- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03447171
Prospective Evaluation of a Smartphone Application, GoCheckKids™, to Detect Amblyopia Risk Factors in Young Children
August 2, 2018 updated by: Gobiquity Mobile Health
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).
Study Overview
Detailed Description
Detection of amblyopia risk factors using photo screening app in children of ages from 12 months to 8 years
Study Type
Observational
Enrollment (Actual)
207
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Alaska
-
Anchorage, Alaska, United States, 99508
- Alaska Children's EYE & Strabismus
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year to 8 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Study population will be selected from eye clinics.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Refractive Error
|
Using GoCheck Kids App Vision Screening to detect Amblyopia Risk Factors
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Sensitivity and specificity of amblyopia risk factors detected by Photorefraction
Time Frame: 1 day
|
Identification of risk factors compared to gold standard cycloplegic refraction
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with gaze error identified by photo screening
Time Frame: 1 day
|
Detection of gaze error compared to cover test examination results
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Sean Donahue, MD, PhD, Vanderbilt University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 7, 2018
Primary Completion (Actual)
June 4, 2018
Study Completion (Actual)
June 4, 2018
Study Registration Dates
First Submitted
February 21, 2018
First Submitted That Met QC Criteria
February 21, 2018
First Posted (Actual)
February 27, 2018
Study Record Updates
Last Update Posted (Actual)
August 3, 2018
Last Update Submitted That Met QC Criteria
August 2, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2018-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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