Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03119675
Recruitment Status : Completed
First Posted : April 18, 2017
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
Gobiquity Mobile Health

Tracking Information
First Submitted Date  ICMJE April 11, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date March 13, 2018
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Sensitivity and specificity of amblyopia risk factors detected by photo refraction [ Time Frame: 1 Day ]
Identification of risk factors as compared to gold standard cycloplegic refraction
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 17, 2017)
Number of patients with gaze error identified by photo screening [ Time Frame: 1 day ]
Detection of gaze error compared to cover test examination results
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
Official Title  ICMJE Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Amblyopia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE Photorefraction of ages 1 to 6 years
Clinical Validation of GoCheck Kids Smartphone App
Interventions:
  • Device: GoCheck Kids (iOS)
  • Device: GoCheck Kids (Windows)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 12, 2018)
358
Original Estimated Enrollment  ICMJE
 (submitted: April 17, 2017)
592
Actual Study Completion Date  ICMJE May 2017
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 6 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03119675
Other Study ID Numbers  ICMJE 2016-001
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gobiquity Mobile Health
Study Sponsor  ICMJE Gobiquity Mobile Health
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sean Donahue, MD, PhD Vanderbilt University
PRS Account Gobiquity Mobile Health
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP