Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Not Applicable
Completed
- Conditions
- Amblyopia
- Interventions
- Device: GoCheck Kids (iOS)Device: GoCheck Kids (Windows)
- Registration Number
- NCT03119675
- Lead Sponsor
- Gobiquity Mobile Health
- Brief Summary
Objective: Prospective evaluation of GoCheckKids™, a smartphone application ('App') as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs)
Method: Photorefraction images are captured using up to 4 different devices with GoCheckKids™ App and patients are evaluated with cycloplegic refraction.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 358
Inclusion Criteria
- Age 12 months to 6 years inclusive.
- Informed consent given by parent or legal guardian.
Exclusion Criteria
- History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Photorefraction of ages 1 to 6 years GoCheck Kids (Windows) Clinical Validation of GoCheck Kids Smartphone App Photorefraction of ages 1 to 6 years GoCheck Kids (iOS) Clinical Validation of GoCheck Kids Smartphone App
- Primary Outcome Measures
Name Time Method Sensitivity and specificity of amblyopia risk factors detected by photo refraction 1 Day Identification of risk factors as compared to gold standard cycloplegic refraction
- Secondary Outcome Measures
Name Time Method Number of patients with gaze error identified by photo screening 1 day Detection of gaze error compared to cover test examination results