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

Not Applicable

Recruiting

• Conditions: Eye Diseases; Vision Disorders
• Interventions: Other: Questionnaire for visual function assessment of preverbal children

• Registration Number: NCT04428541
• Lead Sponsor: Fondation Ophtalmologique Adolphe de Rothschild

Brief 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.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-10
• Study First Posted: 2020-06-11
• Study Start: 2020-07-16
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-11
• Last Update Posted: 2025-02-13
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Questionnaire	Questionnaire for visual function assessment of preverbal children	Description : 18 items questionnaire, filled by the parents of the child

Primary Outcome Measures

Name	Time	Method
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children	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

Trial Locations

Locations (1)

Fondation A de Rothschild; 🇫🇷 Paris, France