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

Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05484453
Enrollment
460
Registered
2022-08-02
Start date
2021-08-04
Completion date
2025-05-31
Last updated
2024-07-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amblyopia, Infant

Keywords

Eye screening

Brief 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.

Detailed description

Comparison of the results of the GoCheck Kids application on iPhone with a complete eye examination (gold standard) including cycloplegic refraction with retinoscopy, performed by an ophthalmologist.

Interventions

DIAGNOSTIC_TESTComplete Eye Examination by Ophthalmologist

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

Sponsors

Universitaire Ziekenhuizen KU Leuven
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Months to 16 Months

Inclusion criteria

* GoCheck Kids (GCK) evaluation at Child and Family Agency at the age between 11-16 months.

Exclusion criteria

* Allergy for the used cycloplegia cyclopentolate 0.5%. * Any history of ocular surgery * The time window between GCK measurement and the complete eye examination may not exceed 2 months. * The parents or legal representatives of the child do not understand or speak Dutch, French or English.

Design outcomes

Primary

MeasureTime frameDescription
SensitivityDay 1Sensitivity of GCK eye screener
SpecificityDay 1Specificity of GCK eye screener
Positive predictive valueDay 1Positive predictive value of GCK eye screener
Negative predictive valueDay 1Negative predictive value of GCK eye screener

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026