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

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.

Study Overview

• Status: Completed
• Conditions: Eye Diseases; Vision Disorders
• Intervention / Treatment: Other: Questionnaire for visual function assessment of preverbal children

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Fondation A de Rothschild

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 second to 3 years (Child)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Questionnaire; Description : 18 items questionnaire, filled by the parents of the child	Other: Questionnaire for visual function assessment of preverbal children; 18 items questionnaire

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild
• Investigators: Principal Investigator: Pascal DUREAU, MD, Fondation A. de Rothschild

Study record dates

Study Major Dates

• Study Start (Actual): July 16, 2020
• Primary Completion (Actual): May 21, 2025
• Study Completion (Actual): May 21, 2025

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 10, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): December 10, 2025
• Last Update Submitted That Met QC Criteria: December 3, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Children; Eye Diseases; Infant; Vision Disorders; Questionnaire Design
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Sensation Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Eye Diseases; Vision Disorders; Health Care Quality, Access, and Evaluation; Investigative Techniques; Epidemiologic Methods; Data Collection; Health Care Evaluation Mechanisms; Quality of Health Care; Public Health; Environment and Public Health; Surveys and Questionnaires
• Other Study ID Numbers: PDU_2020_1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No