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  • 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

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Ophthalmology
Protocol
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
  1. F J Rowe1,
  2. P G Barton2,
  3. E Bedson3,
  4. R Breen3,
  5. E J Conroy4,
  6. E Cwiklinski3,
  7. C Dodridge5,
  8. A Drummond6,
  9. M Garcia-Finana4,
  10. C Howard7,
  11. S Johnson8,
  12. C MacIntosh5,
  13. C P Noonan9,
  14. A Pollock10,
  15. J Rockliffe11,
  16. C Sackley12,
  17. T Shipman13,
  18. VISION (vision impairment in stroke: intervention or not)
  1. 1Department of Health Services Research, University of Liverpool, Liverpool, UK
  2. 2Department of Elderly Care, Warrington and Halton Hospitals NHS Foundation Trust, Warrington, UK
  3. 3Clinical Trials Research Unit, University of Liverpool, Liverpool, UK
  4. 4Department of Biostatistics, University of Liverpool, Liverpool, UK
  5. 5Department of Orthoptics, Oxford University Hospitals NHS Trust, Oxford, UK
  6. 6School of Health Sciences, University of Nottingham, Nottingham, UK
  7. 7Department of Orthoptics, Salford Royal NHS Foundation Trust, Manchester, UK
  8. 8Eye Clinic Impact Team, Royal National Institute for the Blind, Birmingham, UK
  9. 9Department of Ophthalmology, Aintree University Hospital NHS Foundation Trust, Liverpool, UK
  10. 10Nursing, Midwifery and Allied Health Professions Research Unit, Glasgow Caledonian University, Glasgow, UK
  11. 11Speakability North West, London, UK
  12. 12Faculty of Medicine and Health, University of East Anglia, Norwich, UK
  13. 13Department of Orthoptics, Sheffield Teaching Hospitals NHS Foundation Trust, Sheffield, UK
  1. Correspondence to Dr Fiona Rowe; rowef{at}liverpool.ac.uk

Abstract

Introduction Homonymous hemianopia is a common and disabling visual problem after stroke. Currently, prism glasses and visual scanning training are proposed to improve it. The aim of this trial is to determine the effectiveness of these interventions compared to standard care.

Methods and analysis The trial will be a multicentre three arm individually randomised controlled trial with independent assessment at 6 week, 12 week and 26 week post-randomisation. Recruitment will occur in hospital, outpatient and primary care settings in UK hospital trusts. A total of 105 patients with homonymous hemianopia and without ocular motility impairment, visual inattention or pre-existent visual field impairment will be randomised to one of three balanced groups. Randomisation lists will be stratified by site and hemianopia level (partial or complete) and created using simple block randomisation by an independent statistician. Allocations will be disclosed to patients by the treating clinician, maintaining blinding for outcome assessment. The primary outcome will be change in visual field assessment from baseline to 26 weeks. Secondary measures will include the Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual-5D and Short Form-12 questionnaires. Analysis will be by intention to treat.

Ethics and dissemination This study has been developed and supported by the UK Stroke Research Network Clinical Studies Group working with service users. Multicentre ethical approval was obtained through the North West 6 Research ethics committee (Reference 10/H1003/119). The trial is funded by the UK Stroke Association. Trial Registration: Current Controlled Trials ISRCTN05956042. Dissemination will consider usual scholarly options of conference presentation and journal publication in addition to patient and public dissemination with lay summaries and articles.

Trial Registration Current Controlled Trials ISRCTN05956042.

  • STROKE MEDICINE
  • REHABILITATION MEDICINE

This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

https://doi.org/10.1136/bmjopen-2014-005885

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