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NCT03447171 Clinical Trial

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

Amblyopia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03447171
Other study ID # 2018-001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date February 7, 2018
Est. completion date June 4, 2018

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

Clinical Trial 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).

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 207
Est. completion date June 4, 2018
Est. primary completion date June 4, 2018
Accepts healthy volunteers No
Gender All
Age group 1 Year to 8 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• App Vision Screening
Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors

Locations
Country Name City State
United States Alaska Children's Eye & Strabismus Anchorage Alaska

Sponsors (1)
Lead Sponsor Collaborator
Gobiquity Mobile Health

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Sensitivity and specificity of amblyopia risk factors detected by Photorefraction Identification of risk factors 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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