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

Fondation Ophtalmologique Adolphe de Rothschild

Status: Completed

Conditions: Vision Disorders; Eye Diseases

Treatments: Other: Questionnaire for visual function assessment of preverbal children

Study type: Interventional

Funder types: NETWORK

Identifiers

NCT04428541

PDU_2020_1

Details and patient eligibility

About

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.

Enrollment: 150 patients

Sex: All

Ages: Under 36 months old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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150 participants in 1 patient group

Questionnaire

Experimental group

Description:

Description : 18 items questionnaire, filled by the parents of the child

Treatment:

Other: Questionnaire for visual function assessment of preverbal children