Kevin W Ross1, Christopher G Stoeger2, George O D Rosenwasser3, Robert C OʼBrien4, Loretta B Szczotka-Flynn5, Allison R Ayala4, Maureen G Maguire6, Beth Ann Benetz5, Patricia Dahl7, Donna C Drury8, Steven P Dunn9, Sameera M Farazdaghi10, Caroline K Hoover11, Marian S Macsai12, Shahzad I Mian13, Michael L Nordlund14, Jeffrey G Penta15, Mark C Soper16, Mark A Terry17, David D Verdier18, Doyce V Williams19, Jonathan H Lass5. 1. Eversight (formerly Midwest Eye-Banks), Ann Arbor, MI. 2. Lions VisionGift, Portland, OR. 3. Central Pennsylvania Eye Institute, Hershey, PA. 4. Jaeb Center for Health Research, Tampa, FL. Dr. O'Brien is now with the University of Mississippi Medical Center, Jackson, MS. 5. Case Western Reserve University, Department of Ophthalmology and Visual Sciences and University Hospitals Eye Institute, Cleveland, OH. 6. Center for Preventive Ophthalmology and Biostatistics, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA. 7. Eye-Bank for Sight Restoration, New York, NY. 8. Transplant Services, University of Texas, Southwestern, Dallas, TX. 9. Michigan Cornea Consultants, P.C., Southfield, MI. 10. CorneaGen (formerly Tissue Banks International, and KeraLink International), Baltimore, MD. 11. CorneaGen (formerly SightLife), Seattle, WA. 12. Northshore University Health System, Glenview, IL. 13. Kellogg Eye Center, University of Michigan, Ann Arbor, MI. 14. Cincinnati Eye Institute, Cincinnati, OH. 15. San Diego Eye Bank, San Diego, CA. 16. VisionFirst (formerly Indiana Lions Eye Bank), Indianapolis, IN. 17. Devers Eye Institute, Portland, OR. 18. Verdier Eye Center, Grand Rapids, MI. 19. Alabama Eye Bank, Birmingham, AL.
Abstract
PURPOSE: To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study. METHODS: One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (N = 675) or 8 to 14 days (N = 655). Donor factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications. RESULTS: The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 μm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06-1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 μm (99% CI: 516 μm-558 μm) compared with 567 μm (99% CI: 546 μm-588 μm) for PT 8 to 14 days (P < 0.001). CONCLUSIONS: Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.
PURPOSE: To identify donor and recipient factors, including eye bank tissue observations, predictive of operative complications in the Cornea Preservation Time Study. METHODS: One thousand three hundred thirty study eyes undergoing Descemet stripping automated endothelial keratoplasty for Fuchs dystrophy or pseudophakic/aphakic corneal edema were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (N = 675) or 8 to 14 days (N = 655). Donor factors included demographics, prelamellar corneal and postlamellar lenticule dissection thickness, central endothelial cell density, and tissue processing time. Recipient factors included demographics, intraocular pressure, and glaucoma medications or surgery (trabeculectomy, laser trabeculoplasty). Eye bank observations included donor tissue folds, pleomorphism/polymegethism, and endothelial cell abnormalities. Possible tissue-related operative complications were recorded including difficult donor lenticule unfolding and positioning. Multivariable logistic regression with backward selection was used to identify statistically significant (P < 0.01) associations between factors and operative complications. RESULTS: The only factor predictive of operative complications [58 (4.4%) of 1330 surgeries] was prelamellar dissection donor corneal thickness (P = 0.002). For every 50 μm of donor corneal thickness prior to lamellar dissection, operative complication odds increased by 40% (odds ratio [99% confidence interval (CI)]: 1.40 [1.06-1.83]) adjusting for PT and whether the epithelium was on or off. The estimated mean prelamellar dissection donor corneal thickness for PT 0 to 7 days was 537 μm (99% CI: 516 μm-558 μm) compared with 567 μm (99% CI: 546 μm-588 μm) for PT 8 to 14 days (P < 0.001). CONCLUSIONS: Thicker donor tissue (prelamellar dissection) is associated with operative complications and should be considered in tissue selection for Descemet stripping automated endothelial keratoplasty lenticule preparation.
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