Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial

Jonathan H. Lass, Beth Ann Benetz, David D. Verdier, Loretta B. Szczotka-Flynn, Allison R. Ayala, Wendi Liang, Anthony J. Aldave, Steven P. Dunn, Tyrone McCall, Shahzad I. Mian, Lisa C. Navarro, Sanjay V. Patel, Sudeep Pramanik, George O. Rosenwasser, Kevin W. Ross, Mark A. Terry, Craig Kollman, Robin L. Gal, Roy W. Beck, Maryann RedfordGregg Berdy, John Bokosky, Christopher Croasdale, Yassine Daoud, Thomas Gillette, Kenneth Goins, Pankaj Gupta, Kristen Hammersmith, Sadeer Hannush, David Hardten, Bennie Jeng, Marc Jones, William Lahners, W. Barry Lee, Marian Macsai, Thomas Mauger, Kenneth Maverick, Woodford VanMeter, Mark Mifflin, Verinder Nirankari, Michael Nordlund, Matthew Oliva, Irving Raber, Michael Raizman, Jennifer Rose-Nussbaumer, Robert Schultze, John Seedor, Neda Shamie, Jonathan Song, Walter Stark, Cornea Preservation Time Study Group

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Abstract

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.

Original languageEnglish (US)
Pages (from-to)1394-1400
Number of pages7
JournalJAMA Ophthalmology
Volume135
Issue number12
DOIs
StatePublished - Dec 1 2017

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Corneal Endothelial Cell Loss
Descemet Stripping Endothelial Keratoplasty
Time and Motion Studies
Cornea
Randomized Controlled Trials
Endothelial Cells
Cell Count
Eye Banks
Tissue Donors
Fuchs' Endothelial Dystrophy
Transplants

ASJC Scopus subject areas

  • Ophthalmology

Cite this

Lass, J. H., Benetz, B. A., Verdier, D. D., Szczotka-Flynn, L. B., Ayala, A. R., Liang, W., ... Cornea Preservation Time Study Group (2017). Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial. JAMA Ophthalmology, 135(12), 1394-1400. https://doi.org/10.1001/jamaophthalmol.2017.4970

Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial. / Lass, Jonathan H.; Benetz, Beth Ann; Verdier, David D.; Szczotka-Flynn, Loretta B.; Ayala, Allison R.; Liang, Wendi; Aldave, Anthony J.; Dunn, Steven P.; McCall, Tyrone; Mian, Shahzad I.; Navarro, Lisa C.; Patel, Sanjay V.; Pramanik, Sudeep; Rosenwasser, George O.; Ross, Kevin W.; Terry, Mark A.; Kollman, Craig; Gal, Robin L.; Beck, Roy W.; Redford, Maryann; Berdy, Gregg; Bokosky, John; Croasdale, Christopher; Daoud, Yassine; Gillette, Thomas; Goins, Kenneth; Gupta, Pankaj; Hammersmith, Kristen; Hannush, Sadeer; Hardten, David; Jeng, Bennie; Jones, Marc; Lahners, William; Lee, W. Barry; Macsai, Marian; Mauger, Thomas; Maverick, Kenneth; VanMeter, Woodford; Mifflin, Mark; Nirankari, Verinder; Nordlund, Michael; Oliva, Matthew; Raber, Irving; Raizman, Michael; Rose-Nussbaumer, Jennifer; Schultze, Robert; Seedor, John; Shamie, Neda; Song, Jonathan; Stark, Walter; Cornea Preservation Time Study Group.

In: JAMA Ophthalmology, Vol. 135, No. 12, 01.12.2017, p. 1394-1400.

Research output: Contribution to journalArticle

Lass, JH, Benetz, BA, Verdier, DD, Szczotka-Flynn, LB, Ayala, AR, Liang, W, Aldave, AJ, Dunn, SP, McCall, T, Mian, SI, Navarro, LC, Patel, SV, Pramanik, S, Rosenwasser, GO, Ross, KW, Terry, MA, Kollman, C, Gal, RL, Beck, RW, Redford, M, Berdy, G, Bokosky, J, Croasdale, C, Daoud, Y, Gillette, T, Goins, K, Gupta, P, Hammersmith, K, Hannush, S, Hardten, D, Jeng, B, Jones, M, Lahners, W, Lee, WB, Macsai, M, Mauger, T, Maverick, K, VanMeter, W, Mifflin, M, Nirankari, V, Nordlund, M, Oliva, M, Raber, I, Raizman, M, Rose-Nussbaumer, J, Schultze, R, Seedor, J, Shamie, N, Song, J, Stark, W & Cornea Preservation Time Study Group 2017, 'Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial', JAMA Ophthalmology, vol. 135, no. 12, pp. 1394-1400. https://doi.org/10.1001/jamaophthalmol.2017.4970
Lass, Jonathan H. ; Benetz, Beth Ann ; Verdier, David D. ; Szczotka-Flynn, Loretta B. ; Ayala, Allison R. ; Liang, Wendi ; Aldave, Anthony J. ; Dunn, Steven P. ; McCall, Tyrone ; Mian, Shahzad I. ; Navarro, Lisa C. ; Patel, Sanjay V. ; Pramanik, Sudeep ; Rosenwasser, George O. ; Ross, Kevin W. ; Terry, Mark A. ; Kollman, Craig ; Gal, Robin L. ; Beck, Roy W. ; Redford, Maryann ; Berdy, Gregg ; Bokosky, John ; Croasdale, Christopher ; Daoud, Yassine ; Gillette, Thomas ; Goins, Kenneth ; Gupta, Pankaj ; Hammersmith, Kristen ; Hannush, Sadeer ; Hardten, David ; Jeng, Bennie ; Jones, Marc ; Lahners, William ; Lee, W. Barry ; Macsai, Marian ; Mauger, Thomas ; Maverick, Kenneth ; VanMeter, Woodford ; Mifflin, Mark ; Nirankari, Verinder ; Nordlund, Michael ; Oliva, Matthew ; Raber, Irving ; Raizman, Michael ; Rose-Nussbaumer, Jennifer ; Schultze, Robert ; Seedor, John ; Shamie, Neda ; Song, Jonathan ; Stark, Walter ; Cornea Preservation Time Study Group. / Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial. In: JAMA Ophthalmology. 2017 ; Vol. 135, No. 12. pp. 1394-1400.
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title = "Corneal endothelial cell loss 3 years after successful descemet stripping automated endothelial keratoplasty in the cornea preservation time study a randomized clinical trial",
abstract = "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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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 - 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 - Stark, Walter

AU - Cornea Preservation Time Study Group

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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