个性化角膜塑形术控制儿童青少年近视的临床研究

Study on the Safety and Effectiveness of Personalized Orthokeratology for Controlling Myopia in Adolescents

摘要: 目的：通过观察配戴夜戴型角膜塑形镜的近视儿童青少年患者的视力，角膜曲率，角膜中央厚度，眼轴长度，角膜内皮细胞，泪液分泌功能，对比敏感度，像差及角膜生物力学等指标的变化情况及各种并发症发生率，评估个性化角膜塑形术对于控制儿童青少年近视的安全性、有效性及疗效。方法：选择我院眼科门诊就诊的8至18岁的儿童青少年近视患者100例(180眼)，按照角膜塑形镜验配流程规范验配。配镜后随访2年，对比分析戴镜前、后各生物参数的变化、戴镜后疗效及并发症的发生率。采用spss15.0软件统计分析，差异具有统计学意义(P < 0.05)。结果：1) 戴镜后次日屈光度明显下降，裸眼及矫正视力改善，与戴镜前比较差异具有统计学意义(P < 0.01)；戴镜6个月后最佳矫正视力好于戴镜前，但差异无统计学意义；戴镜前、后6个月在20%、40%、60%对比度矫正视力比较，差异无统计学意义(P值大于0.05)。6个月后屈光度较戴镜前明显降低，差异有统计学意义(P < 0.01)；眼轴差异无统计学意义(P > 0.05)。2) 戴镜后角膜中央5 mm光学区的水平K1值与垂直K2均减小，其差异具有统计学意义(P < 0.01)。戴镜3个月角膜塑形稳定，长期随访2年的角膜地形图与戴镜3月图形比较未见明显变化。3) 戴镜2年后，其各生物参数变化与戴镜前比较，差异均无统计学意义(P > 0.05)。结论：1) 个性化角膜塑形术矫治青少年近视是安全的、有效的方法之一。2) 在临床上进一步证实了个性化角膜塑形术能改变角膜弧度，降低屈光度，提高近视患者的裸眼视力，为广大青少年近视防控大数据模型的建立提供了重要的参考指标；为角膜塑形镜优化改良提供了参考数据。

Abstract: Purpose: To evaluate the safety and effectiveness of personalized orthokeratology myopia in ado-lescents by analyzing the variation for observable indices which include visual acuity, corneal curvature, central corneal thickness, axial length, corneal endothelial cells, the tear function, con-trast sensitivity, aberrations, corneal biomechanics and the incidence of various complications in myopia patients after night-wearing orthokeratology contact lenses (OK). Methods: 100 patients (total 180 eyes) were selected from the outpatient department of Shenzhen Children’s Hospital. The comparative analysis performed before wearing OK lens and wearing OK lens 1 day, 1 week, 1 month, 3 months, 6 months, 1 year, 2 years is to observe and compare the variation for observable indices after wearing OK lens. The statistical analysis used SPSS15.0 software package to compare the data before and after wearing OK lens including t test, paired t test and chi-square X2. The de-tection level was P = 0.05 while P < 0.05 indicates the difference is of statistical significance. Results: The diopter decline changed significantly and visual acuity improved significantly after one day. After 6 months, the best corrected visual acuity after wearing is better than before, but the difference is not statistically significant. When the contrast is 20%, 40%, 60%, there was no sig-nificant difference in the visual acuity before and after wearing (P > 0.05). The diopter decline changed significantly after 6 months. There was no obvious change in the axial axis, and the dif-ference was not statistically significant (P > 0.05). The value of K1 and K2 decreased; the difference was statistically significant (P < 0.01). At 3 months, the corneal shape was stable, and there was no significant change in the corneal topography after long-term follow-up of 2 years. No changes of observable indices were found in the period of follow-up. Conclusions: Personalized orthokeratology is one of the safe and effective methods for treating myopia for adolescents. Clinically it is further confirmed that it can change the curvature of the cornea, reduce the diopter, improve the visual acuity of patients with myopia, and provide important reference indicators for the establishment of the prevention and control big data model of adolescent myopia. It also provides reference data for the optimization and improvement of the Ortho-K contact lenses.