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

NCT ID: NCT04428541

Last Updated: 2025-12-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-16
• Study Completion Date: 2025-05-21

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.

Conditions

Eye Diseases; Vision Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Questionnaire

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

Group Type: EXPERIMENTAL

Questionnaire for visual function assessment of preverbal children

Intervention Type: OTHER

18 items questionnaire

Interventions

Questionnaire for visual function assessment of preverbal children

18 items questionnaire

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 0 Months
• Maximum Eligible Age: 36 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondation Ophtalmologique Adolphe de Rothschild

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pascal DUREAU, MD

Role: PRINCIPAL_INVESTIGATOR

Fondation A. de Rothschild

Locations

Fondation A de Rothschild

Paris, , France

Countries

France

Other Identifiers

PDU_2020_1

Identifier Type: -

Identifier Source: org_study_id