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Smartphone Flicker Fusion Test for Patients With Optic Disorders.

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ClinicalTrials.gov Identifier: NCT03475147
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : July 16, 2018
Sponsor:
Information provided by (Responsible Party):
Randy Kardon, University of Iowa

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.

Condition or disease Intervention/treatment Phase
Scotoma Device: eyeFusion Not Applicable

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 : Interventional  (Clinical Trial)
Estimated Enrollment : 500 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Validation of a Smartphone-Based Flicker Fusion Test
Actual Study Start Date : January 27, 2017
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : January 1, 2020

Arm Intervention/treatment
Active Comparator: eyeFusion Control Subjects
Healthy normal controls with no known eye disorders age 18-80.
Device: eyeFusion
Smartphone app based flicker fusion test.

Experimental: eyeFusion Patients
Scotoma subjects aged 18-80.
Device: eyeFusion
Smartphone app based flicker fusion test.




Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03475147


Contacts
Contact: Julie K Nellis, BSN 319-356-2780 julie-nellis@uiowa.edu
Contact: Jan Full, BSN 319-356-8299 jan-full@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52240
Contact: Randy Kardon, MD, PhD    319-356-2260    randy-kardon@uiowa.edu   
Sponsors and Collaborators
Randy Kardon
Investigators
Principal Investigator: Randy Kardon, MD, PhD University of Iowa

Responsible Party: Randy Kardon, MD, PhD, University of Iowa
ClinicalTrials.gov Identifier: NCT03475147     History of Changes
Other Study ID Numbers: 201610703
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: July 16, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Additional relevant MeSH terms:
Scotoma
Vision Disorders
Sensation Disorders
Neurologic Manifestations
Nervous System Diseases
Eye Diseases
Signs and Symptoms