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.
≥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).
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).
Parallel
Baduanjin
BehavioralParticipants perform Baduanjin 5 times per week for 12 weeks. The standardized version, endorsed by the General Administration of Sport of China, includes 8 movements performed for 10 to 15 minutes.
Laughter exercise
BehavioralLaunch the "smile face recognition" APP on smart phone, after user guidance and pretest, a smile exercise will display on the phone, while facing the front camera on the phone, participant will do an exercise emphasizing facial movements, as exaggerated as possible. The exercise last for 12 weeks and 4 times a day
Artificial tears
DrugParticipants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.
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.
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)
Change in OSDI score at week 48
OSDI scores change from baseline to week 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.
Change in non-invasive tear film break up time at week 48
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.
Change in blood pressure at week 12
Participants rest quietly for at least 5 minutes. Blood pressure is then measured using an electronic or mercury sphygmomanometer. Two measurements are taken, 1-2 minutes apart, and the average of the two readings is recorded for systolic and diastolic pressure (mmHg). If the two measurements differ by more than 5 mmHg, a third measurement is taken, and the average of all three is used.
Change in blood pressure at week 48
Participants rest quietly for at least 5 minutes. Blood pressure is then measured using an electronic or mercury sphygmomanometer. Two measurements are taken, 1-2 minutes apart, and the average of the two readings is recorded for systolic and diastolic pressure (mmHg). If the two measurements differ by more than 5 mmHg, a third measurement is taken, and the average of all three is used.
Change in heart rate at week 12
While the participant is at rest, heart rate (beats per minute) is measured by palpating the radial artery or using the heart rate monitor function of an electronic blood pressure device.
Change in heart rate at week 48
While the participant is at rest, heart rate (beats per minute) is measured by palpating the radial artery or using the heart rate monitor function of an electronic blood pressure device.
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