Effect of Acupuncture on Visual Acuity and Visual Field in Patients With Primary Open-angle Glaucoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- visual acuity
研究概览
简要总结
The goal of this clinical trial is to test the therapeutic effect of acupuncture at the Jingming and the Qiuhou acupoints on the visual acuity and visual field in patients with primary open-angle glaucoma.
Participants will get acupuncture or Wangbuliu Xingzi Paste (sham acupuncture) on both sides of the Jingming and the Qiuhou, once a week, once for 20 minutes, for 24 weeks.
Researchers will compare acupuncture group and sham acupuncture group to see if the visual acuity, visual field, intraocular pressure, optic nerve fiber layer thickness, serum homocysteine concentration, and scores on the WHOQOL-REF (Taiwan version) scale would be improved.
详细描述
Glaucoma is a syndrome. The long-term increase in intraocular pressure eventually leads to visual field defect and blindness. Lowering the intraocular pressure in patients with glaucoma is considered to be the most effective way to treat glaucoma. Many studies believe that both blood circulation around the eyes and increased intraocular pressure play a critical role in glaucoma. Some studies have shown that acupuncture can adjust intraocular pressure and improve optic nerve activity, as well as increase blood flow of the eye fundus. Jingming (BL1) can communicate yin and yang, nourish and improve eyesight, and Qiuhou (EX-HN7) can promote qi and blood circulation, and improve vision. The results of our previous research found that acupuncture or electroacupuncture can reduce the intraocular pressure in patients with glaucoma. Therefore, the purpose of this study is to assess the therapeutic effect of acupuncture at the Jingming and the Qiuhou acupoints on the visual acuity and visual field in patients with primary open-angle glaucoma. This study designed a randomized, single-blind, controlled clinical trial. A total of 40 patients with primary open-angle glaucoma were randomly divided into two groups equally as follows: 1) Sham acupuncture group: Only use Wangbuliu Xingzi Paste on the skin on the acupoints on both sides of the Jingming and the Qiuhou, once a week, once for 20 minutes, for 24 weeks; 2) Acupuncture group: The method is the same as the sham acupuncture group, but the stainless steel needles are used to insert into the two points of Jingming and the Qiuhou, and der-qi, once a week, once for 20 minutes, for 24 consecutive weeks. The main assessment is visual acuity and visual field; the secondary assessment includes intraocular pressure, optic nerve fiber layer thickness, serum homocysteine concentration, and changes in scores on the WHOQOL-REF (Taiwan version) scale.
It is expected that acupuncture intervention can improve the visual acuity and visual field in patients with glaucoma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Open-angle glaucoma diagnosis at least 3 months previously.
- •Use of one or no intraocular hypotensive drugs.
- •There is no evidence of other eye diseases other than glaucoma.
- •Clear consciousness that enabled the participant to sign the informed consent form and cooperate with the trial procedure.
排除标准
- •Comorbidity with other chronic diseases, such as hypertension and diabetes, and taking multiple drugs.
- •Laser surgery for either glaucoma or myopia.
- •Pregnancy or lactation.
- •Intolerance to acupuncture treatment.
- •Allergy to acupuncture needles.
- •Refusal to sign the informed consent form.
研究组 & 干预措施
Sham acupuncture group
Use Wangbuliu Xingzi Paste on the skin, once a week, once for 20 minutes, for 24 weeks.
干预措施: Acupuncture (Device)
Acupuncture group
Use stainless steel needles on the skin, once a week, once for 20 minutes, for 24 consecutive weeks.
干预措施: Acupuncture (Device)
结局指标
主要结局
visual acuity
时间窗: 24 weeks
Primary outcome measure was the changes of visual acuity
visual field
时间窗: 24 weeks
Primary outcome measure was the changes of visual field
次要结局
- optic nerve fiber layer thickness(24 weeks)
- serum homocysteine concentration(24 weeks)
- the World Health Organization Quality of Life brief (Taiwan version) scale(24 weeks)
- intraocular pressure(24 weeks)