The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease Graft Survival after 10 Years in the Cornea Donor Study
The Effect of Donor Age on Penetrating Keratoplasty for Endothelial Disease Graft Survival after 10 Years in the Cornea Donor Study
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DOI：
10.1016/j.ophtha.2013.08.026
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发表时间：
2013-12-01
期刊：
影响因子：
13.7
通讯作者：
Beck, Roy W.
中科院分区：
文献类型：
--
作者：
Mannis, Mark J.;Holland, Edward J.;Beck, Roy W.
目的：确定角膜内皮疾病穿透性角膜移植术的10年成功率是否与供体年龄相关。设计：多中心，前瞻性，双盲临床试验。参与者：共有1090名参与者在80个部位接受穿透性角膜移植术，治疗Fuchs营养不良（62%）、人工晶状体/无晶状体角膜水肿（34%），或另一种角膜内皮疾病（4%），并随访长达12 years.Methods：43眼库提供角膜供体年龄在12至75岁，使用随机分配的方法，捐赠角膜研究参与者不尊重受体因素。手术和术后护理按照外科医生的常规程序进行。主要结果测量：移植失败定义为再移植，或在没有再移植的情况下，混浊的角膜是足够不透明的损害视力连续3个月。结果如下：在初步分析中，年龄在12至65岁之间的707例角膜供体的10年成功率为77%，而年龄在66至75岁之间的383例供体的10年成功率为71%（差异，+6%; 95%置信区间，-1至+12; P = 0.11）。当作为连续变量分析时，供体年龄越大，5年后移植成功率越低（P < 0.001）。进一步探索这种关联，我们观察到34至71岁的供体的10年成功率相对恒定（75%）。80名12至33岁的供体成功率较高（96%），130名72至75岁的供体成功率较低（62%）。直到第6年后，才观察到供体年龄72至75岁的成功率相对下降。结论：尽管初步分析并未显示供体年龄12至65岁和66至75岁之间的10年成功率存在显着差异，但有证据表明，在年龄范围的极端情况下，供体年龄会产生影响。由于我们观察到年龄在34 - 71岁之间的供体的10年成功率相当稳定，这占美国可用于移植的角膜的约75%，角膜供体研究结果表明供体年龄不是大多数内皮疾病穿透性角膜移植术的重要因素。(C)2013年由美国眼科学会。
Objective: To determine whether the 10-year success rate of penetrating keratoplasty for corneal endothelial disorders is associated with donor age.Design: Multicenter, prospective, double-masked clinical trial.Participants: A total of 1090 participants undergoing penetrating keratoplasty at 80 sites for Fuchs' dystrophy (62%), pseudophakic/aphakic corneal edema (34%), or another corneal endothelial disorder (4%) and followed for up to 12 years.Methods: Forty-three eye banks provided corneas from donors aged 12 to 75 years, using a randomized approach to assign donor corneas to study participants without respect to recipient factors. Surgery and postoperative care were performed according to the surgeons' usual routines.Main Outcome Measures: Graft failure defined as a regraft or, in the absence of a regraft, a cloudy cornea that was sufficiently opaque to compromise vision for 3 consecutive months. Results: In the primary analysis, the 10-year success rate was 77% for 707 corneas from donors aged 12 to 65 years compared with 71% for 383 donors aged 66 to 75 years (difference, +6%; 95% confidence interval, -1 to +12; P = 0.11). When analyzed as a continuous variable, higher donor age was associated with lower graft success beyond the first 5 years (P < 0.001). Exploring this association further, we observed that the 10-year success rate was relatively constant for donors aged 34 to 71 years (75%). The success rate was higher for 80 donors aged 12 to 33 years (96%) and lower for 130 donors aged 72 to 75 years (62%). The relative decrease in the success rate with donor ages 72 to 75 years was not observed until after year 6.Conclusions: Although the primary analysis did not show a significant difference in 10-year success rates comparing donor ages 12 to 65 years and 66 to 75 years, there was evidence of a donor age effect at the extremes of the age range. Because we observed a fairly constant 10-year success rate for donors aged 34 to 71 years, which account for approximately 75% of corneas in the United States available for transplant, the Cornea Donor Study results indicate that donor age is not an important factor in most penetrating keratoplasties for endothelial disease. (C) 2013 by the American Academy of Ophthalmology.