Rong Han1, Xie-He Kong2, Feng Zhao3, Yan-Ting Yang2, Xiao-Qing Dong1, Li Zeng4, Zhi Chen4, Yue Zhao2, Guang Yang2, Jue Hong2, Xing-Tao Zhou5, Xiao-Peng Ma6,7. 1. Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. 2. Shanghai Research Institute of Acupuncture and Meridian, Shanghai, 200030, China. 3. Department of Ophthalmology, Shuguang Hospital, Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. 4. Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, 200031, China. 5. Department of Ophthalmology, Eye and ENT Hospital of Fudan University, Shanghai, 200031, China. xingtaozhou@163.com. 6. Shanghai University of Traditional Chinese Medicine, Shanghai, 201203, China. pengpengma@163.com. 7. Shanghai Research Institute of Acupuncture and Meridian, Shanghai, 200030, China. pengpengma@163.com.
Abstract
BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000038456 . Registered on September 23, 2020.
RCT Entities:
BACKGROUND: 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. DISCUSSION: 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. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR2000038456 . Registered on September 23, 2020.
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