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

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

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.

Study Overview

• Status: Completed
• Conditions: Strabismus; Amblyopia; Anisometropia
• Intervention / Treatment: Drug: Instillation of cyclopentolate

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 Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75019
    • Robert Debre Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 years to 4 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Three-dimensional screening for visual disorders using the RetinoMax Device; 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.	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.
ACTIVE_COMPARATOR: Non-standardized device for usual vision disorders; 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	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Emmanuel BUI-QUOC, MD, Assistance Publique - Hôpitaux de Paris

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2021
• Primary Completion (ACTUAL): September 1, 2021
• Study Completion (ACTUAL): September 1, 2021

Study Registration Dates

• First Submitted: September 22, 2021
• First Submitted That Met QC Criteria: January 10, 2022
• First Posted (ACTUAL): January 24, 2022

Study Record Updates

• Last Update Posted (ACTUAL): January 24, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Eye Diseases; Neurologic Manifestations; Cranial Nerve Diseases; Sensation Disorders; Refractive Errors; Ocular Motility Disorders; Strabismus; Vision Disorders; Amblyopia; Anisometropia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Muscarinic Antagonists; Cholinergic Antagonists; Cholinergic Agents; Mydriatics; Cyclopentolate
• Other Study ID Numbers: APHP201100; 2019-A03128-49 (REGISTRY: ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No