Evaluation of Auricular Acupressure on Myopia Prevention among Children Aged 6-12 Years with Pre-Myopia in China: Study Protocol of a Prospective Multi-Center Randomized Controlled Trial.

Abstract

Background: The increasing prevalence of myopia among Chinese children and adolescents, especially at younger ages, has emerged as a significant concern in recent years. Pre-myopia is a key period for myopia prevention and control in children and adolescents. Previous studies suggested auricular acupressure (AA) therapy might offer a viable approach to prevent and slow down myopia progression. Nonetheless, these studies lack robust, high-quality, large-scale, multi-center evidence to conclusively support such assertions. The purpose of this research is to evaluate the efficacy, safety, and economic benefits of AA therapy in preventing myopia in Chinese children aged 6-12 years with pre-myopia.

Methods: The single-blind, multi-center, parallel-group, randomized controlled trial will involve 318 pre-myopic children from 20 different centers across China. After recruitment, these participants will be randomly assigned to two groups (the AA group and the control group) at a 1:1 ratio. The AA group will receive auricular point sticking therapy along with health education for a period of 24 weeks, while the control group will be provided the sham AA treatment and routine health education. The assessments of outcomes will be conducted at the start of this study, and then after 4, 8, 12, and 24 weeks. The primary outcome is the change in spherical equivalent refraction at various follow-up times. The secondary outcomes include the number of myopia cases, uncorrected visual acuity, axial length, corneal curvature radius, accommodation amplitude, retinal and choroidal thickness, and eye behavior management. In addition, the cost-effectiveness analysis will be used as the evaluation index for economic assessment.

Discussion: The results of this research will provide evidence on the efficacy, safety, and economic benefits of AA therapy in preventing myopia among children aged 6-12 years with pre-myopia in China.