Effect of cornea preservation time on success of descemet stripping automated endothelial keratoplasty a randomized clinical trial

Cornea Preservation Time Study Group

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Abstract

IMPORTANCE Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. OBJECTIVE To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). INTERVENTIONS Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Graft success at 3 years. RESULTS Of the 1090 participants (1330 study eyes; 60.2%women and 39.8%men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3%(95%CI, 93.6%-96.9%) in the 0-7d PT group and 92.1%(95%CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95%CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4%in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95%CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5%(95%CI, 92.3%-98.4%) for PT of 4 days or less, 94.9%(95%CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95%CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3%(95%CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). CONCLUSIONS AND RELEVANCE The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

Original languageEnglish (US)
Pages (from-to)1401-1409
Number of pages9
JournalJAMA Ophthalmology
Volume135
Issue number12
DOIs
StatePublished - Dec 1 2017

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Descemet Stripping Endothelial Keratoplasty
Cornea
Randomized Controlled Trials
Tissue Donors
Transplants

ASJC Scopus subject areas

  • Ophthalmology

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Effect of cornea preservation time on success of descemet stripping automated endothelial keratoplasty a randomized clinical trial. / Cornea Preservation Time Study Group.

In: JAMA Ophthalmology, Vol. 135, No. 12, 01.12.2017, p. 1401-1409.

Research output: Contribution to journalArticle

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abstract = "IMPORTANCE Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. OBJECTIVE To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4{\%}] for Fuchs endothelial corneal dystrophy). INTERVENTIONS Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Graft success at 3 years. RESULTS Of the 1090 participants (1330 study eyes; 60.2{\%}women and 39.8{\%}men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3{\%}(95{\%}CI, 93.6{\%}-96.9{\%}) in the 0-7d PT group and 92.1{\%}(95{\%}CI, 89.9{\%}-94.2{\%}) in the 8-14d PT group (difference, 3.2{\%}). The upper limit of the 1-sided 95{\%}CI on the difference was 5.4{\%}, exceeding the prespecified noninferiority limit of 4{\%}. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4{\%}in the 0-7d PT group and 3.1{\%} in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95{\%}CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5{\%}(95{\%}CI, 92.3{\%}-98.4{\%}) for PT of 4 days or less, 94.9{\%}(95{\%}CI, 92.5{\%}-96.6{\%}) for PT of 5 to 7 days, 93.8{\%} (95{\%}CI, 91.0{\%}-95.8{\%}) for PT of 8 to 11 days, and 89.3{\%}(95{\%}CI, 84.4{\%}-92.7{\%}) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). CONCLUSIONS AND RELEVANCE The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.",
author = "{Cornea Preservation Time Study Group} and Rosenwasser, {George O.} and Szczotka-Flynn, {Loretta B.} and Ayala, {Allison R.} and Wendi Liang and Aldave, {Anthony J.} and Dunn, {Steven P.} and Tyrone McCall and Navarro, {Lisa C.} and Sudeep Pramanik and Ross, {Kevin W.} and Stulting, {R. Doyle} and Terry, {Mark A.} and Tu, {Elmer Y.} and Verdier, {David D.} and Craig Kollman and Gal, {Robin L.} and Beck, {Roy W.} and Lass, {Jonathan H.} and Benetz, {Beth Ann} and Maryann Redford and Gregg Berdy and John Bokosky and Christopher Croasdale and Yassine Daoud and Thomas Gillette and Kenneth Goins and Pankaj Gupta and Kristen Hammersmith and Sadeer Hannush and David Hardten and Bennie Jeng and Marc Jones and William Lahners and Lee, {W. Barry} and Marian Macsai and Thomas Mauger and Kenneth Maverick and {Van Meter}, Woodford and Shahzad Mian and Mark Mifflin and Verinder Nirankari and Michael Nordlund and Matthew Oliva and Sanjay Patel and Irving Raber and Michael Raizman and Jennifer Rose-Nussbaumer and Robert Schultze and John Seedor and Yoo, {Sonia H}",
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T1 - Effect of cornea preservation time on success of descemet stripping automated endothelial keratoplasty a randomized clinical trial

AU - Cornea Preservation Time Study Group

AU - Rosenwasser, George O.

AU - Szczotka-Flynn, Loretta B.

AU - Ayala, Allison R.

AU - Liang, Wendi

AU - Aldave, Anthony J.

AU - Dunn, Steven P.

AU - McCall, Tyrone

AU - Navarro, Lisa C.

AU - Pramanik, Sudeep

AU - Ross, Kevin W.

AU - Stulting, R. Doyle

AU - Terry, Mark A.

AU - Tu, Elmer Y.

AU - Verdier, David D.

AU - Kollman, Craig

AU - Gal, Robin L.

AU - Beck, Roy W.

AU - Lass, Jonathan H.

AU - Benetz, Beth Ann

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 - Van Meter, Woodford

AU - Mian, Shahzad

AU - Mifflin, Mark

AU - Nirankari, Verinder

AU - Nordlund, Michael

AU - Oliva, Matthew

AU - Patel, Sanjay

AU - Raber, Irving

AU - Raizman, Michael

AU - Rose-Nussbaumer, Jennifer

AU - Schultze, Robert

AU - Seedor, John

AU - Yoo, Sonia H

PY - 2017/12/1

Y1 - 2017/12/1

N2 - IMPORTANCE Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. OBJECTIVE To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). INTERVENTIONS Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Graft success at 3 years. RESULTS Of the 1090 participants (1330 study eyes; 60.2%women and 39.8%men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3%(95%CI, 93.6%-96.9%) in the 0-7d PT group and 92.1%(95%CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95%CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4%in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95%CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5%(95%CI, 92.3%-98.4%) for PT of 4 days or less, 94.9%(95%CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95%CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3%(95%CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). CONCLUSIONS AND RELEVANCE The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

AB - IMPORTANCE Demonstrating that success of Descemet stripping automated endothelial keratoplasty is similar across donor cornea preservation times (PTs) could increase the donor pool. OBJECTIVE To determine whether the 3-year rate of graft success using corneal donor tissue preserved 8 to 14 days is noninferior to that of donor tissue preserved 7 days or less. DESIGN, SETTING, AND PARTICIPANTS A multicenter, double-masked, randomized noninferiority clinical trial was conducted from April 16, 2012, to June 5, 2017, at 40 clinical sites (70 surgeons) in the United States, with donor corneas provided by 23 US eye banks. A total of 1090 individuals (1330 study eyes) underwent Descemet stripping automated endothelial keratoplasty (1255 eyes [94.4%] for Fuchs endothelial corneal dystrophy). INTERVENTIONS Descemet stripping automated endothelial keratoplasty with random assignment of a donor cornea with a PT of 7 days or less (0-7d PT) or 8 to 14 days (8-14d PT). MAIN OUTCOMES AND MEASURES Graft success at 3 years. RESULTS Of the 1090 participants (1330 study eyes; 60.2%women and 39.8%men; median age at enrollment, 70 years [range, 42-90 years]), the 3-year cumulative probability of graft success was 95.3%(95%CI, 93.6%-96.9%) in the 0-7d PT group and 92.1%(95%CI, 89.9%-94.2%) in the 8-14d PT group (difference, 3.2%). The upper limit of the 1-sided 95%CI on the difference was 5.4%, exceeding the prespecified noninferiority limit of 4%. The difference was mostly owing to more primary donor failures in the 8-14d PT group, with the conditional probability of failure after the first month being 2.4%in the 0-7d PT group and 3.1% in the 8-14d PT group. In preplanned secondary analyses, longer PT was associated with a lower rate of graft success (unadjusted hazard ratio for graft failure per additional day of PT, 1.10; 95%CI, 1.03-1.18; P = .008 [PT analyzed as days]), with success rates of 96.5%(95%CI, 92.3%-98.4%) for PT of 4 days or less, 94.9%(95%CI, 92.5%-96.6%) for PT of 5 to 7 days, 93.8% (95%CI, 91.0%-95.8%) for PT of 8 to 11 days, and 89.3%(95%CI, 84.4%-92.7%) for PT of 12 to 14 days (P = .01 [PT analyzed as categorical variable]). CONCLUSIONS AND RELEVANCE The 3-year success rate in eyes undergoing Descemet stripping automated endothelial keratoplasty was high irrespective of PT. However, the study was unable to conclude that the success rate with donor corneas preserved 8 to 14 days was similar to that of corneas preserved 7 days or less with respect to the prespecified noninferiority limit. Although longer PT was associated with a lower success rate, the difference in rates was small when PT was less than 12 days.

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JO - JAMA Ophthalmology

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