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

ABSTRACT

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).