Effect of Eye-Transcutaneous Electrical Acupoint Stimulation on Myopia Incidence in Children: A Randomized Clinical Trial.

Abstract

Our study aimed to evaluate the efficacy of eye-transcutaneous electrical acupoint stimulation (ETEAS) in reducing myopia incidence in children with premyopia. Multicenter, randomized, double-masked, sham-controlled trial (Chinese Clinical Trial Registry identifier, ChiCTR2000039781). A total of 680 participants, 6 to 12 years of age with a cycloplegic spherical equivalent refraction (SER) of between +0.75 and -0.50 diopter (D), astigmatism of 1.50 D or less, and uncorrected visual acuity (UCVA) of 0.0 logarithm of the minimum angle of resolution or less, were enrolled from February 2021 through December 2021. Follow-up was completed in December 2022. Participants were assigned randomly (1:1) to receive ETEAS (n = 340) or sham ETEAS (n = 340). Treatments were self-administered under parental supervision at least 3 times weekly (30 minutes per session) for 24 weeks, followed by a 24-week nonintervention observation period. Eye-transcutaneous electrical acupoint stimulation was delivered using personalized, 3-dimensional customized masks to ensure accurate acupoint placement across sessions. Compliance was tracked through an online management system. The primary outcome was the 48-week myopia incidence rate (defined as cycloplegic SER ≤ -0.50 D). Secondary outcomes included the 24-week myopia incidence rate and changes in cycloplegic SER and axial length (AL) from baseline to 24 and 48 weeks. A total of 668 children (98.2%) were included in the primary outcome analysis (332 in the ETEAS group and 336 in the sham ETEAS group). The 48-week myopia incidence was significantly lower in the ETEAS group (29.0% [97/332]) compared with the sham ETEAS group (38.1% [128/336]), with an absolute difference of 9.1% (95% confidence interval, 1.6%-16.6%; P = 0.0180). Additionally, ETEAS significantly slowed myopia progression, as evidenced by less cycloplegic SER progression (-0.47 D vs -0.75 D; P < 0.0001), less AL elongation (0.21 mm vs 0.36 mm; P < 0.0001), and significant improvement in 10 of 15 secondary outcomes. No treatment-related adverse events were reported. Eye-transcutaneous electrical acupoint stimulation is a noninvasive intervention that effectively reduces myopia incidence and slows myopia progression in children with premyopia, with standardized and reproducible delivery. The author(s) have no proprietary or commercial interest in any materials discussed in this article.