CORNEAL DONOR STUDY--SPECULAR MICROSCOPY ANCILLARY STUDY

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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.