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

NCT04428541 | Completed

• 1 other identifier: PDU_2020_1
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

Eye Diseases; Vision Disorders; Questionnaire Design; Children; Infant

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Questionnaire

EXPERIMENTAL

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

Other: Questionnaire for visual function assessment of preverbal children

Interventions

Questionnaire for visual function assessment of preverbal children OTHER

18 items questionnaire

Questionnaire

Eligibility Criteria

• Age: 0 Months - 36 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Patient with unilateral ocular pathology
• Verbal patients (able to express themselves through speech)

Sponsors & Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild: lead

Study Sites (1)

Fondation A de Rothschild

Paris, 75019, France

Location

MeSH Terms

Conditions

Eye Diseases; Vision Disorders

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Pascal DUREAU, MD

  Fondation A. de Rothschild

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 11, 2020
• Study Start: July 16, 2020
• Primary Completion: May 21, 2025
• Study Completion: May 21, 2025
• Last Updated: December 10, 2025

Record last verified: 2025-12

Locations

FR (1)