Visual impairment in stroke: intervention or not (VISION)

ISRCTN	ISRCTN05956042
DOI	https://doi.org/10.1186/ISRCTN05956042
Secondary identifying numbers	10134

Submission date: 08/04/2011
Registration date: 08/04/2011
Last edited: 23/04/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English Summary

Not provided at time of registration

Contact information

Dr Fiona Rowe
Scientific

Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
United Kingdom

Study information

Study design	Randomised interventional screening trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Screening
Participant information sheet	Not available in web format, please use the contact details to request a patient information sheet
Scientific title	Visual Impairment in Stroke: Intervention Or Not (VISION) - a randomised controlled trial to investigate whether prism glasses or visual search training are more effective than information only (standard care) in patients with a homonymous hemianopia follow stroke
Study acronym	VISION
Study hypothesis	The aim of this trial is to be the first step in determining the effectiveness of Fresnel Prisms and Visual Search Strategies compared to standard care in patients with homonymous hemianopia (HH) following a stroke. The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6, 12 and 26 weeks post randomisation. Recruitment will occur in hospital and outpatient settings in Bath, Nottingham, Oxford, Salford and Sheffield. 105 patients with HH and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to 3 groups using an online randomisation system. Allocation will be revealed to the treating clinician, patient and trial coordinator, maintaining blinding for the assessors. The primary outcome will be visual field assessment. Secondary measures will include the Rivermead Mobility Index, VFQ25/10, Nottingham EADL, EQ5D and SF12 questionnaires. Analysis will be by intention to treat. This study has been developed and supported by the UKSRN CSG working with service users. The findings will support a future HTA application. Website: www.strokevision.org.uk (under construction)
Ethics approval(s)	10/H1003/119
Condition	Stroke Research Network; Rehabilitation
Intervention	1. After assessment of eligibility patients will be randomised to either treatment with Fresnel prisms, visual search strategies or control group (information only) 2. Prisms will be worn for a minimum of 2 hours per day and visual search strategies will be done for a minimum of 30 minutes per day, both for a minimum of 6 weeks 3. Patients will then be followed up at 6, 12 and 26 weeks post treatment start 4. At baseline and follow up visits participants will have their visual fields will be assessed (primary endpoint) and complete a participant completed outcome measures questionnaire pack along with a reading accuracy test (secondary endpoints) 5. Total duration of participant involvement: 26 weeks
Intervention type	Other
Primary outcome measure	Visual field
Secondary outcome measures	1. Visual function questionnaire (VFQ 25-10) change in perceived ability relating to activities of daily living 2. Rivermead mobility index change in functional mobility 3. Nottingham extended activities of daily living (NEADL) change in extended daily living index 4. EQ-5D change in health related quality of life 5. SF-12 change of general health status 6. Assessment of reading speed and accuracy (Radner Test)
Overall study start date	01/03/2011
Overall study end date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Planned Sample Size: 105; UK Sample Size: 105
Total final enrolment	87
Participant inclusion criteria	1. 18 years of age and older 2. Best corrected visual acuity of 6/18 in either eye 3. Homonymous hemianopia 4. Refractive error within ±5Dioptres 5. Vision measures will be established by orthoptic assessment 6. Male or female
Participant exclusion criteria	1. Inability to consent due to severe cognitive impairment 2. Unwilling to participate in the study 3. Ocularmotility impairment and visual inattention in addition to the visual field impairment (as assessed by the orthoptist) 4. Preexisting visual field impairment
Recruitment start date	01/03/2011
Recruitment end date	31/08/2013

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Thompson Yates Building

Liverpool
L69 3GB
United Kingdom

Sponsor information

University of Liverpool (UK)
University/education

c/o Ms Lindsay Carter
Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
Liverpool
L69 3GB
England
United Kingdom

"ROR"	https://ror.org/04xs57h96

Funders

Funder type

Charity

The Stroke Association (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Protocol article	protocol	17/07/2014	Yes	No
Results article	results	19/01/2016	Yes	No
Results article	results	01/10/2017	Yes	No
Results article	results	01/09/2019	Yes	No

Editorial Notes

23/04/2019: Publication reference and total final enrolment added.
04/10/2018: Publication references added.