1 Eye Hospital, Wenzhou Medical University, Wenzhou 325027, China
2 Eye and ENT Hospital of Fudan University, Shanghai 200031, China
3 Zhongshan Ophthalmic Center, Sun Yet-Sen University, Guangzhou 510060, China
4 First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou 310003, China
5 Second Xiangya Hospital, Central South University, Changsha 410000, China
6 West China Hospital, Sichuan University, Chengdu 610041, China
7 People's Hospital of Guangxi Zhuang Autonomous Region, Nanning 530021, China
Abstract：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.
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