ClinicalTrials.gg
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

Where this study stands

Counted across the records on this site · 2026-11-12

Among 82 studies in Amblyopia with a site in United States — 16 open to participants now, 17 under way, 3 of them phase 3. Amblyopia · United States.

Enrollment
8th of 19
207 · median 156
Started
2018
with 3 others
Observational
19 of 82
2 open now
Registered
50th of 82
by date

Among the 82 studies in Amblyopia with a site in United States, this one is the 8th largest by enrollment of the 19 observational ones, is one of 4 that started in 2018, is one of 19 observational ones, and was the 50th registered.

By phase

82 studies; the count open now beside each. This study's row is marked.

No phase32 · 8 open
Observationalthis study19 · 2 open
Phase 319 · 3 open
Phase 14 · 0 open
Phase 1/24 · 2 open
Phase 22 · 1 open
Phase 42 · 0 open

By the year they started

First in 1999; this study’s year is marked. 4 started in 2018.

Size and results

Median enrollment 53 across the 62 interventional studies, 156 across the 19 observational. Of the 56 that completed or were terminated, 19 (34%) have results posted.

Was this useful?
Watch this landscapeDownload CSVWith an account: a weekly mail of what changed among 82 studies in Amblyopia with a site in United States, or all of them as a file.
02

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

03

Conditions studied

  • Amblyopia

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
04

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.

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 8 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

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

06

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

07

Study locations

1 site
  • Alaska Children's Eye & Strabismus
    Anchorage, Alaska 99508, United States
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

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 Feb 2018 to primary completion in Jun 2018, 3 months.

Of 16 observational studies under Amblyopia, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 22. This study's 3 months is below that.

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

Registered
Feb 21, 2018
First posted
Feb 27, 2018
StartActual
Feb 7, 2018
Primary completionActual
Jun 4, 2018
CompletionActual
Jun 4, 2018
Last update
Aug 3, 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 Aug 3, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

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 ↗

Not currently enrolling

This study is completed, as verified in Aug 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