TY - JOUR
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 - Song, Jonathan
AU - Stark, Walter
N1 - Publisher Copyright:
© 2017 American Medical Association. All rights reserved.
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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U2 - 10.1001/jamaophthalmol.2017.4989
DO - 10.1001/jamaophthalmol.2017.4989
M3 - Article
C2 - 29127431
AN - SCOPUS:85039970539
SN - 2168-6165
VL - 135
SP - 1401
EP - 1409
JO - JAMA ophthalmology
JF - JAMA ophthalmology
IS - 12
ER -