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

Study Overview
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Brief Summary
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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.

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

Conditions
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Eye Diseases, Vision Disorders

Intervention / Treatment
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* Other: Questionnaire for visual function assessment of preverbal children


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 0 Months
Maximum Age: 36 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Questionnaire<br>Description : 18 items questionnaire, filled by the parents of the child | Other: Questionnaire for visual function assessment of preverbal children<br>* 18 items questionnaire<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Inclusion | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant