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Screening for 3-D Visual Disorders in Preschool Children (VISION)

Primary Purpose

Amblyopia, Strabismus, Anisometropia

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Instillation of cyclopentolate
Sponsored by
Assistance Publique - Hôpitaux de Paris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Amblyopia

Eligibility Criteria

3 Years - 4 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Children aged 3 to 4 years
  • Enrolled in kindergarten in the first section
  • In the 19th district of Paris
  • Who should benefit from visual screening via the school medical service

Exclusion Criteria:

  • Children who do not speak French
  • Children who are physically or cognitively unable to participate in the screening

Sites / Locations

  • Robert Debre Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Three-dimensional screening for visual disorders using the RetinoMax Device

Non-standardized device for usual vision disorders

Arm Description

Instillation of cyclopentolate of 3 drops of cyclopentolate at T0',T5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.

Screening device for usual vision disorders, performed by the school doctor during the usual prevention visit, with the tools used in the school doctor's current practice, non-standardized, according to his preference

Outcomes

Primary Outcome Measures

Screening for 3-dimensional visual disorders
Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard

Secondary Outcome Measures

Full Information

First Posted
September 22, 2021
Last Updated
January 10, 2022
Sponsor
Assistance Publique - Hôpitaux de Paris
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1. Study Identification

Unique Protocol Identification Number
NCT05204069
Brief Title
Screening for 3-D Visual Disorders in Preschool Children
Acronym
VISION
Official Title
Screening for 3-D Visual Disorders in Preschool Children, VISION Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2021 (Actual)
Study Completion Date
September 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation.
Detailed Description
Visual screening is necessary among pre-school children as they found themselves in a critical period of visual developement. To date, there are no national vision screening program that has been implemented nationwide. Methodology: The "Association Française de Strabologie et d'Ophtalmologie Pédiatrique" AFSOP proposed criteria based on a 3-dimensions visual screening to assess whether or not a child presents risk factors of amblyopia such as ametropia, strabismus and anisometropia. Vision is a pilot feasibility multicentric cluster study comparing the sensitivity of "AFSOP 3 dimensional visual screening protocol in a population of 3 to 4-year-old pre-school children conducted in 4 kindergarten preschools in Paris with gold-standard ophthalmic examination confirmation. Expected results: We assume that a vision screening operated with the AFSOP 3 dimension screening recommendations and conducted by paramedical actors such as orthoptists will prove more sensitive and easier to implement on a national scale.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia, Strabismus, Anisometropia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Three-dimensional screening for visual disorders using the RetinoMax Device
Arm Type
Experimental
Arm Description
Instillation of cyclopentolate of 3 drops of cyclopentolate at T0',T5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.
Arm Title
Non-standardized device for usual vision disorders
Arm Type
Active Comparator
Arm Description
Screening device for usual vision disorders, performed by the school doctor during the usual prevention visit, with the tools used in the school doctor's current practice, non-standardized, according to his preference
Intervention Type
Drug
Intervention Name(s)
Instillation of cyclopentolate
Intervention Description
Instillation of cyclopentolate of 3 drops of cyclopentolate at t0',t5' and t10' with to induce a certain level of cycloplegia and evaluate manifest refraction at t45' using the RetinoMax Device.
Primary Outcome Measure Information:
Title
Screening for 3-dimensional visual disorders
Description
Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard
Time Frame
1 day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
4 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Children aged 3 to 4 years Enrolled in kindergarten in the first section In the 19th district of Paris Who should benefit from visual screening via the school medical service Exclusion Criteria: Children who do not speak French Children who are physically or cognitively unable to participate in the screening
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuel BUI-QUOC, MD
Organizational Affiliation
Assistance Publique - Hôpitaux de Paris
Official's Role
Principal Investigator
Facility Information:
Facility Name
Robert Debre Hospital
City
Paris
ZIP/Postal Code
75019
Country
France

12. IPD Sharing Statement

Plan to Share IPD
Undecided

Learn more about this trial

Screening for 3-D Visual Disorders in Preschool Children

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