Gao Jiajia, Lai Zhipeng, Hu Yin, Yang Xiao
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.
State Key Laboratory of Ophthalmology, Zhongshan Ophthalmic Center, Sun Yat-Sen University, Guangzhou, China.
Cont Lens Anterior Eye. 2025 Jun;48(3):102366. doi: 10.1016/j.clae.2024.102366. Epub 2025 Jan 10.
To develop a Chinese version of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) with cross-cultural adaption and clinical validation among soft contact lens wearers (SCL) in China.
The translation and adaptation of the Chinese CLDEQ-8 (C-CLDEQ-8) followed a rigorous methodological process based on cross-cultural research guidelines consisting of three main phases: 1) forward and backward translation of original CLDEQ-8 into Chinese, 2) cross-cultural adaptation performed by medical advising committee, and 3) clinical validation and repeatability test of the translated questionnaire on Chinese SCL wearers. Rasch analysis was also performed to investigate the psychometric properties of C-CLDEQ-8.
134 experienced SCL wearers aged 18-45 completed the C-CLDEQ-8. C-CLDEQ-8 score was linearly related to the overall opinion of SCLs (beta = 2.16, p = 0.002), gestalt eye dryness response (beta = 2.90, p < 0.001), and sensitivity response (beta = 1.83, p = 0.001). The questionnaire showed excellent test-retest repeatability with an intra-class correlation coefficient (ICC) of 0.95 and great internal consistency with a Cronbach's alpha of 0.83. The corrected index of homogeneity for each item was more significant than 0.5. In Rasch analysis, the infit and outfit values for eight items were all within 0.6-1.4, suggesting a good fit for the Rasch model. Martin-Löf test result indicated that the Rasch model was unidimensional (p = 1.0). Item characteristics curves suggested combining categories 3-4 and 5-6 in item 5 of C-CLDEQ-8.
This study produced a Chinese version of CLDEQ-8 with great validity and reliability and proved capable of evaluating SCL-related symptoms.
开发8项接触镜干眼问卷（CLDEQ - 8）中文版，并在中国软性接触镜佩戴者（SCL）中进行跨文化调适和临床验证。
中文CLDEQ - 8（C - CLDEQ - 8）的翻译和调适遵循基于跨文化研究指南的严格方法流程，包括三个主要阶段：1）将原始CLDEQ - 8正向和反向翻译成中文；2）由医学咨询委员会进行跨文化调适；3）对翻译后的问卷在中国SCL佩戴者中进行临床验证和重复性测试。还进行了Rasch分析以研究C - CLDEQ - 8的心理测量特性。
134名年龄在18 - 45岁的有经验的SCL佩戴者完成了C - CLDEQ - 8。C - CLDEQ - 8得分与SCL的总体评价呈线性相关（β = 2.16，p = 0.002），与整体眼部干燥反应呈线性相关（β = 2.90，p < 0.001），与敏感度反应呈线性相关（β = 1.83，p = 0.001）。该问卷显示出极好的重测重复性，组内相关系数（ICC）为0.95，具有很高的内部一致性，Cronbach's α为0.83。各项目的校正同质性指数均大于0.5。在Rasch分析中，8个项目的内拟合和外拟合值均在0.6 - 1.4之间，表明该问卷与Rasch模型拟合良好。Martin - Löf检验结果表明Rasch模型是单维的（p = 1.0）。项目特征曲线表明应将C - CLDEQ - 8第5项中的类别3 - 4和5 - 6合并。
本研究产生了具有良好效度和信度的CLDEQ - 8中文版，并证明能够评估与SCL相关的症状。
