Amblyopia Clinical Trial
Official title:
Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
| Verified date | March 2018 |
| Source | Gobiquity Mobile Health |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 358 |
| Est. completion date | May 2017 |
| Est. primary completion date | March 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 1 Year to 6 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Gobiquity Mobile Health |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sensitivity and specificity of amblyopia risk factors detected by photo refraction | Identification of risk factors as compared to gold standard cycloplegic refraction | 1 Day | |
| Secondary | Number of patients with gaze error identified by photo screening | Detection of gaze error compared to cover test examination results | 1 day |
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