Assessment of Acupuncture on Eye Fatigue : a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- eye accommodation ability
研究概览
简要总结
The study is designed to assess the effiacy of acupuncutre on eye fatigue. The indicator of eye fatigue is eye accommodation ability. Patients will be randomly assigned to the experimental group and the control group. The experimental group will receive acupuncture treatment, while the control group will receive sham acupuncture stimulation. The eye accommodation ability of both groups will be easured before and after the intervention, and the differences in eye accommodation ability before and after treatment will be analyzed.
详细描述
A dual-arm, parallel, randomized single-blind, sham-controlled trial will be conducted. The aim of the study is to assess the effiacy of acupuncutre on eye fatigue. Patients will be recruited from outpatient clinics. Subjects will be assessed at a Traditional Chinese Medicine (TCM) outpatient clinic and then have their accommodation function tested in an optometry room . This will determine if they meet the inclusion criteria.
Those who meet the inclusion criteria will be randomly assigned to the experimental group or the control group. The experimental group will receive treatment at seven acupuncture points: Fengfu (GV16), bilateral Fengchi (GB20), Yumen (TH2), and Hegu (LI4), using Jiasun 42G 1-inch acupuncture needles. The needles will be inserted perpendicularly to achieve the "De Qi" sensation, with a depth of 0.5 inches, and retained for 25 minutes before removal. The control group will undergo sham acupuncture at the same points using specially designed acupuncture needles from the manufacturer, which give the sensation of needling but retract into the handle without penetrating the skin, thus providing no real stimulation. Both groups will be treated by TCM physician .
After needle removal, visual acuity will be tested again to compare the differences in values between the pre- and post-test measurements of both groups.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjective experience of eye fatigue after using electronic devices at least twice a week.
- •Age ≥ 18 years.
- •Agreement to sign the informed consent form for this study.
排除标准
- •Accommodation assessment: Interocular accommodation difference greater than 3 diopters (D).
- •History of metabolic diseases with accompanying retinal conditions (e.g., diabetic retinopathy, hypertensive/hyperlipidemic patients with macular edema, retinal hemorrhage, glaucoma, etc.).
- •Current treatment for ocular inflammation or infection (e.g., conjunctivitis, orbital cellulitis).
- •Underwent eye surgery within the last 3 months (including LASIK surgery).
- •Received acupuncture treatment for eye-related symptoms in the past month.
- •Diagnosed with severe ophthalmic conditions (e.g., optic atrophy) and deemed unsuitable for the trial by an ophthalmologist.
- •Diagnosed with anemia, hypotension, or chronic fatigue in the past three months, making them unsuitable for acupuncture due to a tendency to faint.
- •Pregnant women.
- •Major diseases such as renal insufficiency, cerebrovascular disease, or cancer, deemed unsuitable for clinical research participation by the principal investigator.
研究组 & 干预措施
acupuncture group
干预措施: acupuncture (Device)
pseudo-acupuncture group
干预措施: pseudo-acupuncture (Device)
结局指标
主要结局
eye accommodation ability
时间窗: From enrollment to the end of treatment in 30 minutes
Value of eye accommodation ability difference before and after the intervention, measured by an autorefractor
次要结局
未报告次要终点