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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorZhongshan Ophthalmic Center, Sun Yat-sen University

About this trial

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.

Eligibility criteria

Qualifiers

≥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).

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Baduanjin
  • Laughter exercise
  • Artificial tears

Treatment groups

540 Participants
are divided into 3 treatment groups

Locations

This trial has no locations