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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:
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：
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Baduanjin alone | Experimental | Perform Baduanjin 5 times per week for 12 weeks. During the first 4 weeks, participants will practice with a coach in person once per week. The remaining sessions will be done by following a video or live online class. Each session lasts 24 minutes. |
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| Laughter exercise plus artificial tears | Experimental | Perform laughter exercise 4 times per day and use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day. |
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| Artificial tears | Active Comparator | Use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day for 12 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Baduanjin | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From baseline to weeks 1, 2, 4, 6, 8, 10, and 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From baseline to the end of interventions at week 12 |
| Change in OSDI score at week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lingyi Liang | Contact | 13829738319 | lianglingyi@gzzoc.com |
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| Laughter exercise | Behavioral | 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 |
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| Artificial tears | Drug | Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes. |
|
OSDI scores change from baseline to week 48. |
| 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. | From baseline to weeks 4, 8, and 12 |
| 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in tear meniscus height at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in tear meniscus height at week 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. | From enrollment to the weeks 16, 24, 36, and 48 |
| Change in corneal fluorescein staining score at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in corneal fluorescein staining score at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in lipid layer thickness at week 12 | Lipid layer thickness, measured automatically using a Lipiview interferometer. | From baseline to weeks 4, 8, and 12 |
| Change in lipid layer thickness at week 48 | Lipid layer thickness, measured automatically using a Lipiview interferometer. | From baseline to weeks 16, 24, 36, and 48 |
| Change in Self-Rating Anxiety Scale at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in Self-Rating Anxiety Scale at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in Self-Rating Depression Scale at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in Self-Rating Depression Scale at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in Subjective Happiness Scale at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in Subjective Happiness Scale at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in Pittsburgh Sleep Quality Index at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in Pittsburgh Sleep Quality Index at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in SF-36 Scale at week 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. | From baseline to weeks 4, 8, and 12 |
| Change in SF-36 Scale at week 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. | From baseline to weeks 16, 24, 36, and 48 |
| From baseline to weeks 4, 8, and 12 |
| 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. | From baseline to weeks 16, 24, 36, and 48 |
| 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. | From baseline to weeks 4, 8, and 12 |
| 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. | From baseline to weeks 16, 24, 36, and 48 |
| Change in respiratory rate at week 12 | While the participant is resting quietly and unaware of being observed, the number of breaths per minute is counted by watching the rise and fall of the chest or abdomen. The measurement lasts at least 60 seconds. To avoid voluntary breath control, the participant's attention is diverted before the measurement. | From baseline to weeks 4, 8, and 12 |
| Change in respiratory rate at week 48 | While the participant is resting quietly and unaware of being observed, the number of breaths per minute is counted by watching the rise and fall of the chest or abdomen. The measurement lasts at least 60 seconds. To avoid voluntary breath control, the participant's attention is diverted before the measurement. | From baseline to weeks 16, 24, 36, and 48 |
| Change in visual acuity at week 12 | Visual acuity measured with habitual correction, i.e., participants wear their usual glasses or none. If it is below 0.5, corrected (pinhole) visual acuity is also measured. | From baseline to weeks 4, 8, and 12 |
| Change in visual acuity at week 48 | Visual acuity measured with habitual correction, i.e., participants wear their usual glasses or none. If it is below 0.5, corrected (pinhole) visual acuity is also measured. | From baseline to weeks 16, 24, 36, and 48 |
| Change in introcular pressure at week 12 | Intraocular pressure is measured using a non-contact tonometer. Three measurements are taken, and the average is recorded (mmHg). | From baseline to weeks 4, 8, and 12 |
| Change in introcular pressure at week 48 | Intraocular pressure is measured using a non-contact tonometer. Three measurements are taken, and the average is recorded (mmHg). | From baseline to weeks 16, 24, 36, and 48 |
| Adherence to intervention at week 12 | Adherence is defined as the ratio of the number of completed training sessions to the number of planned sessions, expressed as a percentage. | From baseline to week 12 |
| Adherence to intervention at week 48 | Adherence is defined as the ratio of the number of completed training sessions to the number of planned sessions, expressed as a percentage. | From baseline to weeks 24 and 48 |
| Change in blood glucose at week 12 | A fasting venous blood sample (approximately 5 mL) is collected from the participant in the morning after an overnight fast. The blood is placed in a vacuum tube containing a coagulant or gel separator and centrifuged to separate serum. Fasting blood glucose is measured using an automated biochemical analyzer. If postprandial glucose or glucose tolerance-related measures are needed, the blood collection time should be specified separately. Results are recorded in mmol/L. | From baseline to week 12 |
| Change in blood glucose at week 48 | A fasting venous blood sample (approximately 5 mL) is collected from the participant in the morning after an overnight fast. The blood is placed in a vacuum tube containing a coagulant or gel separator and centrifuged to separate serum. Fasting blood glucose is measured using an automated biochemical analyzer. If postprandial glucose or glucose tolerance-related measures are needed, the blood collection time should be specified separately. Results are recorded in mmol/L. | From baseline to weeks 16, 24, 36, and 48 |
| Change in blood lipids at week 12 | A fasting venous blood sample (approximately 5 mL) is collected from the participant in the morning after an overnight fast. The blood is placed in a vacuum tube containing a coagulant or gel separator and centrifuged to separate serum. Total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and fasting blood glucose are measured using an automated biochemical analyzer. Results are recorded in mmol/L. | From baseline to week 12 |
| Change in blood lipids at week 48 | A fasting venous blood sample (approximately 5 mL) is collected from the participant in the morning after an overnight fast. The blood is placed in a vacuum tube containing a coagulant or gel separator and centrifuged to separate serum. Total cholesterol, triglycerides, low-density lipoprotein cholesterol (LDL-C), high-density lipoprotein cholesterol (HDL-C), and fasting blood glucose are measured using an automated biochemical analyzer. Results are recorded in mmol/L. | From baseline to weeks 16, 24, 36, and 48 |
| Change in tear inflammatory cytokine levels at week 12 | MMP-9, IL-6 are inflammatory markers measured in tear samples. Levels are assessed using a laboratory method with a tear test kit. Higher levels indicate greater inflammation. | From baseline to weeks 4, 8, and 12 |
| Change in tear inflammatory cytokine levels at week 48 | MMP-9, IL-6 are inflammatory markers measured in tear samples. Levels are assessed using a laboratory method with a tear test kit. Higher levels indicate greater inflammation. | From baseline to weeks 16, 24, 36, and 48 |
| Change in meibum expressibility at week 12 | On the lower eyelid, pressure is applied over the central 5 meibomian gland openings along the lash line. The number of glands that secrete any meibum is counted. Scoring (0-3 per eye):
| From baseline to weeks 4, 8, and 12 |
| Change in meibum expressibility at week 48 | On the lower eyelid, pressure is applied over the central 5 meibomian gland openings along the lash line. The number of glands that secrete any meibum is counted. Scoring (0-3 per eye):
| From baseline to weeks 16, 24, 36, and 48 |
| Change in meibum quality at week 12 | The upper eyelid meibomian glands are pressed, and the consistency of the expressed meibum is graded using the highest grade observed. Scoring (0-3 per eye):
| From baseline to weeks 4, 8, and 12 |
| Change in meibum quality at week 48 | The upper eyelid meibomian glands are pressed, and the consistency of the expressed meibum is graded using the highest grade observed. Scoring (0-3 per eye):
| From baseline to weeks 16, 24, 36, and 48 |
| Change in meibomian gland dropout grading at week 12 | Images of the meibomian glands are taken with a Keratograph 5M and graded by the same experienced ophthalmologist. The grade of gland dropout in the eyelid is scored (0-3 for upper and lower lids separately):
| From baseline to weeks 4, 8, and 12 |
| Change in meibomian gland dropout grading at week 48 | Images of the meibomian glands are taken with a Keratograph 5M and graded by the same experienced ophthalmologist. The grade of gland dropout in the eyelid is scored (0-3 for upper and lower lids separately):
| From baseline to weeks 16, 24, 36, and 48 |
| ID | Term |
|---|---|
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D065346 | Lubricant Eye Drops |
| ID | Term |
|---|---|
| D009883 | Ophthalmic Solutions |
| D019999 | Pharmaceutical Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
| D045506 | Therapeutic Uses |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D054327 | Lubricants |
| D020313 | Specialty Uses of Chemicals |
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