Dry Eye Disease (DED)
Conditions
Brief 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.
Interventions
BEHAVIORALBaduanjin
Participants 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.
BEHAVIORALLaughter exercise
Launch 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
DRUGArtificial tears
Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.
Sponsors
Zhongshan Ophthalmic Center, Sun Yat-sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of OSDI scores at week 12 | From baseline to weeks 1, 2, 4, 6, 8, 10, and 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of patients with 10 points or more decreased in OSDI at week 12 | From baseline to the end of interventions 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 | From baseline to weeks 16, 24, 36, and 48. | OSDI scores change from baseline to week 48. |
| Change in non-invasive tear film break up time at week 12 | From baseline to weeks 4, 8, and 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 | From baseline to weeks 16, 24, 36, and 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 tear meniscus height at week 12 | From baseline to weeks 4, 8, and 12 | Tear meniscus height, measured using a keratograph (Keratograph 5M) as the vertical height of the tear fluid just below the pupil margin, reflecting tear secretion volume. |
| Change in tear meniscus height at week 48 | From enrollment to the weeks 16, 24, 36, and 48 | Tear meniscus height, measured using a keratograph (Keratograph 5M) as the vertical height of the tear fluid just below the pupil margin, reflecting tear secretion volume. |
| Change in corneal fluorescein staining score at week 12 | From baseline to weeks 4, 8, and 12 | Corneal fluorescein staining score (NIH scale, 0-15). The cornea is divided into 5 regions, each scored 0-3 based on the number of staining dots, for a total score of 0 to 15. |
| Change in corneal fluorescein staining score at week 48 | From baseline to weeks 16, 24, 36, and 48 | Corneal fluorescein staining score (NIH scale, 0-15). The cornea is divided into 5 regions, each scored 0-3 based on the number of staining dots, for a total score of 0 to 15. |
| Change in lipid layer thickness at week 12 | From baseline to weeks 4, 8, and 12 | Lipid layer thickness, measured automatically using a Lipiview interferometer. |
| Change in lipid layer thickness at week 48 | From baseline to weeks 16, 24, 36, and 48 | Lipid layer thickness, measured automatically using a Lipiview interferometer. |
| Change in Self-Rating Anxiety Scale at week 12 | From baseline to weeks 4, 8, and 12 | The Self-Rating Anxiety Scale consists of 20 items related to anxiety symptoms. It assesses the severity of anxiety over the past week across dimensions such as subjective anxiety feelings, autonomic nervous system disturbances, and motor tension. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe anxiety. |
| Change in Self-Rating Anxiety Scale at week 48 | From baseline to weeks 16, 24, 36, and 48 | The Self-Rating Anxiety Scale consists of 20 items related to anxiety symptoms. It assesses the severity of anxiety over the past week across dimensions such as subjective anxiety feelings, autonomic nervous system disturbances, and motor tension. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe anxiety. |
| Change in Self-Rating Depression Scale at week 12 | From baseline to weeks 4, 8, and 12 | The Self-Rating Depression Scale consists of 20 items related to depressive symptoms. It assesses the severity of depression over the past week across core dimensions including low mood, slowed thinking, somatic symptoms (e.g., sleep disturbances, loss of appetite), and reduced volitional activity. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe depression. |
| Change in Self-Rating Depression Scale at week 48 | From baseline to weeks 16, 24, 36, and 48 | The Self-Rating Depression Scale consists of 20 items related to depressive symptoms. It assesses the severity of depression over the past week across core dimensions including low mood, slowed thinking, somatic symptoms (e.g., sleep disturbances, loss of appetite), and reduced volitional activity. The raw score is the sum of all item scores, which is then converted to a standardized score ranging from 0 to 100. Higher scores indicate more severe depression. |
| Change in Subjective Happiness Scale at week 12 | From baseline to weeks 4, 8, and 12 | The Subjective Happiness Scale consists of 4 items measuring subjective well-being, covering life satisfaction, positive emotional experiences, and frequency of negative emotions. The total score is the average of the item scores, ranging from 0 to 7. Higher scores indicate a higher level of subjective happiness. |
| Change in Subjective Happiness Scale at week 48 | From baseline to weeks 16, 24, 36, and 48 | The Subjective Happiness Scale consists of 4 items measuring subjective well-being, covering life satisfaction, positive emotional experiences, and frequency of negative emotions. The total score is the average of the item scores, ranging from 0 to 7. Higher scores indicate a higher level of subjective happiness. |
| Change in Pittsburgh Sleep Quality Index at week 12 | From baseline to weeks 4, 8, and 12 | The Pittsburgh Sleep Quality Index consists of 15 items assessing sleep quality over the past month across 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are summed to give a global score ranging from 0 to 21. Higher scores indicate worse sleep quality. |
| Change in Pittsburgh Sleep Quality Index at week 48 | From baseline to weeks 16, 24, 36, and 48 | The Pittsburgh Sleep Quality Index consists of 15 items assessing sleep quality over the past month across 7 dimensions: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. The component scores are summed to give a global score ranging from 0 to 21. Higher scores indicate worse sleep quality. |
| Change in SF-36 Scale at week 12 | From baseline to weeks 4, 8, and 12 | The 36-Item Short Form Health Survey (SF-36) consists of 36 items measuring health-related quality of life across 8 dimensions: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each dimension score is standardized to a range of 0 to 100. Higher scores indicate better health status in that dimension. |
| Change in SF-36 Scale at week 48 | From baseline to weeks 16, 24, 36, and 48 | The 36-Item Short Form Health Survey (SF-36) consists of 36 items measuring health-related quality of life across 8 dimensions: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. Each dimension score is standardized to a range of 0 to 100. Higher scores indicate better health status in that dimension. |
Contacts
CONTACTLingyi Liang
Outcome results
None listed