Low VisionNCT04281732
Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
An observational study of Low Vision and Retinitis Pigmentosa, run by Queen's University, Belfast at 1 site in United Kingdom.
Trial summary
Purpose: To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a… Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Low Vision, Retinitis Pigmentosa, Stargardt Disease 1
- What is being tested?
- Virtual Reality Headset based tests
- Type of treatment
- Medical device
- How many people
- 18 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Oct 2018to 31 Dec 2021
- 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 20 to 50 years
- All sexes
- Adult
Study population: Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.
Who may be able to join
- Male and female participants
- Age 20-50
- Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
- Sight impairment criteria are as follows:
- Visual acuity of 3 / 60 to 6 / 60 with a full field of vision.
- Visual acuity of up to 6 / 24 with a moderate reduction of field of vision
Who cannot join
- Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
- A history of vertigo or 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
Purpose:
To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.
Read the detailed description
Aims of the Research Project:
- To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
- To quantify the reproducibility of the performance-based tests.
- To gather acceptability and ease-of-use data from patients.
- Conditions
- Low Vision, Retinitis Pigmentosa, Stargardt Disease 1, Stargardt Disease 3, Stargardt Disease 4, Albinism
- Being tested
- Virtual Reality Headset based tests
- Keywords
- Virtual Reality, Quality of life
- Medical subject headings
- Vision, Low, Retinitis Pigmentosa, Stargardt Disease, Stargardt disease 3, Stargardt disease 4, Albinism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Headset based testsDevice
Visual task tests based on Oculus Rift
What is being measured
The primary outcome is the main question the study is designed to answer.
Test repeatability
Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.
Measured: All statistical analysis will take place once all data collection has ended, average 1 year.
Secondary outcomes (1)
Ease of use and acceptability questionnaire
Modified from Tay et al, Br J Ophthalmol 2004;88:719-720
Ask the following questions for virtual reality test:
- Was the test comfortable? If no- How?
- Was the test too long?
- How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how?
- How would you feel if you knew you had to perform this test at every clinic appointment?
- Do you have any other comments about the test?
Measured: Responses from all participants will be collated and summarised at the end of the study, 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 posted24 Feb 2020
- Study start1 Oct 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low VisionStudies 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
- 18 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
- NCT04281732
- Sponsor's protocol ID
- 17/NI/0002
- 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
- Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision
- ClinicalTrials.gov ID
- NCT04281732
- Acronym / sponsor ID
- 17/NI/0002
- Conditions
- Low Vision, Retinitis Pigmentosa, Stargardt Disease 1, Stargardt Disease 3, Stargardt Disease 4, Albinism
- Keywords
- Virtual Reality, Quality of life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Queen's University, BelfastUniversity, hospital or other
- Collaborators
- University of Sussex
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 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.
Purpose:
To validate a newly developed battery of performance-based tests of visual function to be presented using virtual reality. The tests are intended as potential outcome measures for clinical trials of treatments of eye disease: they measure visual performance in patients with low vision on visual tasks that a relevant for daily life.
Detailed description
Aims of the Research Project:
- To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
- To quantify the reproducibility of the performance-based tests.
- To gather acceptability and ease-of-use data from patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Age groups
- Adult
- Study population
- Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.
Key inclusion criteria (6 listed)
- Male and female participants
- Age 20-50
- Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
- Sight impairment criteria are as follows:
Key exclusion criteria (2 listed)
- Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
- A history of vertigo or 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 |
|---|---|---|
| Virtual Reality Headset based testsVisual task tests based on Oculus Rift | Device | – |
Primary outcome
Test repeatability
Time frame: All statistical analysis will take place once all data collection has ended, average 1 year.
Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.
1 secondary outcome
Ease of use and acceptability questionnaire
Time frame: Responses from all participants will be collated and summarised at the end of the study, 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 Low Vision and Retinitis Pigmentosa, 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 6 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 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?
Test repeatability (time frame: All statistical analysis will take place once all data collection has ended, average 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 26 Oct 2026.