北京生物醫(yī)學(xué)工程

人工晶狀體理化穩(wěn)定性能測(cè)試

Test for physical and chemical stability of intraocular lens

作者：劉麗柯林楠王碩王迎陸頌芳

單位：中國(guó)食品藥品檢定研究院醫(yī)療器械檢驗(yàn)中心(北京100050)

關(guān)鍵詞：人工晶狀體；光焦度；成像質(zhì)量

分類號(hào)：

出版年·卷·期（頁(yè)碼）：2013·1·4（336-341）

摘要：

目的以實(shí)驗(yàn)室測(cè)試為基礎(chǔ)，研究人工晶狀體理化穩(wěn)定性能。方法采用加速方法。水解試驗(yàn)在90℃水環(huán)境下進(jìn)行164d，光照穩(wěn)定性試驗(yàn)在8mW/cm2輻照強(qiáng)度下進(jìn)行35d，Nd-YAG激光照射試驗(yàn)采用5mJ單脈沖能量，脈沖數(shù)量50個(gè)，激光束聚焦在人工晶狀體后表面。試驗(yàn)后對(duì)每一組試驗(yàn)樣品外觀、光焦度、調(diào)制傳遞函數(shù)(modulation transfer function，MTF)進(jìn)行測(cè)試。結(jié)果水解試驗(yàn)和光照試驗(yàn)后，人工晶狀體的外觀、光焦度偏差、MTF無(wú)明顯變化。Nd-YAG激光照射試驗(yàn)后，人工晶狀體的表面出現(xiàn)許多近圓形小洞，MTF顯著降低，而光焦度偏差無(wú)明顯變化。結(jié)論激光照射對(duì)人工晶狀體成像質(zhì)量有較大影響。在臨床上進(jìn)行Nd-YAG激光晶狀體后囊切開術(shù)時(shí)，應(yīng)盡可能地將激光照射點(diǎn)控制在直徑3mm中心區(qū)域外，以保證用于成像的人工晶狀體光學(xué)區(qū)域在激光照射過(guò)程中不受到損傷。

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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