Aims To report the 1-year results of the efficacy of a defocus distributed multipoint (DDM) lens in controlling myopia progression in a multicentre, randomised controlled trial. Methods Overall, 168 children aged 6–13 years were recruited and randomly assigned to wear a DDM lens (n=84) or single-vision (SV) lens (n=84) in three centres. Cycloplegic autorefraction (spherical equivalent refraction (SER)) and axial length (AL) were measured. Linear mixed model analysis was performed to compare between-group SER and AL changes. Logistic regression analysis was used to analyse the between-group difference in rapid myopia progression (SER increase≥0.75 D per year or AL growth≥0.40 mm per year). Results After 1 year, mean changes in SER were significantly lower in the DDM group (−0.47±0.37 D) than in the SV group (−0.71±0.42 D) (p<0.001). Similarly, mean changes in AL were significantly lower in the DDM group (0.21±0.17 mm) than in the SV group (0.34±0.16 mm) (p<0.001). After adjusting for age, sex, daily wearing time and parental myopia, rapid myopia progression risk was higher in the SV group than in the DDM group (OR=3.51, 95% CI: 1.77 to 6.99), especially for children who wore a lens for >12 hours per day, boys and younger children (6–9 years) with ORs (95% CIs) of 10.82 (3.22 to 36.37), 5.34 (1.93 to 14.78) and 8.73 (2.6 to 29.33), respectively. Conclusions After 1 year, DDM lenses effectively retarded myopia progression in children. Longer daily wearing time of DDM lens improved the efficacy of myopia control. Future long-term studies are needed for validation. Trial registration number [NCT05340699][1]. Data are available upon reasonable request. [1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05340699&atom=%2Fbjophthalmol%2F108%2F11%2F1583.atom

中文翻译：

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散焦分布式多点镜片控制近视的一年疗效：一项多中心随机对照试验


目的 在一项多中心、随机对照试验中报告散焦分布式多点 （DDM） 镜片控制近视加深疗效的 1 年结果。方法 总体而言，招募了 168 名 6-13 岁的儿童，并随机分配到三个中心佩戴 DDM 镜片 （n=84） 或单光 （SV） 镜片 （n=84）。测量睫状肌麻痹自屈光 （球面等效屈光 （SER）） 和轴向长度 （AL）。进行线性混合模型分析以比较组间 SER 和 AL 变化。采用 Logistic 回归分析快速近视进展的组间差异 （SER 增加 ≥ 每年 0.75 D 或 AL 增长 ≥每年 0.40 mm）。结果 1 年后，DDM 组 （-0.47±0.37 D） 的 SER 平均变化显著低于 SV 组 （-0.71±0.42 D） （p<0.001）。同样，DDM 组 （0.21±0.17 mm） 的 AL 平均变化显著低于 SV 组 （0.34±0.16 mm） （p<0.001）。在调整年龄、性别、每日佩戴时间和父母近视后，SV 组的快速近视进展风险高于 DDM 组（OR=3.51,95% CI：1.77 至 6.99），尤其是每天佩戴镜片 >12 小时的儿童，男孩和更小的儿童（6-9 岁），OR（95% CI）为 10.82（3.22 至 36.37）， 分别为 5.34（1.93 至 14.78）和 8.73（2.6 至 29.33）。结论 1 年后，DDM 镜片可有效延缓儿童近视加深。DDM 镜片的每日佩戴时间更长提高了近视控制的有效性。需要未来的长期研究进行验证。试验注册号 [NCT05340699][1]。数据可根据合理要求提供。[1]： /lookup/external-ref？link_type=CLINTRIALGOV&access_num=NCT05340699&atom=%2Fbjophthalmol%2F108%2F11%2F1583.atom