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Completed

NCT Number: NCT05204069

Screening for 3-D Visual Disorders in Preschool Children

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.

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Key information

About this 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. 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Screening for 3-dimensional visual disorders

    Time frame: 1 day

    Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard

Sponsors and collaborators

Lead sponsor

Assistance Publique - Hôpitaux de Paris

Other

Registry information

Official study title

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

Acronym: VISION

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jan 24, 2022
Registry last updated
Jan 24, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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