Back to resultsSmartphone Flicker Fusion Test for Patients With Optic Disorders.
Primary Purpose
Scotoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
eyeFusion
Sponsored by
About this trial
This is an interventional screening trial for Scotoma
Eligibility 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
Sites / Locations
- University of IowaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
eyeFusion Control Subjects
eyeFusion Patients
Arm Description
Healthy normal controls with no known eye disorders age 18-80.
Scotoma subjects aged 18-80.
Outcomes
Primary Outcome Measures
Assess Validity of the test construct measuring flicker fusion thresholds.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03475147
Brief Title
Smartphone Flicker Fusion Test for Patients With Optic Disorders.
Official Title
Validation of a Smartphone-Based Flicker Fusion Test
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 27, 2017 (Actual)
Primary Completion Date
January 1, 2026 (Anticipated)
Study Completion Date
January 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Randy Kardon
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scotoma
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
eyeFusion Control Subjects
Arm Type
Active Comparator
Arm Description
Healthy normal controls with no known eye disorders age 18-80.
Arm Title
eyeFusion Patients
Arm Type
Experimental
Arm Description
Scotoma subjects aged 18-80.
Intervention Type
Device
Intervention Name(s)
eyeFusion
Intervention Description
Smartphone app based flicker fusion test.
Primary Outcome Measure Information:
Title
Assess Validity of the test construct measuring flicker fusion thresholds.
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. 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.
Time Frame
1/1/2020
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Julie K Nellis, BSN
Phone
319-356-2780
Email
julie-nellis@uiowa.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Full, BSN
Phone
319-356-8299
Email
jan-full@uiowa.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Randy Kardon, MD, PhD
Organizational Affiliation
University of Iowa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Iowa
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52240
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Randy Kardon, MD, PhD
Phone
319-356-2260
Email
randy-kardon@uiowa.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Smartphone Flicker Fusion Test for Patients With Optic Disorders.
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