Stein Eye Institute, University of California, Los Angeles, Los Angeles, California, USA.
Devers Eye Institute, Portland, Oregon, USA.
Am J Ophthalmol. 2019 Jul;203:78-88. doi: 10.1016/j.ajo.2019.02.029. Epub 2019 Mar 6.
To examine the association of donor, recipient, and operative factors on graft dislocation after Descemet stripping automated endothelial keratoplasty (DSAEK) in the Cornea Preservation Time Study (CPTS) as well as the effects of graft dislocation and elevated IOP on graft success and endothelial cell density (ECD) 3 years postoperatively.
Cohort study within a multi-center, double-masked, randomized clinical trial.
1090 individuals (1330 study eyes), median age 70 years, undergoing DSAEK for Fuchs endothelial corneal dystrophy (94% of eyes) or pseudophakic or aphakic corneal edema (6% of eyes). Recipient eyes receiving donor corneal tissue randomized by preservation time (PT) of 0-7 days (N = 675) or 8-14 days (N = 655) were monitored for early or late graft failure through 3 years. Donor, recipient, operative, and postoperative parameters were recorded including graft dislocation (GD), partial detachment, and pre- and post-operative IOP. Pre- and postoperative central donor ECD were determined by a central image analysis reading center. Proportional hazards, mixed effects, and logistic regression models estimated risk ratios and (99% confidence intervals).
Three independent predictive factors for GD were identified: a history of donor diabetes (odds ratio [OR]: 2.29 [1.30, 4.02]), increased pre-lamellar dissection central corneal thickness (OR: 1.13 [1.01, 1.27] per 25µ increase), and operative complications (OR: 2.97 [1.24, 7.11]). Among 104 (8%) eyes with GD, 30 (28.9%) developed primary donor or early failure and 5 (4.8%) developed late failure vs. 15 (1.2%; P < .001) and 29 (2.4%; P = .04), respectively, of 1226 eyes without GD. 24 (2%) of 1330 study eyes had early acutely elevated postoperative IOP that was associated with a higher risk of graft failure through 3 years (hazard ratio: 3.42 [1.01, 11.53]), but not with a lower mean 3-year ECD (mean difference 61 (-479, 601) cells/mm, P = .77). History of elevated postoperative IOP beyond 1 month was not significantly associated with 3-year graft success or ECD.
Donor diabetes, increased donor corneal thickness, and intraoperative complications were associated with an increased risk of GD. Early acutely elevated postoperative IOP and GD significantly increased the risk for graft failure following DSAEK.
在角膜保存时间研究（CPTS）中，检查供体、受体和手术因素与 Descemet 剥离自动内皮角膜移植术（DSAEK）后移植物脱位的关系，以及移植物脱位和眼内压升高对移植物成功和内皮细胞密度（ECD）的影响术后 3 年。
多中心、双盲、随机临床试验中的队列研究。
1090 名个体（1330 只研究眼），中位年龄 70 岁，因 Fuchs 内皮角膜营养不良（94%的眼）或白内障或无晶状体性角膜水肿（6%的眼）接受 DSAEK。通过保存时间（PT）将接受供体角膜组织的受体眼随机分配为 0-7 天（N = 675）或 8-14 天（N = 655），通过 3 年监测早期或晚期移植物失功。记录供体、受体、手术和术后参数，包括移植物脱位（GD）、部分脱离和术前及术后眼压。通过中央图像分析阅读中心确定术前和术后中央供体 ECD。比例风险、混合效应和逻辑回归模型估计风险比和（99%置信区间）。
确定了 3 个独立的 GD 预测因素：供体糖尿病史（优势比[OR]：2.29[1.30，4.02]）、前板层分离中央角膜厚度增加（OR：每增加 25µm，增加 1.13[1.01，1.27]）和手术并发症（OR：2.97[1.24，7.11]）。在 104 只（8%）GD 眼中，30 只（28.9%）出现原发性供体或早期失功，5 只（4.8%）出现晚期失功，而 1226 只无 GD 眼中，15 只（1.2%；P<.001）和 29 只（2.4%；P =.04）分别出现晚期失功。1330 只研究眼中有 24 只（2%）术后早期急性眼压升高，与 3 年内移植物失功风险增加相关（风险比：3.42[1.01，11.53]），但与 3 年平均 ECD 降低无关（平均差异 61（-479，601）细胞/mm，P =.77）。术后 1 个月以上的眼压升高史与 3 年移植物成功率或 ECD 无显著相关性。
供体糖尿病、供体角膜厚度增加和术中并发症与 GD 风险增加相关。术后早期急性眼压升高和 GD 显著增加 DSAEK 后移植物失功的风险。
