Amblyopia, Anisometropia, Strabismus
Conditions
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.
Interventions
DRUGInstillation of cyclopentolate
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.
Sponsors
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Years to 4 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Screening for 3-dimensional visual disorders | 1 day | Sensitivity of the AFSOP 3-dimensional screening vs PARIS protocol screening using a comprehensive ophthalmological examination as a gold standard |
Countries
France
Outcome results
None listed