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

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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

Study Description
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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
Amblyopia Device: GoCheck Kids (iOS) Device: GoCheck Kids (Windows) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : November 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : May 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Arms and Interventions
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Arm Intervention/treatment
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
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Number of patients with gaze error identified by photo screening [ Time Frame: 1 day ]
    Detection of gaze error compared to cover test examination results


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 6 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03119675


Sponsors and Collaborators
Gobiquity Mobile Health
Investigators
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Principal Investigator: Sean Donahue, MD, PhD Vanderbilt University
More Information
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Responsible Party: Gobiquity Mobile Health
ClinicalTrials.gov Identifier: NCT03119675    
Other Study ID Numbers: 2016-001
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Gobiquity Mobile Health:
Myopia
Hyperopia
Anisometropia
Amblyopia Risk Factors
Risk Factors
 Smartphone Application (App)
Photoscreening
Vision Screening
Mobile Vision Screening
Additional relevant MeSH terms:
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Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases