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

PURPOSE: Our study aimed to evaluate the efficacy of eye-transcutaneous electrical acupoint stimulation (ETEAS) in reducing myopia incidence in children with premyopia.

DESIGN

Multicenter, randomized, double-masked, sham-controlled trial (Chinese Clinical Trial Registry identifier, ChiCTR2000039781).

PARTICIPANTS

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.

METHODS

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.

MAIN OUTCOME MEASURES: 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.

RESULTS

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.

CONCLUSIONS

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.

FINANCIAL DISCLOSURE(S): The author(s) have no proprietary or commercial interest in any materials discussed in this article.