Effect of Plum-blossom Needle vs. Tropicamide Eye Drops on Juvenile Myopia: A Cross-over Single-blind Randomized Study
试验速览
- 阶段
- 不适用
- 入组人数
- 98
- 试验地点
- 1
- 主要终点
- Changes of vision acuity
研究概览
简要总结
The purpose of this study is to determine whether plum-blossom needle is effective in the treatment of juvenile myopia and compare the efficacy with Tropicamide Eye Drops.
详细描述
Plum-blossom needle is a historical treatment technology of Traditional Chinese Medicine, and has been applied to ophthalmic diseases, such as myopia and glaucoma, for nearly one hundred years.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The result of retinoscopy is myopic refractive error, near visual acuity and other visual functions must be normal
- •Distance visual acuity can be corrected to normal using negative spherical or cylindrical lenses
- •Myopia diopter spherical lenses must be ≤-3.00 D which measured under cycloplegia
- •Subjects must be between 8 and 20 years of age
排除标准
- •Diopter spherical lenses be >-3.00 D , or uncorrected distance visual acuity <0.1, or pathologic myopia with eye complications
- •Diopter spherical lense ≥1.50 D or cylindrical lenses ≥1.00 D, as measured under cycloplegia
- •The affected eyes have other diseases which affect the determination of acupuncture efficacy
- •Subjects with serious systemic diseases, such as cerebrovascular, liver, kidney, hematopoietic system, and psychiatric diseases
- •Longterm use of other related drugs or treatments, which have not been terminated
- •Parents or subjects refuse to participate this trial
- •Participating other ongoing clinical trials
研究组 & 干预措施
PbN-TED
Treated with plum-blossom needle first for 10 times during 20 days, followed with a one-month wash-out period and a 10-day period with Tropicamide Eye Drops.
干预措施: Plum-blossom Needle (Other)
PbN-TED
Treated with plum-blossom needle first for 10 times during 20 days, followed with a one-month wash-out period and a 10-day period with Tropicamide Eye Drops.
干预措施: Tropicamide Eye Drops (Drug)
TED-PbN
Treated with Tropicamide Eye Drops for 10 days first, followed with a one-month wash-out period and 10 times of plum-blossom needle treatment for 20 days.
干预措施: Plum-blossom Needle (Other)
TED-PbN
Treated with Tropicamide Eye Drops for 10 days first, followed with a one-month wash-out period and 10 times of plum-blossom needle treatment for 20 days.
干预措施: Tropicamide Eye Drops (Drug)
结局指标
主要结局
Changes of vision acuity
时间窗: Every 30 days for 150 days
International Standard Visual Acuity Chart
Changes of cycloplegic refractive errors
时间窗: Every 30 days for 150 days
Measured using subjective refraction
次要结局
- Changes of accommodation responses(Every 30 days for 150 days)
- Changes of accommodation facility(Every 30 days for 150 days)
- Changes of ciliary body thickness(Every 30 days for 150 days)
- Changes of axial length(Every 30 days for 150 days)
研究者
Tang Lewei
Principal Investigator
Wenzhou Medical University