Shizuka Koh1, Robin Chalmers2, Daijiro Kabata3, Ayumi Shintani3, Kohji Nishida4. 1. Department of Innovative Visual Science, Osaka University Graduate School of Medicine, Osaka, Japan; Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan. Electronic address: skoh@ophthal.med.osaka-u.ac.jp. 2. Clinical Trial Consultant, Atlanta, GA, USA. 3. Department of Medical Statistics, Osaka City University Graduate School of Medicine, Osaka, Japan. 4. Department of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Abstract
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.
PURPOSE: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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.