ClinicalTrials.gg
CompletedNCT03119675Updated Mar 13, 2018

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

An interventional study of GoCheck Kids (iOS) and GoCheck Kids (Windows) in Amblyopia, sponsored by Gobiquity Mobile Health. Completed. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Gobiquity Mobile Health · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2016, registered Apr 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
358
Allocation
Not applicable
Ages
1 Year to 6 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Amblyopia

Keywords

  • Myopia
  • Hyperopia
  • Anisometropia
  • Amblyopia Risk Factors
  • Risk Factors
  • Smartphone Application (App)
  • Photoscreening
  • Vision Screening
  • Mobile Vision Screening
03

In context

Amblyopia

189 studies on the registry are indexed under Amblyopia; 41 are open to participants now.

This study's enrollment of 358 is above the median of 60 across 137 interventional studies indexed under Amblyopia.

Browse Amblyopia studies →

Lead sponsor

Gobiquity Mobile Health is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Year to 6 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Age 12 months to 6 years inclusive.
  • 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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
358 participants (actual)

Study arms

  • Other
    Photorefraction of ages 1 to 6 years

    Clinical Validation of GoCheck Kids Smartphone App

    Device: GoCheck Kids (iOS) · Device: GoCheck Kids (Windows)

Interventions

  • DeviceGoCheck Kids (iOS)

    Photorefraction method is used to screen amblyopia risk factors.

  • DeviceGoCheck Kids (Windows)

    Photorefraction method is used to screen amblyopia risk factors.

06

What researchers measure

Primary outcomes

  1. Sensitivity and specificity of amblyopia risk factors detected by photo refraction

    Identification of risk factors as 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

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2016 to primary completion in Mar 2017, 4 months.

Of 71 interventional studies with no phase under Amblyopia, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 47. This study's 4 months is below that.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 11, 2017
First posted
Apr 18, 2017
StartActual
Nov 2016
Primary completionActual
Mar 2017
CompletionActual
May 2017
Last update
Mar 13, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 13, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03119675
Lead sponsor
Gobiquity Mobile Health
Responsible party
Sponsor
First posted
Apr 18, 2017
Start date
Nov 2016
Primary completion
Mar 2017
Completion
May 2017
Last update
Mar 13, 2018

Study contacts

Sean Donahue, MD, PhD
principal investigator · Vanderbilt University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

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

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion