TY - JOUR
T1 - Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial
AU - Cornea Preservation Time Study Group
AU - Lass, Jonathan H.
AU - Benetz, Beth Ann
AU - Verdier, David D.
AU - Szczotka-Flynn, Loretta B.
AU - Ayala, Allison R.
AU - Liang, Wendi
AU - Aldave, Anthony J.
AU - Dunn, Steven P.
AU - McCall, Tyrone
AU - Mian, Shahzad I.
AU - Navarro, Lisa C.
AU - Patel, Sanjay V.
AU - Pramanik, Sudeep
AU - Rosenwasser, George O.
AU - Ross, Kevin W.
AU - Terry, Mark A.
AU - Kollman, Craig
AU - Gal, Robin L.
AU - Beck, Roy W.
AU - Redford, Maryann
AU - Berdy, Gregg
AU - Bokosky, John
AU - Croasdale, Christopher
AU - Daoud, Yassine
AU - Gillette, Thomas
AU - Goins, Kenneth
AU - Gupta, Pankaj
AU - Hammersmith, Kristen
AU - Hannush, Sadeer
AU - Hardten, David
AU - Jeng, Bennie
AU - Jones, Marc
AU - Lahners, William
AU - Lee, W. Barry
AU - Macsai, Marian
AU - Mauger, Thomas
AU - Maverick, Kenneth
AU - VanMeter, Woodford
AU - Mifflin, Mark
AU - Nirankari, Verinder
AU - Nordlund, Michael
AU - Oliva, Matthew
AU - Raber, Irving
AU - Raizman, Michael
AU - Rose-Nussbaumer, Jennifer
AU - Schultze, Robert
AU - Seedor, John
AU - Shamie, Neda
AU - Song, Jonathan
AU - Drury, Donna
N1 - Funding Information:
Funding/Support: The study was supported by cooperative agreements EY20797 and EY20798 with the National Eye Institute, National Institutes of Health, Department of Health and Human Services.
Funding Information:
Institute, National Institutes of Health, Department of Health and Human Services (EY20797 and EY20798) had roles in the design and conduct of the study; collection, management, analysis, and interpretation of the data; preparation, review, and approval of the manuscript; and decision to submit the manuscript for publication The following sponsors had no role the design, conduct, management, analysis, interpretation or publication of the study data, but provided additional support for ancillary work pertaining to this study: Eye Bank Association of America, The Cornea Society, Vision Share, Inc, Alabama Eye Bank, Cleveland Eye Bank Foundation, Eversight, Eye Bank for Sight Restoration, Iowa Lions Eye Bank, Lions Eye Bank of Albany, San Diego Eye Bank, and SightLife.
Publisher Copyright:
© 2017 American Medical Association. All rights reserved.
PY - 2017/12/1
Y1 - 2017/12/1
N2 - IMPORTANCE Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty. OBJECTIVE To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96%of the cohort). The study was conducted from April 16, 2012, to June 5, 2017. INTERVENTIONS DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images. RESULTS Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8%women, 93.0%white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEKwere included. At the initial eye bank tissue screening, mean (SD) central ECDwas 2746 (297) cells/mm2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37%(21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm2 and 1642 (631) cells/mm2, respectively (mean difference, 73 cells/mm2; 95%CI, 8-138 cells/mm2; P = .03). When analyzed as a continuous variable (days), longer PTwas associated with lower ECD (mean difference by days, 15 cells/mm2; 95%CI, 4-26 cells/mm2; P = .006). Endothelial cell loss (ECL)was comparable from 4 to 13 days' PT (n = 878; 36%-43%when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm2 and mean [SD] ECL, 41%[23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm2 and mean [SD] ECL, 44%[23%]) (mean difference, 112 cells/mm2; 95%CI, 5-219 cells/mm2; P = .04). CONCLUSIONS AND RELEVANCE Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days' PT.
AB - IMPORTANCE Demonstrating that endothelial cell loss following Descemet stripping automated endothelial keratoplasty (DSAEK) is independent of donor cornea preservation time (PT) could increase the pool of corneal tissue available for keratoplasty. OBJECTIVE To determine whether endothelial cell loss 3 years after successful DSAEK is related to PT. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized clinical trial included 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 945 eyes of 769 participants were included in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEK, performed primarily for Fuchs endothelial corneal dystrophy (96%of the cohort). The study was conducted from April 16, 2012, to June 5, 2017. INTERVENTIONS DSAEK with random assignment of a donor cornea with PT of 0 to 7 days (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Endothelial cell density (ECD) at 3 years determined by a central image analysis reading center from clinical specular or confocal central endothelial images. RESULTS Nine hundred forty-five eyes of 769 participants (median age, 70 years [range, 42-90 years], 60.8%women, 93.0%white) in the Cornea Preservation Time Study that had not experienced graft failure 3 years after DSAEKwere included. At the initial eye bank tissue screening, mean (SD) central ECDwas 2746 (297) cells/mm2 in the 0-7d PT group (n = 485) and 2723 (284) cells/mm2 in the 8-14d PT group (n = 460). At 3 years, the mean (SD) ECD decreased from baseline by 37%(21%) in the 0-7d PT group and 40% (22%) in the 8-14d PT group to 1722 (626) cells/mm2 and 1642 (631) cells/mm2, respectively (mean difference, 73 cells/mm2; 95%CI, 8-138 cells/mm2; P = .03). When analyzed as a continuous variable (days), longer PTwas associated with lower ECD (mean difference by days, 15 cells/mm2; 95%CI, 4-26 cells/mm2; P = .006). Endothelial cell loss (ECL)was comparable from 4 to 13 days' PT (n = 878; 36%-43%when tabulated by day). Available extension study ECD results at 4 years mirrored those at 3 years in the 203 eyes in the 0-7d PT group (mean [SD] ECD, 1620 [673] cells/mm2 and mean [SD] ECL, 41%[23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm2 and mean [SD] ECL, 44%[23%]) (mean difference, 112 cells/mm2; 95%CI, 5-219 cells/mm2; P = .04). CONCLUSIONS AND RELEVANCE Although ECL 3 years after Descemet stripping automated endothelial keratoplasty is greater with longer PT, the effect of PT on ECL is comparable from 4 to 13 days' PT.
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U2 - 10.1001/jamaophthalmol.2017.4970
DO - 10.1001/jamaophthalmol.2017.4970
M3 - Article
C2 - 29127432
AN - SCOPUS:85039947469
SN - 2168-6165
VL - 135
SP - 1394
EP - 1400
JO - JAMA Ophthalmology
JF - JAMA Ophthalmology
IS - 12
ER -