Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Sponsor
Gobiquity Mobile Health (Industry)
Overall Status
Completed
CT.gov ID
NCT03119675
Collaborator
(none)
358
1
5.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
358 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Actual Study Start Date
:
Nov 1, 2016
Actual Primary Completion Date
:
Mar 1, 2017
Actual Study Completion Date
:
May 1, 2017
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Photorefraction of ages 1 to 6 years Clinical Validation of GoCheck Kids Smartphone App |
Device: GoCheck Kids (iOS)
Photorefraction method is used to screen amblyopia risk factors.
Device: GoCheck Kids (Windows)
Photorefraction method is used to screen amblyopia risk factors.
|
Outcome Measures
Primary Outcome Measures
- 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
- Number of patients with gaze error identified by photo screening [1 day]
Detection of gaze error compared to cover test examination results
Eligibility Criteria
Criteria
Ages Eligible for Study:
1 Year
to 6 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Gobiquity Mobile Health
Investigators
- Principal Investigator: Sean Donahue, MD, PhD, Vanderbilt University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Gobiquity Mobile Health
ClinicalTrials.gov Identifier:
NCT03119675
Other Study ID Numbers:
- 2016-001
First Posted:
Apr 18, 2017
Last Update Posted:
Mar 13, 2018
Last Verified:
Mar 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Gobiquity Mobile Health
Additional relevant MeSH terms: