Back to resultsEvaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Primary Purpose
Amblyopia
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
GoCheck Kids (iOS)
GoCheck Kids (Windows)
Sponsored by
About this trial
This is an interventional screening trial for Amblyopia focused on measuring Myopia, Hyperopia, Anisometropia, Amblyopia Risk Factors, Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening, Mobile Vision Screening
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Photorefraction of ages 1 to 6 years
Arm Description
Clinical Validation of GoCheck Kids Smartphone App
Outcomes
Primary Outcome Measures
Sensitivity and specificity of amblyopia risk factors detected by photo refraction
Identification of risk factors as compared to gold standard cycloplegic refraction
Secondary Outcome Measures
Number of patients with gaze error identified by photo screening
Detection of gaze error compared to cover test examination results
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03119675
Brief Title
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Official Title
Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Study Type
Interventional
2. Study Status
Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
March 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gobiquity Mobile Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Amblyopia
Keywords
Myopia, Hyperopia, Anisometropia, Amblyopia Risk Factors, Risk Factors, Smartphone Application (App), Photoscreening, Vision Screening, Mobile Vision Screening
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
358 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Photorefraction of ages 1 to 6 years
Arm Type
Other
Arm Description
Clinical Validation of GoCheck Kids Smartphone App
Intervention Type
Device
Intervention Name(s)
GoCheck Kids (iOS)
Intervention Description
Photorefraction method is used to screen amblyopia risk factors.
Intervention Type
Device
Intervention Name(s)
GoCheck Kids (Windows)
Intervention Description
Photorefraction method is used to screen amblyopia risk factors.
Primary Outcome Measure Information:
Title
Sensitivity and specificity of amblyopia risk factors detected by photo refraction
Description
Identification of risk factors as compared to gold standard cycloplegic refraction
Time Frame
1 Day
Secondary Outcome Measure Information:
Title
Number of patients with gaze error identified by photo screening
Description
Detection of gaze error compared to cover test examination results
Time Frame
1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean Donahue, MD, PhD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
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