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.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
1U10EY012728-01
Application #
2900440
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Project Start
1999-08-01
Project End
2004-07-31
Budget Start
1999-08-01
Budget End
2000-07-31
Support Year
1
Fiscal Year
1999
Total Cost
Indirect Cost
Name
Case Western Reserve University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
077758407
City
Cleveland
State
OH
Country
United States
Zip Code
44106
Writing Committee for the Cornea Donor Study Research Group; Sugar, Alan; Gal, Robin L et al. (2015) Factors associated with corneal graft survival in the cornea donor study. JAMA Ophthalmol 133:246-54
Lass, Jonathan H; Riddlesworth, Tonya D; Gal, Robin L et al. (2015) The effect of donor diabetes history on graft failure and endothelial cell density 10 years after penetrating keratoplasty. Ophthalmology 122:448-56
Writing Committee for the Cornea Donor Study Research Group; Lass, Jonathan H; Benetz, Beth Ann et al. (2013) Donor age and factors related to endothelial cell loss 10 years after penetrating keratoplasty: Specular Microscopy Ancillary Study. Ophthalmology 120:2428-2435
Benetz, Beth Ann; Lass, Jonathan H; Gal, Robin L et al. (2013) Endothelial morphometric measures to predict endothelial graft failure after penetrating keratoplasty. JAMA Ophthalmol 131:601-608
Writing Committee for the Cornea Donor Study Research Group; Mannis, Mark J; Holland, Edward J et al. (2013) The effect of donor age on penetrating keratoplasty for endothelial disease: graft survival after 10 years in the Cornea Donor Study. Ophthalmology 120:2419-2427
Stulting, R Doyle; Sugar, Alan; Beck, Roy et al. (2012) Effect of donor and recipient factors on corneal graft rejection. Cornea 31:1141-7
Sugar, Alan; Montoya, Monty M; Beck, Roy et al. (2012) Impact of the cornea donor study on acceptance of corneas from older donors. Cornea 31:1441-5
Lass, Jonathan H; Beck, Roy W; Benetz, Beth Ann et al. (2011) Baseline factors related to endothelial cell loss following penetrating keratoplasty. Arch Ophthalmol 129:1149-54
Lass, Jonathan H; Sugar, Alan; Benetz, Beth Ann et al. (2010) Endothelial cell density to predict endothelial graft failure after penetrating keratoplasty. Arch Ophthalmol 128:63-9
Price, Marianne O; Gorovoy, Mark; Benetz, Beth A et al. (2010) Descemet's stripping automated endothelial keratoplasty outcomes compared with penetrating keratoplasty from the Cornea Donor Study. Ophthalmology 117:438-44

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