ClinicalTrials.gg
CompletedNCT04281732Updated Oct 26, 2026

Visual Performance Measures in a Virtual Reality Environment for Assessing Clinical Trial Outcomes in Those With Severely Reduced Vision

An observational study in Low Vision, Retinitis Pigmentosa and Stargardt Disease 1, sponsored by Queen's University, Belfast. Completed at 1 site in United Kingdom. Open to participants aged 20 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Queen's University, Belfast · Observational

Updated Oct 26, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
18
Ages
20 Years to 50 Years
Sex
All
01

Study 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 relevant for daily life.

Read the detailed description

Aims of the Research Project:

  1. To validate a new virtual reality (VR)-based battery of performance-based tests of visual function that are relevant for patients' daily lives.
  2. To quantify the reproducibility of the performance-based tests.
  3. To gather acceptability and ease-of-use data from patients.
02

Conditions studied

  • Low Vision
  • Retinitis Pigmentosa
  • Stargardt Disease 1
  • Stargardt Disease 3
  • Stargardt Disease 4
  • Albinism

Keywords

  • Virtual Reality
  • Quality of life
03

In context

Vision, Low

98 studies on the registry are indexed under Vision, Low; 23 are open to participants now.

This study's enrollment of 18 is below the median of 100 across 19 observational studies indexed under Vision, Low.

Browse Vision, Low studies →

Lead sponsor

Queen's University, Belfast is the lead sponsor of 117 studies on the registry; 14 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 50 Years
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Patients with Stargardt's disease, advanced retinitis pigmentosa and Albinism.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. Male and female participants
  2. Age 20-50
  3. Bilateral sight impairment due to Stargardt's disease, retinitis pigmentosa or albinism.
  4. 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

Exclusion criteria

Exclusion Criteria:

  1. Any physical impairment that would make use of the virtual reality headset difficult or unsafe.
  2. A history of vertigo or dizziness.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
18 participants (actual)
Patient registry
No

Interventions

  • DeviceVirtual Reality Headset based tests

    Visual task tests based on Oculus Rift

06

What researchers measure

Primary outcomes

  1. Test repeatability

    Bland and Altman analysis will be used to investigate the repeatability of the tests between visit 1 and visit 2.

    Time frame: 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: 1. Was the test comfortable? If no- How? 2. Was the test too long? 3. How did you find the test? Would you describe it as easy or difficult? If you found it difficult- how? 4. How would you feel if you knew you had to perform this test at every clinic appointment? 5. Do you have any other comments about the test?

    Time frame: Responses from all participants will be collated and summarised at the end of the study, average 1 year.

07

Study locations

1 site
  • NI Clinical Research Facility
    Belfast, Northern Ireland BT9 7AB, United Kingdom
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Updates

1 registry update since Sep 25, 2026
Status
Status unknown→Completed
changed Oct 26, 2026
Primary completion
Sep 30, 2020→Dec 31, 2021 (actual)
Oct 26, 2026
Study completion
Dec 31, 2020→Dec 31, 2021 (actual)
Oct 26, 2026
Enrollment
20 (estimated)→18 (actual)
Oct 26, 2026
Show all 1 update
  1. Oct 26, 2026
    Status unknown→Completed
    Primary completion Sep 30, 2020→Dec 31, 2021 (now actual)
    Study completion Dec 31, 2020→Dec 31, 2021 (now actual)
    Enrollment 20 (estimated)→18 (actual)
    + 4 other changes: verification date, contact details, site details and index terms

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04281732
Collaborators
University of Sussex
Responsible party
Ruth Hogg (Principal Investigator, Queen's University, Belfast) — Principal investigator
First posted
Feb 24, 2020
Start date
Oct 1, 2018
Primary completion
Dec 31, 2021
Completion
Dec 31, 2021
Last update
Oct 26, 2026

Study contacts

Ruth E Hogg, PhD
principal investigator · Queen's University, Belfast

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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