眼科光学相干断层扫描成像设备关键参数计量技术研究  

Research on Key Parameter Metrology Technology of Ophthalmic Optical Coherence Tomography Imaging Equipment

作　　者：李修宇 吴福宝 胡志雄[1] 王红婷 乔鸿展 钟凯[2] 刘文丽[1] LI Xiuyu;WU Fubao;HU Zhixiong;WANG Hongting;QIAO Hongzhan;ZHONG Kai;LIU Wenli(Division of Medical and Biological Metrology,National Institute of Metrology,Beijing 100029,China;School of Precision Instruments and Optoelectronics Engineering,Tianjin University,Tianjin 300072,China)

机构地区：[1]中国计量科学研究院医学与生物计量研究所,北京100029 [2]天津大学精密仪器与光电子工程学院,天津300072

出　　处：《中国医疗设备》2019年第11期16-21,29,共7页China Medical Devices

基　　金：国家重点研发计划资助（2016YFF0201005）;计量院前沿创新探索项目（AKYCX1815）

摘　　要：光学相干断层扫描成像技术(Optical Coherence Tomography,OCT)是一种新兴的三维成像技术,在眼科诊断领域已得到广泛临床应用。基于OCT技术准确有效诊疗的前提是OCT设备输出的量值精准可靠,而这又离不开对OCT设备关键参数的准确计量与有效评价。针对眼科OCT设备,本研究设计、制作并测试了几种计量校准工具:基于国际标准ISO16971:2015设计的校准工具,基于3D打印技术制作的三维分辨率模型眼,基于自旋涂覆薄膜技术制作的层状结构模型眼和基于点扩散函数(Point Spread Function,PSF)理论制作的PSF模体。对比不同校准工具在检测OCT设备横向分辨率、轴向分辨率、视场角、深度测量准确性、信噪比、OCT扫描与眼底预览图像匹配程度等关键参数时的特点与差异。结果表明,现有的这几种校准工具适用于不同的参数检测,一种集成度更高、适用范围更大、具备完整溯源链且能够较长时间保持性能稳定可靠的校准工具依然值得期待。Optical coherence tomography(OCT),widely used in the field of ophthalmic clinical diagnosis,is an emerging three-dimensional imaging technology.To achieve an accurate and effective diagnosis based on OCT technology,the outputs from OCT equipment needed to be reliable.It could not be guaranteed except that the key parameters of OCT equipment were verified and calibrated periodically.For ophthalmic OCT equipment,a series of metrological calibration tools were designed,fabricated and tested in this study,including calibration tools based on the international standard ISO 16971:2015,3 D resolution model eyes based on 3 D printing technology,layered structure model eyes based on spin-coated film technology and point spread function(PSF)phantoms based on PSF theory.The characteristics and differences of these calibration tools were compared by verifying basic OCT parameters such as lateral resolution,axial resolution,field of view,depth measurement,signal-to-noise ratio,and co-alignment of fundus image and OCT scan.The results showed that the existing calibration tools are suitable for different parameter detection.A more integrated,more versatile,reliable calibration tool with a complete traceability chain and long-term consistent performance is still worth looking forward to.

关 键 词：光学相干断层 计量 校准工具 模型眼 点扩散函数 

分 类 号：R774.1[医药卫生—眼科] TH786[医药卫生—临床医学]