NCT03447171

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
207

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 7, 2018

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

February 21, 2018

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 27, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 4, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 4, 2018

Completed
Last Updated

August 3, 2018

Status Verified

August 1, 2018

Enrollment Period

4 months

First QC Date

February 21, 2018

Last Update Submit

August 2, 2018

Conditions

Amblyopia

Keywords

AmblyopiaMyopiaHyperopiaRisk FactorsAmblyopia Risk FactorsSmartphone Application (App)PhotoscreeningVision ScreeningMobile Vision ScreeningVision Screening AppPreschool childrenObjective vision screening

Outcome Measures

Primary Outcomes (1)

  • Sensitivity and specificity of amblyopia risk factors detected by Photorefraction

    Identification of risk factors compared to gold standard cycloplegic refraction

    1 day

Secondary Outcomes (1)

  • Number of patients with gaze error identified by photo screening

    1 day

Study Arms (1)

Refractive Error

Device: App Vision Screening

Interventions

App Vision ScreeningDEVICE

Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors

Refractive Error

Eligibility Criteria

Age1 Year - 8 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Study population will be selected from eye clinics.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Alaska Children's Eye & Strabismus

Anchorage, Alaska, 99508, United States

Location

MeSH Terms

Conditions

AmblyopiaMyopiaHyperopiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesVision DisordersSensation DisordersNeurologic ManifestationsEye DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsRefractive ErrorsDementiaTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Study Officials

  • Sean Donahue, MD, PhD

    Vanderbilt University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2018

First Posted

February 27, 2018

Study Start

February 7, 2018

Primary Completion

June 4, 2018

Study Completion

June 4, 2018

Last Updated

August 3, 2018

Record last verified: 2018-08

Locations

US(1)