Purpose

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).

Design

Cohort study within a multicenter, double-masked, randomized clinical trial.

Participants

One thousand ninety individuals (1330 study eyes) with a median age of 70 years undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (PACE; 6% of eyes).

Methods

Eyes undergoing DSAEK were randomized to receive a donor cornea with preservation time (PT) of 0 to 7 days (n = 675) or 8 to 14 days (n = 655). Donor, recipient, and operative parameters were recorded prospectively. Graft failure was defined as regraft for any reason, a graft that failed to clear by 8 weeks after surgery, or an initially clear graft that became and remained cloudy for 90 days. Failure in the first 8 weeks was classified further as primary donor failure or early 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 (CIs) for graft failure.

Main Outcome Measures

Graft success at 3 years.

Results

One thousand two hundred fifty-one of 1330 grafts (94%) remained clear at 3 years and were considered successful. After adjusting for PT, tissue from donors with diabetes (RR, 2.35; 99% CI, 1.03–5.33) and operative complications (RR, 4.21; 99% CI, 1.42–12.47) were associated with increased risk for primary or early failure. Preoperative diagnosis of PACE (RR, 3.59; 99% CI, 1.05–12.24) was associated with increased risk for late failure by 3 years after surgery compared with Fuchs dystrophy. Graft success showed little variation among other factors evaluated, including donor age (RR, 1.19 per decade; 99% CI, 0.91–1.56 per decade), preoperative donor endothelial cell density (RR, 1.10 per 500 cells; 99% CI, 0.74–1.63 per 500 cells), graft diameter (RR, 1.22 per 1 mm; 99% CI, 0.39–3.76 per 1 mm), and injector use for graft insertion (RR, 0.92; 99% CI, 0.40–2.10).

Conclusions

Descemet stripping automated endothelial keratoplasty success in the early and entire postoperative period is more likely when the donor did not have diabetes and was without operative complications and in the long-term postoperative period in recipients with Fuchs dystrophy compared with those with PACE. Mechanisms whereby diabetic donors and PACE recipients reduce the rate of graft success after DSAEK warrant further study.

中文翻译：

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角膜保存时间研究中与移植成功相关的供体、受体和手术因素

目的

在角膜保存时间研究 (CPTS) 中，将供体、受体和手术因素与后弹力层剥离自动内皮角膜移植术 (DSAEK) 3 年后的移植成功相关联。

设计

多中心、双盲、随机临床试验中的队列研究。

参加者

1,90 名中位年龄为 70 岁的个体（1330 只研究眼）因 Fuchs 内皮性角膜营养不良（94% 的眼睛）或人工晶状体或无晶状体角膜水肿（PACE；6% 的眼睛）而接受 DSAEK。

方法

接受 DSAEK 的眼睛被随机接受保存时间 (PT) 为 0 至 7 天 (n = 675) 或 8 至 14 天 (n = 655) 的供体角膜。前瞻性地记录供体、受体和手术参数。移植失败被定义为任何原因的再移植，移植物在手术后 8 周内未能透明，或最初透明的移植物在 90 天内变得浑浊。前 8 周内的失败进一步分为主要供体失败或早期失败，分别是不存在或存在手术并发症。使用比例风险和逻辑回归模型来估计移植失败的风险比 (RR) 和 99% 置信区间 (CI)。

主要观察指标

3年后移植成功。

结果

1330 例移植物中有 1251 例 (94%) 在 3 年后仍保持清晰并被认为是成功的。调整 PT 后，来自患有糖尿病（RR，2.35；99% CI，1.03-5.33）和手术并发症（RR，4.21；99% CI，1.42-12.47）的捐献者的组织与原发性或早期失败的风险增加相关。与 Fuchs 营养不良相比，术前诊断 PACE（RR，3.59；99% CI，1.05-12.24）与术后 3 年晚期失败的风险增加相关。移植成功率在其他评估因素中几乎没有变化，包括供体年龄（RR，每十年 1.19；99% CI，每十年 0.91-1.56）、术前供体内皮细胞密度（RR，每 500 个细胞 1.10；99% CI，0.74- 1.63/500 个细胞）、移植物直径（RR，1.22/1 mm；99% CI，0.39-3.76/1 mm）以及移植物插入注射器的使用情况（RR，0.92；99% CI，0.40-2.10）。

结论

与 PACE 患者相比，当供者没有糖尿病且无手术并发症时，Fuchs 营养不良受者在术后早期和整个术后期间以及在术后长期成功的可能性更大。糖尿病供体和 PACE 受者在 DSAEK 后降低移植成功率的机制值得进一步研究。