Acupuncture as Adjuvant Therapy for Glaucoma - Protocol for a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Intraocular pressure-Change
研究概览
简要总结
This clinical trial used acupuncture as an adjunctive treatment for glaucoma patients. A randomized, controlled trial involving 50 subjects will be conducted and observed for 12 weeks to evaluate the clinical efficacy of acupuncture. This study aims to provide a reference for future clinical treatment guidelines.
详细描述
This clinical trial utilized acupuncture as an adjunctive treatment for glaucoma patients. It is estimated a randomized clinical trial that 50 subjects will be enrolled and observed for 12 weeks to evaluate the clinical efficacy of acupuncture, providing a reference for future clinical treatment guidelines. Participants will be randomly divided into two groups: Ophthalmic Acupoint Treatment Group and Non-ophthalmological Acupoint Control Group. Participants in the treatment group will undergo acupuncture targeting ophthalmology-related acupuncture points, aiming to elicit the 'De Qi' sensation. Conversely, the control group will receive minimum acupuncture stimulation targeting non-ophthalmic acupuncture points without the intention of achieving the 'De Qi' sensation. Both groups will undergo acupuncture therapy once a week for a total of six sessions and will be observed for twelve weeks. On each visit, intraocular pressure, blood pressure, and heart rate will be assessed. Questionnaires of Glaucoma Symptom Scale (GSS) and The Glaucoma Quality of Life-15 (GQL-15) will be performed. The data of central corneal thickness, optical coherence tomography angiography, optical coherence tomography, visual field, and best-corrected visual acuity will be collected and analyzed before acupuncture and in the 12th week.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary open angle glaucoma diagnosed at least 3 months ago.
- •Diagnosed with mild or moderate open angel glaucoma.
- •Use 1 or 2 kinds of glaucoma drugs.
- •Age ≥ 20 years old.
- •Participants sign the informed consent and cooperate with the experimental procedures.
排除标准
- •Accept any ophthalmic laser or surgery within one year.
- •High myopia.
- •Use of any drugs that affect intraocular pressure.
- •Visual acuity with correction lower than 0.
- •Previous or existing uveitis or retinopathy.
- •Unable to receive acupuncture treatment continuously or allergic to acupuncture needles.
- •Pregnancy or breastfeeding.
- •Refusal to sign the informed consent form.
研究组 & 干预措施
Ophthalmic Acupoint Treatment Group
Ophthalmic acupoint treatment group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Fengchi(GB20), Cuanzhu(BL2), Sibai(ST2), Taiyang(EX-HN5), Hegu(LI4), Taichong(LR3), a total of six acupoints.
干预措施: Acupuncture (Other)
Non-ophthalmological Acupoint Control Group
Non-ophthalmological acupoint control group will receive a total of 6 courses of treatment, once a week, a total of six weeks, 20 minutes each time.
Acupuncture points: Yinlingquan(SP9), Liangqiu (ST34),Xiajuxu(ST39), Yanglingquan (GB34), Shousanli(LI10), Sanyangluo(TE8), a total of six acupoints. The Non-ophthalmological acupoint control group points are not indicated for the treatment of ophthalmological related pathologies, and are not reported to improve ophthalmological function.
干预措施: Acupuncture placebo (Other)
结局指标
主要结局
Intraocular pressure-Change
时间窗: Change from baseline intraocular pressure at 12 weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye. Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-pre-treatment
时间窗: Every weeks pre-acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
Intraocular pressure-after-treatment
时间窗: Every weeks 15 minutes after acupuncture treatment up to six weeks.
Intraocular pressure (IOP) is the fluid pressure of the eye.TOPCON CT-80 Computerized Tonometer is used for measurement.The unit of value is mmHg.
次要结局
- Visual field- mean deviation(Change from baseline visual field at 12 weeks.)
- Optical coherence tomography angiography-RPC density(Change from baseline RPC density at 6 weeks.)
- Optical coherence tomography-C/D ratio(Change from baseline C/D ratio at 12 weeks.)
- Best corrected visual acuity(Change from baseline best corrected visual acuity at 12 weeks.)
- Visual field- visual field index(Change from baseline visual field at 12 weeks.)
- Glaucoma Quality of Life - 15(On the first and 12th week for baseline and follow up tracing.)
- Blood pressure(we measure blood pressure every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.)
- Heart rate(we measure heart rate every weeks before and after acupuncture treatment of totally six weeks, and first and 12th week for baseline and follow up tracing.)
- Optical coherence tomography-RNFL symmety(Change from baseline RNFL symmety at 12 weeks.)
- Central corneal thickness(On the first and 12th week for baseline and follow up tracing.)
- Glaucoma Symptom Scale(On the first and 12th week for baseline and follow up tracing.)