R Doyle Stulting1, Jonathan H Lass2, Mark A Terry3, Beth Ann Benetz4, Nathan J Cohen5, Allison R Ayala5, Maureen G Maguire6, Christopher Croasdale7, Yassine J Daoud8, Steven P Dunn9, Kenneth M Goins10, Pankaj C Gupta4, Marian S Macsai11, Shahzad I Mian12, Sudeep Pramanik13, Jennifer Rose-Nussbaumer14, Jonathan C Song15, Walter J Stark8, Alan Sugar12, David D Verdier16, Loretta B Szczotka-Flynn4. 1. Woolfson Eye Institute, Atlanta, Georgia, USA. 2. Case Western Reserve University Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, Ohio, USA. Electronic address: jlasscornea@gmail.com. 3. Devers Eye Institute, Portland, Oregon, USA. 4. Case Western Reserve University Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, Ohio, USA. 5. Jaeb Center for Health Research, Tampa, Florida, USA. 6. Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 7. SSM Health - Dean Medical Group, Madison, Wisconsin, USA. 8. The Wilmer Eye Institute, Johns Hopkins University, Baltimore, Maryland, USA. 9. Michigan Cornea Consultants, P.C., Southfield, Michigan, USA. 10. University of Iowa Department of Ophthalmology and Visual Sciences, Iowa City, Iowa, USA. 11. Northshore University Health System, Glenview, Illinois, USA. 12. Kellogg Eye Center, University of Michigan, Ann Arbor, Michigan, USA. 13. Mid Atlantic Cornea Consultants, Baltimore, Maryland, USA. 14. University of California - San Francisco, and Francis I Proctor Foundation, San Francisco, California, USA. 15. University of Southern California Roski Eye Institute, Los Angeles, California, USA. 16. Verdier Eye Center, Grand Rapids, Michigan, USA.
Abstract
PURPOSE: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS). DESIGN: Cohort study within a multicenter randomized clinical trial. METHODS:A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection. RESULTS:Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS. CONCLUSIONS:Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure.
RCT Entities:
PURPOSE: To identify factors related to graft rejection following Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS). DESIGN: Cohort study within a multicenter randomized clinical trial. METHODS: A total of 1330 eyes of 1090 subjects undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (n = 675) or 8-14 days (n = 655) and followed for 3 years. Central endothelial cell density (ECD) was determined by a central image analysis reading center. Multivariable Cox models adjusted for PT, recipient diagnosis, and surgeon effect were used to identify factors associated with rejection. RESULTS: Cumulative probability of definite graft rejection was 3.6% (99% confidence interval 2.5%-5.3%). Younger recipient age was associated with graft rejection (P < .001; hazard ratio: 0.53 [0.33, 0.83] per decade). PT, donor-recipient sex mismatch, recipient diagnosis, recipient race, graft size, discontinuation of topical corticosteroids and immune-modulators, prior immunizations within 3 months, and prior glaucoma surgery were not associated with rejection (P > .01). Among clear grafts with an ECD measurement at baseline and 3 years (n = 913), endothelial cell loss (ECL) was greater in eyes that experienced a rejection episode (n = 27) than in those that did not (n = 886) (48% vs 38%, P = .03). Twelve of 44 eyes (27%) with definite graft rejection subsequently failed, comprising 15% of the 79 failures in the CPTS. CONCLUSIONS: Graft rejection is uncommon after DSAEK and more likely with younger age, in a study cohort mostly > 50 years old. Rejection increases ECL, but it is not a leading cause of DSAEK failure.
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