NCT03475147

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress85%
Jan 2017Jan 2028

Study Start

First participant enrolled

January 27, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

March 16, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 23, 2018

Completed
9.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2028

Last Updated

November 24, 2025

Status Verified

May 1, 2025

Enrollment Period

10.9 years

First QC Date

March 16, 2018

Last Update Submit

November 18, 2025

Conditions

Scotoma

Outcome Measures

Primary Outcomes (1)

  • 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.

    1/1/2020

Study Arms (2)

eyeFusion Control Subjects

ACTIVE COMPARATOR

Healthy normal controls with no known eye disorders age 18-80.

Device: eyeFusion

eyeFusion Patients

EXPERIMENTAL

Scotoma subjects aged 18-80.

Device: eyeFusion

Interventions

eyeFusionDEVICE

Smartphone app based flicker fusion test.

eyeFusion Control SubjectseyeFusion Patients

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Scotoma or any other ocular disorder
  • Age 18-80
  • Clinically associated scotoma
  • Any other ocular disorder

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Iowa

Iowa City, Iowa, 52240, United States

RECRUITING

MeSH Terms

Conditions

Scotoma

Condition Hierarchy (Ancestors)

Vision DisordersSensation DisordersNeurologic ManifestationsNervous System DiseasesEye DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Randy Kardon, MD, PhD

    University of Iowa

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie K Nellis, BSN

CONTACT

319-356-2780julie-nellis@uiowa.edu

Jan Full, BSN

CONTACT

319-356-8299jan-full@uiowa.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 16, 2018

First Posted

March 23, 2018

Study Start

January 27, 2017

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2028

Last Updated

November 24, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

US(1)