Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study A Randomized Clinical Trial
Corneal Endothelial Cell Loss 3 Years After Successful Descemet Stripping Automated Endothelial Keratoplasty in the Cornea Preservation Time Study A Randomized Clinical Trial
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DOI：
10.1001/jamaophthalmol.2017.4970
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发表时间：
2017-12-01
影响因子：
8.1
通讯作者：
Beck, Roy W.
中科院分区：
文献类型：
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作者：
Lass, Jonathan H.;Benetz, Beth Ann;Beck, Roy W.
一项多中心、双盲、随机临床试验，包括美国40个临床站点(70名外科医生)，供体角膜由23家美国眼库提供供体角膜。共有769名参与者的945只眼参加了角膜保存时间研究，这些人在DSAEK术后3年内没有发生移植失败，主要是为Fuchs内皮角膜营养不良(96%的队列)进行了手术。研究从2012年4月16日至2017年6月5日，随机分配供体角膜，角膜移植时间为0~7天(0~7天)或8~14天(8~14天)。主要结果和测量3年后内皮细胞密度(ECD)的结果由中央图像分析阅读中心从临床镜面或共焦中心图像确定。结果受试者945只眼(中位年龄70岁[范围42-90岁]，60.8%女性，在角膜保存时间研究中，包括DSAEK术后3年未发生移植失败的患者。在最初的眼库组织筛查中，0-7d组(n=485)和8-14d组(n=460)的平均中央ECD分别为2746(297)个/mm(2)和2723(284)个/mm(2)。3年后，PT0-7d组和PT8-14d组的平均(SD)ECD分别下降37%(21%)和40%(22%)，分别降至1722(626)个/mm(2)和1642(631)个/mm(2)(平均差异，73个/mm(2)；95%可信区间，8-138个/mm(2)；P=.03)。当作为连续变量(天)分析时，PT较长与较低的ECD相关(平均天数差异，15细胞/毫米(2)；95%可信区间，4-26细胞/毫米(2)；P=0.006)。内皮细胞丢失(ECL)在PT后4~13天相似(n=878；按天计算为36%~43%)。4年后可用扩展研究的ECD结果反映了0-7d组203只眼3年的结果(平均[SD]ECD，1620[673]cell/mm(2)和平均[SD]ECL，41%[23%])和209只眼(平均[SD]ECD，1537[683]cell/mm(2)和平均[SD]ECL，44%[23%])(平均差异，112个/mm(2)；95%可信区间，5-219个/mm(2))；结论：尽管后遗症剥离后3年的自动角膜内皮移植术后PT越长，其对ECL的影响也越大，但PT对ECL的影响在术后4~13天是相当的。
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 DSAEK were included. At the initial eye bank tissue screening, mean (SD) central ECD was 2746 (297) cells/mm(2) in the 0-7d PT group (n = 485) and 2723 (284) cells/mm(2) 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/mm(2) and 1642 (631) cells/mm(2), respectively (mean difference, 73 cells/mm(2); 95% CI, 8-138 cells/mm(2); P = .03). When analyzed as a continuous variable (days), longer PT was associated with lower ECD (mean difference by days, 15 cells/mm(2); 95% CI, 4-26 cells/mm(2); 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/mm(2) and mean [SD] ECL, 41%[23%]) and 209 eyes in the 8-14d PT group (mean [SD] ECD, 1537 [683] cells/mm(2) and mean [SD] ECL, 44%[23%]) (mean difference, 112 cells/mm(2); 95% CI, 5-219 cells/mm(2); 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.