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NOR型非球面角膜塑形镜临床有效性和安全性的多中心研究
A multicenter study of clinical efficacy and safety of NOR aspherical orthokeratology lenses
【摘要】 目的 评估NOR型非球面角膜塑形镜矫正近视的临床有效性和安全性。设计前瞻性多中心队列研究。研究对象2019年5月至2020年12月11家医院配戴NOR型非球面角膜塑形镜的近视患者456例(912眼)。方法 所有患者均配戴NOR型非球面角膜塑形镜,并完成戴镜前及戴镜后1天、1周、1个月、3个月的检查与随访。主要指标裸眼远视力、球镜度、柱镜度、等效球镜度、眼压、角膜内皮细胞密度、角膜内皮细胞多形性级别、并发症、镜片配适及镜片状态。结果 456例(912眼)中女性300例,平均年龄15.59±8.24岁。戴镜后各随访时间点,双眼裸眼远视力与基线期比较均有显著提升(P均<0.05)。戴镜3个月,裸眼远视力达到0.0 LogMAR的比例为67.76%(右眼)和65.88%(左眼);右眼球镜度由基线(-2.47±0.87)D下降至(-0.30±0.62)D(P<0.001),左眼球镜度由基线(-2.37±0.87)D下降至(-0.26±0.57)D(P<0.001);右眼柱镜度由基线(-0.41±0.44)D下降至(-0.12±0.30)D(P<0.001),左眼柱镜度由基线(-0.50±0.45)D下降至(-0.16±0.38)D(P<0.001);与基线比较,等效球镜度降低(2.31±1.04)D(右眼)和(2.26±1.01)D(左眼);双眼角膜内皮细胞密度和角膜内皮细胞多形性分级与基线期比较均无显著性差异(P均>0.05);双眼非接触式眼压与基线期比较均显著降低(P均<0.05);双眼未出现严重并发症,仅个别病例出现1级或2级球结膜充血、角膜上皮点染及角膜浸润,经停戴或药物控制后均可实现继续戴镜;镜片配适情况及镜片状态总体良好。结论 配戴NOR型非球面角膜塑形镜可有效提升青少年近视患者裸眼远视力,降低等效球镜度,且对角膜内皮细胞参数和眼压影响较小,镜片配适和镜片状态良好。(眼科,2023,32:33-38)
【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 All456 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)
- 【文献出处】 眼科 ,Ophthalmology in China , 编辑部邮箱 ,2023年01期
- 【分类号】R778.11
- 【下载频次】10