- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06158906
Validity of Web-Based OSDI-6 Questionnaire in a Chinese Adult Population
February 17, 2024 updated by: He Eye Hospital
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
Study Overview
Status
Completed
Conditions
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 (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 Type
Observational
Enrollment (Actual)
270
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jiayan Chen
- Phone Number: +8618304019060
- Email: cjy100009@outlook.com
Study Locations
-
-
None Selected
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Shenyang, None Selected, China, 110034
- He Eye Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Patients who have been diagnosed with dry eye
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Study group
Dry eye patients were recruited to fill in the questionnaire
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Schiffman RM, Christianson MD, Jacobsen G, Hirsch JD, Reis BL. Reliability and validity of the Ocular Surface Disease Index. Arch Ophthalmol. 2000 May;118(5):615-21. doi: 10.1001/archopht.118.5.615.
- Craig JP, Nichols KK, Akpek EK, Caffery B, Dua HS, Joo CK, Liu Z, Nelson JD, Nichols JJ, Tsubota K, Stapleton F. TFOS DEWS II Definition and Classification Report. Ocul Surf. 2017 Jul;15(3):276-283. doi: 10.1016/j.jtos.2017.05.008. Epub 2017 Jul 20.
- Jones L, Downie LE, Korb D, Benitez-Del-Castillo JM, Dana R, Deng SX, Dong PN, Geerling G, Hida RY, Liu Y, Seo KY, Tauber J, Wakamatsu TH, Xu J, Wolffsohn JS, Craig JP. TFOS DEWS II Management and Therapy Report. Ocul Surf. 2017 Jul;15(3):575-628. doi: 10.1016/j.jtos.2017.05.006. Epub 2017 Jul 20.
- Nichols KK, Mitchell GL, Zadnik K. Performance and repeatability of the NEI-VFQ-25 in patients with dry eye. Cornea. 2002 Aug;21(6):578-83. doi: 10.1097/00003226-200208000-00009.
- Lu F, Tao A, Hu Y, Tao W, Lu P. Evaluation of Reliability and Validity of Three Common Dry Eye Questionnaires in Chinese. J Ophthalmol. 2018 Aug 27;2018:2401213. doi: 10.1155/2018/2401213. eCollection 2018.
- Midorikawa-Inomata A, Inomata T, Nojiri S, Nakamura M, Iwagami M, Fujimoto K, Okumura Y, Iwata N, Eguchi A, Hasegawa H, Kinouchi H, Murakami A, Kobayashi H. Reliability and validity of the Japanese version of the Ocular Surface Disease Index for dry eye disease. BMJ Open. 2019 Nov 25;9(11):e033940. doi: 10.1136/bmjopen-2019-033940.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2023
Primary Completion (Actual)
February 17, 2024
Study Completion (Actual)
February 17, 2024
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
November 28, 2023
First Posted (Actual)
December 6, 2023
Study Record Updates
Last Update Posted (Actual)
February 20, 2024
Last Update Submitted That Met QC Criteria
February 17, 2024
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OSDI6
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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