Amblyopia Clinical Trial
Official title:
Validation of the Eye Screeningtest GoCheckKids (GCK) for the Detection of Amblyopia Risk Factors in Toddlers in Flanders.
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 |
Verified date | July 2022 |
Source | Universitaire Ziekenhuizen Leuven |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
Country | Name | City | State |
---|---|---|---|
Belgium | UZ Leuven | Leuven |
Lead Sponsor | Collaborator |
---|---|
Universitaire Ziekenhuizen Leuven |
Belgium,
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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