Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.

Donor, Recipient, and Operative Factors Associated with Graft Success in the Cornea Preservation Time Study.
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DOI:
10.1016/j.ophtha.2018.08.002
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发表时间:
2018-11
期刊:
影响因子:
13.7
通讯作者:
Cornea Preservation Time Study Group
Cornea Preservation Time Study Group
中科院分区:
医学1区
文献类型:
--
作者:
Terry MA;Aldave AJ;Szczotka-Flynn LB;Liang W;Ayala AR;Maguire MG;Croasdale C;Daoud YJ;Dunn SP;Hoover CK;Macsai MS;Mauger TF;Pramanik S;Rosenwasser GOD;Rose-Nussbaumer J;Stulting RD;Sugar A;Tu EY;Verdier DD;Yoo SH;Lass JH;Cornea Preservation Time Study Group

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在角膜保存时间研究(CPTS)中,Descemet剥离自动内皮角膜移植术(DSAEK)后3年,将供体、受体和手术因素与移植成功联系起来。多中心、双盲、随机临床试验中的队列研究。1090人(1330只研究眼),中位年龄70岁,因Fuchs角膜内皮营养不良(94%的眼睛)或假性角膜/无晶状体角膜水肿(PACE, 6%的眼睛)接受DSAEK治疗。接受DSAEK手术的眼睛随机接受保存时间(PT)为0-7天(N=675)或8-14天(N=655)的供体角膜。前瞻性记录供体、受体和手术参数。移植失败被定义为任何原因的再移植,术后8周移植物不能清除,或最初清除的移植物变成并保持混浊90天。在没有或存在手术并发症的情况下,前8周的失败进一步分为原发性或早期供体失败。比例风险和逻辑回归模型用于估计移植失败的风险比(RR)和{99%置信区间}。3年后移植成功1251/1330例移植(94%)在3年后仍然清晰,被认为是成功的。调整PT后,糖尿病供体组织(RR: 2.35{1.03, 5.33})和手术并发症(RR: 4.21{1.42, 12.47})与原发性/早期衰竭风险增加相关。与Fuchs营养不良相比,术前诊断PACE (RR: 3.59{1.05, 12.24})与术后3年晚期衰竭风险增加相关。移植成功率在供体年龄(RR: 1.19{0.91, 1.56} / 10年)、术前供体内皮细胞密度(RR: 1.10{0.74, 1.63} / 500个细胞)、移植物直径(RR: 1.22 {0.39, 3.76} / mm)和移植物插入注射器使用(RR: 0.92{0.40, 2.10})等因素之间变化不大。与PACE相比,当供体没有糖尿病且无手术并发症时,DSAEK在早期和整个术后期间更有可能成功,并且在术后长期内,患有Fuchs营养不良的受体更有可能成功。糖尿病供体和PACE受体降低DSAEK术后移植成功率的机制值得进一步研究。在角膜保存时间研究中,1330例内皮角膜移植术中有94%成功。糖尿病供体和手术并发症增加了原发性/早期失败的风险;受者诊断为假晶状体/无晶状体角膜水肿增加了晚期手术失败的风险。
To associate donor, recipient, and operative factors with graft success 3 years after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS). Cohort study within a multi-center, double-masked, randomized clinical trial. 1,090 individuals (1,330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic/aphakic corneal edema (PACE, 6% of eyes). Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0-7 days (N=675) or 8-14 days (N=655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as re-graft for any reason, a graft that failed to clear by 8 weeks post-operatively, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was further classified as primary or early donor failure, in the absence or presence of operative complications, respectively. Proportional hazards and logistic regression models were used to estimate risk ratios (RR) and {99% confidence intervals} for graft failure. Graft success at 3 years 1251/1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR: 2.35 {1.03, 5.33}) and operative complications (RR: 4.21 {1.42, 12.47}) were associated with increased risk for primary/early failure. Preoperative diagnosis of PACE (RR: 3.59 {1.05, 12.24}) was associated with increased risk for late failure by 3 years postoperatively compared to Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR: 1.19 {0.91, 1.56} per decade), preoperative donor endothelial cell density (RR: 1.10 {0.74, 1.63} per 500 cells), graft diameter (RR: 1.22 {0.39, 3.76} per mm) and injector use for graft insertion (RR: 0.92 {0.40, 2.10}). DSAEK success in the early and entire postoperative period is more likely when the donor did not have diabetes and without operative complications, and in the long term postoperative period in recipients with Fuchs dystrophy compared to PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success following DSAEK warrant further study. In the Cornea Preservation Time Study, 94% of 1330 endothelial keratoplasty grafts were successful. Diabetic donors and operative complications increased risk for primary/early failures; recipient diagnosis of pseudophakic/aphakic corneal edema increased risk for late failures.
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