NCT06997354

Brief Summary

Some children present visual difficulties linked not to damage to the eye, but to damage to the brain. This type of dysfunction of the visual cerebral pathways leads, for example, to difficulties in recognition, visuomotor coordination or visuo-spatial disorders. These highly specific disorders are known as "cortical visual impairment" (CVI). Despite their real impact on children's development, these disorders are still poorly diagnosed in the French-speaking world. As a result, follow-up and care for these children are poorly adapted. A better understanding of neurovisual disorders and the availability of validated tools in French are therefore essential. Indeed, it is currently considered that 3 to 4% of children aged four to six, i.e. around one child per kindergarten class, have a CVI following a neuro-logical lesion acquired in the perinatal period. Because of the lack of a valid tool in French, the aim of the present study is to provide the results of a validation study of a parental questionnaire for screening children with warning signs of CVI in French. This questionnaire will be offered online using the Qualtrics tool. In order to evaluate the relevance of this questionnaire, it will be proposed, on the one hand, to parents whose child (aged 3 to 12) does not present any particular developmental difficulties, and on the other hand, to parents whose child (aged 3 to 12) seems to present signs of neurovisual disorders. By comparing their answers, the investigators hope that certain questions will reveal elements typical of neurovisual disorders/CVI, thus demonstrating the relevance of this questionnaire in facilitating diagnosis.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
2mo 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 Progress91%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 1, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 12, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

May 30, 2025

Completed
16 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2026

Expected
Last Updated

May 30, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 12, 2025

Last Update Submit

May 21, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • typical behaviors of CVI

    The scores obtained represent a difficulty, an absence of mastery of a skill. Thus, a high score means that the child has some visual difficulties, while a low score means that the child has no difficulties.

    Through study completion, an average of 14 months

Study Arms (1)

questionnaire

Each parent has to complete a online questionnaire

Diagnostic Test: Questionnaire

Interventions

QuestionnaireDIAGNOSTIC_TEST

The parents have to complete a questionnaire

questionnaire

Eligibility Criteria

Age3 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

In order to evaluate the relevance of this questionnaire, it will be proposed to parents whose children (aged 3 to 12) do not present any particular developmental difficulties, and to parents whose children (aged 3 to 12) appear to present signs of neurovisual disorders.

You may qualify if:

  • Parents of a child aged between 3 and 12
  • Their mother tongue must be French, to ensure that they understand the questions asked in writing.
  • Control group:
  • \- Children of the parents surveyed who do not present any medical, school or family developmental particularities.
  • Clinical group
  • \- Children of the parents interviewed who present warning signs of CVI reported by a multidisciplinary team specialized in visual impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

10 place cardinal Mercier

Louvain-la-Neuve, 1348, Belgium

RECRUITING

MeSH Terms

Interventions

Pain Measurement

Intervention Hierarchy (Ancestors)

Neurologic ExaminationPhysical ExaminationDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Anne Bragard, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2025

First Posted

May 30, 2025

Study Start

April 1, 2025

Primary Completion

June 15, 2025

Study Completion (Estimated)

June 15, 2026

Last Updated

May 30, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations