硬性透气性角膜接触镜矫正近视的安全性和有效性

Safety and Efficacy of Rigid Gas Permeable Contact Lenses for Myopia Correction

目的: 评价普诺瞳?硬性透气性角膜接触镜(RGPCL)应用于视力矫正的安全性和有效性。方法: 前瞻性随机对照研究。选取2016年6月至2017年7月期间在温州医科大学附属眼视光医院、广西壮族自治区人民医院、复旦大学附属眼耳鼻喉科医院就诊的双眼近视患者, 随机分配至观察组和对照组, 观察组配戴爱博诺德(北京)医疗科技股份有限公司生产的普诺瞳?RGPCL(型号:RAR、RAS), 对照组配戴香港易安易光学有限公司生产的RGPCL(型号:XO RGP)。在配戴当天, 配戴后1周、1个月、3个月进行访视, 对双眼进行评估, 包括裸眼远视力(UCDVA)、框架镜最佳矫正远视力(BCDVA)、RGPCL矫正远视力(CDVA)、等效球镜度(SE)、角膜K值、角膜内皮细胞、镜片适配状态、镜片情况及不良反应等。采用独立样本t检验、Wilcoxon秩和检验、CMH检验等进行数据分析。结果: 共155例患者完成初次配戴, 观察组76例, 对照组79例。戴镜当天, 观察组和对照组RGPCL CDVA分别为右眼0(-0.10, 0)、0(-0.20, 0)和左眼0(-0.20, 0)、0(-0.20, 0), 组间差异无统计学意义。配戴后各随访时间点, 2组双眼的UCDVA、框架镜BCDVA、RGPCL CDVA、裸眼主观验光SE、戴RGPCL主观验光SE、角膜K值的组间差异均无统计学意义。戴镜3个月, 均未出现严重并发症, 2组结膜充血发生率、角膜上皮点状着色发生率的差异均无统计学意义。结论: 普诺瞳?RGPCL与XO RGP型号的RGPCL用于矫正近视的疗效一致且均具有较高的安全性。

Objective:To evaluate the efficacy and safety of the rigid gas permeable contact lens(RGPCL)for myopia correction.Methods:In a prospective randomized controlled study,patients were recruited from June 2016 to July 2017 from the Eye Hospital,Wenzhou Medical University,the People's Hospital of Guangxi Zhuang Autonomous Region,and the Eye and ENT Hospital of Fudan University.Binocular myopia patients were randomly assigned to a study group or a control group.The study group wore the iBright®RGPCL made by Eyebright Medical Technology(Beijing)Co.,Ltd.(model:RAR,RAS),and the control group wore the RGPCL made by E&E OPTICS LIMITED(HongKong),(model:XO RGP).Both eyes were evaluated on the first day of wearing the lenses and 1 week,1 month,and 3 months after wearing the lenses.Measurements included uncorrected distance visual acuity(UCDVA),best corrected distance visual acuity(BCDVA)with frame lenses,RGPCL corrected distance visual acuity(RGPCL CDVA),spherical equivalent(SE),corneal K value,corneal endothelial cells,lens fitting status,lens condition,adverse reactions,etc.An independent samples t test,Wilcoxon rank-sum test,CMH test,etc.,were used for data analysis.Results:A total of 155 patients(76 patients in the study group and 79 patients in the control group)completed the initial wearing.On the first day of wearing the RGPCLs,the RGPCL CDVA of the study group and the control group were 0(-0.10,0),0(-0.20,0)for the right eye,and 0(-0.20,0),0(-0.20,0)for the left eye,respectively.There was no significant difference between the two groups for the CMH test.At each follow-up time after wearing,there were no statistically significant differences in the left and right eyes between the two groups for UCDVA,frame lens BCDVA,RGPCL CDVA,naked-eye and RGPCL subjective refraction SE,and corneal K value.After wearing the lenses for 3 months,none of the patients had serious complications.In the study and control groups,the incidence of conjunctival hyperemia,and the incidence of corneal epithelial punctate staining showed no statistically significant differences.Conclusions:The iBright®RGPCL and the control RGPCL(model:XO RGP)have the same efficacy and high safety for the correction of myopia.