Visual scanning training for loss of vision in half the visual field (hemianopia) - SEARCH trial
ISRCTN | ISRCTN93008420 |
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DOI | https://doi.org/10.1186/ISRCTN93008420 |
IRAS number | 293576 |
Secondary identifying numbers | IRAS 293576 |
- Submission date
- 07/01/2021
- Registration date
- 08/01/2021
- Last edited
- 18/03/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Ear, Nose and Throat
Plain English summary of protocol
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 March 2024
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
Contact information
Scientific
Institute for Population Health
University of Liverpool
Waterhouse Building Block B
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
0000-0001-9210-9131 | |
Phone | +44 (0)1517944956 |
rowef@liverpool.ac.uk |
Public
Institute for Population Health
University of Liverpool
Waterhouse Building Block B
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Phone | +44 (0)1517944956 |
---|---|
searcht@liverpool.ac.uk |
Study information
Study design | Multi-centre blinded randomized parallel two-arm trial |
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Primary study design | Interventional |
Secondary study design | Randomised controlled trial |
Study setting(s) | Hospital |
Study type | Treatment |
Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
Scientific title | A randomised controlled trial of Scanning Eye trAining as a Rehabilitation Choice for Hemianopia after stroke (SEARCH) |
Study acronym | SEARCH |
Study objectives | The primary objective is to determine the clinical effectiveness of visual scanning training to treat homonymous hemianopia in stroke survivors. |
Ethics approval(s) | Approved 12/03/2021, Wales Research Ethics Committee 1 Cardiff (Health and Care Research Wales, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 (0)2920 785738; Wales.REC1@wales.nhs.uk), REC ref: 21/WA/0030 |
Health condition(s) or problem(s) studied | 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 |
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 study start date | 01/12/2020 |
Completion date | 31/03/2024 |
Eligibility
Participant type(s) | Patient |
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Age group | Adult |
Lower age limit | 18 Years |
Sex | Both |
Target number of participants | 157 |
Total final enrolment | 160 |
Key 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 |
Key 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) |
Date of first enrolment | 01/05/2021 |
Date of final enrolment | 31/07/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Waterhouse Building Block B
1-3 Brownlow Street
Liverpool
L69 3GL
United Kingdom
Salford
M6 8HD
United Kingdom
Croesnewydd Road
Wrexham
LL13 7TD
United Kingdom
Arrowe Park Road
Upton
Wirral
CH49 5PE
United Kingdom
Ipswich Hospital
Heath Road
Whiston
L35 5DR
United Kingdom
Rochdale Road
Ipswich
IP4 5PD
United Kingdom
Oldham
OL1 2JH
United Kingdom
Warrington
WA5 1QG
United Kingdom
Preston
PR2 9HT
United Kingdom
Bournemouth
BH7 7DW
United Kingdom
Lincoln
LN2 4AX
United Kingdom
London
W2 1NY
United Kingdom
Bradford
BD9 6RJ
United Kingdom
London
SE5 9RS
United Kingdom
Bolton
BL4 0JR
United Kingdom
Sheffield
S10 2JF
United Kingdom
Birmingham
B9 5SS
United Kingdom
Oxford
OX3 9DU
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Whitechapel
London
E1 1FR
United Kingdom
Crewe
CW1 4QJ
United Kingdom
Leytonstone
London
E11 1NR
United Kingdom
Whitechapel
London
E1 1FR
United Kingdom
Thornton Heath
CR7 7YE
United Kingdom
Cheltenham
GL53 7AN
United Kingdom
Bedfordshire Hospital NHS Foundation Trust and Dunstable University Hospital, Lewsey Road
Luton
LU4 0DZ
United Kingdom
Eaglestone
Milton Keynes
MK6 5LD
United Kingdom
Halifax
HX3 OPW
United Kingdom
Aylesbury
HP21 8AL
United Kingdom
Torquay
TQ2 7AA
United Kingdom
Higher Kingston
Yeovil
BA21 4AT
United Kingdom
Dunfermline
KY12 0SU
United Kingdom
Inverness
IV2 3UJ
United Kingdom
218 Eaglesham Rd
East Kilbride
Glasgow
G75 8RG
United Kingdom
Derriford Road
Derriford
Plymouth
PL6 8DH
United Kingdom
Blackshaw Road
London
SW17 0QT
United Kingdom
Sponsor information
University/education
Clinical Directorate
Waterhouse Building Block C
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
Phone | +44 (0)151 7948722 |
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sponsor@liverpool.ac.uk | |
Website | http://www.liv.ac.uk/ |
https://ror.org/04xs57h96 |
Funders
Funder type
Charity
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- Fight for Sight, Inc., National Council to Combat Blindness, Fight for Sight (U.S.), FFS
- Location
- United States of America
Private sector organisation / Associations and societies (private and public)
- Location
- United Kingdom
Results and Publications
Intention to publish date | 31/05/2025 |
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Individual participant data (IPD) Intention to share | Yes |
IPD sharing plan summary | Available on request |
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 plan | 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. |
Study outputs
Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
---|---|---|---|---|---|
HRA research summary | 28/06/2023 | No | No | ||
Results article | 13/03/2025 | 18/03/2025 | Yes | No |
Editorial Notes
18/03/2025: Publication reference added.
01/03/2024: The overall end date was changed from 12/02/2024 to 31/03/2024.
10/07/2023: The overall end date was changed from 31/12/2023 to 12/02/2024.
12/06/2023: The following changes have been made to the study record:
1. Sandwell and West Birmingham Hospitals NHS Trust, The Royal Wolverhampton NHS Foundation Trust and Royal United Hospitals Bath NHS Foundation Trust were removed as trial centres and Moorfields Eye Centre at St George's Hospital was added as a trial centre.
2. The recruitment end date has been changed from 18/06/2023 to 31/07/2023.
3. The target number of participants has been changed from 142 to 157.
03/11/2022: The following changes have been made:
1. Blackpool Teaching Hospitals NHS Foundation Trust, Aneurin Bevan University LHB Trust, Southport and Ormskirk Hospitals NHS Foundation Trust, and East Lancashire Hospitals NHS Foundation Trust were removed as trial centres.
2. Leighton Hospital, Whipps Cross University Hospital, The Royal London Hospital, Moorfields Eye Centre at Croydon University Hospital, Cheltenham General Hospital, Cambridgeshire Community Services NHS Trust, Milton Keynes University Hospital, Calderdale Royal Hospital, Stoke Mandeville Hospital, Torbay District General Hospital, Yeovil District Hospital, Queen Margaret Hospital, Raigmore Hospital, NHS Lanarkshire and University Hospitals Plymouth NHS Trust were added as trial centres and Scotland was added as a location accordingly.
11/10/2022: The following changes have been made:
1. The recruitment end date has been changed from 31/10/2022 to 18/06/2023.
2. The overall trial end date has been changed from 30/11/2023 to 31/12/2023 and the plain English summary updated accordingly.
3. The intention to publish date has been changed from 30/11/2024 to 31/05/2025.
13/05/2021: The ethics approval details and trial website were added.
08/01/2021: Trial’s existence confirmed by Fight for Sight.