NCT04668131已完成不适用
Study on Curative Effect and Mechanism of Acupuncture on Neuropathic Pain in Dry Eye Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Visual Analogue Score
研究概览
简要总结
This project is designed as a prospective, randomized, open, controlled clinical trial. For the first time, acupuncture was applied to the treatment of dry ocular neuropathic pain. Its mechanism was discussed by comparing the efficacy between acupuncture and artificial tears.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •According to the DEWS diagnostic criteria, the OSDI score ≥ 13, with positive signs of dry eye (SIt ≤ 10mm/5min or TBUT ≤ 10s) or CFS positive;
- •Signed informed consent.
排除标准
- •Patients with dry eye who have had irritants directly irritating the ocular surface in the past 3 days;
- •Eyeball infections, allergies, deformities, abnormal movements
- •Any history of eye surgery
- •Have had eye trauma or fundus laser treatment within 3 months
- •Used drugs that affect tear production such as antihistamines, antidepressants, etc. within 30 days
- •Suffer from systemic diseases that affect tear production, including Sjogren's syndrome, diabetes, mental illness, malignant tumors, etc.
研究组 & 干预措施
Artificial tears
Experimental
Artificial tears
干预措施: Sodium hyaluronate eye drops (Drug)
Acupuncture
Active Comparator
Acupuncture
干预措施: acupuncture (Other)
结局指标
主要结局
Visual Analogue Score
时间窗: The treatment period for each enrolled subject is one month
Ask the patient to mark the corresponding position on the ruler that can represent the pain or discomfort during the onset
次要结局
- OSDI(The treatment period for each enrolled subject is one month)
- TBUT(The treatment period for each enrolled subject is one month)
- SIt(The treatment period for each enrolled subject is one month)
- CFS score(The treatment period for each enrolled subject is one month)
- Density and curvature of corneal subbasal nerve(The treatment period for each enrolled subject is one month)
- Tear pain factor content(The treatment period for each enrolled subject is one month)
研究者
研究点 (1)
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