Children Suffering From Cortical Visual ImpairmentNCT06997354
Validation of a Parental Questionnaire for Screening Children for Neurovisual Disorders
An observational study of Children Suffering From Cortical Visual Impairment, run by Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 years and olderHealthy volunteers can take part
- Conditions the study is for
- Children Suffering From Cortical Visual Impairment
- What is being tested?
- Questionnaire
- How many people
- 250 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Apr 2025to 15 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 3 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- no specific criteria (see inclusion criteria)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Belgium1 site, 1 recruiting
- Recruiting
10 place cardinal Mercier
Louvain-la-Neuve, 1348
Anne Bragard, PhD, +3210474393, anne.bragard@uclouvain.be
About this study
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.
- Being tested
- Questionnaire
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QuestionnaireDiagnostic test
The parents have to complete a questionnaire
| Study group | Role | What they receive |
|---|---|---|
| questionnaire | Each parent has to complete a online questionnaire Receives: Diagnostic Test: Questionnaire |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2025
- Study start1 Apr 2025
- Primary completion15 Jun 2025 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Children Suffering From Cortical Visual ImpairmentStudies of the same condition, open and under way.
- More trials run by Université Catholique de LouvainThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université Catholique de Louvain
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06997354
- Sponsor's protocol ID
- QP-TNV
- Status last verified
- May 2025
- First submitted
- 12 May 2025
- Last updated
- 30 May 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 30 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Parental Questionnaire for Screening Children for Neurovisual Disorders
- ClinicalTrials.gov ID
- NCT06997354
- Acronym / sponsor ID
- QP-TNV
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Université Catholique de LouvainUniversity, hospital or other
- Study start
- 1 Apr 2025 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 30 May 2025 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| questionnaire | – | Diagnostic Test: QuestionnaireEach parent has to complete a online questionnaire |
Who may qualify
- Ages
- 3 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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.
- 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.
Key exclusion criteria (1 listed)
- no specific criteria (see inclusion criteria)
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 |
|---|---|---|
| QuestionnaireThe parents have to complete a questionnaire | Diagnostic test | questionnaire |
Primary outcome
typical behaviors of CVI
Time frame: Through study completion, an average of 14 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2025.
- Individual participant dataSharing planned: No
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Children Suffering From Cortical Visual Impairment, run by Université Catholique de Louvain at 1 site in Belgium.
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 6 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: looking for participants now, as of the sponsor's last update on 30 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anne Bragard, PhD (+3210474393, anne.bragard@uclouvain.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
typical behaviors of CVI (time frame: Through study completion, an average of 14 months). 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 30 May 2025.