Feasibility of Visual Field Screening Apps (VISA)

Accuracy and Feasibility of Visual Field Screening Apps - the visualFields Easy App

A visual field (VF) is a measurement of how wide an area our eyes can see when fixed onto a point. Visual field testing is one of the ways of assessing how much vision there is in each eye and how much vision might have been lost over time. Defects in the visual field are seen in diseases such as glaucoma, which is one of the leading causes of blindness. VF tests should be performed regularly during outpatient appointments to help monitor these conditions before they progress. Monitoring individuals with VF defects presents a large strain on eye services at University Hospitals Southampton (UHS).

Recently an Apple iPad-based application called 'VisualFields easy' has been developed that could be used at home to test visual fields, opening up the possibility of remote monitoring. This is especially significant since the onset of the COVID-19 pandemic which has left outpatient clinics across the UK with large patient backlogs. However, it's not understood yet to what level of accuracy this iPad test can be performed by untrained people and whether the results of this test are medically reliable.

This study will measure if there's a correlation between iPad-based VF measurements and the standard clinic-based measurements taken by professionals. The potential of this app to be used at home will also be assessed with a usability questionnaire. These measurements will be taken during routine eye and neurology outpatient clinics at UHS. Home-based VF testing could allow those who weren't able to access eye services during the pandemic greater follow-up and monitoring. Through providing regular, up-to-date information on a patient's condition and progress, VF tests at home may improve outcomes. The investigators also foresee the benefits of this app on NHS clinical services, with the potential of reduced outpatient appointments and waiting times thus easing pressure on the NHS.

Study Overview

• Status: Completed
• Conditions: Visual Field Defect, Peripheral
• Intervention / Treatment: Diagnostic test: iPad-Based Visual Field Test

• Study Type: Observational
• Enrollment (Actual): 45

Contacts and Locations

Study Locations

• United Kingdom
  • Southampton, United Kingdom, SO16 6YD
    • Eye Unit, University Hospitals Southampton NHS Foundation Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 17 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All participants will be recruited from the ophthalmology and neurology outpatient clinics in Southampton General Hospital. Typically, patients in these clinics are seen for a variety of ocular and neurological diagnoses and will be undergoing visual field testing as part of their routine care.

Description

Inclusion Criteria:

• Participant aged 17 or older
• Familiar with and able to use tablet technology

Exclusion Criteria:

• Patient not willing to participate in the study and give written informed consent
• Patients with learning difficulties that preclude reliable assessment of visual fields

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy of the visualFields easy App	To determine the statistical strength and / or presence or absence of correlation between the iPad-based visual field assessment procedure in comparison to clinic-based visual field assessment.	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of home-based visual field assessment	To explore through a quantitative questionnaire, the possible feasibility and utility of home-based visual field assessment	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: University Hospital Southampton NHS Foundation Trust
• Collaborators: University of Southampton
• Investigators: Principal Investigator: Helena Lee, PhD, Associate Professor & Honorary Consultant Ophthalmologist

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 10, 2021
• Primary Completion (ACTUAL): August 19, 2022
• Study Completion (ACTUAL): August 19, 2022

Study Registration Dates

• First Submitted: September 20, 2021
• First Submitted That Met QC Criteria: December 9, 2021
• First Posted (ACTUAL): December 27, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 26, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: RHM OPH0297

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: No