Screening for 3-D Visual Disorders in Preschool Children

NCT05204069 | Completed

• 2 other identifiers: APHP2011002019-A03128-49
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Amblyopia; Strabismus; Anisometropia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Three-dimensional screening for visual disorders using the RetinoMax Device

EXPERIMENTAL

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

Non-standardized device for usual vision disorders

ACTIVE COMPARATOR

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

Interventions

Instillation of cyclopentolate DRUG

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; Three-dimensional screening for visual disorders using the RetinoMax Device

Eligibility Criteria

• Age: 3 Years - 4 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Children who do not speak French
• Children who are physically or cognitively unable to participate in the screening

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Robert Debre Hospital

Paris, 75019, France

Location

MeSH Terms

Conditions

Amblyopia; Strabismus; Anisometropia

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vision Disorders; Sensation Disorders; Neurologic Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Ocular Motility Disorders; Cranial Nerve Diseases; Refractive Errors

Study Officials

• Emmanuel BUI-QUOC, MD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2021
• First Posted: January 24, 2022
• Study Start: January 1, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 1, 2021
• Last Updated: January 24, 2022

Record last verified: 2021-09

Locations

FR (1)