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硅水凝胶人工晶状体的早期混浊:6个外植体的实验室分析

Early opacification of silicone intraocular lenses: Laboratory analyses of 6 explants.

作者信息

Werner Liliana, Dornelles Fabio, Hilgert Christiana R, Botelho Fernando, Conte Paulo F, Rozot Pascal, Andrenyak David M, Mamalis Nick, Olson Randall J

机构信息

John A. Moran Eye Center, University of Utah, Salt Lake City, Utah 84132, USA.

出版信息

J Cataract Refract Surg. 2006 Mar;32(3):499-509. doi: 10.1016/j.jcrs.2005.12.137.

Abstract

PURPOSE

To report laboratory analyses of 6 intraocular lenses (IOLs) explanted from patients who had visual disturbances caused by early postoperative opacification of the lens optic.

SETTING

John A. Moran Eye Center, University of Utah, Salt Lake City, Utah, USA.

METHODS

Six patients with 3-piece silicone lenses presented with optic cloudiness as early as a few hours after implantation. The lenses were implanted in 4 locations in Brazil and in France. The lenses in Brazil were stored at the same location before implantation. Gross and microscopic analyses were performed (dry and hydrated states). One half of each specimen underwent gas chromatography/mass spectrometry (GC/MS) analysis and/or extraction by isopropyl alcohol or acetonitrile. One lens also underwent scanning electron microscopy (SEM) with energy dispersive x-ray spectroscopy (EDS). The IOLs were examined for the presence of contaminants or deposits that could cause fast optic opacification.

RESULTS

The IOLs showed a white optic discoloration in the hydrated state but became transparent on complete dehydration. Suspect exogenous chemical compounds were identified in GC/MS analyses; general classes included terpenes and ketones, typically found in industrial cleaning agents and fumigants. Surface analysis (SEM and EDS) did not show any significant deposits on the external surfaces and sagittal cut in 1 of the specimens.

CONCLUSIONS

Most IOLs are enclosed in semipermeable packages to allow sterilization by ethylene oxide gas. During cleaning or disinfection of storage rooms, aerosolized solutions may introduce chemicals through the package and onto the IOLs. This may cause surface changes in the IOL, promoting opacification by water ingress in the aqueous environment. Cleaning and disinfection procedures of IOL storage areas should be monitored carefully.

摘要

目的

报告对6枚人工晶状体(IOL)进行的实验室分析,这些人工晶状体是从因晶状体光学部早期术后浑浊而出现视觉障碍的患者眼中取出的。

机构

美国犹他州盐湖城犹他大学约翰·A·莫兰眼科中心。

方法

6例植入三片式硅胶人工晶状体的患者在植入后数小时内即出现光学部浑浊。这些人工晶状体分别在巴西和法国的4个地点植入。巴西的人工晶状体在植入前存放在同一地点。进行了大体和显微镜分析(干燥和水合状态)。每个样本的一半进行气相色谱/质谱(GC/MS)分析和/或用异丙醇或乙腈提取。一枚人工晶状体还进行了扫描电子显微镜(SEM)和能量色散X射线光谱(EDS)分析。检查人工晶状体是否存在可能导致快速光学部浑浊的污染物或沉积物。

结果

人工晶状体在水合状态下呈现白色光学变色,但完全脱水后变得透明。在GC/MS分析中鉴定出可疑的外源性化合物;一般类别包括萜类和酮类,通常存在于工业清洁剂和熏蒸剂中。表面分析(SEM和EDS)未在1个样本的外表面和矢状切面上显示任何明显的沉积物。

结论

大多数人工晶状体封装在半透性包装中,以允许通过环氧乙烷气体进行灭菌。在储存室清洁或消毒期间,雾化溶液可能通过包装将化学物质引入并附着在人工晶状体上。这可能会导致人工晶状体表面发生变化,在水性环境中因水进入而促进浑浊形成。应仔细监测人工晶状体储存区域的清洁和消毒程序。

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