小矫正区角膜塑形镜对儿童青少年近视眼长期防控效果分析

Long-term prevention and control effects of orthokeratology lenses designed for small treatment zones on children and adolescents with myopia

目的探讨小矫正区设计的角膜塑形镜的特点及其对儿童青少年近视眼长期防控的效果和安全性。方法前瞻性队列研究。连续纳入2019年1月至2020年5月在山东第一医科大学附属青岛眼科医院行角膜塑形矫正的青少年近视眼患者65例(65只眼)。将患者通过计算机随机法随机分为小矫正区组和常规组,分别配戴小矫正区设计和常规设计的角膜塑形镜。于戴镜前及戴镜后6、12、18个月检查所有患者的裸眼视力、最佳矫正视力、屈光度数和眼轴长度,并进行Pentacam角膜地形图检查,采用Matlab软件计算患者的角膜矫正区面积及直径。结果最终60例(60只眼)近视眼患者被纳入研究,其中男性29例,女性31例;年龄为(10.40±1.01)岁;等效球镜度数为(-2.88±0.42)D。小矫正区组和常规组各30例。矫正后不同时间2个组裸眼视力和等效球镜度数的差异均无统计学意义(P均>0.05)。术后6、12、18个月,常规组眼轴长度增长量分别为(0.16±0.09)、(0.28±0.17)和(0.37±0.20)mm;小矫正区组则分别为(0.06±0.05)、(0.12±0.10)和(0.18±0.14)mm,分别为常规组的37.50%、42.86%和48.64%。常规组和小矫正区组的角膜矫正区面积分别为(6.98±0.89)和(5.36±0.73)mm²,差异有统计学意义(P<0.05)。相关性分析结果显示,戴镜18个月后的眼轴长度增长量与戴镜时的年龄呈负相关(P<0.05),与角膜矫正区面积呈正相关(P<0.05);与瞳孔直径和等效球镜度数无相关性(P均>0.05)。2个组各有3例(10%)患者戴镜后出现不良反应,均为轻度干眼等较轻的不良反应,于对症治疗后消失。结论与常规设计的角膜塑形镜相比,小矫正区设计角膜塑形镜在角膜表面塑形出的光学矫正区更小,能够显著减缓儿童青少年近视眼进展;其安全性与常规设计角膜塑形镜相似。

Objective To explore the characteristics of orthokeratology lenses designed for small correction zones and their effectiveness and safety in long-term prevention and control of myopia in children and adolescents.Methods It was a prospective cohort study that included myopic children and adolescents who received corneal reshaping treatment at the Qingdao Eye Hospital of Shandong First Medical University between January 2019 and May 2020.The patients were randomly divided into two groups using computer-generated randomization,and were fitted with corneal reshaping lenses with small treatment zones and conventional designs,respectively.The uncorrected visual acuity,best-corrected visual acuity,refractive error,and axial length were measured before and after 6,12,and 18 months of wearing the lenses.Corneal topography with the Pentacam was also performed,and the area and diameter of the corneal treatment zone were calculated using the Matlab software.Results A total of 60 myopic patients(60 eyes)were enrolled,including 29 males and 31 females,with an age of(10.40±1.01)years and a spherical equivalent of(-2.88±0.42)D.There were 30 cases in the small correction zone group and 30 cases in the conventional group.There was no significant difference in uncorrected visual acuity and spherical equivalent between the two groups at each time point after treatment.The axial growth in the conventional group was(0.16±0.09)mm at 6 months after treatment,(0.28±0.17)mm at 12 months,and(0.37±0.20)mm at 18 months,whereas in the small treatment zone group it was(0.06±0.05)mm,(0.12±0.10)mm,and(0.18±0.14)mm,respectively.The myopia progression rate in the small treatment zone group was only 37.50%,42.86%,and 48.64%of the conventional group at 6,12,and 18 months,respectively.Corneal topography showed that the treatment area in the conventional group was(6.98±0.89)mm²,while in the small treatment zone group it decreased by 23.2%[(5.36±0.73)mm²](P<0.05).Correlation analysis revealed that the axial increase after 18 months of lens wearing was negatively correlated with the age before lens wearing(P<0.05),positively correlated with the corneal surface treatment zone size(P<0.05),and not correlated with the pupil diameter and spherical equivalent(all P>0.05).After the shaping treatment,the rate of adverse reaction,which was mild,in both groups was 10%,and the symptoms disappeared.Conclusion Orthokeratology lenses with smaller treatment zones can significantly reduce the rate of axial length growth in children and adolescents compared to lenses with conventional treatment zones,without compromising treatment safety.