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Completed

NCT Number: NCT06158906

Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population

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

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

He Eye Hospital

Shenyang, None Selected, 110034, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Diagnosed dry eye
  • Able and willing to comply with the schedule
  • Able to read and understand the C-OSDI-12 questionnaire independently

Exclusion criteria

  • The researchers judged to be not suitable

Treatment and study plan

Primary outcomes

  1. OSDI12

    Time frame: Baseline

    The patient will answer each question on a scale ranging from 0 to 4, with 0 indicating 'none of the time' and 4 indicating 'all of the time'. If a certain question is deemed irrelevant, it will be marked as 'not applicable (N/A)' and excluded from the analysis. The OSDI total score is calculated according to the following formula. The scale ranges from 0 to 100, with higher scores representing more severe cases of dry eye syndrome

Sponsors and collaborators

Lead sponsor

He Eye Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Dec 6, 2023
Registry last updated
Feb 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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