Effect of progressive addition lenses on myopia progression in Japanese children: a prospective, randomized, double-masked, crossover trial.

PURPOSE This prospective, randomized, double-masked, crossover trial was conducted to evaluate the clinical effectiveness of progressive addition lenses (PALs) compared with single-vision lenses (SVLs) on myopia progression in Japanese children. METHODS Ninety-two children fulfilling the inclusion criteria (age: 6-12 years, spherical equivalent refractive errors: -1.25 to -6.00 D) were randomly allocated to either 18 months of wearing PALs (near addition: +1.50 D) followed by 18 months of SVLs (group 1), or 18 months of wearing SVLs followed by 18 months of wearing PALs (group 2), and were followed up for 3 years (two-stage crossover design). The primary outcome measure was myopia progression, as determined by cycloplegic autorefraction. RESULTS Eighty-six (93%) children completed both treatment periods. A mixed-model, two-way analysis of variance (ANOVA) performed using 3-year data identified a significant treatment effect of PALs compared with SVLs (P = 0.0007), with a mean 18-month difference of 0.17 D (95% CI: 0.07-0.26 D). This analysis also indicated a significant period effect (P = 0.0040) and a significant treatment-by-period interaction (P = 0.0223): Group 1 showed a slower myopia progression than did group 2. CONCLUSIONS The use of PALs slowed myopia progression, although the treatment effect was small, as previously reported in ethnically diverse children in the United States. The significant treatment-by-period interaction suggests that early application of PALs would probably be more beneficial for these age and refraction ranges (isrctn.org number, 28611140).