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CompletedNCT03447171Updated Aug 3, 2018

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

An observational study in Amblyopia, sponsored by Gobiquity Mobile Health. Completed at 1 site in United States. Open to participants aged 1 Year to 8 Years. Per ClinicalTrials.gov, last updated 2018-08-03.

Sponsored by Gobiquity Mobile Health · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
207
Ages
1 Year to 8 Years
Sex
All
01

Study 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).

Read the detailed description

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

02

Conditions studied

  • Amblyopia

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Keywords

  • 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
03

Who can participate

Ages eligible
1 Year to 8 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Study population will be selected from eye clinics.

Inclusion criteria

  • Age 12 months to 8 years inclusive.
  • Informed consent given by parent or legal guardian.

Exclusion criteria

Exclusion Criteria:

  • History of ocular surgery and any condition that would preclude the ability of the investigator to obtain a reliable image and measurement
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
207 participants (actual)
Patient registry
No

Groups and cohorts

  • Refractive Error

    Device: App Vision Screening

Interventions

  • DeviceApp Vision Screening

    Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors

05

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of amblyopia risk factors detected by Photorefraction

    Identification of risk factors compared to gold standard cycloplegic refraction

    Time frame: 1 day

Secondary outcomes

  1. Number of patients with gaze error identified by photo screening

    Detection of gaze error compared to cover test examination results

    Time frame: 1 day

06

Study locations

1 site
  • Alaska Children's Eye & Strabismus
    Anchorage, Alaska 99508, United States
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03447171
Lead sponsor
Gobiquity Mobile Health
Responsible party
Sponsor
First posted
Feb 27, 2018
Start date
Feb 7, 2018
Primary completion
Jun 4, 2018
Completion
Jun 4, 2018
Last update
Aug 3, 2018

Study contacts

Sean Donahue, MD, PhD
principal investigator · Vanderbilt University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.

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