Nishi Yutaro, Rabsilber Tanja M, Limberger Il-Joo, Reuland Andreas J, Auffarth Gerd U
International Vision Correction Research Centre, Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.
J Cataract Refract Surg. 2007 Feb;33(2):227-31. doi: 10.1016/j.jcrs.2006.10.020.
To compare the rate of posterior capsule opacification (PCO) with the single-piece hydrophilic acrylic foldable Rayner Centerflex 570H intraocular lens (IOL), which has a sharp optic edge design excluding the optic-haptic junction, and the Rayner C-flex 570C IOL, which has an improved 360-degree sharp edge.
Department of Ophthalmology, University of Heidelberg, Heidelberg, Germany.
As part of a multicenter U.S. Food and Drug Administration (FDA) study, 42 patients who had implantation of a C-flex IOL in 1 eye after uneventful phacoemulsification were enrolled. Six and 12 months postoperatively, PCO was evaluated by retroillumination photographs using Evaluation of Posterior Capsule Opacification (EPCO) 2000 image-analysis software. The data were then compared with those in a matched group of patients with a Centerflex IOL who participated in a previous FDA study.
The mean age of the patients with the C-flex IOL was 71.5 years +/- 8.2 (SD) There was a statistically significant difference in EPCO scores between the C-flex group and Centerflex group. Six months after surgery, the mean EPCO value (total IOL optic) was 0.07 +/- 0.17 in the C-flex group (n = 37) and 0.20 +/- 0.20 in the Centerflex group (n = 36) (P<.01, Wilcoxon test). By 12 months, the mean had increased to 0.16 +/- 0.20 in the C-flex group (n = 37) and 0.35 +/- 0.22 in the Centerflex group (n = 31) (P<.01, Wilcoxon test).
The C-flex IOLs showed good functional results and significantly lower PCO formation than the earlier model Centerflex IOL. The enhanced edge of the C-flex IOL seemed to improve PCO prevention clinically.
比较单件式亲水性丙烯酸可折叠瑞纳Centerflex 570H人工晶状体(IOL)(其光学边缘设计锐利,不包括光学部-襻交界处)与具有改进的360度锐利边缘的瑞纳C-flex 570C IOL的后囊膜混浊(PCO)发生率。
德国海德堡大学眼科。
作为美国食品药品监督管理局(FDA)一项多中心研究的一部分,42例在白内障超声乳化术后一只眼植入C-flex IOL的患者入组。术后6个月和12个月,使用后囊膜混浊评估(EPCO)2000图像分析软件通过后照法照片评估PCO。然后将数据与参与先前FDA研究的匹配的Centerflex IOL患者组的数据进行比较。
C-flex IOL患者的平均年龄为71.5岁±8.2(标准差)。C-flex组和Centerflex组的EPCO评分存在统计学显著差异。术后6个月,C-flex组(n = 37)的平均EPCO值(整个IOL光学部)为0.07±0.17,Centerflex组(n = 36)为0.20±0.20(P<0.01,Wilcoxon检验)。到12个月时,C-flex组(n = 37)的平均值增至0.16±0.20,Centerflex组(n = 31)为0.35±0.22(P<0.01,Wilcoxon检验)。
C-flex IOL显示出良好的功能结果,且与早期型号的Centerflex IOL相比,PCO形成明显更低。C-flex IOL增强的边缘似乎在临床上改善了PCO的预防。