非球面角膜塑形镜矫正近视的有效性和安全性

目的：评价非球面角膜塑形镜矫正近视的临床有效性和安全性。方法：前瞻性随机对照研究。选取年龄≥8岁的双眼近视患者，通过中央随机系统随机分配至试验组和对照组，试验组配戴NOR型非球面角膜塑形镜，对照组配戴欧几里德夜戴型角膜塑形镜。配戴后1 d、1周、2周、1个月、3个月、 6个月、9个月、1年进行随访，评估裸眼远视力、屈光度、角膜K值、裂隙灯显微镜检查结果、镜片情况、角膜内皮细胞计数、角膜厚度、眼压。采用独立样本t检验、Wilcoxon秩和检验、卡方检验等方法进行数据分析。结果：共291例受试者完成初次配戴，试验组143例，对照组148例。配戴后各随访时间点，2组左、右眼LogMAR裸眼远视力、屈光度及其相对于基线期变化值的差异均无统计学 意义（P>0.05）；2组左、右眼角膜平坦K值及右眼角膜陡峭K值相对于基线变化值差异均无统计学意 义（P>0.05）。除配戴后1 d、9个月以外，其余随访时间点，2组左眼角膜陡峭K值相对于基线变化值 差异均无统计学意义（P>0.05）。配戴后6个月、1年时，2组左、右眼角膜厚度、角膜内皮细胞计数、 眼压及其相对于基线期变化值的差异均无统计学意义（P>0.05）。各随访时间点，2组受试者均未出现严重并发症，并发症发生率的组间差异均无统计学意义（P>0.05）。配戴后1年时，2组角膜塑形镜 配适状态和镜片状态均良好且组间比较差异无统计学意义（P>0.05）。结论：NOR型非球面角膜塑形镜与夜戴型角膜塑形镜矫正近视的有效性和安全性良好，2种角膜塑形镜疗效一致且均具有较高的安全性。

Efficacy and Safety of Aspherical Orthokeratology Lens for the Correction of Myopia

Objective: To evaluate the clinical efficacy and safety of the NOR aspherical orthokeratology lens for the correction of myopia. Methods: This was a prospective randomized controlled study. Subjects over 8 years of age with binocular myopia were randomly assigned to a study group or a control group. The study group wore a NOR aspherical orthokeratology lens, and the control group wore a Euclid orthokeratology lens (model: Night-wear). Follow-up was performed at 1 day, 1 week, 2 weeks, 1 month, 3 months, 6 months, 9 months, and 1 year after wearing the lenses. Uncorrected distance visual acuity, refractive error, keratometry value (K value), slit lamp examination results, lens condition, endothelial cell count, corneal thickness and intraocular pressure were recorded. Data analysis was performed using statistical methods such as an independent samples t test, Wilcoxon rank sum test, and Chi-square test. Results: A total of 291 subjects (143 subjects in the study group and 148 subjects in the control group) completed the initial wear. At each follow-up time after wearing the lenses, there were no statistically significant differences in the left and right eyes between the two groups (P>0.05) for visual acuity, refractive error or changes from baseline. There were no statistically significant differences in changes in the flat K value of both eyes or the steep K value of the right eyes (P>0.05). The differences in the changes in the steep K value of the left eye were not statistically significant except for 1 day and 9 months after wearing the lenses. There were no statistically significant differences in corneal thickness, endothelial cell count, intraocular pressure or their changes from baseline in the two groups (P>0.05) at 6-month and 1-year visits. At each follow-up time point, there were no serious complications in the two groups and there was no statistically significant difference in the incidence of complications between the two groups (P>0.05). At 1 year after wearing the lenses, the two groups of OK lenses were in good condition and were well fitted, and the comparison between the two groups showed no statistically significant difference (P>0.05). Conclusions: The NOR aspheric orthokeratology lens and the night-wearing orthokeratology lens are effective and safe for correcting myopia. The two orthokeratology lenses have the same efficacy and both have high security.