Mester Ulrich, Fabian Ekkehard, Gerl Ralf, Hunold Wilfried, Hütz Werner, Strobel Jürgen, Hoyer Heike, Kohnen Thomas
Department of Ophthalmology, Bundesknappschaft's Hospital, Sulzbach, Germany.
J Cataract Refract Surg. 2004 May;30(5):978-85. doi: 10.1016/j.jcrs.2003.09.052.
To perform an intraindividual comparison of posterior capsule opacification (PCO) with 2 foldable intraocular lenses (IOLs) and a foldable acrylic IOL 1 year after in-the-bag implantation.
Seven German ophthalmology centers.
In an open prospective randomized multicenter study, each center intraindividually compared a high-refractive-index, sharp-edged optic silicone IOL (CeeOn Edge 911A, Pharmacia) with a high-refractive-index, round-edged optic silicone IOL (PhacoFlex SI-40NB, Allergan) or a sharp-edged optic acrylic IOL (AcrySof MA60BM, Alcon). Of 288 randomized patients, 247 had standard phacoemulsification with in-the-bag IOL implantation in both eyes by the same surgeon. One eye of each patient received a CeeOn Edge IOL and the fellow eye, an AcrySof or PhacoFlex IOL. A morphologic evaluation of PCO was performed using the Evaluation of Posterior Capsule Opacification (EPCO) system 1 to 2 weeks and 11 to 14 months after surgery. The digital pictures were evaluated by an independent investigator who was blind to the type of IOL. Intraindividual differences in EPCO scores were statistically evaluated by a 1-sided binomial test at an alpha-level of 5%.
One year after surgery, 127 patients with the AcrySof IOL and 102 patients with the PhacoFlex IOL in the control eye were reexamined. Functional results, safety, and handling were not significantly different between the 3 IOLs. All reexamined eyes had a very low PCO grade. The EPCO values revealed less PCO in eyes with the CeeOn Edge IOL than in eyes with the AcrySof or PhacoFlex IOL, but the difference was not statistically significant. A neodymium:YAG laser capsulotomy was performed in 1 eye with a CeeOn Edge IOL, 1 eye with an AcrySof IOL, and 2 eyes with a PhacoFlex IOL.
The EPCO PCO grade was low 1 year after implantation of CeeOn Edge 911A, PhacoFlex SI-40NB, and AcrySof MA60BM IOLs; there was no statistically significant difference between the IOLs. The impact of IOL material and edge design on PCO development might be relevant in a long-term follow-up of this study.
对两枚可折叠人工晶状体（IOL）和一枚可折叠丙烯酸酯IOL囊袋内植入1年后的后囊膜混浊（PCO）情况进行个体内比较。
七个德国眼科中心。
在一项开放的前瞻性随机多中心研究中，每个中心对一枚高折射率、锐边光学部硅胶IOL（CeeOn Edge 911A，法玛西亚公司）与一枚高折射率、圆边光学部硅胶IOL（PhacoFlex SI - 40NB，爱尔康公司）或一枚锐边光学部丙烯酸酯IOL（AcrySof MA60BM，爱尔康公司）进行个体内比较。在288例随机分组的患者中，247例由同一位外科医生对双眼进行标准超声乳化白内障吸除联合囊袋内IOL植入术。每位患者的一只眼植入CeeOn Edge IOL，另一只眼植入AcrySof或PhacoFlex IOL。分别在术后1至2周和11至14个月使用后囊膜混浊评估（EPCO）系统对PCO进行形态学评估。由一位对IOL类型不知情的独立研究者对数码照片进行评估。通过单侧二项式检验在5%的α水平上对EPCO评分的个体内差异进行统计学评估。
术后1年，对127例对照眼植入AcrySof IOL的患者和102例对照眼植入PhacoFlex IOL的患者进行了复查。三种IOL在功能结果、安全性和操作性方面无显著差异。所有复查眼的PCO分级都很低。EPCO值显示植入CeeOn Edge IOL的眼内PCO比植入AcrySof或PhacoFlex IOL的眼内少，但差异无统计学意义。1例植入CeeOn Edge IOL的眼、1例植入AcrySof IOL的眼和2例植入PhacoFlex IOL的眼进行了钕:钇铝石榴石激光晶状体后囊切开术。
植入CeeOn Edge 911A、PhacoFlex SI - 40NB和AcrySof MA60BM IOL 1年后EPCO的PCO分级较低；三种IOL之间无统计学显著差异。IOL材料和边缘设计对PCO发展的影响在本研究的长期随访中可能具有相关性。
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