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三种不同襻设计的人工晶状体的生物力学稳定性:体内外评估。

Biomechanical Stability of Three Intraocular Lenses With Different Haptic Designs: In Silico and In Vivo Evaluation.

出版信息

J Refract Surg. 2020 Sep 1;36(9):617-624. doi: 10.3928/1081597X-20200713-02.

DOI:10.3928/1081597X-20200713-02
PMID:32901830
Abstract

PURPOSE

To assess the biomechanical stability of three different marketed intraocular lenses (IOLs) with different haptic designs (four-loop IOL [Micro F FineVision model] and double C-loop IOL [POD F and POD FT models], all manufactured by PhysIOL), in silico (computer simulation) and in vivo (in the context of lens surgery).

METHODS

An in silico simulation investigation was performed using finite element modeling (FEM) software to reproduce the compression test defined by the International Organization for Standardization and in vivo implantation in patients in the context of lens surgery was evaluated 1 day and 3 months postoperatively. IOL decentration and rotation were tested. In addition, the stress and strains were analyzed with the finite element method.

RESULTS

In the in silico evaluation, the compression force for the POD F IOL was slightly lower than for the POD FT IOL and Micro F IOL for all compression diameters. The axial displacement was maximum for the POD FT IOL and the tilt, rotation, and lateral decentration were substantially lower than the acceptable tolerance limits established in ISO 11979-2. In the in vivo evaluation, a total of 45 eyes from 45 patients were selected, 15 eyes for each IOL model under assessment. Statistically significant differences were found between the Micro F and POD F IOLs for lateral decentration in x-direction (in absolute value) at 3 months postoperatively (P = .03).

CONCLUSIONS

Although statistically significant differences have been found when comparing the displacement, tilt, and rotation between the different lenses, these differences cannot be considered clinically relevant, which would suggest that all three IOL models yield excellent stability in those terms. FEM appears to be a powerful tool for numerical studies of the biomechanical properties of IOLs. [J Refract Surg. 2020;36(9):617-624.].

摘要

目的

评估三种不同的眼内透镜(IOL)在不同的襻设计(四襻 IOL [Micro F FineVision 模型]和双 C 襻 IOL [POD F 和 POD FT 模型],均由 PhysIOL 制造)在体内(在晶状体手术背景下)和体外(在晶状体手术背景下)的生物力学稳定性。

方法

使用有限元建模(FEM)软件进行体外模拟研究,以复制国际标准化组织定义的压缩测试,并在手术后 1 天和 3 个月评估在患者体内的植入情况。测试了 IOL 的偏心和旋转。此外,还通过有限元法分析了应力和应变。

结果

在体外评估中,对于所有压缩直径,POD F IOL 的压缩力略低于 POD FT IOL 和 Micro F IOL。轴向位移对于 POD FT IOL 最大,倾斜、旋转和横向偏心明显低于 ISO 11979-2 规定的可接受公差极限。在体内评估中,共选择了 45 名患者的 45 只眼,每种评估的 IOL 模型各 15 只眼。术后 3 个月时,Micro F 和 POD F IOL 之间的横向偏心(绝对值)在 x 方向存在统计学显著差异(P =.03)。

结论

尽管在比较不同透镜的位移、倾斜和旋转时发现了统计学上的显著差异,但这些差异不能被认为具有临床相关性,这表明所有三种 IOL 模型在这些方面都具有出色的稳定性。有限元法似乎是研究 IOL 生物力学特性的强大数值工具。[J Refract Surg. 2020;36(9):617-624.]。

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