Prospective Evaluation of a Smartphone Application, GoChe... | NCT03447171

Studies
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children

NCT03447171

Sponsor

Gobiquity Mobile Health

Status

Completed

Last Update Posted

Aug 3, 2018Actual

Enrollment

207Actual

Phase

Not provided

Conditions

Amblyopia

Interventions

App Vision Screening

Countries

United States

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

Aug 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

Feb 7, 2018Actual

Primary Completion Date

Jun 4, 2018Actual

Completion Date

Jun 4, 2018Actual

First Submitted Date

Feb 21, 2018

First Submission Date that Met QC Criteria

Feb 21, 2018

First Posted Date

Feb 27, 2018Actual

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

Aug 2, 2018

Last Update Posted Date

Aug 3, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Yes

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

207Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Refractive Error			Device: App Vision Screening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
App Vision Screening	Device	Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors	Refractive Error

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Sensitivity and specificity of amblyopia risk factors detected by Photorefraction	Identification of risk factors 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 8 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

8 Years

Standard Ages

Child

Study Population

Study population will be selected from eye clinics.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alaska Children's Eye & Strabismus		Anchorage	Alaska	99508	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D000550	Amblyopia
D009216	Myopia
D006956	Hyperopia
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