Aims To evaluate the 1-year efficacy of two new myopia control spectacle lenses with lenslets of different asphericity. Methods One hundred seventy schoolchildren aged 8–13 years with myopia of −0.75 D to −4.75 D were randomised to receive spectacle lenses with highly aspherical lenslets (HAL), spectacle lenses with slightly aspherical lenslets (SAL), or single-vision spectacle lenses (SVL). Cycloplegic autorefraction (spherical equivalent refraction (SER)), axial length (AL) and best-corrected visual acuity (BCVA) were measured at baseline and 6-month intervals. Adaptation and compliance questionnaires were administered during all visits. Results After 1 year, the mean changes in the SER (±SE) and AL (±SE) in the SVL group were −0.81±0.06 D and 0.36±0.02 mm. Compared with SVL, the myopia control efficacy measured using SER was 67% (difference of 0.53 D) for HAL and 41% (difference of 0.33 D) for SAL, and the efficacy measured using AL was 64% (difference of 0.23 mm) for HAL and 31% (difference of 0.11 mm) for SAL (all p<0.01). HAL resulted in significantly greater myopia control than SAL for SER (difference of 0.21 D, p<0.001) and AL (difference of 0.12 mm, p<0.001). The mean BCVA (−0.01±0.1 logMAR, p=0.22) and mean daily wearing time (13.2±2.6 hours, p=0.26) were similar among the three groups. All groups adapted to their lenses with no reported adverse events, complaints or discomfort. Conclusions Spectacle lenses with aspherical lenslets effectively slow myopia progression and axial elongation compared with SVL. Myopia control efficacy increased with lenslet asphericity. Trial registration number ChiCTR1800017683. Data are available upon reasonable request.

中文翻译：

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非球面镜片对近视控制一年的疗效

目的 评估两种具有不同非球面小透镜的新型近视控制眼镜片的 1 年疗效。方法 170 名 8-13 岁近视度数为 -0.75 D 至 -4.75 D 的学童随机接受高度非球面镜片 (HAL)、微非球面镜片 (SAL) 镜片或单光镜片(SVL)。在基线和 6 个月的时间间隔测量睫状体麻痹自动屈光度（球面等效屈光度 (SER)）、眼轴长度 (AL) 和最佳矫正视力 (BCVA)。在所有访问期间都进行了适应和依从性调查问卷。结果 1年后，SVL组SER（±SE）和AL（±SE）的平均变化分别为-0.81±0.06 D和0.36±0.02 mm。与 SVL 相比，使用 SER 测量的近视控制效果对于 HAL 为 67%（差异为 0.53 D），对于 SAL 为 41%（差异为 0.33 D），使用 AL 测量的效果对于 HAL 为 64%（差异为 0.23 mm）和 31% SAL（所有 p<0.01）（差异为 0.11 mm）。对于 SER（差异为 0.21 D，p<0.001）和 AL（差异为 0.12 mm，p<0.001），HAL 对近视的控制显着优于 SAL。三组的平均 BCVA（-0.01±0.1 logMAR，p=0.22）和平均每日佩戴时间（13.2±2.6 小时，p=0.26）相似。所有组都适应了他们的镜片，没有报告不良事件、抱怨或不适。结论 与 SVL 相比，具有非球面小透镜的眼镜片可有效减缓近视进展和轴向伸长。近视控制效果随着小透镜非球面度的增加而增加。试用注册号 ChiCTR1800017683。可根据合理要求提供数据。