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%2Fearly%2F2024%2F03%2F19%2Fbjo-2023-324243.atom

中文翻译：

---

散焦分布式多点镜片控制近视的一年疗效：多中心随机对照试验

目的 报告一项多中心、随机对照试验中散焦分布式多点 (DDM) 镜片在控制近视进展方面的一年疗效结果。方法 总体而言，三个中心招募了 168 名 6-13 岁儿童，并随机分配佩戴 DDM 镜片 (n=84) 或单光 (SV) 镜片 (n=84)。测量散瞳自动验光（球面等效屈光（SER））和眼轴长度（AL）。进行线性混合模型分析以比较组间 SER 和 AL 变化。采用Logistic回归分析分析近视快速进展（每年SER增长≥0.75 D或每年AL增长≥0.40 mm）的组间差异。结果 1 年后，DDM 组 (-0.47±0.37 D) 的 SER 平均变化显着低于 SV 组 (-0.71±0.42 D) (p<0.001)。同样，DDM 组的 AL 平均变化 (0.21±0.17 mm) 显着低于 SV 组 (0.34±0.16 mm) (p<0.001)。调整年龄、性别、每日配戴时间和父母近视度数后，SV组近视快速进展风险高于DDM组（OR=3.51，95% CI：1.77至6.99），特别是对于佩戴镜片的儿童每天超过 12 小时，男孩和年龄较小的儿童（6-9 岁）的 OR（95% CI）分别为 10.82（3.22 至 36.37）、5.34（1.93 至 14.78）和 8.73（2.6 至 29.33）。结论 1年后，DDM镜片有效延缓儿童近视加深。DDM镜片每日配戴时间较长，可提高近视控制效果。未来需要进行长期研究来验证。试用注册号[NCT05340699][1]。数据可根据合理要求提供。[1]: /lookup/external-ref?link_type=CLINTRIALGOV&access_num=NCT05340699&atom=%2Fbjophamol%2Fearly%2F2024%2F03%2F19%2Fbjo-2023-324243.atom