CompletedNCT03119675Updated Mar 13, 2018

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

An interventional study of GoCheck Kids (iOS) and GoCheck Kids (Windows) in Amblyopia, sponsored by Gobiquity Mobile Health. Completed. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2018-03-13.

Sponsored by Gobiquity Mobile Health · Not applicable, Interventional, and Screening

Phase: Not applicable
Study type: Interventional
Enrollment: 358
Allocation: Not applicable
Ages: 1 Year to 6 Years
Sex: All

Study 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.

Conditions studied

Amblyopia

Browse trials for

Amblyopia 182

Keywords

Myopia
Hyperopia
Anisometropia
Amblyopia Risk Factors
Risk Factors
Smartphone Application (App)
Photoscreening
Vision Screening
Mobile Vision Screening

Who can participate

Ages eligible: 1 Year to 6 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

Age 12 months to 6 years inclusive.
Informed consent given by parent or legal guardian.

Exclusion criteria

Exclusion Criteria:

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

Study design

Phase: Not applicable
Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 358 participants (actual)

Study arms

Other
Photorefraction of ages 1 to 6 years
Clinical Validation of GoCheck Kids Smartphone App
Device: GoCheck Kids (iOS) · Device: GoCheck Kids (Windows)

Interventions

DeviceGoCheck Kids (iOS)
Photorefraction method is used to screen amblyopia risk factors.
DeviceGoCheck Kids (Windows)
Photorefraction method is used to screen amblyopia risk factors.

What researchers measure

Primary outcomes

Sensitivity and specificity of amblyopia risk factors detected by photo refraction
Identification of risk factors as compared to gold standard cycloplegic refraction
Time frame: 1 Day

Secondary outcomes

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

Study locations

No study locations are listed for this record.

Registry details

Key details

Study ID: NCT03119675
Lead sponsor: Gobiquity Mobile Health
Responsible party: Sponsor
First posted: Apr 18, 2017
Start date: Nov 2016
Primary completion: Mar 2017
Completion: May 2017
Last update: Mar 13, 2018

Study contacts

Sean Donahue, MD, PhD

principal investigator · Vanderbilt University

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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