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NCT03119675 Clinical Trial

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

Amblyopia Clinical Trial

Official title:
Prospective Evaluation of a Smartphone Application, GoCheckKids™ as a Photo Screening Tool in a Pediatric Population

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03119675
Other study ID # 2016-001
Secondary ID
Status Completed
Phase N/A
First received April 11, 2017
Last updated March 12, 2018
Start date November 2016
Est. completion date May 2017

Study information
Verified date March 2018
Source Gobiquity Mobile Health
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 358
Est. completion date May 2017
Est. primary completion date March 2017
Accepts healthy volunteers No
Gender All
Age group 1 Year to 6 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• GoCheck Kids (iOS)
Photorefraction method is used to screen amblyopia risk factors.
• GoCheck Kids (Windows)
Photorefraction method is used to screen amblyopia risk factors.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Gobiquity Mobile Health

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Number of patients with gaze error identified by photo screening Detection of gaze error compared to cover test examination results 1 day
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