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

NCT ID: NCT03119675

Last Updated: 2018-03-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

358 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Amblyopia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Photorefraction of ages 1 to 6 years

Clinical Validation of GoCheck Kids Smartphone App

Group Type OTHER

GoCheck Kids (iOS)

Intervention Type DEVICE

Photorefraction method is used to screen amblyopia risk factors.

GoCheck Kids (Windows)

Intervention Type DEVICE

Photorefraction method is used to screen amblyopia risk factors.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

GoCheck Kids (iOS)

Photorefraction method is used to screen amblyopia risk factors.

Intervention Type DEVICE

GoCheck Kids (Windows)

Photorefraction method is used to screen amblyopia risk factors.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Gobiquity Mobile Health

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Sean Donahue, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt University

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2016-001

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

OKKO Space Academy to Check Children's Vision at Home
NCT05313516 ENROLLING_BY_INVITATION NA
Binocularly Balanced Viewing Study
NCT03754153 COMPLETED NA