Evaluation of a Smartphone Application, GoCheckKids™ as a... | NCT03119675

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

NCT03119675

Sponsor

Gobiquity Mobile Health

Status

Completed

Last Update Posted

Mar 13, 2018Actual

Enrollment

358Actual

Phase

Not Applicable

Conditions

Amblyopia

Interventions

GoCheck Kids (iOS)
GoCheck Kids (Windows)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2016Actual

Primary Completion Date

Mar 2017Actual

Completion Date

May 2017Actual

First Submitted Date

Apr 11, 2017

First Submission Date that Met QC Criteria

Apr 17, 2017

First Posted Date

Apr 18, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 12, 2018

Last Update Posted Date

Mar 13, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

358Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Photorefraction of ages 1 to 6 years	Other	Clinical Validation of GoCheck Kids Smartphone App	Device: GoCheck Kids (iOS) Device: GoCheck Kids (Windows)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
GoCheck Kids (iOS)	Device	Photorefraction method is used to screen amblyopia risk factors.	Photorefraction of ages 1 to 6 years

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

6 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Sean Donahue, MD, PhD	Vanderbilt University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000550	Amblyopia
D009216	Myopia
D006956	Hyperopia
D015858	Anisometropia
D000544	Alzheimer Disease

Ancestor Terms

ID	Term
D001927	Brain Diseases
D002493	Central Nervous System Diseases
D009422	Nervous System Diseases
D014786	Vision Disorders

Browse Leaves

Not provided

Browse Branches

Not provided