Effect of plum-blossom needling versus tropicamide eye drops on adolescent myopia: protocol for a randomized crossover trial

Abstract

Objective: Myopia is the most common eye problem and affects an estimated 28.3% of the global population. Its incidence is increasing annually. Myopia treatment is limited to correcting visual acuity. Acupuncture is one of the main therapies in traditional Chinese medicine and includes plum-blossom needling, which has been widely used for both the prevention and treatment of adolescent myopia. We hypothesized that plum-blossom needling would be effective in treating myopia compared with a tropicamide eye drops control.

Methods: This is a crossover randomized controlled trial involving adolescents with myopia. Participants will be randomized 1∶1 to plum-blossom needle or tropicamide eye drops arms. Subjects in each arm will be treated for 20 d, followed by a 1-month washout period and treatment change for another 20 d. The primary outcome is uncorrected distance and cycloplegic refractive errors. The secondary outcomes comprise corneal curvature, lens thickness, axial length, ciliary body thickness, accommodation amplitude, the NRA/PRA (negative/positive relative accommodation), flexible adjustment, and near point of convergence. The outcome measures will be assessed at baseline, after the first treatment course (the first month), at the end of the washout period (the second month), after the second treatment course (the third month), and at follow-up (the sixth month).

Discussion: The results of the trial will help to provide evidence for the efficacy of plum-blossom needling for myopia in China.

Trial registration: ClinicalTrials.gov NCT03097198.

Keywords: Clinical protocol; Crossover studie; Myopia; Ophthalmic solution; Plum-blossom needle; Tropicamide.