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RecruitingNCT06997354Updated May 30, 2025

Validation of a Parental Questionnaire for Screening Children for Neurovisual Disorders

An observational study in Children Suffering From Cortical Visual Impairment, sponsored by Université Catholique de Louvain. Recruiting at 1 site in Belgium. Open to participants aged 3 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-30.

Sponsored by Université Catholique de Louvain · Observational

From the registry’s dates

  • Primary completion was expected by Jun 2025, 1 year 4 months ago, but the record still lists the study as recruiting.
  • Started Apr 2025; still recruiting 1 year 7 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
250
Ages
3 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Children Suffering From Cortical Visual Impairment

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03

In context

Vision Disorders

360 studies on the registry are indexed under Vision Disorders; 84 are open to participants now.

This study's planned enrollment of 250 is above the median of 126 across 97 observational studies indexed under Vision Disorders.

Browse Vision Disorders studies →

Lead sponsor

Université Catholique de Louvain is the lead sponsor of 154 studies on the registry; 59 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
3 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • no specific criteria (see inclusion criteria)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
250 participants (estimated)
Patient registry
No

Groups and cohorts

  • questionnaire

    Each parent has to complete a online questionnaire

    Diagnostic Test: Questionnaire

Interventions

  • Diagnostic testQuestionnaire

    The parents have to complete a questionnaire

06

What researchers measure

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.

    Time frame: Through study completion, an average of 14 months

07

Study locations

1 of 1 sites recruiting
  • 10 place cardinal Mercier
    Louvain la Neuve, 1348, Belgium
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 30, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06997354
Responsible party
Sponsor
First posted
May 30, 2025
Start date
Apr 1, 2025
Primary completion
Jun 15, 2025 (estimated)
Completion
Jun 15, 2026 (estimated)
Last update
May 30, 2025

Study contacts

Anne Bragard, PhD
Contact
anne.bragard@uclouvain.be
+3210474393

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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