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

February 15, 2024 updated by: Fondation Ophtalmologique Adolphe de Rothschild

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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Paris, France, 75019
        • Recruiting
        • Fondation A De Rothschild
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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
Inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fondation Ophtalmologique Adolphe de Rothschild

Investigators

  • Principal Investigator: Pascal DUREAU, MD, Fondation A. de Rothschild

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 16, 2020

Primary Completion (Estimated)

January 1, 2025

Study Completion (Estimated)

January 1, 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)

February 16, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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