Clinical Trial

Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial

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Summary
The goal of this clinical trial is to compare the effect of behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears in patients with dry eye disease. The main questions it aims to answer are: * Does the Baduanjin improve the Ocular Surface Disease Index score of patients with dry eye disease? * Does the laughter exercise plus artificial tears improve the Ocular Surface Disease Index score of patients with dry eye disease? Researchers will compare behavioral intervention (Baduanjin alone or laughter exercise plus artificial tears) versus artificial tears to see if behavioral intervention works to treat dry eye disease. Participants will: * Do the Baduanjin 5 times per week, or do laughter exercise plus artifical tears 4 times per day, or use artificial tears alone 4 times per day for 12 weeks * Visit the clinic once right before the intervention and the 4, 8, 12, 16, 24, 36, and 48 weeks after starting the intervention for checkups and tests * Use the app developed by our study to record the behavioral intervention and/or use of eye drops.
Trial Details
NCT Number NCT07524725
Lead Sponsor Zhongshan Ophthalmic Center, Sun Yat-sen University
Conditions Dry Eye Disease (DED)
Enrollment 540 participants
Start Date 2027-01-01
Primary Completion 2032-12-31 (estimated)
Study Completion 2033-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-13