Ignite Creation Date:
2024-05-06 @ 7:51 PM
Last Modification Date:
2024-10-26 @ 3:15 PM
Study NCT ID:
NCT06158906
Status:
COMPLETED
Last Update Posted:
2024-02-20
First Post:
2023-11-28
Brief Title:
Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
Sponsor:
He Eye Hospital
Organization:
He Eye Hospital
Study Overview
Official Title:
Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 272 points for the Chinese version and 363 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None