Cornea Image Analysis Reading Center, Department of Ophthalmology and Visual Sciences, University Hospitals Eye Institute, Case Western Reserve University, Cleveland, Ohio.
Department of Ophthalmology, Mayo Clinic, Rochester, Minnesota.
JAMA Ophthalmol. 2019 Feb 1;137(2):185-193. doi: 10.1001/jamaophthalmol.2018.5669.
Determining factors associated with endothelial cell loss after Descemet stripping automated endothelial keratoplasty (DSAEK) could improve long-term graft survival.
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.
The DSAEK procedure, with random assignment of a donor cornea with a preservation time of 0 to 7 days or 8 to 14 days.
Endothelial cell density at 3 years as determined by a reading center from eye bank and clinical specular or confocal central endothelial images.
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/mm2), lower screening ECD (-234 [-331 to -137] per 500 cells/mm2), recipient diagnosis of PACE (-257 [-483 to -31] in cells/mm2), and operative complications (-324 [-516 to -133] in cells/mm2). 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.
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.
确定 Descemet 撕囊自动角膜内皮移植术（DSAEK）后内皮细胞丢失的相关因素可以提高长期移植物存活率。
在角膜保存时间研究中评估供体、受者和手术因素与 DSAEK 术后 3 年内皮细胞密度（ECD）的相关性。
设计、地点和参与者：这是一项多中心、双盲、随机临床试验的二次分析队列研究。23 家美国眼库的 70 名外科医生参与了 40 个美国临床地点的研究，供体角膜由这些眼库提供。纳入因 Fuchs 营养不良或白内障/无晶状体角膜水肿而行 DSAEK 手术的个体。
DSAEK 手术，供体角膜的随机分配保存时间为 0-7 天或 8-14 天。
由眼库和临床共聚焦或角膜内皮镜图像读数中心确定的术后 3 年的内皮细胞密度。
这项研究纳入了 1090 名参与者（中位年龄 70 岁），共 1330 只患眼（240 例双眼病例[22.0%]），因 Fuchs 营养不良（1255 只眼[94.4%]）或白内障/无晶状体角膜水肿（PACE）（75 只眼[5.6%]）而行 DSAEK 手术。其中，801 只眼（60.2%）属于女性，1207 只眼（90.8%）属于白人。共有 749 名参与者（913 只眼；164 例[21.9%]双眼病例）术前和术后 3 年均有功能良好的移植物，且内皮图像可接受，被纳入此分析。多变量模型中与术后 3 年 ECD 较低相关的因素包括供体患有糖尿病（-103[-196 至-9]个细胞/mm2）、筛检 ECD 较低（-234[-331 至-137]每 500 个细胞/mm2）、受者诊断为 PACE（-257[-483 至-31]个细胞/mm2）和手术并发症（-324[-516 至-133]个细胞/mm2）。从术前测量到术后 3 年测量的内皮细胞丢失（ECD），接受糖尿病供体组织的参与者为 47%（99%CI，42%-52%），而无糖尿病的参与者为 43%（99%CI，39%-48%）；诊断为 PACE 的参与者为 53%（99%CI，44%-62%），而诊断为 Fuchs 营养不良的参与者为 44%（99%CI，39%-49%），发生手术并发症的参与者为 55%（99%CI，48%-63%），而无手术并发症的参与者为 44%（99%CI，39%-48%）。其他供体、受者或手术因素与 3 年 ECD 无显著相关性。
供体糖尿病、较低的筛检 ECD、受者为 PACE 诊断以及手术并发症与 DSAEK 术后 3 年 ECD 较低相关，可能与长期移植物成功相关。虽然不能推断因果关系，但进一步研究供体糖尿病和受者 PACE 与 3 年 ECD 较低的相关性值得进一步研究。
