Han Rong, Kong Xie-He, Zhao Feng, Yang Yan-Ting, Dong Xiao-Qing, Zeng Li, Chen Zhi, Zhao Yue, Yang Guang, Hong Jue, Zhou Xing-Tao, Ma Xiao-Peng
Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China.
Shanghai Research Institute of Acupuncture and Meridian, Shanghai, 200030, China.
Trials. 2021 Jun 7;22(1):387. doi: 10.1186/s13063-021-05334-1.
Nowadays, because of the increasing incidence, the prevention and control of myopia has become an urgent issue. In China, auricular acupressure has been commonly used in the clinical treatment of myopia in children, but the exact effectiveness remains unproven. The purpose of this trial is to observe the efficacy of auricular acupressure in myopia prevention and control, as well as its effect on the choroidal and retinal thickness.
METHOD/DESIGN: A total of 480 subjects at 8-9 years old will be randomized in a 1:1 ratio to an intervention group versus a control group. The intervention group will receive auricular acupressure for 12 months, while the control group will be taken as a blank control. The primary and secondary outcomes will be measured at baseline, and again at 3, 6, 9, and 12 months after recruitment. The myopia incidence (spherical equivalent ≤ - 0.50 D) and the mean change of spherical equivalent will be taken as the primary variables; the secondary outcome measures include axial length, uncorrected visual acuity, and choroidal and retinal thickness.
This trial aims to evaluate the effectiveness of auricular acupressure for myopia prevention and control with objective evidence and to preliminarily explore the plausible mechanism and provide reference for adopting this approach to retard the onset and control the progression of myopia.
Chinese Clinical Trial Registry ChiCTR2000038456 . Registered on September 23, 2020.
如今，由于近视发病率不断上升，近视的防控已成为一个紧迫问题。在中国，耳穴按压已普遍用于儿童近视的临床治疗，但其确切疗效仍未得到证实。本试验的目的是观察耳穴按压在近视防控中的疗效及其对脉络膜和视网膜厚度的影响。
方法/设计：总共480名8至9岁的受试者将按1:1的比例随机分为干预组和对照组。干预组将接受为期12个月的耳穴按压，而对照组将作为空白对照。主要和次要结局指标将在基线时测量，并在招募后的3、6、9和12个月再次测量。近视发病率（等效球镜度≤-0.50 D）和等效球镜度的平均变化将作为主要变量；次要结局指标包括眼轴长度、裸眼视力以及脉络膜和视网膜厚度。
本试验旨在以客观证据评估耳穴按压对近视防控的有效性，并初步探索其可能的机制，为采用这种方法延缓近视的发生和控制近视进展提供参考。
中国临床试验注册中心ChiCTR2000038456。于2020年9月23日注册。
