中国组织工程研究
中國組織工程研究
중국조직공정연구
Journal of Clinical Rehabilitative Tissue Engineering Research
2013年
8期
1423-1429
,共7页
何跃%吕红彬%欧阳科%干锦华%徐梅%余玲%张熙伯
何躍%呂紅彬%歐暘科%榦錦華%徐梅%餘玲%張熙伯
하약%려홍빈%구양과%간금화%서매%여령%장희백
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
生物材料%材料生物相容性%水凝膠材料%軟性隱形眼鏡%接觸鏡%安全性%有效性%近視%角膜%視力穩定性
생물재료%재료생물상용성%수응효재료%연성은형안경%접촉경%안전성%유효성%근시%각막%시력은정성
biomaterials%material biocompatibility%hydrogel materials%soft contact lenses%contact lenses%safety%efficacy%myopia%cornea%stability of visual acuity
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7 d、使用30 d、使用90 d 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.
揹景:採用水凝膠材料製作而成的 Extra-Care 軟性親水接觸鏡含水量、透氧繫數、摺射率等指標均已達到國傢標準.目的:通過與已上市的同類產品 TB 軟性隱形眼鏡對比,評價 Extra-Care 軟性親水接觸鏡的有效性和安全性.方法:將135例近視眼誌願者隨機分入配戴 Extra-Care 軟性親水接觸鏡組(試驗組)與配戴 TB 軟性隱形眼鏡組(對照組).所有受試者在入選噹天、使用7 d、使用30 d、使用90 d 時進行視力清晰程度、視力穩定性、配戴舒適度、鏡片中心定位、鏡片覆蓋、眼部異物感、角鞏膜緣充血和角膜點狀染色及淚膜破裂時間檢查.結果與結論:兩組視力清晰程度、視力穩定性、鏡片中心定位、鏡片覆蓋、眼部異物感、角鞏膜緣充血和角膜點狀染色及淚膜破裂時間差異無顯著性意義,但試驗組舒適度優于對照組(P <0.05).錶明Extra-Care 軟性親水接觸鏡的臨床應用是有效和安全的,併提高瞭配戴舒適度.
배경:채용수응효재료제작이성적 Extra-Care 연성친수접촉경함수량、투양계수、절사솔등지표균이체도국가표준.목적:통과여이상시적동류산품 TB 연성은형안경대비,평개 Extra-Care 연성친수접촉경적유효성화안전성.방법:장135례근시안지원자수궤분입배대 Extra-Care 연성친수접촉경조(시험조)여배대 TB 연성은형안경조(대조조).소유수시자재입선당천、사용7 d、사용30 d、사용90 d 시진행시력청석정도、시력은정성、배대서괄도、경편중심정위、경편복개、안부이물감、각공막연충혈화각막점상염색급루막파렬시간검사.결과여결론:량조시력청석정도、시력은정성、경편중심정위、경편복개、안부이물감、각공막연충혈화각막점상염색급루막파렬시간차이무현저성의의,단시험조서괄도우우대조조(P <0.05).표명Extra-Care 연성친수접촉경적림상응용시유효화안전적,병제고료배대서괄도.
@@@@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 Extra-Care soft contact lenses compared with TB soft contact lenses. METHODS: Total y 135 volunteers were enrol ed 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.