Department of Innovative Visual Science, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Clinical Trial Consultant, Atlanta, GA, USA.
Cont Lens Anterior Eye. 2019 Oct;42(5):533-539. doi: 10.1016/j.clae.2019.03.002. Epub 2019 Mar 16.
To translate and validate a Japanese version of the 8-item Contact Lens Dry Eye Questionnaire (CLDEQ-8) among a multicenter sample of Japanese-speaking soft contact lens (SCL) wearers in Japan.
The study comprised two phases, 1) forward and backward translation of the CLDEQ-8 into Japanese, 2) cross-sectional validation of Japanese CLDEQ-8 (J-CLDEQ-8) among Japanese spherical disposable SCL wearers (daily disposable, 2 week, or monthly disposable) against their Overall Opinion of SCLs, and 3) repeatability testing in a subset of subjects.
300 subjects (118 males and 182 females) completed the J-CLDEQ-8 and anchoring Gestalt SCL questions. The J-CLDEQ-8 had a strong significant linear relationship to Overall Opinion of SCLs and the Self-Assessment of Eye Dryness. The Gestalt Eye Sensitivity question did not translate well in Japanese and the relationship between it and the J-CLDEQ-8 was not linear. A cutoff score of <11 points with the J-CLDEQ-8 related best to patients who reported "Excellent" or "Very Good" Overall Opinion of their SCLs, differing slightly from the North American CLDEQ-8 cutoff of <12 points. This <11 points cutoff yielded accuracy of 0.66, and a sensitivity of 0.67 and specificity of 0.66, very similar to the values for the original CLDEQ-8.
The J-CLDEQ-8 was capable of differentiating SCL wearers with different Overall Opinions of their SCLs, comparable to the original CLDEQ-8 in English.
将日本版 8 项软性隐形眼镜干眼症问卷(CLDEQ-8)翻译并验证为日语,以适应日本多中心的日语软性隐形眼镜(SCL)佩戴者。
该研究包括两个阶段,1)CLDEQ-8 日语版的正向和逆向翻译,2)在日本球面一次性 SCL 佩戴者(日抛、双周抛或月抛)中验证日本 CLDEQ-8(J-CLDEQ-8)与他们对隐形眼镜的总体评价之间的相关性,以及 3)在部分受试者中进行可重复性测试。
300 名受试者(118 名男性和 182 名女性)完成了 J-CLDEQ-8 和隐形眼镜整体印象锚定图式问题。J-CLDEQ-8 与隐形眼镜总体印象和自我评估眼睛干燥程度之间存在很强的线性关系。图式眼部敏感度问题在日语中翻译不佳,且与 J-CLDEQ-8 之间的关系也不是线性的。J-CLDEQ-8 的截点<11 分与报告对其隐形眼镜“非常好”或“很好”的总体印象的患者最相关,这与北美 CLDEQ-8 的截点<12 分略有不同。这个<11 分的截点得出的准确性为 0.66,敏感性为 0.67,特异性为 0.66,与原始 CLDEQ-8 的值非常相似。
J-CLDEQ-8 能够区分对隐形眼镜有不同总体评价的佩戴者,与英文版原始 CLDEQ-8 相当。