眼后节光学相干断层扫描仪的有效性评价研究  

The Study on the Effectiveness Evaluation of Optical Coherence Tomography in the Posterior Segment of the Eye

作　　者：王敬涛 彭建华 胡一平 黄涛 Wang Jingtao;Peng Jianhua;Hu Yiping;Huang Tao(Zhejiang Institute of Medical Device Testing,Hangzhou Zhejiang 310018,China;NMPA Key Laboratory for Biomedical Optics,Hangzhou Zhejiang 310018,China;Key Laboratory of Safety Evaluation of Medical Devices of Zhejiang Province,Hangzhou Zhejiang 310018,China)

机构地区：[1]浙江省医疗器械检验研究院,浙江杭州310018 [2]国家药品监督管理局生物医学光学重点实验室,浙江杭州310018 [3]浙江省医疗器械安全性评价研究重点实验室,浙江杭州310018

出　　处：《医疗装备》2024年第22期20-24,共5页Medical Equipment

基　　金：国家重点研发计划(2021YFC2401405)。

摘　　要：光学相干断层扫描仪(OCT)广泛应用于眼科等临床科室。随着医疗技术发展,眼科OCT产品品牌及型号众多,但其质量不一,性能评价标准和试验方法各异,缺乏统一的评价标准,影响了临床诊断的准确性,也为设备采购和评价带来了困难。该研究通过基于ISO 16971:2015标准设计专用的模拟眼底测试装置,对包括视场角、扫描深度、分辨力、信噪比、眼底预览图像与OCT扫描图像的匹配在内的多项性能指标进行测试,旨在建立眼后节OCT有效性的关键指标及试验方法,并优化操作流程。测试结果显示,该试验方法能够有效评估谱域OCT(SD-OCT)和扫频源OCT(SS-OCT)类产品性能,保证了测试结果的一致性和可靠性。研究不仅验证了建立方法的可行性和广泛适用性,还为进一步制定行业标准和提高眼后节OCT产品质量提供了重要参考依据。Optical coherence tomography(OCT)is widely used in multiple clinical departments such as ophthalmology.With the development of medical technology,there are numerous brands and models for ophthalmic OCT products,but their quality varies,performance evaluation standards and testing methods are different,and there is a lack of unified evaluation standards,which affects the accuracy of clinical diagnosis and brings difficulties to equipment procurement and evaluation.In this study,with the design of a specialized simulated fundus testing device based on ISO 16971:2015 standard,the tests were performed for a number of performance indicators including field of view angle,scanning depth,resolution,signal-to-noise ratio,and matching of the fundus preview image with the OCT scan image,to establish the key indicators and test methods for the effectiveness of OCT in the posterior segment of the eye,and optimize the operation process.The test results showed that this research method can effectively evaluate the performance of SD-OCT and SS-OCT products,ensuring the consistency and reliability of the test results.This study not only verified the feasibility and wide applicability of the proposed method,but also provided an important reference for the further development of industry standards and the improvement of the quality of posterior segment OCT products.

关 键 词：光学相干断层扫描技术 有效性评价 视场角 分辨力 信噪比 

分 类 号：R77[医药卫生—眼科]