Chinese Journal of Tissue Engineering Research ›› 2015, Vol. 19 ›› Issue (34): 5485-5490.doi: 10.3969/j.issn.2095-4344.2015.34.015

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Biological safety of hydrophobic acrylic foldable intraocular lens 

Duan Xiao-jie1, Jiang Bao-guang2, Wang Zhao-xu1   

  1. 1National Institutes for Food and Drug Control, Beijing 100050, China; 2Shenyang Baiao Medical Device Co., Ltd., Shenyang 110163, Liaoning Province, China
  • Online:2015-08-20 Published:2015-08-20
  • Contact: Jiang Bao-guang, M.D., Associate professor, Engineer, Shenyang Baiao Medical Device Co., Ltd., Shenyang 110163, Liaoning Province, China
  • About author:Duan Xiao-jie, Assistant researcher, National Institutes for Food and Drug Control, Beijing 100050, China

Abstract:

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.

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

Key words: Lenses, Intraocular, Inflammation, Materials Testing

CLC Number: