Abstract：
OBJECTIVE: The aim of this study was to investigate the effect of individualized ocular refraction customized (IORC) spectacle lenses with different actual amounts of peripheral myopic defocus (MD) on myopia control over 1 year. These lenses compensate for the original peripheral refraction via the free-form surface on the back of the lens.
METHODS: This 1-year, double-masked randomised clinical trial included 184 myopic schoolchildren aged 8-12 years. Participants were randomised to receive IORC lenses with high (IORC-H group, +4.50 D), medium (IORC-M group, +3.50 D) or low (IORC-L group, +2.50 D) MD or single-vision (SV) lenses. The spherical equivalent refractive error (SER) and axial length (AL) were measured at baseline and 6-monthly intervals.
RESULTS: After 1 year, the mean (SD) changes in SER were -0.18 (0.37), -0.36 (0.37), -0.52 (0.39) and -0.60 (0.42) D for the IORC-H, IORC-M, IORC-L and SV groups, respectively. Compared with the SV group, the effects of slowing myopia progression were 70%, 40% and 13% for the IORC-H (difference of 0.47 D, p < 0.001), IORC-M (difference of 0.32 D, p = 0.001) and IORC-L (difference of 0.15 D, p > 0.05) groups, respectively. The mean (SD) changes in AL were 0.12 (0.16), 0.23 (0.17), 0.29 (0.17) and 0.36 (0.17) mm for the IORC-H, IORC-M, IORC-L and SV groups, respectively. The axial elongation was 67%, 36% and 19% lower in the IORC-H (difference of 0.25 mm, p < 0.001), IORC-M (difference of 0.15 mm, p < 0.001) and IORC-L (difference of 0.10 mm, p = 0.04) groups, respectively, compared with the SV group. The IORC-H group exhibited significantly less axial elongation than the IORC-M and IORC-L groups (p = 0.01 and p < 0.001, respectively).
CONCLUSIONS: Compared with the IORC-M and IORC-L lenses, the IORC-H lens was found to have superior efficacy in inhibiting myopic progression and slowing eye growth in schoolchildren, with better myopia control efficacy in younger children.
METHODS: This 1-year, double-masked randomised clinical trial included 184 myopic schoolchildren aged 8-12 years. Participants were randomised to receive IORC lenses with high (IORC-H group, +4.50 D), medium (IORC-M group, +3.50 D) or low (IORC-L group, +2.50 D) MD or single-vision (SV) lenses. The spherical equivalent refractive error (SER) and axial length (AL) were measured at baseline and 6-monthly intervals.
RESULTS: After 1 year, the mean (SD) changes in SER were -0.18 (0.37), -0.36 (0.37), -0.52 (0.39) and -0.60 (0.42) D for the IORC-H, IORC-M, IORC-L and SV groups, respectively. Compared with the SV group, the effects of slowing myopia progression were 70%, 40% and 13% for the IORC-H (difference of 0.47 D, p < 0.001), IORC-M (difference of 0.32 D, p = 0.001) and IORC-L (difference of 0.15 D, p > 0.05) groups, respectively. The mean (SD) changes in AL were 0.12 (0.16), 0.23 (0.17), 0.29 (0.17) and 0.36 (0.17) mm for the IORC-H, IORC-M, IORC-L and SV groups, respectively. The axial elongation was 67%, 36% and 19% lower in the IORC-H (difference of 0.25 mm, p < 0.001), IORC-M (difference of 0.15 mm, p < 0.001) and IORC-L (difference of 0.10 mm, p = 0.04) groups, respectively, compared with the SV group. The IORC-H group exhibited significantly less axial elongation than the IORC-M and IORC-L groups (p = 0.01 and p < 0.001, respectively).
CONCLUSIONS: Compared with the IORC-M and IORC-L lenses, the IORC-H lens was found to have superior efficacy in inhibiting myopic progression and slowing eye growth in schoolchildren, with better myopia control efficacy in younger children.
摘要：
目的：这项研究的目的是研究具有不同实际周围近视散焦量（MD）的个性化眼屈光定制（IORC）眼镜片对1年以上近视控制的影响。这些透镜通过透镜背面的自由表面补偿原始的周边折射。
方法：这一年，双掩蔽随机临床试验包括184名8-12岁的近视学童.参与者被随机分配接受高IORC镜片(IORC-H组，+4.50D),中等(IORC-M组，+3.50D)或低(IORC-L组，+2.50D)MD或单视觉(SV)镜片。以基线和6个月的间隔测量球面等效屈光度（SER）和轴向长度（AL）。
结果：1年后，SER的平均值(SD)变化为-0.18(0.37)，-0.36（0.37），IORC-H的-0.52（0.39）和-0.60（0.42）D，IORC-M,IORC-L和SV组，分别。与SV组相比，减缓近视进展的效果是70%，IORC-H的40%和13%(差异为0.47D，p<0.001)，IORC-M(差异为0.32D，p=0.001)和IORC-L(差0.15D，P>0.05)组，分别。AL的平均值（SD）变化为0.12（0.16），0.23（0.17），IORC-H为0.29（0.17）和0.36（0.17）mm，IORC-M,IORC-L和SV组，分别。轴向伸长率为67%，在IORC-H中降低了36%和19%(差异为0.25毫米，p<0.001)，IORC-M(差0.15mm,p<0.001)和IORC-L(差异为0.10毫米，p=0.04)组，分别,与SV组相比。IORC-H组的轴向伸长率明显低于IORC-M和IORC-L组（分别为p=0.01和p<0.001）。
结论：与IORC-M和IORC-L透镜相比，发现IORC-H晶状体在抑制学龄儿童近视进展和减缓眼睛生长方面具有优异的疗效，对低龄儿童具有较好的近视控制功效。
方法：这一年，双掩蔽随机临床试验包括184名8-12岁的近视学童.参与者被随机分配接受高IORC镜片(IORC-H组，+4.50D),中等(IORC-M组，+3.50D)或低(IORC-L组，+2.50D)MD或单视觉(SV)镜片。以基线和6个月的间隔测量球面等效屈光度（SER）和轴向长度（AL）。
结果：1年后，SER的平均值(SD)变化为-0.18(0.37)，-0.36（0.37），IORC-H的-0.52（0.39）和-0.60（0.42）D，IORC-M,IORC-L和SV组，分别。与SV组相比，减缓近视进展的效果是70%，IORC-H的40%和13%(差异为0.47D，p<0.001)，IORC-M(差异为0.32D，p=0.001)和IORC-L(差0.15D，P>0.05)组，分别。AL的平均值（SD）变化为0.12（0.16），0.23（0.17），IORC-H为0.29（0.17）和0.36（0.17）mm，IORC-M,IORC-L和SV组，分别。轴向伸长率为67%，在IORC-H中降低了36%和19%(差异为0.25毫米，p<0.001)，IORC-M(差0.15mm,p<0.001)和IORC-L(差异为0.10毫米，p=0.04)组，分别,与SV组相比。IORC-H组的轴向伸长率明显低于IORC-M和IORC-L组（分别为p=0.01和p<0.001）。
结论：与IORC-M和IORC-L透镜相比，发现IORC-H晶状体在抑制学龄儿童近视进展和减缓眼睛生长方面具有优异的疗效，对低龄儿童具有较好的近视控制功效。
