Cornea Research Foundation of America, Indianapolis, Indiana 46260, USA.
Ophthalmology. 2010 Mar;117(3):438-44. doi: 10.1016/j.ophtha.2009.07.036. Epub 2010 Jan 19.
To assess outcomes 1 year after Descemet's stripping automated endothelial keratoplasty (DSAEK) in comparison with penetrating keratoplasty (PKP) from the Specular Microscopy Ancillary Study (SMAS) of the Cornea Donor Study.
Multicenter, prospective, nonrandomized clinical trial.
A total of 173 subjects undergoing DSAEK for a moderate risk condition (principally Fuchs' dystrophy or pseudophakic/aphakic corneal edema) compared with 410 subjects undergoing PKP from the SMAS who had clear grafts with at least 1 postoperative specular image within a 15-month follow-up period.
The DSAEK procedures were performed by 2 experienced surgeons per their individual techniques, using the same donor and similar recipient criteria as for the PKP procedures in the SMAS performed by 68 surgeons at 45 sites, with donors provided from 31 eye banks. Graft success and complications for the DSAEK group were assessed and compared with the SMAS group. Endothelial cell density (ECD) was determined from baseline donor, 6-month (range, 5-7 months), and 12-month (range, 9-15 months) postoperative central endothelial images by the same reading center used in the SMAS.
Endothelial cell density and graft survival at 1 year.
Although the DSAEK recipient group criteria were similar to the PKP group, Fuchs' dystrophy was more prevalent in the DSAEK group (85% vs. 64%) and pseudophakic corneal edema was less prevalent (13% vs. 32%, P<0.001). The regraft rate within 15 months was 2.3% (DSAEK group) and 1.3% (PKP group) (P = 0.50). Percent endothelial cell loss was 34+/-22% versus 11+/-20% (6 months) and 38+/-22% versus 20+/-23% (12 months) in the DSAEK and PKP groups, respectively (both P<0.001). Preoperative diagnosis affected endothelial cell loss over time; in the PKP group, the subjects with pseudophakic/aphakic corneal edema experienced significantly higher 12-month cell loss than the subjects with Fuchs' dystrophy (28% vs. 16%, P = 0.01), whereas in the DSAEK group, the 12-month cell loss was comparable for the 2 diagnoses (41% vs. 37%, P = 0.59).
One year post-transplantation, overall graft success was comparable for DSAEK and PKP procedures and endothelial cell loss was higher with DSAEK.
通过角膜供体研究的共焦显微镜辅助研究（SMAS），比较 1 年后 Descemet 膜撕除内皮角膜移植术（DSAEK）与穿透性角膜移植术（PKP）的结果。
多中心、前瞻性、非随机临床试验。
共 173 例接受 DSAEK 治疗中度风险情况（主要为 Fuchs 营养不良或白内障/无晶状体角膜水肿）的患者与 410 例接受 PKP 治疗的患者进行比较，SMAS 中这些患者在术后 15 个月的随访期内均有透明移植物，且至少有 1 个术后共焦镜图像。
由 2 位经验丰富的外科医生按照各自的技术进行 DSAEK 手术，使用与 SMAS 中 PKP 手术相同的供体和类似的受者标准，由 45 个地点的 68 位外科医生进行手术，供体来自 31 个眼库。评估 DSAEK 组的移植物成功率和并发症，并与 SMAS 组进行比较。使用与 SMAS 相同的阅读中心，根据供体的基线、术后 6 个月（范围为 5-7 个月）和 12 个月（范围为 9-15 个月）的中央内皮图像来确定内皮细胞密度（ECD）。
术后 1 年的内皮细胞密度和移植物存活率。
尽管 DSAEK 受者组的标准与 PKP 组相似，但 DSAEK 组中 Fuchs 营养不良更为常见（85% vs. 64%），白内障/无晶状体角膜水肿则较少见（13% vs. 32%，P<0.001）。在 15 个月内再次移植的比例为 2.3%（DSAEK 组）和 1.3%（PKP 组）（P=0.50）。DSAEK 组和 PKP 组在术后 6 个月时的内皮细胞丧失百分比分别为 34+/-22%和 11+/-20%（均 P<0.001），在术后 12 个月时分别为 38+/-22%和 20+/-23%（均 P<0.001）。术前诊断会影响随时间推移的内皮细胞丧失；在 PKP 组中，白内障/无晶状体角膜水肿患者的 12 个月细胞丧失明显高于 Fuchs 营养不良患者（28% vs. 16%，P=0.01），而在 DSAEK 组中，两种诊断的 12 个月细胞丧失相似（41% vs. 37%，P=0.59）。
移植后 1 年，DSAEK 和 PKP 手术的总体移植物成功率相当，而 DSAEK 术后内皮细胞丧失更多。
