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

Active, not recruiting

• Conditions: Amblyopia; Infant
• Interventions: Diagnostic Test: Complete Eye Examination by Ophthalmologist

• Registration Number: NCT05484453
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Study Timeline

• Study Start: 2021-08-04
• Primary Completion: 2022-05-31
• Study First Submitted: 2022-07-29
• Study First Submitted QC: 2022-07-29
• Study First Posted: 2022-08-02
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-01
• Last Update Posted: 2024-07-03
• Study Completion: 2025-05

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 460

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GoCheckKids screening	Complete Eye Examination by Ophthalmologist	GoCheckKids screening at the Child And Family Agency at the age of 12-15 months (+- 1 month) are invited to undergo a complete eye examination by an ophthalmologist for evaluation of amblyopia risk factors.

Primary Outcome Measures

Name	Time	Method
Negative predictive value	Day 1	Negative predictive value of GCK eye screener
Sensitivity	Day 1	Sensitivity of GCK eye screener
Specificity	Day 1	Specificity of GCK eye screener
Positive predictive value	Day 1	Positive predictive value of GCK eye screener

Trial Locations

Locations (1)

UZ Leuven; 🇧🇪 Leuven, Belgium