GlaucomaNCT04273438
Determining the Clinical Utility of Using Virtual Reality Headsets to Assess Visual Function in Those With Glaucoma.
An observational study of Glaucoma, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
To validate a new virtual reality (VR) based visual field test against the gold standard clinical perimetry test (Humphrey Visual field test 24-2). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter and Visual Field Testing using HUmphrey 24-3 Perimeter
- Type of treatment
- Medical device
- How many people
- 17 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 31 Dec 2020
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Professor Azuara-Blanco will identify participants who meet the criteria from his NHS clinics at the Shankill Health and Well-being Centre. He is part of both the direct care team and also a co-investigator on this application. Opportunistic sampling will be used to ensure that different severity levels of visual field deficit will be represented within the sample. Identification of potential participants will involve reviewing their patient records.
Who may be able to join
- Patients with a clinical diagnosis of glaucoma with repeatable defects on standard automated perimetry.
Who cannot join
- Presence of other ocular disease which impacts vision such as age-related macular degeneration or diabetic retinopathy.
- Any physical limitation that would make the participant unable to place their head in the head-rest to perform Humphrey Perimetry (Eg some patients with arthritic or neck problems are unable to use the headrests of ophthalmic devices).
- Any cognitive impairment that would limit their ability to perform perimetry or a history of vertigo/dizziness.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
NI Clinical Research Facility
Belfast, Northern Ireland, BT9 7AB
About this study
To validate a new virtual reality (VR) based visual field test against the gold standard clinical perimetry test (Humphrey Visual field test 24-2).
Read the detailed description
Perimetry (or visual field testing) is a vision test used to evaluate a patient's peripheral vision. It involves a patient fixating on a central target and pressing a button when they see a spot of light in their peripheral vision. It is an important way of deciding whether Glaucoma is progressing or not. Next generation virtual reality (VR) technologies offer an exciting new way of conducting perimetry in either a clinical or home environment, allowing more affordable and more frequent monitoring of disease progression in glaucoma, and an easier and more comfortable experience for patients. The investigators propose to create a perimetry test using a commercially available head mounted display for VR, and to assess its accuracy in glaucoma patients in relation to standard automated perimetry.
- Conditions
- Glaucoma
- Being tested
- Visual field testing using Oculus Rift and Humphrey Visual Field Perimeter, Visual Field Testing using HUmphrey 24-3 Perimeter
- Keywords
- Perimetry, Virtual Reality, Visual field testing
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visual field testing using Oculus Rift and Humphrey Visual Field PerimeterDevice
Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.
Visual Field Testing using HUmphrey 24-3 PerimeterDevice
Glaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments.
What is being measured
The primary outcome is the main question the study is designed to answer.
mean deviation (MD)
Mean deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent generalised loss of visual function.
Measured: All statisitcal analysis will take place once all data collection has ended, average 1 year..
Pattern Standard Deviation
Pattern standard deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent localised loss of visual function.
Measured: All statisitcal analysis will take place once all data collection has ended, average 1 year..
Secondary outcomes (1)
Repeatbility of both devices
Bland and Altman plots and intra-class correlation coefficients will be generated for both tests for visit 1 vs visit 2 data.
Measured: All statisitcal analysis will take place once all data collection has ended, average 1 year..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start1 Oct 2018
- Primary completion30 Sep 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies 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
- Prospective
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University, Belfast
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sussex
- Responsible party
- Principal investigator, Ruth Hogg, Queen's University, Belfast
- Investigators
- Ruth E Hogg, PhD, Principal investigator, Queen's University, Belfast
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04273438
- Sponsor's protocol ID
- 16/NI/0251
- Status last verified
- Oct 2026
- First submitted
- 12 Aug 2019
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Clinical Utility of Using Virtual Reality Headsets to Assess Visual Function in Those With Glaucoma.
- ClinicalTrials.gov ID
- NCT04273438
- Acronym / sponsor ID
- 16/NI/0251
- Conditions
- Glaucoma
- Keywords
- Perimetry, Virtual Reality, Visual field testing
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Sussex
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 18 Feb 2020 (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.
To validate a new virtual reality (VR) based visual field test against the gold standard clinical perimetry test (Humphrey Visual field test 24-2).
Detailed description
Perimetry (or visual field testing) is a vision test used to evaluate a patient's peripheral vision. It involves a patient fixating on a central target and pressing a button when they see a spot of light in their peripheral vision. It is an important way of deciding whether Glaucoma is progressing or not. Next generation virtual reality (VR) technologies offer an exciting new way of conducting perimetry in either a clinical or home environment, allowing more affordable and more frequent monitoring of disease progression in glaucoma, and an easier and more comfortable experience for patients. The investigators propose to create a perimetry test using a commercially available head mounted display for VR, and to assess its accuracy in glaucoma patients in relation to standard automated perimetry.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Professor Azuara-Blanco will identify participants who meet the criteria from his NHS clinics at the Shankill Health and Well-being Centre. He is part of both the direct care team and also a co-investigator on this application. Opportunistic sampling will be used to ensure that different severity levels of visual field deficit will be represented within the sample. Identification of potential participants will involve reviewing their patient records.
Key inclusion criteria (1 listed)
- Patients with a clinical diagnosis of glaucoma with repeatable defects on standard automated perimetry.
Key exclusion criteria (3 listed)
- Presence of other ocular disease which impacts vision such as age-related macular degeneration or diabetic retinopathy.
- Any physical limitation that would make the participant unable to place their head in the head-rest to perform Humphrey Perimetry (Eg some patients with arthritic or neck problems are unable to use the headrests of ophthalmic devices).
- Any cognitive impairment that would limit their ability to perform perimetry or a history of vertigo/dizziness.
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 |
|---|---|---|
| Visual field testing using Oculus Rift and Humphrey Visual Field PerimeterGlaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments. | Device | – |
| Visual Field Testing using HUmphrey 24-3 PerimeterGlaucoma patients at Queen's University, Belfast, will be invited to undergo both Visual field testing using the Oculus Rift and the gold-standard Humphrey 24-2 (Carl Zeiss Meditec, Dublin, CA) at two visits, and evaluating consistency for detecting visual field impairments. | Device | – |
Primary outcome
mean deviation (MD)
Time frame: All statisitcal analysis will take place once all data collection has ended, average 1 year..
Mean deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent generalised loss of visual function.
Pattern Standard Deviation
Time frame: All statisitcal analysis will take place once all data collection has ended, average 1 year..
Pattern standard deviation in decibels (dB), this is a standard summary measure generated by all perimetric tests and is considered to represent localised loss of visual function.
1 secondary outcome
Repeatbility of both devices
Time frame: All statisitcal analysis will take place once all data collection has ended, average 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 26 Oct 2026.
- 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.
Ruth E Hogg, PhD principal investigator
Queen's University, Belfast
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 Glaucoma, run by Queen's University, Belfast 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 1 inclusion and 3 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 26 Oct 2026. 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?
mean deviation (MD) (time frame: All statisitcal analysis will take place once all data collection has ended, average 1 year..). The study lists 2 primary outcomes in all. 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 26 Oct 2026.