摘要
目的 比较应用 0.01%阿托品滴眼液和重复低强度红光(RLRL)照射对近视前期儿童眼部生物学参数的影响.方法 前瞻性随机对照研究.纳入 2021 年 5 月至 2021 年 11 月就诊于郑州大学第一附属医院的近视前期[双眼等效球镜度(SE)为-0.75～+0.50 D]儿童 62 例.按随机数字表法分为两组,阿托品组(30 例)双眼每晚睡前滴 0.01%阿托品滴眼液,红光组(32 例)双眼行RLRL照射,每天 2 次,至少间隔 4 h,每次 3 min,每周使用 5 d.两组儿童均干预 6 个月后停用 1 个月.历史对照组为 2020 年 7 月至 2020 年 10 月观察的与本研究受试者基线资料相匹配、双眼SE为-0.75～+0.50 D的近视前期儿童 25 例.随访 7 个月,观察阿托品组与红光组的SE、眼轴长度(AL)、黄斑中心凹下脉络膜厚度(SFCT)、黄斑中心凹下脉络膜血管指数(SFCVI)、调节幅度、瞳孔直径、散光度、角膜曲率、前房深度和眼压的变化,并分别与历史对照组进行比较.结果 随访 6 个月,阿托品组SE、AL、SFChT和SFCVI分别为(-0.37±0.54)D、(23.75±0.77)mm、(337.16±61.11)μm和 0.37±0.10,其中SE和AL较基线[(-0.22±0.51)D和(23.59±0.74)mm]增加,差异有统计学意义(t= 3.13、7.06,P=0.003、P<0.001);SFCT和SFCVI与基线时[(331.06±55.43)μm和 0.36±0.11]相比差异无统计学意义(t=1.10、0.10,P=0.278、0.921);红光组SE、AL、SFCT和SFCVI分别为(-0.28±0.43)D、(23.70±0.76)mm、(351.67±63.74)μm和 0.41±0.11,其中AL、SFCT和SFCVI相较基线[(23.62±0.77)mm、(335.20±58.90)μm和 0.37±0.12]增加,差异有统计学意义(t= 3.68、3.39、3.23,P= 0.001、0.001、0.002),而 SE 与基线时[(-0.24±0.32)D]相比差异无统计学意义(t = 0.80,P = 0.428).经多因素线性回归分析,阿托品组SE和AL的变化量[0.00(-0.36,0.00)D、(0.16±0.14)mm]均大于红光组[0.00(-0.19,0.00)D、(0.08±0.09)mm],而 SFCT和 SFCVI的变化量[5.48(-8.90,21.79)μm、0.01(-0.05,0.05)]均小于红光组[23.23(2.67,49.10)μm、0.06(0.00,0.10)],差异有统计学意义(β=0.120、-0.072、16.610、0.048,P=0.048、0.029、0.012、0.013).阿托品组调节幅度为(12.52±1.97)D,较基线时减少(t=3.51,P<0.001),瞳孔直径为(6.41±0.87)mm,较基线大(t= 2.31,P=0.016).红光组的调节幅度和瞳孔直径以及两组的散光度、角膜曲率、眼压和前房深度与基线相比均无明显变化(均P>0.05).历史对照组的SE和AL变化量分别为-0.31(-0.50,-0.25)D和(0.28±0.14)mm,红光组和阿托品组的SE进展和AL增长与历史对照组相比,差异均有统计学意义(均P<0.05).停止干预 1 个月后,阿托品组和红光组的SE变化量为(-0.06±0.07)D和(-0.05±0.05)D,AL变化量为(0.04±0.05)mm和(0.02±0.06)mm.两组各参数与基线时相比差异均无统计学意义(均P>0.05).结论 0.01%阿托品滴眼液和RLRL照射均能有效控制近视前期儿童SE进展和AL增长,且RLRL照射效果更好.RLRL照射对SFCT和SFCVI以及 0.01%阿托品滴眼液对调节幅度和瞳孔直径的影响均具有可逆性.
Abstract
Objective To compare the effects of 0.01%atropine eye drops and repeated low-level red-light(RLRL)irradiation on ocular biological parameters in pre-myopic children.Methods This was a prospective randomized controlled study.A total of 62 pre-myopic children with spherical equivalent(SE)from-0.75 D to +0.50 D in both eyes who presented to the First Affiliated Hospital of Zhengzhou University from May 2021 to Nov.2021 were included.They were divided into two groups based on random number table method.The atropine group with 30 cases was given one 0.01%atropine eye drop every night in both eyes,and the red-light group with 32 cases was irradiated with RLRL in both eyes twice daily with a minimum interval of 4 hours,with 3 minutes per session and 5 days per week.All children in both groups were discontinued for 1 month after 6 months of intervention.And the historical control group was the placebo control group with 25 cases observed from Jul.2020 to Oct.2020,and the subjects were pre-myopic children with SE from-0.75 D to +0.50 D in both eyes,matching the baseline data of the subjects in this study.Changes in SE,axial length(AL),subfoveal choroidal thickness(SFCT),subfoveal choroidal vascular index(SFCVI),accommodative amplitude,pupil diameter,astigmatism,corneal curvature,intraocular pressure and anterior chamber depth were observed between the atropine and the red light groups and compared with the historical control group after 7 months of follow-up.Results After 6 months of follow-up,the SE,AL,SFCT and SFCVI in the atropine group were(-0.37±0.54)D,(23.75±0.77)mm,(337.16±61.11)μm and 0.37±0.10,respectively.The SE and AL increased compared with the baseline[(-0.22±0.51)D and(23.59±0.74)mm],and the differences were statistically significant(t=3.13,7.06;P=0.003,P<0.001),while there was no statistically significant difference in SFCT and SFCVI compared with the baseline[(331.06±55.43)μm and 0.36±0.11;t=1.10,0.10;P=0.278,0.921].The SE,AL,SFCT and SFCVI in the red-light group were(-0.28±0.43)D,(23.70±0.76)mm,(351.67±63.74)μm and 0.41±0.11,respectively.The AL,SFCT and SFCVI increased compared with the baseline[(23.62±0.77)mm,(335.20±58.90)μm and 0.37±0.12],and the differences were statistically significant(t=3.68,3.39,3.23;P=0.001,0.001,0.002),while there was no statistically significant difference in SE compared with the baseline[(-0.24±0.32)D;t=0.80,P=0.428].After multivariate linear regression analysis,the changes in SE and AL in the atropine group[0.00(-0.36,0.00)D,(0.16±0.14)mm]were greater than those in the red-light group[0.00(-0.19,0.00)D,(0.08±0.09)mm].The changes in SFCT and SFCVI in the atropine group[5.48(-8.90,21.79)μm,0.01(-0.05,0.05)]were lower than those in the red-light group[23.23(2.67,49.10)μm,0.06(0.00,0.10)],and the differences were statistically significant(β=0.120,-0.072,16.610,0.048;P=0.048,0.029,0.012,0.013).In the atropine group,the accommodative amplitude was(12.52±1.97)D,which was reduced compared with the baseline(t=3.51,P<0.001),and the pupil diameter was(6.41±0.87)mm,which was enlarged compared with the baseline(t=2.31,P=0.016).There were no significant changes in accommodative amplitude and pupil diameter of the red-light group,as well as in astigmatism,corneal curvature,intraocular pressure or anterior chamber depth of the two groups compared with the baseline(all P>0.05).The changes in SE and AL in the historical control group were-0.31(-0.50,0.25)D and(0.28±0.14)mm.The progression of SE and AL were effectively controlled compared with the historical control group(all P<0.05).After stopping intervention for 1 month,SE in the atropine group and the red light group progressed(-0.06±0.07)D and(-0.05±0.05)D,and AL progressed(0.04±0.05)mm and(0.02±0.06)mm,respectively,while there were no significant differences in other ocular parameters except for SE and AL in both groups compared with the baseline(all P>0.05).Conclusion Both 0.01%atropine eye drops and RLRL irradiation can effectively control progression of SE and AL in pre-myopic children,and RLRL irradiation is more effective.The effects of RLRL irradiation on SFCT and SFCVI and 0.01%atropine eye drops on accommodative amplitude and pupil diameter are reversible.
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