Effect of spectacle lenses designed to reduce relative peripheral hyperopia on myopia progression in Japanese children: a 2-year multicenter randomized controlled trial

摘要

Purpose Novel spectacle lenses (MyoVision, Carl Zeiss) designed to reduce relative peripheral hyperopia have been developed and reported to be effective for preventing myopia progression in a subgroup of Chinese children. In this study we examined the efficacy of MyoVision lenses in Japanese children. Study design This was a multicenter prospective randomized double-blind placebo-controlled trial. Method We enrolled 207 participants (aged 6–12 years) with spherical equivalent refractions (SERs) ranging from ?1.5 to ?4.5 diopters (D) and with at least 1 myopic parent. The participants were randomized to receive either single vision lenses (SVLs) or MyoVision lenses and were followed up every 6 months for 2 years. The primary outcome was myopia progression evaluated by cycloplegic autorefraction, and the secondary outcome was elongation of axial length. Results A total of 203 children (98.1%) completed the follow-up. The mean adjusted change in SER was ?1.43 ± 0.10 D in the MyoVision group, which was not significantly different from that of the control group wearing SVLs (?1.39 ± 0.07 D) at the 24-month visit ( P = .65). The adjusted axial length elongation was 0.73 ± 0.04 mm in the MyoVision group, which was not significantly different from that in the control group wearing SVLs (0.69 ± 0.03 mm) at the 24-month visit ( P = .28). Conclusion The results of this clinical trial could not verify the therapeutic effect of MyoVision for slowing down myopia progression in Japanese children. Additional studies are needed to design lenses that can reduce peripheral hyperopic defocus individually and to examine the effectiveness of these lenses in preventing myopia progression.