疏水性丙烯酸酯折叠式人工晶体的生物安全性

背景：在临床试验前，需对疏水性丙烯酸酯人工晶体以新西兰白兔作为植入对象进行生物学评价。目的：观察新型疏水性丙烯酸酯折叠式人工晶体的生物安全性。方法：取新西兰家兔12只，右侧眼做实验眼，植入沈阳百奥医疗器械有限公司研制疏水性丙烯酸酯折叠式人工晶体，左侧眼做对照眼，植入美国爱尔康公司的Acrysof IQ SN60WF人工晶体。结果与结论：与对照眼相比，兔实验眼植入后各时间点角膜、前房、植入物位置、眼后节变化差异无显著性意义；且角膜和晶体囊袋无炎症反应，组织增生差异无显著性意义；人工晶体表面无巨噬细胞等炎症细胞，晶体表面、襻根部可见纤维组织。说明此款新材料与临床中已经广泛应用的产品无显著差别，即具有生物安全性。中国组织工程研究杂志出版内容重点：组织构建；骨细胞；软骨细胞；细胞培养；成纤维细胞；血管内皮细胞；骨质疏松；组织工程

Biological safety of hydrophobic acrylic foldable intraocular lens

BACKGROUND:Hydrophobic acrylic foldable intraocular lens should be evaluated biologically with New Zealand rabbits as implant objects prior to clinical trial. OBJECTIVE:To observe the biological safety of hydrophobic acrylic foldable intraocular lens.METHODS: Twelve New Zealand rabbits were enrolled. The right eyes were implanted with self-developed hydrophobic acrylic foldable intraocular lens (Shenyang Baiao Medical Device Co., Ltd., China) as experimental group, and the left eyes were implanted with Acrysof IQ SN60WF (Alcon, USA) as control group.RESULTS AND CONCLUSION:After implantation, there were no significant differences in the cornea, anterior chamber, implant position, posterior segment of eyeball between two groups. Tissue proliferation had no obviously difference between the two groups, and there were cornea and lens pouch inflammations. No macrophages and other inflammatory cells were visualized on the surface of intraocular lens, and fibrous tissues were found on the intraocular lens surface and in the haptics root. These findings suggest that the self-developed hydrophobic acrylic foldable intraocular lens has no difference from Acrysof IQ SN60WF widely used in clinic, and it has the biological safety.