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

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.

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)

OSDI scores change from baseline to 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.

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.

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.

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.

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.

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.

Lipid layer thickness, measured automatically using a Lipiview interferometer.

Lipid layer thickness, measured automatically using a Lipiview interferometer.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

Intraocular pressure is measured using a non-contact tonometer. Three measurements are taken, and the average is recorded (mmHg).

Intraocular pressure is measured using a non-contact tonometer. Three measurements are taken, and the average is recorded (mmHg).

Adherence is defined as the ratio of the number of completed training sessions to the number of planned sessions, expressed as a percentage.

Adherence is defined as the ratio of the number of completed training sessions to the number of planned sessions, expressed as a percentage.

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.

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.

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.

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.

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.

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.

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):

• 0 (normal) = all 5 glands express meibum
• 1 (mild) = 3 or 4 glands express
• 2 (moderate) = 1 or 2 glands express
• 3 (severe) = no glands express

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):

• 0 (normal) = all 5 glands express meibum
• 1 (mild) = 3 or 4 glands express
• 2 (moderate) = 1 or 2 glands express
• 3 (severe) = no glands express

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):

• 0 (normal) = clear, fluid secretion
• 1 (mild) = cloudy, fluid secretion
• 2 (moderate) = cloudy, granular secretion
• 3 (severe) = thick, toothpaste-like secretion

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):

• 0 (normal) = clear, fluid secretion
• 1 (mild) = cloudy, fluid secretion
• 2 (moderate) = cloudy, granular secretion
• 3 (severe) = thick, toothpaste-like secretion

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):

• 0 (normal) = no gland loss
• 1 (mild) = loss of less than one-third of the gland area
• 2 (moderate) = loss between one-third and two-thirds
• 3 (severe) = loss of more than two-thirds

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):

• 0 (normal) = no gland loss
• 1 (mild) = loss of less than one-third of the gland area
• 2 (moderate) = loss between one-third and two-thirds
• 3 (severe) = loss of more than two-thirds