Back to resultsDetermination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies (EVEIL)
Primary Purpose
Eye Diseases, Vision Disorders
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Questionnaire for visual function assessment of preverbal children
Sponsored by
About this trial
This is an interventional other trial for Eye Diseases focused on measuring Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant
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)
Sites / Locations
- Fondation A de RothschildRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Questionnaire
Arm Description
Description : 18 items questionnaire, filled by the parents of the child
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT04428541
First Posted
June 9, 2020
Last Updated
February 16, 2023
Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
1. Study Identification
Unique Protocol Identification Number
NCT04428541
Brief Title
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
Acronym
EVEIL
Official Title
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 16, 2020 (Actual)
Primary Completion Date
February 2024 (Anticipated)
Study Completion Date
February 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fondation Ophtalmologique Adolphe de Rothschild
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Diseases, Vision Disorders
Keywords
Eye Diseases, Vision Disorders, Questionnaire Design, Children, Infant
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Questionnaire
Arm Type
Experimental
Arm Description
Description : 18 items questionnaire, filled by the parents of the child
Intervention Type
Other
Intervention Name(s)
Questionnaire for visual function assessment of preverbal children
Intervention Description
18 items questionnaire
Primary Outcome Measure Information:
Title
Measure the internal validity of the questionnaire developed to assess the visual acuity of preverbal children
Description
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
Time Frame
Inclusion
10. Eligibility
Sex
All
Minimum Age & Unit of Time
0 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
No
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Amélie YAVCHITZ, MD
Phone
(0)148036454
Ext
+33
Email
ayavchitz@for.paris
First Name & Middle Initial & Last Name or Official Title & Degree
Pascal DUREAU, MD
Email
pdureau@for.paris
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pascal DUREAU, MD
Organizational Affiliation
Fondation A. de Rothschild
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fondation A de Rothschild
City
Paris
ZIP/Postal Code
75019
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pascal DUREAU, MD
Email
pdureau@for.paris
12. IPD Sharing Statement
Learn more about this trial
Determination of the Validity of a Questionnaire to Assess the Visual Function of Preverbal Children With Operable Bilateral Ocular Pathologies
We'll reach out to this number within 24 hrs