Smartphone Flicker Fusion Test for Patients With Optic Disorders.

September 14, 2023 updated by: Randy Kardon

Validation of a Smartphone-Based Flicker Fusion Test

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52240
        • Recruiting
        • University of Iowa
        • Contact:

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

16 years to 78 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

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

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

  • Primary Purpose: Screening
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1/1/2020

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Randy Kardon

Investigators

  • Principal Investigator: Randy Kardon, MD, PhD, University of Iowa

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)

January 27, 2017

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

January 1, 2026

Study Registration Dates

First Submitted

March 16, 2018

First Submitted That Met QC Criteria

March 16, 2018

First Posted (Actual)

March 23, 2018

Study Record Updates

Last Update Posted (Actual)

September 15, 2023

Last Update Submitted That Met QC Criteria

September 14, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201610703

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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.

Yes

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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