Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies

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.

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Key information

Conditions

Eye Diseases Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms Vision Disorders

Age range

0 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fondation A de Rothschild

Paris, 75019, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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:

Patient without ocular pathology inducing a decrease in vision

For positive controls:

Patient with inoperable bilateral ocular pathology
Patient without light perception

Exclusion criteria

Patient with unilateral ocular pathology
Verbal patients (able to express themselves through speech)

Treatment and study plan

Questionnaire for visual function assessment of preverbal children

Other

18 items questionnaire

Primary outcomes

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

Sponsors and collaborators

Lead sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Network

Registry information

Acronym: EVEIL

Important dates

Study start: 2020
Primary completion: 2025
Study completion: 2025
First posted: Jun 11, 2020
Registry last updated: Dec 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed