关键词: 非球面角膜塑形镜, 有效性, 安全性

Abstract: Objective To evaluate the clinical efficacy and safety of NOR aspherical orthokeratology lenses for the correction of myopia. Design A prospective multicenter cohort study. Participants 456 patients (912 eyes) with myopia who wore NOR aspherical orthokeratology lenses in 11 hospitals of China from May 2019 to December 2020. Methods All patients were fitted with NOR aspherical orthokeratology lenses and were followed up before wearing lenses and 1 day, 1 week, 1 month, and 3 months after wearing lenses. Main Outcome Measures Uncorrected distance visual acuity, spherical diopter, cylindrical diopter, spherical equivalent, intraocular pressure, corneal endothelial cell density, corneal endothelial polymorphism grade, complications, lens fit, and lens status. Results All 456 patients were enrolled, including 300 females, with an average age of 15.59±8.24 years. At each follow-up time point after wearing lenses, uncorrected distance visual acuity in both eyes was significantly improved compared with baseline (all P<0.05). After wearing lenses for 3 months, the proportion of uncorrected distance visual acuity reaching 0.0 LogMAR was 67.76% (right eye) and 65.88% (left eye). The spherical diopter of the right eye decreased from -2.47±0.87 D to -0.30±0.62 D (P＜0.001), and the spherical diopter of the left eye decreased from -2.37±0.87 D to -0.26±0.57 D (P＜0.001). The cylindrical diopter of the right eye decreased from -0.41±0.44 D to -0.12±0.30 D (P＜0.001), and the cylindrical diopter of the left eye decreased from -0.50±0.45 D to -0.16±0.38 D (P＜0.001). Compared with baseline, the spherical equivalent was reduced by 2.31±1.04 D (right eye) and 2.26±1.01 D (left eye). There was no significant difference in corneal endothelial cell density and corneal endothelial polymorphic grading in both eyes compared with baseline (all P>0.05). Non-contact intraocular pressure in both eyes was significantly reduced compared with baseline (all P<0.05). There were no serious complications in both eyes, and only individual cases had grade 1 or 2 bulbar conjunctival hyperemia, corneal epithelial spotting and corneal invasion, and continued glasses wearing could be achieved after stopping glasses or drug control therapy. Lens fit and lens conditions are good. Conclusion Wearing NOR aspherical orthokeratology lens can effectively improve the juvenile myopia patient's uncorrected distance visual acuity, reduce the spherical equivalent, and have less impact on corneal endothelial cell parameters and intraocular pressure. Lens fitting and lens condition are good. (Ophthalmol CHN, 2023, 32: 33-38)

Key words: aspherical orthokeratology lens, efficacy, safety