Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study
Donor, Recipient, and Operative Factors Associated With Increased Endothelial Cell Loss in the Cornea Preservation Time Study
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DOI：
10.1001/jamaophthalmol.2018.5669
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发表时间：
2019-02-01
影响因子：
8.1
通讯作者：
Tramber, Michael
中科院分区：
文献类型：
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作者：
Lass, Jonathan H.;Benetz, Beth Ann;Tramber, Michael
角膜保存时间研究中角膜后弹力层剥脱自动内皮角膜移植术（DSAEK）后内皮细胞丢失相关的决定因素可以提高移植物的长期存活率。目的评价角膜保存时间研究中DSAEK术后3年供体、受体和手术因素与内皮细胞密度（ECD）的关系。本队列研究是对多中心、双盲、随机临床试验中收集的数据进行的二次分析。40个美国临床中心的70名外科医生参与了研究，供体角膜由23个美国眼库提供。因Fuchs营养不良或人工晶状体/无晶状体角膜水肿而接受DSAEK的个体包括在内。随机分配供体角膜，保存时间为0 - 7天或8 - 14天。主要结果和指标：由阅读中心从眼库和临床镜面或共焦中央内皮图像中测定3年时的内皮细胞密度。1090例受试者（中位年龄70岁），1330只患眼（240例双侧病例[22.0%]），因Fuchs营养不良（1255只眼[94.4%]）或人工晶状体/无晶状体角膜水肿（PACE）（75只眼[5.6%]）接受DSAEK。其中，801只眼（60.2%）为女性，1207只眼（90.8%）为白色个体。共有749名参与者（913只眼; 164例[21.9%]双侧病例）在术前和术后3年时具有功能正常的移植物，内皮图像可接受，并被纳入本分析。与3年时幼儿发展能力较低相关的因素最终多变量模型中的估计效应（99% CI）包括糖尿病供体（-103 [-196至-9]个细胞/mm（2）），较低筛选ECD（-234 [-331至-137]/500个细胞/mm（2））、接受者PACE诊断（-257 [-483至-31]细胞/mm（2））和手术并发症（-324 [-516至-133]细胞/mm（2））。从术前测量到术后3年测量的内皮细胞损失（ECL）为47%（99% CI，42%-52%），接受糖尿病供体组织的受试者vs 43%（99% CI，39%-48%）无糖尿病;是53%（99% CI，44%-62%），诊断为PACE的受试者vs 44%（99% CI，39%-49%），发生手术并发症的参与者为55%（99% CI，48%-63%），未发生手术并发症的参与者为44%（99% CI，39%-48%）。没有其他捐助者，收件人，或手术因素显着相关3年ECD.CONCLUSIONS和RELEVANCE捐助者糖尿病，较低的筛选ECD，在收件人的PACE诊断，手术并发症与较低的ECD在DSAEK手术后3年，并可能与长期移植成功。虽然因果关系无法推断，但需要对3年ECD较低的受者中供体糖尿病和PACE的相关性进行进一步研究。
IMPORTANCE Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival.OBJECTIVE To evaluate the associations of donor, recipient, and operative factors with endothelial cell density (ECD) 3 years after DSAEK in the Cornea Preservation Time Study.DESIGN, SETTING, AND PARTICIPANTS This cohort study was a secondary analysis of data collected in a multicenter, double-masked, randomized clinical trial. Forty US clinical sites with 70 surgeons participated, with donor corneas provided by 23 US eye banks. Individuals undergoing DSAEK for Fuchs dystrophy or pseudophakic/aphakic corneal edema were included.INTERVENTIONS The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days.MAIN OUTCOMES AND MEASURES Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images.RESULTS The study included 1090 participants (median age, 70 years) with 1330 affected eyes (240 bilateral cases [22.0%]), who underwent DSAEK for Fuchs dystrophy (1255 eyes [94.4%]) or pseudophakic/aphakic corneal edema (PACE) (75 eyes [5.6%]). Of these, 801 eyes (60.2%) belonged to women and 1207 (90.8%) to white individuals. A total of 749 participants (913 eyes; 164 [21.9%] bilateral cases) had functioning grafts with acceptable endothelial images preoperatively and at 3 years postoperatively and were included in this analysis. Factors associated with a lower ECD at 3 years (estimated effect with 99% CI) in the final multivariable model included donors with diabetes (-103 [-196 to -9] cells/mm(2)), lower screening ECD (-234 [-331 to -137] per 500 cells/mm(2)), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm(2)), and operative complications (-324 [-516 to -133] in cells/mm(2)). Endothelial cell loss (ECL) from a preoperative measurement to a 3-year postoperative measurement was 47%(99% CI, 42%-52%) for participants receiving tissue from donors with diabetes vs 43%(99% CI, 39%-48%) without diabetes; it was 53%(99% CI, 44%-62%) for participants diagnosed with PACE vs 44%(99% CI, 39%-49%) for those diagnosed with Fuchs dystrophy, and 55%(99% CI, 48%-63%) in participants who experienced operative complications vs 44%(99% CI, 39%-48%) in those who did not. No other donor, recipient, or operative factors were significantly associated with 3-year ECD.CONCLUSIONS AND RELEVANCE Donor diabetes, lower screening ECD, a PACE diagnosis in the recipient, and operative complications were associated with lower ECD at 3 years after DSAEK surgery and may be associated with long-term graft success. While causation cannot be inferred, further studies on the association of donor diabetes and PACE in recipients with lower 3-year ECD warrant further study.