CORNEAL DONOR STUDY--SPECULAR MICROSCOPY ANCILLARY STUDY

角膜供体研究（CDS）旨在确定供体年龄是否是角膜移植存活的重要决定因素。这不仅具有科学意义，而且对于角膜移植可用供体组织库具有相当大的公共卫生重要性。CDS依赖于移植物存活率的临床评估作为其主要结局评估。我们建议将镜面反射显微镜作为辅助研究添加到CDS中，以帮助解释研究的主要目的。通过角膜内皮显微镜测量角膜内皮细胞密度可以作为角膜健康的指标和替代结果测量，因为较低的内皮细胞密度与移植失败的风险增加相关。角膜内皮图像将在移植前和CDS的5年随访期间按照标准化程序间隔使用角膜内皮显微镜获得。将图像发送至克利夫兰大学医院内皮细胞图像分析阅读中心，在那里测定内皮细胞密度。这些数据将被发送到位于坦帕的Jaeb健康研究中心的CDS数据协调中心，并将其添加到CDS数据集中进行分析。预计参与CDS的14家眼库、22家临床研究中心和29名研究者将参与这项镜面反射显微镜辅助研究（SMAS），共招募450例患者。

The Corneal Donor Study (CDS) has been designed to determine whether donor age is an important determinant of corneal graft survival. This is not only of scientific interest by considerable public health importance with regard to the pool of available donor tissue for corneal transplantation. The CDS is relying on a clinical assessment of graft survival for its primary outcome assessment. We are proposing to add specular microscopy as an ancillary study to the CDS as an aid in the interpretation of the study's primary objective. Measurement of the corneal endothelial cell density by specular microscopy can serve as an indicator of the health of the cornea and a surrogate outcome measure since lower endothelial cell densities are associated with an increased risk of graft failure. Corneal endothelial images will be obtained with specular microscopy prior to transplantation and at intervals during the five-year follow-up period of CDS following standardized procedures. The images will be sent to the University Hospitals of Cleveland Endothelial Image Analysis Reading Center where endothelial cell densities will be determined. The data will be sent to the CDS Data Coordinating Center at the Jaeb Center for Health Research in Tampa where it will be added to the CDS dataset for analysis. It is expected that 14 eye banks, 22 clinical sites, and 29 investigators participating in CDS will participate in this Specular Microscopy Ancillary Study (SMAS) enrolling a total of 450 patients.