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Clinical Trial Summary

This study aimed to evaluate the validity of the Chinese translation version of OSDI-6 (C-OSDI-6) in a theoretical set-up of two questionnaire groups for dry eye


Clinical Trial Description

Screening for dry eye symptoms and quantifying dry eye symptoms aids in assessment, diagnosis, and treatment. Patient-reported outcome (PRO) instruments such as the Ocular Surface Disease Index (OSDI-12) are utilized for assessing patients' subjective experiences and functional abilities. The OSDI-12 comprises of 12-item and is often used in conjunction with other tests in clinical settings to assess individuals with DE. Created in 1997, the original OSDI consisted of 12 items and was designed to evaluate subjective dry eye symptoms and the consequences of DED on vision-related activities of daily life over the preceding week. The 12 items are grouped into three subscales: ocular symptoms (three items), vision-related functions (six items), and environmental triggers (three items). While the original version of the OSDI-12 questionnaire was created in English and was later translated and validated into other languages, it should be used carefully since the cutoff values vary among various languages (27.2 points for the Chinese version and 36.3 points for the Japanese version) . Recent research using Rasch analysis found that separating answer items into four categories by merging "half of the time" and "most of the time" might lead to higher thresholds and better intervals in each category. The OSDI-12 total score is calculated using the formula: [(sum of scores for all questions answered) × 100]/ [(total number of questions answered) × 4]. Ocular Surface Disease Index-6 (OSDI-6) is a derivative and shortened version of the original OSDI-12 and can potentially improve efficiency in a busy clinical setting. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06158906
Study type Observational
Source He Eye Hospital
Contact
Status Completed
Phase
Start date December 1, 2023
Completion date February 17, 2024

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