NCT05169983

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 10, 2021

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

September 20, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

December 27, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 19, 2022

Completed
Last Updated

October 27, 2022

Status Verified

October 1, 2022

Enrollment Period

11 months

First QC Date

September 20, 2021

Last Update Submit

October 26, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Feasibility of home-based visual field assessment

    Through study completion, an average of 1 year

Interventions

In this study, the investigators aim to teach the participants to use the the visualFields easy App . The investigators will be using the app in the clinic with the patients watching, demonstrating its use and discussing and explaining its functions. Having observed how to use the application, the participant will then complete the visual field assessment.

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eye Unit, University Hospitals Southampton NHS Foundation Trust

Southampton, SO16 6YD, United Kingdom

Location

Study Officials

  • Helena Lee, PhD

    Associate Professor & Honorary Consultant Ophthalmologist

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2021

First Posted

December 27, 2021

Study Start

September 10, 2021

Primary Completion

August 19, 2022

Study Completion

August 19, 2022

Last Updated

October 27, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will not share

Locations