Trials / Active Not Recruiting
Active Not RecruitingNCT05484453
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
- Phase
- —
- Study type
- Observational
- Enrollment
- 460 (estimated)
- Sponsor
- Universitaire Ziekenhuizen KU Leuven · Academic / Other
- Sex
- All
- Age
- 11 Months – 16 Months
- Healthy volunteers
- —
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2021-08-04
- Primary completion
- 2022-05-31
- Completion
- 2025-05-01
- First posted
- 2022-08-02
- Last updated
- 2024-07-03
Locations
1 site across 1 country: Belgium
Source: ClinicalTrials.gov record NCT05484453. Inclusion in this directory is not an endorsement.