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
Secondary identifying numbers	2

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Mr Howard Moshtael
Scientific

Scottish Microelectronics Centre, Kings Buildings
West Mains Road
Edinburgh
EH9 3JF
United Kingdom

ORCID ID	0000-0001-6805-2710

Dr Lana Fu
Public

Princess Alexandra Eye Pavilion, 45 Chalmers Street
Edinburgh
EH3 9HA
United Kingdom

ORCID ID	0000-0003-1959-9749
Phone	+44 (0)1315361772
Email	lfu@doctors.org.uk

Study information

Study design	Single centre interventional study
Primary study design	Interventional
Secondary study design	Non randomised study
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	Not available in web format, please use contact details to request a 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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	Extent to which patients can see the display, measured with a perimetry-style test.
Secondary outcome measures	Reading speed will be measured using the Radner reading chart at baseline, to be compared with reading speed using the head-mounted display.
Overall study start date	01/09/2014
Completion date	24/06/2016

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	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

Scotland
United Kingdom

Study participating centre

Princess Alexandra Eye Pavilion

Edinburgh
EH3 9HA
United Kingdom

Sponsor information

Heriot-Watt University
University/education

Edinburgh Campus
Edinburgh
EH14 4AS
Scotland
United Kingdom

Phone	+44 (0)131 449 5111
Email	enquiries@hw.ac.uk
Website	www.hw.ac.uk
"ROR"	https://ror.org/04mghma93

Funders

Funder type

University/education

Heriot-Watt University (UK)

No information available

Results and Publications

Intention to publish date	01/06/2015
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Other
Publication and dissemination plan	We intend to publish an article on the pilot trial during summer 2015. 2017 results published in thesis: https://www.ros.hw.ac.uk/handle/10399/3411?show=full (added 25/03/2021)
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?
Book results	results	04/06/2016	22/03/2021	No	No
Results article		01/12/2019	25/03/2021	Yes	No
HRA research summary			28/06/2023	No	No

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.