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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.

Abstract：

IMPORTANCE: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. OBJECTIVE: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. INTERVENTION: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. MAIN OUTCOMES AND MEASURES: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. RESULTS: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. CONCLUSIONS AND RELEVANCE: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. TRIAL REGISTRATION:clinicaltrials.gov Identifier: NCT00494676.

journal_name

JAMA Ophthalmol

journal_title

JAMA ophthalmology

authors

Bowers AR,Keeney K,Peli E

doi

10.1001/jamaophthalmol.2013.5636

subject

Has Abstract

pub_date

2014-02-01 00:00:00

pages

214-22

issue

eissn

2168-6165

issn

2168-6173

pii

1763096

journal_volume

132

pub_type

杂志文章,多中心研究,随机对照试验

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Randomized crossover clinical trial of real and sham peripheral prism glasses for hemianopia.