, 2025

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

February 12, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

April 8, 2025

Last Update Submit

February 10, 2026

Conditions

CraniosynostosisStrabismusIntracranial HypertensionAmblyopia

Keywords

Craniosynostosisstrabismusamblyopiaintracranial hypertension

Outcome Measures

Primary Outcomes (1)

  • Rate of strabismus and amblyopia

    Rate of strabismus and amblyopia

    6 months

Secondary Outcomes (1)

  • Rate of intracranial hypertension

    6 months

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with craniosynostosis followed at the Amiens University Hospital.

You may qualify if:

  • Diagnosis of craniostenosis

You may not qualify if:

  • Posterior plagiocephalia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Amiens

Amiens, 80054, France

RECRUITING

MeSH Terms

Conditions

CraniosynostosesStrabismusIntracranial HypertensionAmblyopia

Condition Hierarchy (Ancestors)

SynostosisDysostosesBone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesOcular Motility DisordersCranial Nerve DiseasesNervous System DiseasesEye DiseasesBrain DiseasesCentral Nervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Tran Thi Ha Chau, Pr

CONTACT

33+322089224tran.chau@chu-amiens.fr

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 8, 2025

First Posted

April 15, 2025

Study Start

April 4, 2025

Primary Completion (Estimated)

November 1, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

February 12, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)