过夜镜片模式比较（COLM）研究

The comparison of overnight lens modalities (COLM) study.

作者信息

Ritchey Eric R, Barr Joseph T, Mitchell G Lynn

机构信息

University of Missouri-Saint Louis, College of Optometry, Saint Louis, MO, USA.

出版信息

Eye Contact Lens. 2005 Mar;31(2):70-5. doi: 10.1097/01.icl.0000146323.18919.13.

DOI:10.1097/01.icl.0000146323.18919.13

PMID:15798477

Abstract

PURPOSE

The Comparison of Overnight Lens Modalities (COLM) Study is a controlled, randomized, clinical pilot study to determine the sample size required to perform a multicenter clinical trial comparing Paragon CRT lenses with CIBA Vision Focus NIGHT and DAY 30-day continuous-wear silicone hydrogel lenses.

METHODS

Twenty subjects were enrolled in the study. Eighteen subjects, 8 CRT and 10 Focus NIGHT and DAY lens wearers, completed the 3-month study. Visual acuity and refractive quality of life were assessed. Nonparametric statistics were used to analyze differences within and between treatment groups for refraction, visual acuity, and refractive quality of life. The Wilcoxon rank sum test was used to analyze differences between the groups in refraction, visual acuity, and refractive quality of life. The Wilcoxon signed rank test was also used to monitor changes in refraction, refractive quality of life, and visual acuity within a group. Sample size calculations were performed to determine the sample size needed for a large-scale clinical trial.

RESULTS

No statistically significant difference was observed between the groups for 12 of 13 scales on the National Eye Institute Refractive Error Quality of Life Instrument (NEI RQL-42) after treatment. A statistically significant difference was observed between the CRT and Focus NIGHT and DAY groups after 3 months for the NEI RQL-42 dependence-on-correction scale (P=0.0032). There was a significant change within the CRT group between baseline and 3 months (P=0.0156). No statistically significant difference was observed between the two groups in Bailey-Lovie high- and low-contrast visual acuity after 3 months.

CONCLUSIONS

The NEI RQL-42 may be able to detect differences in refractive quality of life between two contact lens treatment groups for the dependence-on-correction scale. Paragon CRT and CIBA Vision Focus NIGHT and DAY lenses produced similar high- and low-contrast visual acuity in this study. A sample size of 126 subjects per group is required to find a 10-unit difference on the NEI RQL-42.

摘要

目的

夜间镜片模式比较（COLM）研究是一项对照、随机临床试验，旨在确定开展一项比较Paragon CRT镜片与CIBA Vision Focus NIGHT and DAY 30天连续佩戴硅水凝胶镜片的多中心临床试验所需的样本量。

方法

20名受试者参与了该研究。18名受试者，8名CRT镜片佩戴者和10名Focus NIGHT and DAY镜片佩戴者完成了为期3个月的研究。评估了视力和屈光生活质量。采用非参数统计分析治疗组内及组间在屈光、视力和屈光生活质量方面的差异。采用Wilcoxon秩和检验分析两组在屈光、视力和屈光生活质量方面的差异。还采用Wilcoxon符号秩检验监测组内屈光、屈光生活质量和视力的变化。进行样本量计算以确定大规模临床试验所需的样本量。

结果

治疗后，在国家眼科研究所屈光不正生活质量量表（NEI RQL-42）的13个量表中有12个量表在两组之间未观察到统计学显著差异。3个月后，CRT组与Focus NIGHT and DAY组在NEI RQL-42矫正依赖量表上观察到统计学显著差异（P = 0.0032）。CRT组在基线和3个月之间有显著变化（P = 0.0156）。3个月后，两组在贝利-洛维高对比度和低对比度视力方面未观察到统计学显著差异。

结论

NEI RQL-42可能能够检测出两个隐形眼镜治疗组在矫正依赖量表上屈光生活质量的差异。在本研究中，Paragon CRT镜片和CIBA Vision Focus NIGHT and DAY镜片产生了相似的高对比度和低对比度视力。每组需要126名受试者的样本量才能在NEI RQL-42上发现10个单位的差异。