Effect of head-mounted displays on the ability of individuals with poor eye sight to see and read
| ISRCTN | ISRCTN16087935 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16087935 |
| Protocol serial number | 2 |
| Sponsor | Heriot-Watt University |
| Funder | Heriot-Watt University (UK) |
- Submission date
- 14/01/2015
- Registration date
- 08/07/2015
- Last edited
- 19/04/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Eye Diseases
Plain English summary of protocol
Background and study aims
Conditions that affect sight are more likely to result in partial blindness than in total loss of sight; the ratio of people with low vision to blindness is 10 to 1 in Europe according to the World Health Organization. The most common cause of blindness in the west is age-related macular degeneration, a condition that affects the central area of vision but not the peripheral (side) vision. Most people with visual impairment need some kind of vision aid to make best use of their residual vision. This aid can be an optical magnifier or, for stronger magnification and better field of view, an electronic magnifier connected to a computer monitor. These head-mounted displays (HMDs) are comprised of one or two small screens (monocular or binocular) placed close to the eyes, with lenses that make the display appear at a comfortable viewing distance. The screens can be opaque, like conventional monitors, or transparent. This study aims to gain further knowledge of the usefulness of HMDs for people who are partly sighted and compare two available models.
Who can participate?
Adults with partial sight.
What does the study involve?
Participants are allocated to one of two groups. Those in group 1 (intervention) wear the Epson Moverio BT-200 HMD. Those in group 2 (intervention) wear the Oculus Rift HMD. All participants wear the HMDs for around 45 minutes during the study, and ability to see the display and speed of reading is assessed.
What are the possible benefits and risks of participating?
The benefits are improvement in the ability to see and read.
Where is the study run from?
Princess Alexandra Eye Pavilion (UK)
When is the study starting and how long is it expected to run for?
September 2014 to June 2016
Who is funding the study?
Heriot-Watt University (UK)
Who is the main contact?
1. Mr H Moshtael (scientific)
2. Dr L Fu (public)
lfu@doctors.org.uk
Contact information
Scientific
Scottish Microelectronics Centre, Kings Buildings
West Mains Road
Edinburgh
EH9 3JF
United Kingdom
 ORCID ID |
0000-0001-6805-2710 |
|---|
Public
Princess Alexandra Eye Pavilion, 45 Chalmers Street
Edinburgh
EH3 9HA
United Kingdom
| ORCID ID |
0000-0003-1959-9749 |
|---|---|
| Phone | +44 (0)1315361772 |
| lfu@doctors.org.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single centre interventional study |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Effect of head-mounted displays on the ability of patients with macular disease to see and read: a pilot study |
| Study objectives | 1. To gather data on the ability of patients with age-related macular disease to see and read from two head-mounted displays (HMDs); the results will inform the development of techniques to modify the presentation of text on the display in order to enhance patients' reading ability. 2. A pilot trial will measure the extent to which patients can see the displays and their ability to read from them. 3. A subsequent main trial will then test the efficacy of these techniques. |
| Ethics approval(s) | Health Research Authority, 07/01/2015, ref: 14/EM/1322 |
| Health condition(s) or problem(s) studied | Macular disease, particularly age-related macular degeneration |
| Intervention | The usefulness of the two kinds of HMDs for people with a central scotoma will be investigated: 1. Epson Moverio BT-200, a transparent glasses-like HMD. 2. Oculus Rift, an opaque and immersive HMD. |
| Intervention type | Device |
| Phase | |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Extent to which patients can see the display, measured with a perimetry-style test. |
| Key secondary outcome measure(s) |
Reading speed will be measured using the Radner reading chart at baseline, to be compared with reading speed using the head-mounted display. |
| Completion date | 24/06/2016 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 10 |
| Total final enrolment | 10 |
| Key inclusion criteria | 1. Macular disease, including Stargardt’s macular dystrophy and age-related macular degeneration 2. Not undergoing active treatment 3. Able to provide consent |
| Key exclusion criteria | 1. Undergoing intravitreal therapy 2. Does not have mental capacity to consent or comply with the trial protocol |
| Date of first enrolment | 02/02/2015 |
| Date of final enrolment | 20/03/2015 |
Locations
Countries of recruitment
- United Kingdom
- Scotland
Study participating centre
EH3 9HA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | Yes |
|---|---|
| IPD sharing plan summary | Other |
| IPD sharing plan | The datasets generated and/or analysed during the current study during this study will be included in the subsequent results publication. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2019 | 25/03/2021 | Yes | No | |
| Book results | results | 04/06/2016 | 22/03/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
19/04/2021: Internal review.
25/03/2021: Publication references added.
23/03/2021: IPD sharing statement added.
22/03/2021: Publication reference and total final enrolment added.
