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

Assistance Publique - Hôpitaux de Paris

Status: Completed

Conditions: Strabismus; Amblyopia; Anisometropia

Treatments: Drug: Instillation of cyclopentolate

Study type: Interventional

Funder types: Other

Identifiers

NCT05204069

2019-A03128-49 (Registry Identifier)

APHP201100

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: All

Ages: 3 to 4 years old

Volunteers: 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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

95 participants in 2 patient groups

Three-dimensional screening for visual disorders using the RetinoMax Device

Experimental group

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.

Treatment:

Drug: Instillation of cyclopentolate

Non-standardized device for usual vision disorders

Active Comparator group

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

Treatment:

Drug: Instillation of cyclopentolate