Condition category
Eye Diseases
Date applied
14/01/2015
Date assigned
08/07/2015
Last edited
08/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

www.hw.ac.uk

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes