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

Dry Eye Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06158906
• Other study ID #: OSDI6
• Status: Completed
• Start date: December 1, 2023
• Est. completion date: February 17, 2024

Study information

• Verified date: November 2023
• Source: He Eye Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: February 17, 2024
• Est. primary completion date: February 17, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dry Eye
• Dry Eye Syndromes

Locations

Country	Name	City	State
China	He Eye Hospital	Shenyang	None Selected

Sponsors (1)

Lead Sponsor	Collaborator
He Eye Hospital

Country where clinical trial is conducted

China, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	OSDI12	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