Eye DiseasesEVEILNCT04428541
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
A study testing Questionnaire for visual function assessment of preverbal children in people with Eye Diseases and Vision Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.
Trial summary
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms. However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age. Read more about this study
- Who is it for?
- Ages 0 to 36 months
- Conditions the study is for
- Eye Diseases, Vision Disorders
- What is being tested?
- Questionnaire for visual function assessment of preverbal children
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- 16 Jul 2020to 21 May 2025
- 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 0 to 36 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Common to the three groups:
- Patient aged 0 to 36 months
- Diagnosis of known ocular pathology
- For patients targeted by the questionnaire:
- Patient with operable bilateral ocular pathology
- For negative controls:
Show all 10Show fewer
- Patient without ocular pathology inducing a decrease in vision
- For positive controls:
- Patient with inoperable bilateral ocular pathology
- Patient without light perception
Who cannot join
- Patient with unilateral ocular pathology
- Verbal patients (able to express themselves through speech)
Trial locations and contacts
1 site in 1 country.
About this study
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.
However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.
The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.
- Conditions
- Eye Diseases, Vision Disorders
- Being tested
- Questionnaire for visual function assessment of preverbal children
- Keywords
- Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant
- Medical subject headings
- Eye Diseases, Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire for visual function assessment of preverbal childrenOther
18 items questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Questionnaire | Experimental | Description : 18 items questionnaire, filled by the parents of the child Receives: Other: Questionnaire for visual function assessment of preverbal children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval.
unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology
Minimum value : 0
Maximum value : 18
Higher scores mean better outcome
Measured: Inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start16 Jul 2020
- Primary completion21 May 2025
- Study completion21 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eye DiseasesStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Pascal DUREAU, MD, Principal investigator, Fondation A. de Rothschild
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04428541
- Sponsor's protocol ID
- PDU_2020_1
- Acronym
- EVEIL
- Status last verified
- Dec 2025
- First submitted
- 9 Jun 2020
- Last updated
- 10 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
- ClinicalTrials.gov ID
- NCT04428541
- Acronym / sponsor ID
- EVEIL / PDU_2020_1
- Conditions
- Eye Diseases, Vision Disorders
- Keywords
- Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 21 May 2025 (actual)
- Study completion
- 21 May 2025 (actual)
- First posted
- 11 Jun 2020 (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.
In some symmetrical pediatric ocular pathologies, the treatment is surgical with usually satisfactory postoperative results in visual terms.
However, it is often difficult to choose the right moment to operate. The main difficulty is that the child's vision is unknown since the child is still in a preverbal age.
The investigators have developed a questionnaire with the aim of quantifying the child's vision so that the decision is most justified. The items of this questionnaire were established based on the literature and were submitted to a panel of experts in ophthalmo-pediatrics. The objective of this study is to determine the internal validity and as far as possible (since there is no equivalent tool) the external validity of the questionnaire developed.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Questionnaire | Experimental | Other: Questionnaire for visual function assessment of preverbal childrenDescription : 18 items questionnaire, filled by the parents of the child |
Who may qualify
- Ages
- 0 to 36 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (10 listed)
- Patient aged 0 to 36 months
- Diagnosis of known ocular pathology
- Patient with operable bilateral ocular pathology
- Patient without ocular pathology inducing a decrease in vision
- Patient with inoperable bilateral ocular pathology
Key exclusion criteria (2 listed)
- Patient with unilateral ocular pathology
- Verbal patients (able to express themselves through speech)
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 |
|---|---|---|
| Questionnaire for visual function assessment of preverbal children18 items questionnaire | Other | Questionnaire |
Primary outcome
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
Time frame: Inclusion
Reliability evaluated by Cronbach's alpha coefficient and its 95% confidence interval. unabbreviated scale title : Assessment of Visual Function in Preverbal Children in Bilateral Ocular Pathology Minimum value : 0 Maximum value : 18 Higher scores mean better outcome
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 10 Dec 2025.
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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.
Pascal DUREAU, MD principal investigator
Fondation A. de Rothschild
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Questionnaire for visual function assessment of preverbal children in people with Eye Diseases and Vision Disorders, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site 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 10 inclusion and 2 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 10 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 1 site 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?
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children (time frame: Inclusion). 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 10 Dec 2025.