Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
Sponsor
Gobiquity Mobile Health (Industry)
Overall Status
Completed
CT.gov ID
NCT03447171
Collaborator
(none)
207
1
3.8
53.9
Study Details
Study Description
Brief Summary
The objective is evaluation of GoCheck Kids, a smartphone application ('App'), for use as a photo screening device in a pediatric population to detect amblyopia risk factors (ARFs).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Detailed Description
Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years
Study Design
Study Type:
Observational
Actual Enrollment
:
207 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
Actual Study Start Date
:
Feb 7, 2018
Actual Primary Completion Date
:
Jun 4, 2018
Actual Study Completion Date
:
Jun 4, 2018
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Refractive Error
|
Device: App Vision Screening
Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors
|
Outcome Measures
Primary Outcome Measures
- Sensitivity and specificity of amblyopia risk factors detected by Photorefraction [1 day]
Identification of risk factors 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 8 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Age 12 months to 8 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
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Alaska Children's Eye & Strabismus | Anchorage | Alaska | United States | 99508 |
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:
NCT03447171
Other Study ID Numbers:
- 2018-001
First Posted:
Feb 27, 2018
Last Update Posted:
Aug 3, 2018
Last Verified:
Aug 1, 2018
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Gobiquity Mobile Health
Additional relevant MeSH terms: