Balcer L J, Baier M L, Pelak V S, Fox R J, Shuwairi S, Galetta S L, Cutter G R, Maguire M G
Department of Neurology, University of Pennsylvania School of Medicine, Philadelphia 19104, USA.
Mult Scler. 2000 Jun;6(3):163-71. doi: 10.1177/135245850000600305.
The quantitative assessment of visual function in multiple sclerosis (MS) clinical trials has been limited to Snellen visual acuity. The purpose of this study was to examine the inter-rater reliability and test characteristics of a new visual outcome measure, the Low-Contrast Sloan Letter Charts, in patients with MS and visually-asymptomatic volunteers. Contrast letter acuity scores (letter scores) were measured at each of four contrast levels (100, 5, 1.25 and 0.6%) by two independent raters. Inter-rater agreement was described with the intraclass correlation coefficient (ICC) and comparison of mean scores. Excellent inter-rater agreement (ICC=0.86 - 0.95) was demonstrated at each contrast level among MS patients (n=100) and visually-asymptomatic volunteers (n=33). Average letter scores at the lowest contrast level (0.6%) were highly variable in the MS group, even among patients with visual acuities of 20/20 or better, and among those who required no assistance for ambulation. Low-Contrast Sloan Letter Chart testing is a highly reliable method of visual assessment, and provides information on an aspect of neurologic impairment in MS which is not captured by Snellen visual acuity or ambulation status. This new method demonstrates excellent potential as a visual function outcome measure for future MS clinical trials.
在多发性硬化症(MS)临床试验中,视觉功能的定量评估一直局限于斯内伦视力表视力检查。本研究的目的是检验一种新的视觉结果测量方法——低对比度斯隆字母视力表,在MS患者和视力无症状志愿者中的评分者间信度和测试特征。由两名独立的评分者在四个对比度水平(100%、5%、1.25%和0.6%)下测量对比度字母视力得分(字母得分)。用组内相关系数(ICC)和平均得分比较来描述评分者间的一致性。在MS患者(n = 100)和视力无症状志愿者(n = 33)的每个对比度水平下,均显示出极好的评分者间一致性(ICC = 0.86 - 0.95)。在MS组中,即使在视力为20/20或更好的患者以及那些行走无需帮助的患者中,最低对比度水平(0.6%)下的平均字母得分也具有高度变异性。低对比度斯隆字母视力表测试是一种高度可靠的视觉评估方法,并且提供了有关MS神经功能损害的一个方面的信息,而这是斯内伦视力表视力检查或行走状态所无法捕捉到的。这种新方法作为未来MS临床试验的视觉功能结果测量方法显示出极好的潜力。