Plain English Summary
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
Trial website
Contact information
Type
Scientific
Primary contact
Mr Howard Moshtael
ORCID ID
http://orcid.org/0000-0001-6805-2710
Contact details
Scottish Microelectronics Centre
Kings Buildings
West Mains Road
Edinburgh
EH9 3JF
United Kingdom
Type
Public
Additional contact
Dr Lana Fu
ORCID ID
http://orcid.org/0000-0003-1959-9749
Contact details
Princess Alexandra Eye Pavilion
45 Chalmers Street
Edinburgh
EH3 9HA
United Kingdom
+44 (0)1315361772
lfu@doctors.org.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2
Study information
Scientific title
Effect of head-mounted displays on the ability of patients with macular disease to see and read: a pilot study
Acronym
Study hypothesis
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
Health Research Authority, 07/01/2015, ref: 14/EM/1322
Study design
Single centre interventional study
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Hospitals
Trial type
Quality of life
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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 names
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 trial start date
01/09/2014
Overall trial end date
24/06/2016
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
10
Participant exclusion criteria
1. Undergoing intravitreal therapy
2. Does not have mental capacity to consent or comply with the trial protocol
Recruitment start date
02/02/2015
Recruitment end date
20/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Princess Alexandra Eye Pavilion
Edinburgh
EH3 9HA
United Kingdom
Sponsor information
Organisation
Heriot-Watt University
Sponsor details
Edinburgh Campus
Edinburgh
EH14 4AS
United Kingdom
+44 (0)131 449 5111
enquiries@hw.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Heriot-Watt University (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
We intend to publish an article on the pilot trial during summer 2015.
Intention to publish date
01/06/2015
Participant level data
Stored in repository
Basic results (scientific)
Publication list