NCT03119675

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
358

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Shorter than P25 for not_applicable

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

November 1, 2016

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

April 11, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 18, 2017

Completed
13 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

March 13, 2018

Status Verified

March 1, 2018

Enrollment Period

4 months

First QC Date

April 11, 2017

Last Update Submit

March 12, 2018

Conditions

Amblyopia

Keywords

MyopiaHyperopiaAnisometropiaAmblyopia Risk FactorsRisk FactorsSmartphone Application (App)PhotoscreeningVision ScreeningMobile Vision Screening

Outcome Measures

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

    1 Day

Secondary Outcomes (1)

  • Number of patients with gaze error identified by photo screening

    1 day

Study Arms (1)

Photorefraction of ages 1 to 6 years

OTHER

Clinical Validation of GoCheck Kids Smartphone App

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

Interventions

GoCheck Kids (iOS)DEVICE

Photorefraction method is used to screen amblyopia risk factors.

Photorefraction of ages 1 to 6 years
GoCheck Kids (Windows)DEVICE

Photorefraction method is used to screen amblyopia risk factors.

Photorefraction of ages 1 to 6 years

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Age 12 months to 6 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

MeSH Terms

Conditions

AmblyopiaMyopiaHyperopiaAnisometropiaAlzheimer 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
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 11, 2017

First Posted

April 18, 2017

Study Start

November 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

March 13, 2018

Record last verified: 2018-03