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Validation of the GoCheck Kids® Eye Screeningtest in Infants in Flanders

NCT05484453 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 460

Last updated 2024-07-03

No results posted yet for this study

Summary

The aim is to validate the new GoCheck Kids application as automatic eye screener for preschool children (\<3 years of age) at 'Child and Family' agency. Sensitivity, specificity, positive and negative predictive value of the GoCheck Kids screening tool are the endpoints of this study.

Conditions

  • Amblyopia
  • Infant

Interventions

DIAGNOSTIC_TEST

Complete Eye Examination by Ophthalmologist

complete eye examination (gold standard) including cover test, biomicroscopy and cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Principal Investigators

  • Catherine Cassiman, MD, PhD · UZ Leuven

Eligibility

Min Age
11 Months
Max Age
16 Months
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-04
Primary Completion
2022-05-31
Completion
2025-05-31

Countries

  • Belgium

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05484453 on ClinicalTrials.gov