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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05169983
Other study ID # RHM OPH0297
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 10, 2021
Est. completion date August 19, 2022

Study information

Verified date October 2022
Source University Hospital Southampton NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 45
Est. completion date August 19, 2022
Est. primary completion date August 19, 2022
Accepts healthy volunteers No
Gender All
Age group 17 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
iPad-Based Visual Field Test
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.

Locations

Country Name City State
United Kingdom Eye Unit, University Hospitals Southampton NHS Foundation Trust Southampton

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Southampton NHS Foundation Trust University of Southampton

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
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