Condition category
Circulatory System
Date applied
08/04/2011
Date assigned
08/04/2011
Last edited
21/07/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Fiona Rowe

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

10134

Study information

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

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

10/H1003/119

Study design

Randomised interventional screening trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

01/03/2011

Overall trial end date

31/08/2013

Reason abandoned

Eligibility

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 type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 105; UK Sample Size: 105

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

United Kingdom

Trial participating centre

Thompson Yates Building
Liverpool
L69 3GB
United Kingdom

Sponsor information

Organisation

University of Liverpool (UK)

Sponsor details

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

Sponsor type

University/education

Website

Funders

Funder type

Charity

Funder name

The Stroke Association (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2014 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25034632

Publication citations

  1. Protocol

    Rowe FJ, Barton PG, Bedson E, Breen R, Conroy EJ, Cwiklinski E, Dodridge C, Drummond A, Garcia-Finana M, Howard C, Johnson S, MacIntosh C, Noonan CP, Pollock A, Rockliffe J, Sackley C, Shipman T, , A randomised controlled trial to compare the clinical and cost-effectiveness of prism glasses, visual search training and standard care in patients with hemianopia following stroke: a protocol., BMJ Open, 2014, 4, 7, e005885, doi: 10.1136/bmjopen-2014-005885.

Additional files

Editorial Notes