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

March 12, 2018 updated by: Gobiquity Mobile Health

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

358

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 months to 4 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 Day

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of patients with gaze error identified by photo screening
Time Frame: 1 day
Detection of gaze error compared to cover test examination results
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gobiquity Mobile Health

Investigators

  • Principal Investigator: Sean Donahue, MD, PhD, Vanderbilt University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

March 1, 2017

Study Completion (Actual)

May 1, 2017

Study Registration Dates

First Submitted

April 11, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 18, 2017

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 12, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2016-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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