Visual impairment in stroke: intervention or not (VISION)

ISRCTN	ISRCTN05956042
DOI	https://doi.org/10.1186/ISRCTN05956042
Protocol serial number	10134
Sponsor	University of Liverpool (UK)
Funder	The Stroke Association (UK)

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 of protocol

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

Primary study design	Interventional
Study design	Randomised interventional screening trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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
Health condition(s) or problem(s) studied	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(s)	Visual field
Key secondary outcome measure(s)	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)
Completion date	31/08/2013

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	105
Total final enrolment	87
Key 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
Key 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
Date of first enrolment	01/03/2011
Date of final enrolment	31/08/2013

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Thompson Yates Building

Liverpool
L69 3GB
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	19/01/2016		Yes	No
Results article	results	01/10/2017		Yes	No
Results article	results	01/09/2019		Yes	No
Protocol article	protocol	17/07/2014		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

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