Condition category
Ear, Nose and Throat
Date applied
07/01/2021
Date assigned
08/01/2021
Last edited
08/01/2021
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

Plain English Summary

Background and study aims
Sight is considered by many as our most important sense. After stroke a common problem is ‘hemianopia’; loss of one half of the visual field leaving people with a ‘blind’ side to their right or left side. Hemianopia occurs suddenly in 30% of stroke survivors with devastating impact on quality of life - individuals cannot drive, bump into people/objects, and can lead to loss of independence, falls and depression. Treatment to help stroke patients compensate for visual field loss is variable and not standardised in the NHS because of uncertainty about what works best and when is the best time to offer treatment. This causes an unacceptable difference in the care individuals receive. Visual scanning training involves repeated practice by the patient at locating different targets on both seeing and blind sides of their visual field. Training can be provided by many methods – some needing paper cards and others needing computers. Paper-based visual scanning training is available to ALL patients; computer training is not. A review of treatment options for hemianopia concluded that visual scanning training is potentially useful. We recently completed a pilot trial (VISION) to test a training card for visual scanning (involving repeated practice by the patient at locating different targets on both seeing and blind sides of their visual field). Our training shows promise and will be carefully investigated in this full trial. We aim to find out how effective paper-based visual scanning training is for hemianopia after stroke.

Who can participate?
Patients aged 18 or over who have recently had a stroke and are having problems with their vision known as homonymous hemianopia.

What does the study involve?
In a randomised clinical trial 71 people will undertake eye scanning training and 71 people will undertake sham training; both for 30 minutes daily, 7 days/week over 6 weeks. Everyone will be followed for 6 months. No additional visits are required. We will test peoples’ visual reactions and independence in daily activities and compare groups to see if there is more benefit from scanning treatment. For both groups, the researcher will record all vision information taken from the participants’ normal eye examination such as level of sight on the vision letter chart and amount of visual field absent with hemianopia. At routine eye clinic visits, they will be asked some additional questions by the researcher about their stroke and their vision, e.g. measures of reading ability and mobility. We will also ask them to complete three questionnaires at each visit. This will give us information about how their loss of vision impacts on day-to-day activities.

What are the possible benefits and risks of participating?
There is potential for visual scanning training to benefit stroke survivors by improving their adaptation to hemianopia. There is potential for cost-savings in NHS/social care through maximising stroke survivor’s use of their remaining vision, so lessening the impact on daily life activities. This trial is important: it addresses an area of treatment for which there is limited evidence and no standard care in the NHS. This treatment is a top priority highlighted by two national surveys involving large numbers of patients and carers. It can take some time for participants to get used to the change in their vision and the treatments to help them adapt, but we do not foresee any additional risks of being involved in this study. We cannot promise that this study will help participants. We expect that the information we get from this study will improve how we deliver treatment in the future.

Where is the study run from?
University of Liverpool (UK)

When is the study starting and how long is it expected to run for?
December 2020 to November 2023

Who is funding the study?
The study is funded by Fight for Sight and the Stroke Association

Who is the main contact?
Prof Fiona Rowe (scientific)
rowef@liverpool.ac.uk
Dr Laura Wright (public)
searcht@liverpool.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Prof Fiona Rowe

ORCID ID

http://orcid.org/0000-0001-9210-9131

Contact details

Institute for Population Health
University of Liverpool
Waterhouse Building Block B
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)1517944956
rowef@liverpool.ac.uk

Type

Public

Additional contact

Dr Laura Wright

ORCID ID

Contact details

Institute for Population Health
University of Liverpool
Waterhouse Building Block B
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)1517944956
searcht@liverpool.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 293576

Study information

Scientific title

A randomised controlled trial of Scanning Eye trAining as a Rehabilitation Choice for Hemianopia after stroke (SEARCH)

Acronym

SEARCH

Study hypothesis

The primary objective is to determine the clinical effectiveness of visual scanning training to treat homonymous hemianopia in stroke survivors.

Ethics approval

Not provided at time of registration

Study design

Multi-centre blinded randomized parallel 2 arm trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet

Condition

Adult stroke survivors with confirmed objective evidence of stable homonymous hemianopia

Intervention

Participants will be randomised via a secure (24-hour) web-based randomisation system controlled centrally by the University of Liverpool to receive either arm A visual scanning training or arm B sham training (in a ratio of 1:1).

Arm A is a paper-based visual scanning training package; consisting of training sheet and training instructions. It is portable, self-administered, does not need expert set-up, does not require expertise to use it or support its use, and can be used at home or any care facility.

The control (arm B) is sham training comprising a series of slow, tracking eye movements undertaken with both eyes open (versions) and with each eye covered in turn (ductions). These movement patterns do not engage scanning eye movements. A training sheet and instructions will be provided, similar to the intervention arm.

The treatment period for both arms is 6 weeks and the total follow up period is 26 weeks.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

Visual function measured using the National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25) score at baseline and 26 weeks

Secondary outcome measures

At baseline and 26 weeks:
1. Daily activity measured using the Nottingham Extended Activities of Daily Living (NEADL)
2. Quality of life measured using the EQ-5D-5L questionnaire
3. Visual impairment impact of stroke measured using the BIVI-IQ questionnaire
4. Visual field measurement (Esterman programme)
5. Visual scanning performance measured using a table-top scanning task (determining speed of detection and accuracy of detection)
6. Adverse events measured using patient records

Overall trial start date

01/12/2020

Overall trial end date

30/11/2023

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Clinically diagnosed stroke
2. Aged 18+ years
3. Stable hemianopia
4. Able to engage in training
5. Informed/proxy consent
6. Written and informed consent obtained from the participant and agreement of the participant to comply with the requirements of the study

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

142

Participant exclusion criteria

1. Inability to undertake treatment (e.g. severe cognition problems)
2. Unwilling to participate
3. Presence of severe visual inattention
4. Other serious concomitant medical condition (e.g. life expectancy <6 months)

Recruitment start date

01/05/2021

Recruitment end date

31/10/2022

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Liverpool
Institute for Population Health Waterhouse Building Block B 1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom

Trial participating centre

Salford Royal NHS Foundation Trust
Stott Lane
Salford
M6 8HD
United Kingdom

Trial participating centre

Betsi Cadwaladr University LHB Trust
Wrexham Maelor Hospital, Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom

Trial participating centre

Wirral University Teaching Hospital NHS Foundation Trust
Arrowe Park Hospital, Arrowe Park Road, Upton , Wirral, Merseyside
Wirral
CH49 5PE
United Kingdom

Trial participating centre

Blackpool Teaching Hospitals NHS Foundation Trust
Victoria Hospital, Whinney Heys Road , Blackpool, Lancashire
Blackpool
FY3 8NR
United Kingdom

Trial participating centre

St Helens and Knowsley Teaching Hospitals NHS Foundation Trust
Whiston Hospital, Warrington Road , Prescot, Merseyside
Whiston
L35 5DR
United Kingdom

Trial participating centre

East Suffolk and North Essex NHS Foundation Trust
Eye Clinic, Ipswich Hospital, Heath Road
Ipswich
IP4 5PD
United Kingdom

Trial participating centre

Pennine Acute Hospitals NHS Foundation Trust
Royal Oldham Hospital, Rochdale Road
Oldham
OL1 2JH
United Kingdom

Trial participating centre

Aneurin Bevan University LHB Trust
Headquarters, Lodge Road, Caerleon, Newport
Newport
NP18 3XQ
United Kingdom

Trial participating centre

Warrington and Halton Teaching Hospitals NHS Foundation Trust
Warrington Hospital, Lovely Lane, Warrington, Cheshire
Warrington
WA5 1QG
United Kingdom

Trial participating centre

Southport and Ormskirk Hospitals NHS Foundation Trust
Town Lane, Southport
Soouthport
PR8 6PN
United Kingdom

Trial participating centre

East Lancashire Hospitals NHS Foundation Trust
Royal Blackburn Hospital, Haslingden Road, Blackburn, Lancashire
Blackburn
BB2 3HH
United Kingdom

Trial participating centre

Lancashire Teaching Hospitals NHS Foundation Trust
Royal Preston Hospital, Sharoe Green Lane, Fulwood , Preston, Lancashire
Preston
PR2 9HT
United Kingdom

Trial participating centre

University Hospitals Dorset NHS Foundation Trust
Eye Unit, Royal Bournemouth Hospital, Castle Lane East
Bournemouth
BH7 7DW
United Kingdom

Trial participating centre

United Lincolnshire Hospitals NHS Foundation Trust
Trust Headquarters, Lincoln County Hospital, Greetwell Road, Lincoln, Lincolnshire
Lincoln
LN2 4AX
United Kingdom

Trial participating centre

Imperial College Healthcare NHS Foundation Trust
St. Marys Hospital, Praed Street, London
London
W2 1NY
United Kingdom

Trial participating centre

Bradford Teaching Hospitals NHS Foundation Trust
Bradford Royal Infirmary, Duckworth Lane, Bradford, West Yorkshire
Bradford
BD9 6RJ
United Kingdom

Trial participating centre

King's College Hospital NHS Foundation Trust
King's College Hospital, Denmark Hill, London
London
SE5 9RS
United Kingdom

Trial participating centre

Bolton NHS Foundation Trust
The Royal Bolton Hospital, Minerva Road, Farnworth, Bolton, Lancashire
Bolton
BL4 0JR
United Kingdom

Trial participating centre

Sheffield Teaching Hospitals NHS Foundation Trust
Royal Hammashire Hospital, Glossop Road, Sheffield, South Yorkshire
Sheffield
S10 2JF
United Kingdom

Trial participating centre

University Hospitals Birmingham NHS Foundation Trust
Orthoptic Department, Heartlands Hospital, Bordesley Green East
Birmingham
B9 5SS
United Kingdom

Trial participating centre

Oxford University Hospitals NHS Foundation Trust
John Radcliffe Hospital, Headley Way, Headington
Oxford
OX3 9DU
United Kingdom

Trial participating centre

The Royal Wolverhampton NHS Foundation Trust
New Cross Hospital, Wolverhampton Road, Heath Town
Wolverhampton
WV10 0QP
United Kingdom

Trial participating centre

Countess of Chester Hospital NHS Foundation Trust
The Countess Of Chester Health Park, Chester, Cheshire
Chester
CH2 1UL
United Kingdom

Trial participating centre

Royal United Hospitals Bath NHS Foundation Trust
Royal United Hospital Bath NHS Trust, Combe Park
Bath
BA1 3NG
United Kingdom

Trial participating centre

Mid Cheshire Hospitals NHS Foundation Trust
Leighton Hospital, Middlewich Road, Crewe, Cheshire
Crewe
CW1 4QJ
United Kingdom

Trial participating centre

Sandwell and West Birmingham Hospitals NHS trust
Sandwell General Hospital, Lyndon, West Bromwich, West Midlands
Birmingham
B71 4HJ
United Kingdom

Sponsor information

Organisation

University of Liverpool

Sponsor details

Clinical Directorate
Waterhouse Building Block C
3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
+44 (0)151 7948722
sponsor@liverpool.ac.uk

Sponsor type

University/education

Website

http://www.liv.ac.uk/

Funders

Funder type

Charity

Funder name

Fight for Sight

Alternative name(s)

Fight for Sight, Inc., FIGHT FOR SIGHT INC, FFS

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United States of America

Funder name

Stroke Association

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Associations and societies (private and public)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The results from different participating sites will be analysed together and published as soon as possible in a high-impact peer-reviewed journal, maintaining participant confidentiality at all times.

IPD sharing statement:
At the end of the trial, after the primary results have been published, the anonymised individual participant data (IPD) and associated documentation (e.g. protocol, statistical analysis plan, annotated blank CRF) will be prepared in order to be shared with external researchers. All requests for access to the IPD will be reviewed by the CI.

Intention to publish date

30/11/2024

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

08/01/2021: Trial’s existence confirmed by Fight for Sight.