Objective:To evaluate the ef?cacy 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 ?rst 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 samplesttest, 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 ?rst 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 signi?cant difference between the two groups for the CMH test. At each follow-up time after wearing, there were no statistically signi?cant 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 ef?cacy and high safety for the correction of myopia.
姜珺,蓝方方,瞿小妹. 硬性透气性角膜接触镜矫正近视的安全性和有效性[J]. 中华眼视光学与视觉科学杂志, 2021, 23(11): 827-834.
Jun Jiang, Fangfang Lan, Xiaomei Qu. Safety and Efficacy of Rigid Gas Permeable Contact Lenses for Myopia Correction. Chinese Journal of Optometry Ophthalmology and Visual science, 2021, 23(11): 827-834. DOI: 10.3760/cma.j.cn115909-20210311-00097
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