Anthony J Aldave1, Mark A Terry2, Loretta B Szczotka-Flynn3, Wendi Liang4, Allison R Ayala4, Maureen G Maguire5, Robert C O'Brien4, Beth Ann Benetz3, John E Bokosky6, Steven P Dunn7, Thomas E Gillette8, Kristin M Hammersmith9, David R Hardten10, Bennie H Jeng11, Marc F Jones12, Richard L Lindstrom10, Kenneth J Maverick13, Verinder S Nirankari14, Matthew S Oliva15, Irving M Raber16, Christopher J Rapuano9, George O D Rosenwasser17, Kevin W Ross18, John W Seedor19, Neda Shamie20, Christopher G Stoeger21, Shachar Tauber22, Woodford S Van Meter23, David D Verdier24, Jonathan H Lass25. 1. Stein Eye Institute, University of California, Los Angeles, Los Angeles, California, USA. 2. Devers Eye Institute, Portland, Oregon, USA. 3. Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA. 4. Jaeb Center for Health Research, Tampa, Florida, USA. 5. Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, Pennsylvania, USA. 6. Eye Care of San Diego, San Diego, California, USA. 7. Michigan Cornea Consultants, P.C., Southfield, Michigan, USA. 8. Eye Associates Northwest, Seattle, Washington, USA. 9. Wills Eye Hospital, Philadelphia, Pennsylvania, USA. 10. Minnesota Eye Consultants, Bloomington, Minnesota, USA. 11. University of California, San Francisco, San Francisco, California, USA. 12. Northeast Ohio Eye Surgeons, Kent, Ohio, USA. 13. Focal Point Vision, San Antonio, Texas, USA. 14. Eye Consultants of Maryland, Owings Mills, Maryland, USA. 15. Medical Eye Center, Medford, Oregon, USA. 16. Ophthalmic Partners of PA, P.C., Bala Cynwyd, Pennsylvania, USA. 17. Central Pennsylvania Eye Institute, Hershey, Pennsylvania, USA. 18. Eversight, Ann Arbor, Michigan, USA. 19. New York Eye and Ear Infirmary, New York, New York, USA. 20. Keck Medical Center of University of Southern California, Ophthalmology, Los Angeles, California, USA. 21. Lions VisionGift, Portland, Oregon, USA. 22. Mercy-St. John's Clinic, Springfield, Missouri, USA. 23. University of Kentucky Department of Ophthalmology, Lexington, Kentucky, USA. 24. Verdier Eye Center, Grand Rapids, Michigan, USA. 25. Case Western Reserve University Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, and the Cornea Image Analysis Reading Center, Cleveland, Ohio, USA. Electronic address: jlasscornea@gmail.com.
Abstract
PURPOSE: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN: Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS:1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS: Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS:Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.
RCT Entities:
PURPOSE: To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively. DESIGN: Cohort study within a multi-center, double-masked, randomized clinical trial. METHODS: 1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donorcorneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donorECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals). RESULTS: Three independent predictive factors for GD were identified: a history of donordiabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm2, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD. CONCLUSIONS:Donordiabetes, increased donorcorneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.
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