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

• Sponsor: Fondation Ophtalmologique Adolphe de Rothschild (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04428541
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 42.5
• Patients Per Site Per Month: 3.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Eye Diseases; Vision Disorders	Other: Questionnaire for visual function assessment of preverbal children	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• Official Title: Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
• Actual Study Start Date: Jul 16, 2020
• Anticipated Primary Completion Date: Feb 1, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 0 Months to 36 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fondation A de Rothschild	Paris		France	75019

Sponsors and Collaborators

• Fondation Ophtalmologique Adolphe de Rothschild

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
• ClinicalTrials.gov Identifier: NCT04428541
• Other Study ID Numbers: PDU_2020_1
• First Posted: Jun 11, 2020
• Last Update Posted: Mar 3, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Fondation Ophtalmologique Adolphe de Rothschild: Eye Diseases; Vision Disorders; Questionnaire Design; Children; Infant
• Additional relevant MeSH terms: Vision Disorders; Eye Diseases

Study Results

No Results Posted as of Mar 3, 2022