Rowe F J, Conroy E J, Bedson E, Cwiklinski E, Drummond A, García-Fiñana M, Howard C, Pollock A, Shipman T, Dodridge C, MacIntosh C, Johnson S, Noonan C, Barton G, Sackley C
Department of Health Services Research, University of Liverpool, Liverpool, UK.
Department of Biostatistics, University of Liverpool, Liverpool, UK.
Acta Neurol Scand. 2017 Oct;136(4):310-321. doi: 10.1111/ane.12725. Epub 2016 Dec 27.
Pilot trial to compare prism therapy and visual search training, for homonymous hemianopia, to standard care (information only).
Prospective, multicentre, parallel, single-blind, three-arm RCT across fifteen UK acute stroke units.
Stroke survivors with homonymous hemianopia.
Arm a (Fresnel prisms) for minimum 2 hours, 5 days per week over 6 weeks. Arm b (visual search training) for minimum 30 minutes, 5 days per week over 6 weeks. Arm c (standard care-information only).
Adult stroke survivors (>18 years), stable hemianopia, visual acuity better than 0.5 logMAR, refractive error within ±5 dioptres, ability to read/understand English and provide consent.
Primary outcomes were change in visual field area from baseline to 26 weeks and calculation of sample size for a definitive trial. Secondary measures included Rivermead Mobility Index, Visual Function Questionnaire 25/10, Nottingham Extended Activities of Daily Living, Euro Qual, Short Form-12 questionnaires and Radner reading ability. Measures were post-randomization at baseline and 6, 12 and 26 weeks.
Randomization block lists stratified by site and partial/complete hemianopia.
Allocations disclosed to patients. Primary outcome assessor blind to treatment allocation.
Eighty-seven patients were recruited: 27-Fresnel prisms, 30-visual search training and 30-standard care; 69% male; mean age 69 years (SD 12). At 26 weeks, full results for 24, 24 and 22 patients, respectively, were compared to baseline. Sample size calculation for a definitive trial determined as 269 participants per arm for a 200 degree visual field area change at 90% power. Non-significant relative change in area of visual field was 5%, 8% and 3.5%, respectively, for the three groups. Visual Function Questionnaire responses improved significantly from baseline to 26 weeks with visual search training (60 [SD 19] to 68.4 [SD 20]) compared to Fresnel prisms (68.5 [SD 16.4] to 68.2 [18.4]: 7% difference) and standard care (63.7 [SD 19.4] to 59.8 [SD 22.7]: 10% difference), P=.05. Related adverse events were common with Fresnel prisms (69.2%; typically headaches).
No significant change occurred for area of visual field area across arms over follow-up. Visual search training had significant improvement in vision-related quality of life. Prism therapy produced adverse events in 69%. Visual search training results warrant further investigation.
开展一项初步试验，比较用于同向性偏盲的棱镜疗法和视觉搜索训练与标准护理（仅提供信息）的效果。
在英国15个急性卒中单元进行的前瞻性、多中心、平行、单盲、三臂随机对照试验。
患有同向性偏盲的卒中幸存者。
A组（菲涅耳棱镜），每周5天，每天至少2小时，持续6周。B组（视觉搜索训练），每周5天，每天至少30分钟，持续6周。C组（仅标准护理信息）。
成年卒中幸存者（>18岁），偏盲稳定，视力优于0.5 logMAR，屈光不正±5屈光度以内，有阅读/理解英语及提供同意书的能力。
主要结果指标是从基线到26周视野面积的变化以及确定最终试验的样本量计算。次要测量指标包括Rivermead运动指数、视觉功能问卷25/10、诺丁汉扩展日常生活活动量表、欧洲五维度健康量表、简明健康调查问卷12以及拉德纳阅读能力。测量在随机分组后基线、6周、12周和26周进行。
随机区组列表按地点和部分/完全偏盲分层。
向患者披露分组情况。主要结果评估者对治疗分组不知情。
招募了87名患者：27名接受菲涅耳棱镜治疗，30名接受视觉搜索训练，30名接受标准护理；69%为男性；平均年龄69岁（标准差12）。在26周时，分别将24名、24名和22名患者的完整结果与基线进行比较。确定最终试验的样本量为每组269名参与者，以90%的检验效能实现200度视野面积变化。三组视野面积的相对变化分别为5%、8%和3.5%，差异无统计学意义。与菲涅耳棱镜组（从68.5[标准差16.4]到68.2[18.4]：差异7%）和标准护理组（从63.7[标准差19.4]到59.8[标准差22.7]：差异10%）相比，视觉搜索训练组从基线到26周视觉功能问卷得分显著改善（从60[标准差19]到68.4[标准差20]），P = 0.05。菲涅耳棱镜组常见相关不良事件（69.2%；通常为头痛）。
随访期间各组视野面积无显著变化。视觉搜索训练在与视力相关的生活质量方面有显著改善。棱镜疗法有69%出现不良事件。视觉搜索训练的结果值得进一步研究。
