北京生物医学工程

人工晶状体理化稳定性能测试

Test for physical and chemical stability of intraocular lens

作者：刘丽柯林楠王硕王迎陆颂芳

单位：中国食品药品检定研究院医疗器械检验中心(北京100050)

关键词：人工晶状体；光焦度；成像质量

分类号：

出版年·卷·期（页码）：2013·1·4（336-341）

摘要：

目的以实验室测试为基础，研究人工晶状体理化稳定性能。方法采用加速方法。水解试验在90℃水环境下进行164d，光照稳定性试验在8mW/cm2辐照强度下进行35d，Nd-YAG激光照射试验采用5mJ单脉冲能量，脉冲数量50个，激光束聚焦在人工晶状体后表面。试验后对每一组试验样品外观、光焦度、调制传递函数(modulation transfer function，MTF)进行测试。结果水解试验和光照试验后，人工晶状体的外观、光焦度偏差、MTF无明显变化。Nd-YAG激光照射试验后，人工晶状体的表面出现许多近圆形小洞，MTF显著降低，而光焦度偏差无明显变化。结论激光照射对人工晶状体成像质量有较大影响。在临床上进行Nd-YAG激光晶状体后囊切开术时，应尽可能地将激光照射点控制在直径3mm中心区域外，以保证用于成像的人工晶状体光学区域在激光照射过程中不受到损伤。

Objective To study the physical and chemical stability of intraocular lens (IOL) based on laboratory test. Methods Accelerated test was applied. The hydrolysis test was operated at 90℃ for 164 days. Illumination test was operated at 8mW/cm2，and the samples were placed in water for 35 days. At the Nd-YAG laser test，the posterior surfaces of IOLs were irradiated for 50 times，and each pulse was 5 mJ. The appearance of the IOLs was observed with reflecting microscope，and the power and MTF were observed with the IOL optical analyzer. Results The appearance，the power and the MTF of the IOLs did not change much at the hydrolysis test and illumination test. Yet at the Nd-YAG laser test，the injuring of the IOLs were almost round and the rim were broken when they were reserved under the scanning electron microscope for 40 times magnification. The diameters of the injuring were almost 50μm. Observed with the IOL optical analyzer，little change of the power was found and the MTF of the injured IOLs reduced. Conclusions The MTF of the IOLs injured at Nd-YAG laser test reduced. In clinical surgery，the posterior surface of IOLs should not be irradiated in the center of 3mm diameter area to avoid injuring.

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