Screening for 3-D Visual Disorders in Preschool Children

Amblyopia Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05204069
• Other study ID #: APHP201100
• Secondary ID: 2019-A03128-49
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: September 1, 2021

Study information

• Verified date: September 2021
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 4 Years

Eligibility

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

Related Conditions & MeSH terms

• Amblyopia
• Anisometropia
• Strabismus
• Vision Disorders

Intervention

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.

Locations

Country	Name	City	State
France	Robert Debre Hospital	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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