水凝胶软性亲水接触镜临床应用及安全性  

Extra-Care soft contact lenses:Clinical efficacy and safety

作　　者：何跃[1] 吕红彬[1] 欧阳科[1] 干锦华[1] 徐梅[1] 余玲[1] 张熙伯[1] 

机构地区：[1]泸州医学院附属医院眼科,四川省泸州市646000

出　　处：《中国组织工程研究》2013年第8期1423-1429,共7页Chinese Journal of Tissue Engineering Research

摘　　要：背景:采用水凝胶材料制作而成的Extra-Care软性亲水接触镜含水量、透氧系数、折射率等指标均已达到国家标准。目的:通过与已上市的同类产品TB软性隐形眼镜对比,评价Extra-Care软性亲水接触镜的有效性和安全性。方法:将135例近视眼志愿者随机分入配戴Extra-Care软性亲水接触镜组(试验组)与配戴TB软性隐形眼镜组(对照组)。所有受试者在入选当天、使用7d、使用30d、使用90d时进行视力清晰程度、视力稳定性、配戴舒适度、镜片中心定位、镜片覆盖、眼部异物感、角巩膜缘充血和角膜点状染色及泪膜破裂时间检查。结果与结论:两组视力清晰程度、视力稳定性、镜片中心定位、镜片覆盖、眼部异物感、角巩膜缘充血和角膜点状染色及泪膜破裂时间差异无显著性意义,但试验组舒适度优于对照组(P<0.05)。表明Extra-Care软性亲水接触镜的临床应用是有效和安全的,并提高了配戴舒适度。BACKGROUND： Extra-Care soft contact lenses are made of hydrogel, and their water content, oxygen permeability coefficient and refractive index have reached national standards. OBJECTIVE： To evaluate the effectiveness and safety of Extrea-Care soft contact lenses compared with TB soft contact lenses. METHODS： Totally 135 volunteers were enrolled in this trial, and randomly divided into trial group treated with Extra-Care soft contact lenses and control group treated with TB soft contact lenses. Subjective symptoms, visual clarity, stability of visual acuity, lens comfort, lens positioning, lens covering, foreign body sensation, corneal punctate staining, limbal hyperemia and tear breakup time were evaluated immediately,7 days, 30 days and 90 days after wearing. RESULTS AND CONCLUSION： There were no significant differences in the visual clarity, stability of visual acuity lens positioning, lens covering, foreign body sensation, corneal punctate staining, limbal hyperemia and tear film breakup time between the two groups. However, the lens comfort in the trial group was superior to that in the control group （P 〈 0.05）. The results indicated that Extra-Care soft contact lenses are effective and safe, improving lens comfort.

关 键 词：生物材料 材料生物相容性 水凝胶材料 软性隐形眼镜 接触镜 安全性 有效性 近视 角膜 视力稳定性 

分 类 号：R318[医药卫生—生物医学工程]