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

Starting soon · Not applicable

Conditions studied: Dry Eye Disease (DED)

In brief

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.

Key facts

Study ID

NCT07524725

Run by

Zhongshan Ophthalmic Center, Sun Yat-sen University

People needed

540

Starts

2027-01-01

Expected to finish

2033-12-31

Last updated by the study team

2026-04-13

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥18 TO ≤45 years of age, any sex.
• Meet the dry eye diagnostic criteria of the DEWS international consensus, and show both of the following two conditions: OSDI score between 18 and 80; NIBUT (Non-invasive tear break-up time) < 8 seconds
• Best corrected visual acuity ≥ 0.5(10/20) (in each eye).
• Intraocular pressure between 5 and 21 mmHg (in each eye).
• Women of childbearing potential must agree to use safe contraception during the study.
• Willingness/ability to return for all study visits and to follow instructions from the study investigator and their staff.
• Voluntary participation and signing of the informed consent form approved by the Ethics Committee.

You may not qualify if…

• NEI corneal fluorescein staining score > 5 (in either eye).
• Wore contact lenses within the past 14 days and cannot commit to not wearing them during the study period (3 months) (in either eye).
• Received refractive surgery (LASIK, SMILE) or other ocular surgery, or had ocular trauma within the past 12 months (in either eye).
• Had acute allergic conjunctivitis, infection, or ocular surface inflammation within the past 3 months (in either eye).
• Eyelid abnormalities that affect eyelid function, such as nystagmus, blepharospasm, ectropion, entropion, or severe trichiasis (in either eye).
• Previously diagnosed with glaucoma and received medical or surgical treatment (in either eye).
• Currently receiving other ophthalmic or systemic treatments that may affect the tear film.
• Allergy to fluorescein sodium.
• Have a serious health condition that may limit their ability to participate.
• Pregnant, breastfeeding, or planning to become pregnant.
• Diagnosed with neurological or psychiatric disorders (e.g., severe anxiety, depression, or severe sleep disorder).
• Have difficulty with physical movement.
• Previous experience with traditional exercise such as Baduanjin.
• Previous experience with laughter exercise.

Full record on ClinicalTrials.gov

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