近视眼配戴非球面软性亲水性角膜接触镜与NUV型软性亲水性角膜接触镜的效果和安全性的随机对照临床研究  

A randomized controlled clinical trial of the effectiveness and safety between aspherical and NUV soft hydrophilic contact lenses for myopia patients

作　　者：王洪格[1] 万霞 王亚玲[1] 孙学华[1] 兰晓燕[1] 张捷[1] 

机构地区：[1]青岛市市立医院眼科,青岛266011 [2]武汉市武昌区积玉桥街社区卫生服务中心,武汉430060

出　　处：《中华实验眼科杂志》2015年第6期537-540,共4页Chinese Journal Of Experimental Ophthalmology

摘　　要：背景软性角膜接触镜矫正近视的效果较好，适合高度近视及屈光参差而不方便佩戴框架眼镜者，理论上非球面软性亲水性角膜接触镜有更好的视觉质量，但是很多文献报道角膜接触镜导致泪膜异常，甚至角膜、结膜发生病变，因而，非球面软性亲水性角膜接触镜的疗效和安全性值得关注。目的比较近视患者佩戴非球面和NUV型软性亲水性角膜接触镜的有效性和安全性。方法采用前瞻性随机、双盲、平行对照试验设计，纳入2012年7-10月在青岛市市立医院眼科就诊的配戴软性角膜接触镜的近视受试者70例140眼，采用随机数字表法将受试者随机分为试验组和对照组，分别配戴非球面软性亲水性角膜接触镜和NUV型软性亲水性角膜接触镜。分别记录2个组受试者配戴15min、1周、2周、1个月时镜片的表面特性、矫正视力以及受试者眼部体征和主观症状评分，对2种软性亲水性角膜接触镜的疗效和安全性进行比较。结果2个组受试者配戴15min、1周、2周、1个月2种角膜接触镜前表面吸湿度、前表面沉淀物和后表面沉淀物均为0分。2个组受试者戴镜前及戴镜后各时间点的矫正视力均≥1．0。2个组受试者戴镜各时间点不同眼部症状评分为2-3分的眼数均为0，试验组各时间点睑结膜充血和角膜缘充血评分为1分的眼数明显多于对照组，差异均有统计学意义（均P〈0．05），但各时间点2个组间不同角膜点状染色评分的眼数分布差异均无统计学意义（均P〉0．05）。2个组受试者戴镜各时间点不同眼部主观症状评分为2～3分的眼数均为0，试验组各时间点异物感为1分的眼数明显多于对照组，差异均有统计学意义（P=0．002、0．006、0．005、0．005），各时间点试验组视力清晰程度和视力稳定性为1分的眼数虽均多于对照组，但差异均无统计学意义（均P〉0．05）。结论非球面软Background The clinical effectiveness of soft corneal contact lens for correction of myopia has been confirmed. Theoretically, aspherical soft hydrophilic corneal contact lens has better visual qualify for myopic eyes,and the lenses have been applied widely. But abnormal tear film, even many cornea and conjuctiva diseases caused by soft contact lens have been reported, so the effectiveness and safety of aspherical soft hydrophilic corneal contact lens are worth concerning. Objective This clinical trail was to compare the effectiveness and safety between aspherical and NUV soft hydrophilic contact lens for myopic eyes. Methods A randomized,double-blind and controlled clinical study was performed under the approval of Ethic Committee of Qingdao Municipal Hospital and informed consent of each patient. One hundred and forty eyes of 70 myopic patients were enrolled in Qingdao Municipal Hospital from July to October,2012. The subjects were randomized into the trial group and control group using random number table. Aspherical soft hydrophilic contact lenses were worn in the trial group and NUV soft hydrophilic contact lenses were worn in the control group. The characteristics of the lens surface, outcomes and the eye number in different scores of ocular signs and symptoms were assessed before and 15 minutes, 1 week,2 weeks and 1 month after wearing lenses. Results The sores of humidity of anterior surface, the sediment in anterior and posterior surface are 0 in both lenses in various time points after wearing. The corrected visual acuity of all the subjects were ≥ 1.0. The eye number of 2-3 scores in various ocular signs was 0 in both groups,but the eye number of 1 score in palpebral conjunctival congestion and limbus congestion were more in the trail group than those in the control group in different time points （ all at P〈0.05 ）. There were significant differences in corneal fluorescine staining between the groups in different time points （ all at P〉0.05 ）. There was no eye for 2-3 scores of eye symptom

关 键 词：软性亲水性角膜接触镜/不良反应 近视 非球面透镜 有效性 安全性 随机对照临床试验 

分 类 号：R778.11[医药卫生—眼科]