Screening for 3-D Visual Disorders in Preschool Children

Not Applicable

Completed

• Conditions: Amblyopia; Anisometropia; Strabismus
• Interventions: Drug: Instillation of cyclopentolate

• Registration Number: NCT05204069
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

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.

Study Timeline

• Study Start: 2021-01-01
• Status Verified: 2021-09
• Primary Completion: 2021-09-01
• Study Completion: 2021-09-01
• Study First Submitted: 2021-09-22
• Study First Submitted QC: 2022-01-10
• Last Update Submitted: 2022-01-10
• Study First Posted: 2022-01-24
• Last Update Posted: 2022-01-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 95

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-dimensional screening for visual disorders using the RetinoMax Device	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	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

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Robert Debre Hospital; 🇫🇷 Paris, France