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角膜保存时间对后弹力层剥离自动化内皮角膜移植术成功率的影响:一项随机临床试验

Rosenwasser, G.O., Szczotka-Flynn, L.B., Ayala, A.R., et al.

期刊名称:JAMA Ophthalmology

卷期:2017年第135卷第12期

摘要

摘要:目的:旨在确定使用保存了814天的角膜组织的角膜移植3年成功率不劣于7天或更短保存的供体组织。设计,设置和研究对象:从2012416日至201765日,在美国40个临床点进行了一项多中心,双盲,随机非劣性临床试验(70名外科医生),手术用的角膜由23家美国眼库提供。共有1090人(1330只研究眼)接受了后弹力层剥离自动化内皮角膜移植术(Fuchs内皮角膜营养不良1255[94.4])。干预:后弹力层剥离自动化内皮角膜移植术,随机分配7天(0-7d PT)或8-14天(8-14d PT)供体角膜。主要观察指标:3年后移植成功。结果:1090名受试者(1330名研究对象; 60.2%女性和39.8%男性; 招募时平均年龄70岁(范围42-90岁), 0-7d PT组移植3年累积成功率为95.3%(95CI93.6-96.9%),8-14d PT3年累积成功率为92.1%(95CI89.9-94.2%),差异有统计学意义(3.2%)。单侧95%可信区间上限为5.4%,超过预先规定的非劣性限度4%。差异主要是由于8-14d PT组原发性供者失败较多,0-7d PT组术后1个月失败的条件概率为4%,8-14d PT组为3.1%。在预先计划的二次分析中,较长的PT与较低的移植成功率相关(PT每增加一天移植失败的未调整风险比为为1.10; 95CI1.031.18; P = 0.008 [按天PT分析] PT 4天以内成功率为96.5%(95CI 92.398.4%),PT 5794.9%(95CI 92.596.6%), PT811天的成功率为93.8%95CI91.095.8%),PT1214天的成功率为89.3%(95CI84.492.7%)(P = 0.01 [PT按分类变量分析]。结论和意义:接受后弹力层剥离自动化内皮角膜移植术眼的3年成功率与PT无关。然而,该研究无法得出结论,即按预先规定的非劣性限定值,保存814天的供体角膜的成功率与保持7天或更短的角膜的成功率相似。虽然较长的PT与成功率较低有关,但当PT小于12天时,差异较小。

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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