目的:探讨近视儿童佩戴1年具有正(PLARI)和负(NLARI)屈光力透镜的新型Lenslet-ARray整合型(LARI)眼镜片的近视控制效果。
方法:随机化,双面蒙面,对照临床试验。
方法:共有240名儿童,6至12岁,球面等效折射(SER)在-4.00和-1.00屈光度(D)之间,1.50D或更小的散光,屈光参差为1.00D或更小。
方法:参与者以1:1:1的比例随机分配给PLARI,NLARI,和对照组(单视力(SV))。在佩戴镜片后,在基线和6个月间隔测量晶状体麻痹的自屈光和轴向长度。
方法:SER的变化,轴向伸长率(AE),和群体之间的差异。
结果:1年后,PLARI和NLARI组的SER变化和AE明显小于SV组(SER:-0.30±0.48D,-0.21±0.35D,-0.66±0.40D;AE:0.19±0.20mm,0.17±0.14mm,0.34±0.18mm,分别)(所有P<0.001)。PLARI组和NLARI组之间的SER变化和AE没有显着差异(分别为P=0.54和P=1.00)。在SV组(r=0.40,P<0.001,r=-0.59,P<0.001)和PLARI组(r=0.46,P<0.001,r=-0.52,P<0.001)中,年龄越小,SER增加越快,AE越大,但在NLARI组中没有(分别为r=-0.002,P=0.98和r=-0.08,P=0.48)。
结论:与SV组相比,PLARI组和NARI组在SER和眼轴伸长方面均显示近视进展显著减慢.近视进展更快,就SER和AE而言,在SV和PLARI组中与年龄较小有关,但不是在NLARI组。
OBJECTIVE: To investigate the myopia control efficacy of novel Lenslet-ARray-Integrated (LARI) spectacle lenses with positive (PLARI) and negative (NLARI) power lenslets worn for one year in myopic children.
METHODS: Randomized, double-masked, controlled clinical trial.
METHODS: A total of 240 children, aged 6 to 12 years, with spherical equivalent refraction (SER) between -4.00 and -1.00 diopter (D), astigmatism of 1.50 D or less, and anisometropia of 1.00 D or less.
METHODS: Participants were assigned randomly in a 1:1:1 ratio to PLARI, NLARI, and a control (single-vision (SV)) groups. Cycloplegic autorefraction and axial length were measured at baseline and 6-month intervals after lens wear.
METHODS: Changes in SER, axial elongation (AE), and differences between groups.
RESULTS: After 1-year, SER changes and AE in the PLARI and NLARI groups were significantly less than those in the SV group (SER: -0.30 ± 0.48 D, -0.21 ± 0.35 D, -0.66 ± 0.40 D; AE: 0.19 ± 0.20 mm, 0.17 ± 0.14 mm, 0.34 ± 0.18 mm, respectively) (all P < 0.001). There were no significant differences in SER changes and AE between PLARI and NLARI groups (P = 0.54 and P = 1.00, respectively). Younger age was associated with more rapid SER increase and larger AE in the SV (r = 0.40, P < 0.001 and r = -0.59, P < 0.001, respectively) and PLARI (r= 0.46, P < 0.001 and r = -0.52, P < 0.001, respectively) groups, but not in the NLARI group (r = -0.002, P = 0.98 and r = -0.08, P = 0.48, respectively).
CONCLUSIONS: Compared with the SV group, both PLARI and NARI groups showed significantly slower myopia progression in terms of SER and axial elongation. Faster myopia progression, in terms of both SER and AE, was associated with younger age in the SV and PLARI groups, but not in the NLARI group.