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

N/ANot Yet RecruitingNCT07524725

Zhongshan Ophthalmic Center, Sun Yat-sen University540 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

540

Conditions

Dry Eye Disease (DED)

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

Inclusion Criteria: * ≥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. Exclusion Criteria: * 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.

Outcomes

Primary Outcomes

Change of OSDI scores at week 12

The OSDI is a 12-item patient-reported outcomes questionnaire designed by a staff of a pharmaceutical company (Allergan, Inc.) to provide a rapid assessment of the range of ocular surface symptoms, including symptoms related to chronic dry eye, their severity, and their impact on the patient's ability to function. In addition to an overall score, there are three subscales of the OSDI: ocular symptoms, vision-related function, and environmental triggers. The OSDI score is calculated as: (total points from all answers × 100) / (number of answered questions × 4). A higher score indicates worse symptoms.

Time frame: From baseline to weeks 1, 2, 4, 6, 8, 10, and 12

Secondary Outcomes

Proportion of patients with 10 points or more decreased in OSDI at week 12

The proportion of patients with a decrease from baseline in the ocular surface disease index score (OSDI) of 10 points or more (the minimal clinically meaningful cut-off)

Time frame: From baseline to the end of interventions at week 12

Change in OSDI score at week 48

OSDI scores change from baseline to week 48.

Time frame: From baseline to weeks 16, 24, 36, and 48.

Change in non-invasive tear film break up time at week 12

Non-invasive tear break-up time (NIBUT), measured using a keratograph (Keratograph 5M). Participants blink twice, then the time to first dry spot on the cornea is recorded using Placido disk principle. The average of three measurements is used.