中华实验眼科杂志
中華實驗眼科雜誌
중화실험안과잡지
CHINESE JOURNAL OF EXPERIMENTAL OPHTHALMOLOGY
2015年
6期
537-540
,共4页
王洪格%万霞%王亚玲%孙学华%兰晓燕%张捷
王洪格%萬霞%王亞玲%孫學華%蘭曉燕%張捷
왕홍격%만하%왕아령%손학화%란효연%장첩
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
軟性親水性角膜接觸鏡/不良反應%近視%非毬麵透鏡%有效性%安全性%隨機對照臨床試驗
연성친수성각막접촉경/불량반응%근시%비구면투경%유효성%안전성%수궤대조림상시험
Contact lenses,hydrophilic/adverse effects%Myopia%Aspherical lens%Effectiveness%Safety%Randomized controlled clinical trail
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15 min、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15 min、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 非球面软性亲水性角膜接触镜的表面特性及矫正视力效果与NUV型软性亲水性角膜接触镜相同,但非球面软性亲水性角膜接触镜的眼部不良反应稍重于NUV型软性亲水性角膜接触镜.
揹景 軟性角膜接觸鏡矯正近視的效果較好,適閤高度近視及屈光參差而不方便珮戴框架眼鏡者,理論上非毬麵軟性親水性角膜接觸鏡有更好的視覺質量,但是很多文獻報道角膜接觸鏡導緻淚膜異常,甚至角膜、結膜髮生病變,因而,非毬麵軟性親水性角膜接觸鏡的療效和安全性值得關註. 目的 比較近視患者珮戴非毬麵和NUV型軟性親水性角膜接觸鏡的有效性和安全性. 方法 採用前瞻性隨機、雙盲、平行對照試驗設計,納入2012年7-10月在青島市市立醫院眼科就診的配戴軟性角膜接觸鏡的近視受試者70例140眼,採用隨機數字錶法將受試者隨機分為試驗組和對照組,分彆配戴非毬麵軟性親水性角膜接觸鏡和NUV型軟性親水性角膜接觸鏡.分彆記錄2箇組受試者配戴15 min、1週、2週、1箇月時鏡片的錶麵特性、矯正視力以及受試者眼部體徵和主觀癥狀評分,對2種軟性親水性角膜接觸鏡的療效和安全性進行比較.結果 2箇組受試者配戴15 min、1週、2週、1箇月2種角膜接觸鏡前錶麵吸濕度、前錶麵沉澱物和後錶麵沉澱物均為0分.2箇組受試者戴鏡前及戴鏡後各時間點的矯正視力均≥1.0.2箇組受試者戴鏡各時間點不同眼部癥狀評分為2～3分的眼數均為0,試驗組各時間點瞼結膜充血和角膜緣充血評分為1分的眼數明顯多于對照組,差異均有統計學意義(均P＜0.05),但各時間點2箇組間不同角膜點狀染色評分的眼數分佈差異均無統計學意義(均P＞0.05).2箇組受試者戴鏡各時間點不同眼部主觀癥狀評分為2～3分的眼數均為0,試驗組各時間點異物感為1分的眼數明顯多于對照組,差異均有統計學意義(P=0.002、0.006、0.005、0.005),各時間點試驗組視力清晰程度和視力穩定性為1分的眼數雖均多于對照組,但差異均無統計學意義(均P＞0.05). 結論 非毬麵軟性親水性角膜接觸鏡的錶麵特性及矯正視力效果與NUV型軟性親水性角膜接觸鏡相同,但非毬麵軟性親水性角膜接觸鏡的眼部不良反應稍重于NUV型軟性親水性角膜接觸鏡.
배경 연성각막접촉경교정근시적효과교호,괄합고도근시급굴광삼차이불방편패대광가안경자,이론상비구면연성친수성각막접촉경유경호적시각질량,단시흔다문헌보도각막접촉경도치루막이상,심지각막、결막발생병변,인이,비구면연성친수성각막접촉경적료효화안전성치득관주. 목적 비교근시환자패대비구면화NUV형연성친수성각막접촉경적유효성화안전성. 방법 채용전첨성수궤、쌍맹、평행대조시험설계,납입2012년7-10월재청도시시립의원안과취진적배대연성각막접촉경적근시수시자70례140안,채용수궤수자표법장수시자수궤분위시험조화대조조,분별배대비구면연성친수성각막접촉경화NUV형연성친수성각막접촉경.분별기록2개조수시자배대15 min、1주、2주、1개월시경편적표면특성、교정시력이급수시자안부체정화주관증상평분,대2충연성친수성각막접촉경적료효화안전성진행비교.결과 2개조수시자배대15 min、1주、2주、1개월2충각막접촉경전표면흡습도、전표면침정물화후표면침정물균위0분.2개조수시자대경전급대경후각시간점적교정시력균≥1.0.2개조수시자대경각시간점불동안부증상평분위2～3분적안수균위0,시험조각시간점검결막충혈화각막연충혈평분위1분적안수명현다우대조조,차이균유통계학의의(균P＜0.05),단각시간점2개조간불동각막점상염색평분적안수분포차이균무통계학의의(균P＞0.05).2개조수시자대경각시간점불동안부주관증상평분위2～3분적안수균위0,시험조각시간점이물감위1분적안수명현다우대조조,차이균유통계학의의(P=0.002、0.006、0.005、0.005),각시간점시험조시력청석정도화시력은정성위1분적안수수균다우대조조,단차이균무통계학의의(균P＞0.05). 결론 비구면연성친수성각막접촉경적표면특성급교정시력효과여NUV형연성친수성각막접촉경상동,단비구면연성친수성각막접촉경적안부불량반응초중우NUV형연성친수성각막접촉경.
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 QingdaoMunicipal 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 symptoms in both groups.The eye number for 1 score in foreign body sensation increased in the target-trail group compared to the control group at various time points (P =0.002,0.006,0.005,0.005).However,there was no statistically significant differences in the eye number for 1 score in visual clearness and stability between the two groups at the follow-up duration (all at P＞ 0.05).Conclusions Aspherical soft hydrophilic corneal contact lens has good outcomes in corrected visual acuity for myopia like NUV soft hydrophilic contact lens,but the wearing of aspherical soft hydrophilic corneal contact lens induces more ocular discomfortableness.
