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

Обзор

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.

Вмешательства

• Поведенческое Baduanjin
  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.
• Поведенческое Laughter 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
• Препарат Artificial tears
  Participants use 0.1% sodium hyaluronate eye drops 4 times per day in both eyes.

Первичные конечные точки

• Change of OSDI scores at week 12 [Срок оценки: From baseline to weeks 1, 2, 4, 6, 8, 10, and 12]

Вторичные конечные точки (12)

• Proportion of patients with 10 points or more decreased in OSDI at week 12 [Срок оценки: From baseline to the end of interventions at week 12]
• Change in OSDI score at week 48 [Срок оценки: From baseline to weeks 16, 24, 36, and 48.]
• Change in non-invasive tear film break up time at week 12 [Срок оценки: From baseline to weeks 4, 8, and 12]
• Change in non-invasive tear film break up time at week 48 [Срок оценки: From baseline to weeks 16, 24, 36, and 48]
• Change in tear meniscus height at week 12 [Срок оценки: From baseline to weeks 4, 8, and 12]
• Change in tear meniscus height at week 48 [Срок оценки: From enrollment to the weeks 16, 24, 36, and 48]
• Change in corneal fluorescein staining score at week 12 [Срок оценки: From baseline to weeks 4, 8, and 12]
• Change in corneal fluorescein staining score at week 48 [Срок оценки: From baseline to weeks 16, 24, 36, and 48]
• Change in lipid layer thickness at week 12 [Срок оценки: From baseline to weeks 4, 8, and 12]
• Change in lipid layer thickness at week 48 [Срок оценки: From baseline to weeks 16, 24, 36, and 48]
• Change in Self-Rating Anxiety Scale at week 12 [Срок оценки: From baseline to weeks 4, 8, and 12]
• Change in Self-Rating Anxiety Scale at week 48 [Срок оценки: From baseline to weeks 16, 24, 36, and 48]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07524725 · 2026LSPJ089

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗