胶原性眼内接触镜眼内植入后的生物相容性评价(英文)

Biocompatibility of collagen intraocular contact lens after implantation in eyes

背景:有晶体眼后房型人工晶体(又称眼内接触镜)植入术是近年来兴起的一种矫治高度近视的晶体屈光性手术。Starr公司将IV型胶原与水凝胶聚合而成的新型材料Collamer,是研制眼内接触镜的理想材料,但国外产品价格昂贵,一定程度上限制了该手术的开展。目的:通过兔眼动物实验摸索理想的胶原性眼内接触镜植入方法,观察眼内接触镜植入术后炎症反应和炎症递质的变化,并对其植入眼内的生物相容性进行评价。设计:单一样本,开放性实验。单位:上海交通大学医学院附属新华医院眼科。材料:实验于1999-08/2000-03在上海交通大学医学院附属新华医院和上海南洋放射免疫测试中心完成。选取成年新西兰纯种白兔20只,随机数字表法分为3组:眼内接触镜植入组8只、手术对照组6只、空白对照组6只。方法:①眼内接触镜植入组右眼行眼内接触镜植入+虹膜周切术,手术对照组右眼单纯行虹膜周切术,手术由专人按同一方式施行。术后两组术眼滴用激素抗菌素眼药水,4次/d,共10d。均于术后1,4,7d结膜下注射地塞米松2.5mg+庆大霉素4万U。空白对照组不进行手术。②分别于术后1,4,7,14d和1个月对眼内接触镜植入组、手术对照组的术眼进行眼压波动、角膜损伤、前房蛋白细胞渗出、前房深度、前房出血、虹膜后粘连、眼内接触镜偏位以及晶体混浊等监测。③分别于术后1,4,7,14d和1个月对眼内接触镜植入组、手术对照组的术眼进行房水取样,空白对照组也在相应时间取样,采用放射免疫分析法测定前列腺素E2浓度。主要观察指标:①术前及术后各时间点前房反应检测结果。②术后各组房水中炎症递质前列腺素E2浓度检测结果。结果:实验选取新西兰纯种白兔20只,全部进入结果分析。①术前及术后各时间点眼压的变化:与术前比较,眼内接触镜植入组、手术对照组术后各时间点眼压均无明显变化(P>0.05)。②术后角膜损伤和前房渗出情况:眼内接触镜植入组:5只兔眼术后第1天出现不同程度的前房变浅,1周内均恢复正常;2只兔眼出现少量前房出血,2周后吸收;2只兔眼分别出现虹膜前粘连和后粘连,瞳孔轻度变形;2只兔眼出现不同程度眼内接触镜偏位;1只兔眼术后1个月出现晶体前囊膜下点状混浊。手术对照组:6只兔眼术后第1天前房出现1～2级渗出,1周后均吸收;各兔眼角膜透明,无前房出血、前房变浅、虹膜后粘、晶体混浊等变化。③术后各组房水中炎症递质前列腺素E2浓度检测结果:眼内接触镜植入组术后1～4d房水中前列腺素E2含量最高,以后含量逐步递减。术后14d和1个月,各组均基本相似(P>0.05)。结论:眼内接触镜植入术后前房无明显慢性葡萄膜炎发生。房水中前列腺素E2浓度逐步降低,表现了眼内接触镜植入后典型的异物肉芽肿炎症过程,反映其良好的眼内耐受性。

BACKGROUND： Intraocular contract lens （ICL） implantation emerges as a crystal refrangibilit operation to rectify and cure high myopia in recent years. Collagen, a new material, is consisted of collagen IV and aquagel in Starr Company. It is an ideal material for ICL： however, high price is restricted to its development at a certain degree. OBJECTIVE： To find out ideal method of collagen ICL implantation through animal experiment in rabbit eyes and evaluate intraoeular bioeompatibility by observing inflammatory reaction and variation of inflammatory mediators. DESIGN： Single exponent and opening study. SETTING： Department of Ophthahnology, Xinhua Hospital affiliated to Medical College of Shanghai Jiaotong University. MATERIALS： The experiment was carried out in Xinhua Hospital affiliated to Medical College of Shanghai Jiaotong University and Shanghai Nanyang Radio-immunity Testing Center from August 1999 to March 2000. Twenty New Zealand rabbits were divided into three groups according to randomly digital table： ICL implantation group （n=8）, operative control group （n=6） and blank control group （n=6）. METHODS： （1） Right eyes of rabbits in ICL implantation group were suffered from ICL implantation and peripheral operation of iris ; however, right eyes of rabbits in operative control group were only suffered from peripheral operation of iris. After operation, hormone-antibiohie eyedrops were dribbled into eyes four times a day for total 10 days. At 1, 4 and 7 days after operation, 2.5 mg dexasone ＋ 40 000 U cidomycin were subcon- junctivally injected into eyes. Rabbits in blaek control group did not receive any operation. （2） At 1, 4, 7, 14 days and 1 month after operation, indexes of operative eyes in ICL implantation group and operative control group were measured including fluctuation of intraocular pressure, damage of corneal endothelium, protein leakage in anterior chamber, depth of anterior chamber, hyphema, posterior syneehiae of iris, ICL decentration and lens opacity. （3） At 1, 4, 7, 14 days and 1 month, samples of aqueous humor were aspirated from operative eyes of rabbits in ICL implantation group, operative control group and blank control group. Radioimmunoassay （RIA） was used to examine the concentration of prostaglandin-E2 （PGE2） in aqueous. MAIN OUTCOME MEASURES： （1） Results of reaction in anterior chamber at each time point before and after operation; （2） results of PGE2 concentration of inflammatory mediators in aqueous humor after operation. RESULTS： All 20 rabbits were involved in the final analysis. （1） Changes of intraocular pressure at eaeh time point before and after operation： As compared with that before operation, intraocular pressure was not changed in ICL implantation group and operative control group at each time point after operation （P 〉 0.05）. （2） Damage of corneal endothelium and leakage in anterior chamber after operation： ICL implantation group： Five eyes were shown as shallow anterior chamber at various degrees on the first day after operation, and recovered normally within 1 week; hemorrhage was observed in anterior chamber of two eyes and absorbed after 2 weeks： two eyes had anterior and posterior synechiae of iris, respectively, and pupil was deformed slightly; ICL decentration at various degrees was observed in two eyes; point-like opaeity was observed in anterior bursal membrane of crystal in one eye after 1 month. Operative control group： Leakage of grade 1- 2 was observed in 6 eyes on the first day after operation and was absorbed within 1 week. Cornea was elearing, and hyphema, shallow anterior chamber, posterior synechiae of iris and lens opacity were not changed. （3） PGE2 concentration of inflammatory mediators in aqueous humor after operation： PGE2 concentration was the highest in ICL implantation group at 1-4 days after operation, and then it was decreased gradually： however, PGE2 concentration was similar at 14 days and 1 month after operation （P 〉 0.05）. CONCLUSION： There is no obvious occurrence of chronic uveitis in anterior chamber after ICL implantation. PGE2 concentration in anterior chamber is decreased gradually, and this suggests that a classic foreignbody granulomatous inflammation emerges after ICL implantation, which reflects a good tolerance of ICL for ocular tissue.