Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children

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: NCT03447171
Recruitment Status : Completed
First Posted : February 27, 2018
Last Update Posted : August 3, 2018
Sponsor:
Information provided by (Responsible Party):
Gobiquity Mobile Health

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
Amblyopia Device: App Vision Screening

Detailed Description:
Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years

Layout table for study information
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 : February 7, 2018
Actual Primary Completion Date : June 4, 2018
Actual Study Completion Date : June 4, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Amblyopia

Group/Cohort Intervention/treatment
Refractive Error Device: App Vision Screening
Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors




Primary Outcome Measures :
  1. Sensitivity and specificity of amblyopia risk factors detected by Photorefraction [ Time Frame: 1 day ]
    Identification of risk factors 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 8 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study population will be selected from eye clinics.
Criteria

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


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): NCT03447171


Locations
Layout table for location information
United States, Alaska
Alaska Children's Eye & Strabismus
Anchorage, Alaska, United States, 99508
Sponsors and Collaborators
Gobiquity Mobile Health
Investigators
Layout table for investigator information
Principal Investigator: Sean Donahue, MD, PhD Vanderbilt University

Layout table for additonal information
Responsible Party: Gobiquity Mobile Health
ClinicalTrials.gov Identifier: NCT03447171     History of Changes
Other Study ID Numbers: 2018-001
First Posted: February 27, 2018    Key Record Dates
Last Update Posted: August 3, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Gobiquity Mobile Health:
Amblyopia
Myopia
Hyperopia
Risk Factors
Amblyopia Risk Factors
Smartphone Application (App)
Photoscreening
Vision Screening
Mobile Vision Screening
Vision Screening App
Preschool children
Objective vision screening
Additional relevant MeSH terms:
Layout table for MeSH terms
Amblyopia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Eye Diseases
Signs and Symptoms