Schepens Eye Research Institute, Massachusetts Eye and Ear, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
Chadwick Optical, Inc, Souderton, Philadelphia.
JAMA Ophthalmol. 2014 Feb;132(2):214-22. doi: 10.1001/jamaophthalmol.2013.5636.
There is a major lack of randomized controlled clinical trials evaluating the efficacy of prismatic treatments for hemianopia. Evidence for their effectiveness is mostly based on anecdotal case reports and open-label evaluations without a control condition.
To evaluate the efficacy of real relative to sham peripheral prism glasses for patients with complete homonymous hemianopia.
DESIGN, SETTING, AND PARTICIPANTS: Double-masked, randomized crossover trial at 13 study sites, including the Peli laboratory at Schepens Eye Research Institute, 11 vision rehabilitation clinics in the United States, and 1 in the United Kingdom. Patients were 18 years or older with complete homonymous hemianopia for at least 3 months and without visual neglect or significant cognitive decline.
Patients were allocated by minimization into 2 groups. One group received real (57-prism diopter) oblique and sham (<5-prism diopter) horizontal prisms; the other received real horizontal and sham oblique, in counterbalanced order. Each crossover period was 4 weeks.
The primary outcome was the overall difference, across the 2 periods of the crossover, between the proportion of participants who wanted to continue with (said yes to) real prisms and the proportion who said yes to sham prisms. The secondary outcome was the difference in perceived mobility improvement between real and sham prisms.
Of 73 patients randomized, 61 completed the crossover. A significantly higher proportion said yes to real than sham prisms (64% vs 36%; odds ratio, 5.3; 95% CI, 1.8-21.0). Participants who continued wear after 6 months reported greater improvement in mobility with real than sham prisms at crossover end (P = .002); participants who discontinued wear reported no difference.
Real peripheral prism glasses were more helpful for obstacle avoidance when walking than sham glasses, with no differences between the horizontal and oblique designs. Peripheral prism glasses provide a simple and inexpensive mobility rehabilitation intervention for hemianopia.
clinicaltrials.gov Identifier: NCT00494676.
评估棱镜治疗对完全同侧偏盲患者疗效的随机对照临床试验非常缺乏。其疗效的证据主要基于轶事病例报告和无对照条件的开放标签评估。
评估真性相对于假性周边棱镜眼镜对完全同侧偏盲患者的疗效。
设计、地点和参与者：在 13 个研究地点进行的双盲、随机交叉试验，包括 Schepens 眼科研究所的 Peli 实验室、美国的 11 个视力康复诊所和英国的 1 个诊所。患者年龄在 18 岁或以上，至少有 3 个月的完全同侧偏盲，无视觉忽略或明显认知能力下降。
患者通过最小化分配到 2 组。一组接受真（57 棱镜度）斜和假（<5 棱镜度）水平棱镜；另一组接受真水平和假斜棱镜，以平衡方式交替。每个交叉期为 4 周。
主要结果是在交叉的 2 个周期中，参与者中想要继续使用（对）真棱镜和想要使用（对）假棱镜的比例之间的总体差异。次要结果是真棱镜和假棱镜之间感知移动改善的差异。
在 73 名随机患者中，有 61 名完成了交叉。选择真棱镜的比例明显高于选择假棱镜的比例（64%比 36%；优势比，5.3；95%置信区间，1.8-21.0）。在交叉结束时，继续佩戴 6 个月后的参与者报告称，真棱镜在移动性方面的改善明显大于假棱镜（P=0.002）；停止佩戴的参与者则报告没有差异。
与假性棱镜眼镜相比，真性周边棱镜眼镜在行走时对障碍物的回避更有帮助，水平和斜设计之间没有差异。周边棱镜眼镜为偏盲提供了一种简单且经济的移动康复干预措施。
clinicaltrials.gov 标识符：NCT00494676。
