Visual Field Defect, PeripheralVISANCT05169983
Feasibility of Visual Field Screening Apps
An observational study of Visual Field Defect, Peripheral, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 17 years and older
- Conditions the study is for
- Visual Field Defect, Peripheral
- What is being tested?
- iPad-Based Visual Field Test
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 10 Sep 2021to 19 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 17 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- Participant aged 17 or older
- Familiar with and able to use tablet technology
Who cannot join
- Patient not willing to participate in the study and give written informed consent
- Patients with learning difficulties that preclude reliable assessment of visual fields
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Eye Unit, University Hospitals Southampton NHS Foundation Trust
Southampton, SO16 6YD
About this study
Official title: 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.
- Conditions
- Visual Field Defect, Peripheral
- Being tested
- iPad-Based Visual Field Test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iPad-Based Visual Field TestDiagnostic 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Through study completion, an average of 1 year
Secondary outcomes (1)
Feasibility of home-based visual field assessment
To explore through a quantitative questionnaire, the possible feasibility and utility of home-based visual field assessment
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2021
- Study start10 Sep 2021
- Primary completion19 Aug 2022
- Study completion19 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Visual Field Defect, PeripheralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- University of Southampton
- Responsible party
- Sponsor
- Investigators
- Helena Lee, PhD, Principal investigator, Associate Professor & Honorary Consultant Ophthalmologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05169983
- Sponsor's protocol ID
- RHM OPH0297
- Acronym
- VISA
- Status last verified
- Oct 2022
- First submitted
- 20 Sep 2021
- Last updated
- 27 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy and Feasibility of Visual Field Screening Apps - the visualFields Easy App
- ClinicalTrials.gov ID
- NCT05169983
- Acronym / sponsor ID
- VISA / RHM OPH0297
- Conditions
- Visual Field Defect, Peripheral
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- University of Southampton
- Study start
- 10 Sep 2021 (actual)
- Primary completion
- 19 Aug 2022 (actual)
- Study completion
- 19 Aug 2022 (actual)
- First posted
- 27 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 17 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Participant aged 17 or older
- Familiar with and able to use tablet technology
Key exclusion criteria (2 listed)
- Patient not willing to participate in the study and give written informed consent
- Patients with learning difficulties that preclude reliable assessment of visual fields
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iPad-Based Visual Field TestIn 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. | Diagnostic test | – |
Primary outcome
Accuracy of the visualFields easy App
Time frame: Through study completion, an average of 1 year
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.
1 secondary outcome
Feasibility of home-based visual field assessment
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Helena Lee, PhD principal investigator
Associate Professor & Honorary Consultant Ophthalmologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Visual Field Defect, Peripheral, run by University Hospital Southampton NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Accuracy of the visualFields easy App (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2022.