Multicenter, Randomized, Single-blinded, Sham-Controlled Trial of Electroacupuncture on Mild-to-moderate Dry Eye
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 168
- 试验地点
- 1
- 主要终点
- Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)
研究概览
简要总结
To determine if electroacupuncture acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes and neuroimmunomodulatory indicators.
详细描述
Acupuncture is an important method in the treatment of diseases in Chinese medicine and plays an important role in the treatment of many diseases. Electroacupuncture (EA), as a combination of acupuncture and electric stimulation, is now widely used in research and clinical treatment. Our preliminary study found that compared with 0.1% sodium hyaluronate eye drops, EA exerted more beneficial and durable effects after four weeks of treatment. However, the placebo effect of EA cannot be ruled out yet. The aim of this study is to determine if EA acts as an dry eye treatment rather than a placebo, and identify if benefits are linked to corneal subbasal nerve changes.
This is a multicenter, randomized, subject-blinded, sham-controlled trial. A total of 168 participants with mild-to-moderate dry eye will be randomly assigned (1:1) to verum EA or non-penetrating non-acupoint sham EA (3 times weekly for 4 weeks), followed by a 24-week follow-up. The primary efficacy outcome is the change from baseline to week 4 in the Noninvasive Tear Breakup Time (NIBUT). Secondary efficacy outcomes include tear meniscus height (TMH), Schirmer I test (SⅠT), corneal topography, corneal and conjunctival sensation, scores of Ocular Surface Disease Index (OSDI), corneal fluorescein staining (CFS), Numerical rating scale (NRS), and Chinese Dry Eye Related Quality of Life Scale (CDERQOL) . Additionally, we will apply the Patient Health Questionnaire-9 (PHQ-9) and the Generalized Anxiety Disorder (GAD-7) to understand the mental health conditions of patients. IVCM will be performed to observe the morphological changes of the corneal basal nerve. The changes of NGF, CGRP, NPY, 8-OHDG, 4-HNE, MDA and other neuroimmunomodulatory indicators in tears and conjunctival cells will be detected by immunofluorescence, ELISA, or other techniques.
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
- Triple (Participant, Care Provider, 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
- •Patients meeting the diagnostic criteria for dry eye according to the TFOS DEWS Ⅱ
- •Ages 18-65 years, no gender limit
排除标准
- •Diagnosed with severe dry eye
- •Combined with other eye diseases (e.g. severe blepharitis, blepharospasm, conjunctival laxity, strabismus, amblyopia, glaucoma, cataract, fundus disease, ocular trauma)
- •With active eye diseases or a history of eye surgery within 3 months
- •Received acupuncture treatment or other dry eye treatment measures within 1 month that may influence the assessment of efficacy
- •Previously experienced electroacupuncture intervention
- •Pregnant or breastfeeding females
- •Serious systemic diseases such as cardiovascular, cerebrovascular, hepatic, renal, and hematopoietic system and psychiatric disorders
- •With autoimmune diseases such as Sjögren's syndrome, rheumatoid arthritis, systemic lupus erythematosus, or ankylosing spondylitis
- •With damaged, ulcerated, infected, or scarred skin at the selected acupoints
- •Allergic to metal or tape
结局指标
主要结局
Change from Baseline in Noninvasive Tear Breakup Time (NIBUT)
时间窗: Baseline, Week 4, Week 8, Week 16, Week 28
The interval between a complete blink and the first breakup of tear film (indicated by a break or deformed Placido disc image on the screen) will be recorded. The measurements are carried out 3 times and the average value is considered as NIBUT.
次要结局
- Adverse events(Week 4)
- Change From Baseline in Ocular Surface Disease Index (OSDI)(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Chinese Dry Eye Related Quality of Life Scale (CDERQOL)(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Numerical Rating Scale (NRS)(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Tear Meniscus Height (TMH)(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Corneal Topography(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Corneal Fluorescein Staining (CFS)(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Corneal and Conjunctival sensation(Baseline, Week 4, Week 8, Week 16, Week 28)
- Change From Baseline in Schirmer I test (SⅠT)(Baseline, Week 4, Week 8, Week 16, Week 28)