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NCT05484453 Clinical Trial

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

Amblyopia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05484453
Other study ID # S64113
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date August 4, 2021
Est. completion date May 2023

Study information
Verified date July 2022
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 460
Est. completion date May 2023
Est. primary completion date May 31, 2022
Accepts healthy volunteers
Gender All
Age group 11 Months to 16 Months
Eligibility 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

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity Sensitivity of GCK eye screener Day 1
Primary Specificity Specificity of GCK eye screener Day 1
Primary Positive predictive value Positive predictive value of GCK eye screener Day 1
Primary Negative predictive value Negative predictive value of GCK eye screener Day 1
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