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ISRCTN
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ISRCTN05956042
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ClinicalTrials.gov identifier
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Public title
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Visual impairment in stroke: intervention or not (VISION)
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Scientific title
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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
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Acronym
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VISION
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Serial number at source
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10134
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Study hypothesis
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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)
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Lay summary
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Ethics approval
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10/H1003/119
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Study design
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Randomised, interventional screening trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Stroke Research Network; Rehabilitation
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/03/2011
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Anticipated end date
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31/08/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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Planned Sample Size: 105; UK Sample Size: 105
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Interventions
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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
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Primary outcome measure(s)
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Visual field
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Secondary outcome measure(s)
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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)
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Sources of funding
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The Stroke Association (UK)
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Trial website
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Publications
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Contact name
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Dr
Fiona
Rowe
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Address
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Thompson Yates Building
Quadrangle Brownlow Hill
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City/town
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Liverpool
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Zip/Postcode
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L69 3GB
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Country
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United Kingdom
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Sponsor
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University of Liverpool (UK)
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Address
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c/o Ms Lindsay Carter
Department of Clinical Psychology
Thompson Yates Building
Quadrangle Brownlow Hill
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City/town
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Liverpool
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Zip/Postcode
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L69 3GB
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Country
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United Kingdom
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Date applied
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08/04/2011
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Last edited
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17/05/2011
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Date ISRCTN assigned
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08/04/2011
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