Screening for 3-D Visual Disorders in Preschool Children

NCT05204069 — Not applicable, Completed, 95 participants, Assistance Publique - Hôpitaux de Paris

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

RegistryNCT05204069, acronym VISION
StatusCompleted
PhaseNot applicable
Study typeInterventional; randomized, parallel, masking: none, diagnostic
Enrollment95 (Actual)
SponsorAssistance Publique - Hôpitaux de Paris (Other)
ConditionsAmblyopia, Strabismus, Anisometropia
InterventionsInstillation of cyclopentolate (Drug)
Datesstart 2021-01-01, primary completion 2021-09-01, completion 2021-09-01, first posted 2022-01-24, last updated 2022-01-24
Locations1 site in France

Related Papers Related Patents Related Grants Related Experts
All trials for Amblyopia All trials for Strabismus All trials of Instillation of cyclopentolate

-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.

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+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.

+Arms and interventions

ArmTypeInterventionsDescription
Three-dimensional screening for visual disorders using the RetinoMax DeviceExperimentalDrug: Instillation of cyclopentolateInstillation 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 disordersActive comparatorDrug: Instillation of cyclopentolateScreening 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
  • 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.

+Outcome measures

Primary outcomes

  • Screening for 3-dimensional visual disorders [1 day]: Sensitivity of the " AFSOP 3-dimensional screening" vs "PARIS protocol screening" using a comprehensive ophthalmological examination as a gold standard

+Eligibility

Sex: All, ages: 3 Years to 4 Years, 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

+Locations (1)

FacilityCityCountryStatus
Robert Debre HospitalParisFrance

+Investigators

  • Emmanuel BUI-QUOC, MD, Principal investigator, Assistance Publique - Hôpitaux de Paris