Screening for 3-D Visual Disorders in Preschool Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Screening for 3-D Visual Disorders in Preschool Children, VISION Study

Conditions
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Amblyopia, Strabismus, Anisometropia

Intervention / Treatment
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* Drug: Instillation of cyclopentolate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Years
Maximum Age: 4 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-dimensional screening for visual disorders using the RetinoMax Device<br>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. | Drug: Instillation of cyclopentolate<br>* 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.<br>|
| Active Comparator: Non-standardized device for usual vision disorders<br>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 | Drug: Instillation of cyclopentolate<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 1 day |