Screening for 3-D Visual Disorders in Preschool Children, VISION Study
| Registry | NCT05204069, acronym VISION |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, diagnostic |
| Enrollment | 95 (Actual) |
| Sponsor | Assistance Publique - Hôpitaux de Paris (Other) |
| Conditions | Amblyopia, Strabismus, Anisometropia |
| Interventions | Instillation of cyclopentolate (Drug) |
| Dates | start 2021-01-01, primary completion 2021-09-01, completion 2021-09-01, first posted 2022-01-24, last updated 2022-01-24 |
| Locations | 1 site in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Amblyopia All trials for Strabismus All trials of Instillation of cyclopentolate
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Three-dimensional screening for visual disorders using the RetinoMax Device | Experimental | Drug: Instillation 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. |
| Non-standardized device for usual vision disorders | Active comparator | Drug: Instillation of cyclopentolate | 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 |
Sex: All, ages: 3 Years to 4 Years, accepts 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
| Facility | City | Country | Status |
|---|---|---|---|
| Robert Debre Hospital | Paris | France |