Effect of Behavioral Intervention (Baduanjin Alone or Laughter Exercise Plus Artificial Tears) Versus Artificial Tear on Dry Eye Disease: a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 540
- 主要终点
- Change of OSDI scores at week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥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.
排除标准
- •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.
研究组 & 干预措施
Baduanjin alone
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.
干预措施: Baduanjin (Behavioral)
Laughter exercise plus artificial tears
Perform laughter exercise 4 times per day and use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day.
干预措施: Laughter exercise (Behavioral)
Laughter exercise plus artificial tears
Perform laughter exercise 4 times per day and use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day.
干预措施: Artificial tears (Drug)
Artificial tears
Use 0.1% sodium hyaluronate eye drops in both eyes 4 times per day for 12 weeks.
干预措施: Artificial tears (Drug)
结局指标
主要结局
Change of OSDI scores at week 12
时间窗: 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.
次要结局
- Proportion of patients with 10 points or more decreased in OSDI at week 12(From baseline to the end of interventions at week 12)
- Change in OSDI score at week 48(From baseline to weeks 16, 24, 36, and 48.)
- Change in non-invasive tear film break up time at week 12(From baseline to weeks 4, 8, and 12)
- Change in non-invasive tear film break up time at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in tear meniscus height at week 12(From baseline to weeks 4, 8, and 12)
- Change in tear meniscus height at week 48(From enrollment to the weeks 16, 24, 36, and 48)
- Change in corneal fluorescein staining score at week 12(From baseline to weeks 4, 8, and 12)
- Change in corneal fluorescein staining score at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in lipid layer thickness at week 12(From baseline to weeks 4, 8, and 12)
- Change in lipid layer thickness at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in Self-Rating Anxiety Scale at week 12(From baseline to weeks 4, 8, and 12)
- Change in Self-Rating Anxiety Scale at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in Self-Rating Depression Scale at week 12(From baseline to weeks 4, 8, and 12)
- Change in Self-Rating Depression Scale at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in Subjective Happiness Scale at week 12(From baseline to weeks 4, 8, and 12)
- Change in Subjective Happiness Scale at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in Pittsburgh Sleep Quality Index at week 12(From baseline to weeks 4, 8, and 12)
- Change in Pittsburgh Sleep Quality Index at week 48(From baseline to weeks 16, 24, 36, and 48)
- Change in SF-36 Scale at week 12(From baseline to weeks 4, 8, and 12)
- Change in SF-36 Scale at week 48(From baseline to weeks 16, 24, 36, and 48)
研究者
Lingyi Liang
Professor; Vice President of Zhongshan Ophthalmic Center, Head of the Preventive Ophthalmology Department
Zhongshan Ophthalmic Center, Sun Yat-sen University