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OpenTrials
Completed

NCT Number: NCT03447171

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

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).

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Key information

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

App Vision Screening

Device

Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Gobiquity Mobile Health

Industry

Registry information

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Feb 27, 2018
Registry last updated
Aug 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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