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Smartphone Flicker Fusion Test for Patients With Optic Disorders.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03475147
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : January 21, 2020
Sponsor:
Information provided by (Responsible Party):
Randy Kardon, University of Iowa

Tracking Information
First Submitted Date  ICMJE March 16, 2018
First Posted Date  ICMJE March 23, 2018
Last Update Posted Date January 21, 2020
Actual Study Start Date  ICMJE January 27, 2017
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 12, 2018)
Assess Validity of the test construct measuring flicker fusion thresholds. [ Time Frame: 1/1/2020 ]
The smartphone app developed is a flicker fusion that presents the subject with a series of stimuli consisting of a flickering pattern of bars above or below a static rectangle. The study will assess the validity of the test construct in measuring flicker fusion thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies.
Original Primary Outcome Measures  ICMJE
 (submitted: March 16, 2018)
Assess Validity of the test construct measuring flicker fusion thresholds. [ Time Frame: 1/1/2020 ]
Assess validity of the test construct measuring flicker fusion thresholds.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Smartphone Flicker Fusion Test for Patients With Optic Disorders.
Official Title  ICMJE Validation of a Smartphone-Based Flicker Fusion Test
Brief Summary The purpose of this project is to validate a quick, easy-to-use and administer smartphone flicker fusion test. The app (called eyeFusion) can potentially be used to easily and quickly collect critical flicker fusion measurements on patients admitted with optic disorders as part of the clinical care process.
Detailed Description

The smartphone app developed is a flicker fusion that presents the subject with a series of stimuli consisting of a flickering pattern of bars above or below a static rectangle. For each stimulus presentation, the user has to tap the region that is flickering. The duration of the app is less than 2 minutes.

This study will assess the validity of the test construct in measuring flicker fusion thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Scotoma
Intervention  ICMJE Device: eyeFusion
Smartphone app based flicker fusion test.
Study Arms  ICMJE
  • Active Comparator: eyeFusion Control Subjects
    Healthy normal controls with no known eye disorders age 18-80.
    Intervention: Device: eyeFusion
  • Experimental: eyeFusion Patients
    Scotoma subjects aged 18-80.
    Intervention: Device: eyeFusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 16, 2018)
500
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE January 1, 2021
Estimated Primary Completion Date January 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Control

  • Age matched 18-80 years of age.
  • Healthy normal controls with no known eye disorders.

Exclusion Criteria:

  • Scotoma or any other ocular disorder

Inclusion Criteria - Patients

  • Age 18-80
  • Clinically associated scotoma

Exclusion Criteria - Patients

-Any other ocular disorder

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Julie K Nellis, BSN 319-356-2780 julie-nellis@uiowa.edu
Contact: Jan Full, BSN 319-356-8299 jan-full@uiowa.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03475147
Other Study ID Numbers  ICMJE 201610703
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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.: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Randy Kardon, University of Iowa
Study Sponsor  ICMJE Randy Kardon
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Randy Kardon, MD, PhD University of Iowa
PRS Account University of Iowa
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP