Laser Acupuncture Therapy in Patients With Dry Eye: A Two-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Ocular Surface Disease Index
研究概览
简要总结
Subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The effects of laser acupuncture therapy for patients with dry eye are investigated.
详细描述
Objective
Dry eye is a common ophthalmologic disorder causing ocular discomfort in daily life. The investigators aim to investigate the effects of laser acupuncture therapy for patients with dry eye.
Methods: 200 subjects with dry eye are enrolled at two ophthalmic centers and randomly assigned to a laser acupuncture group and control group under conventional treatment with artificial tears. The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using verum or sham laser acupuncture during 3 sessions per week. After 4 and 12 weeks of treatment, the differences in the Tear film break-up time, Schirmer test, visual analogue scale, Ocular Surface Disease Index of the patients are analyzed, and compared between the laser acupuncture and control groups using paired t-test and one way ANOVA.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Sham laser acupuncture: laser acupuncture without laser output.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20 < age < 65, with aggravated dry eye (one or both eyes), evaluated by ophthalmologist and provides informed consent.
- •Tear film break-up time < 10 s
- •Schirmer's strips with anesthesia < 5mm/ 5min
排除标准
- •presence of eye lesions, received operation for eye during the past three months, combination of other ophthalmic medication, or using contact lens
- •pregnancy, diabetes mellitus, vitamin A deficiency, sequelae of Bell's palsy, hemodialysis
- •critical illness such as Stevens-Johnson syndrome, etc
- •has taken or needs active treatment (including Chinese medicine)
- •presence of a pacemaker; history of seizure or epilepsy; using immunosuppressants; cancer; infectious disease of skin
- •does not meet the physician's assessment for recruitment
- •lack of informed consent.
研究组 & 干预措施
Laser acupuncture
The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using laser acupuncture during 3 sessions per week for 12 weeks.
干预措施: Laser acupuncture (Procedure)
Sham laser acupuncture
The subjects are treated at acupoints including BL2, TE23, ST2, LI4, ST36, and GB37 using sham laser acupuncture (without laser output) during 3 sessions per week for 12 weeks.
干预措施: Sham laser acupuncture (Procedure)
结局指标
主要结局
Ocular Surface Disease Index
时间窗: 12 weeks
The Ocular Surface Disease Index (OSDI) is a 12-item scale for the assessment of symptoms related to dry eye disease and their effect on vision.
次要结局
- Schirmer test(12 weeks)
- Visual analogue scale of eye discomfort(12 weeks)
- Tear film break-up time(12 weeks)