The effect of donor age on corneal transplantation outcome: Results of the cornea donor study
The effect of donor age on corneal transplantation outcome: Results of the cornea donor study
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DOI：
10.1016/j.ophtha.2008.01.003
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发表时间：
2008-04-01
期刊：
影响因子：
13.7
通讯作者：
Verdier, David D.
中科院分区：
文献类型：
--
作者：
Gal, Robin L.;Dontchev, Mariya;Verdier, David D.
目的：确定在5年随访期间，使用65岁以上供体角膜组织的移植物存活率是否与使用年轻供体角膜组织的移植物存活率相似。设计：多中心前瞻性、双盲、对照临床试验。参与者：接受中度风险角膜移植（主要是Fuchs营养不良或假性角膜水肿）的190例受试者；11名诊断不合格的受试者未被纳入。方法：43家参与的眼库采用不考虑受体因素的随机方法，提供年龄在12至75岁之间内皮细胞密度为2300至3300细胞/mm(2)的供体角膜。80个地点的105名参与手术的外科医生不知道捐赠角膜的信息，包括捐赠角膜的年龄。手术及术后护理按手术常规进行。研究对象随访5年。主要结局指标：移植失败，定义为移植或混浊的角膜，足够不透明，损害视力至少连续3个月。结果：< 66.0岁供体组和< 66.0岁供体组5年累计移植成活率均为86%；>= 66.0供体年龄组（差异= 0%，单侧95%置信区间上限= 4%）。在以供体年龄为连续变量的统计模型中，供体年龄与预后无显著相关（P = 0.11）。3例移植失败是由于原发供体失败，8例是由于无法矫正的屈光不正，48例是由于移植排斥反应，46例是由于内皮失代偿（其中23例先前有可能或明确的移植排斥反应），30例是由于其他原因。移植失败原因的分布在供体年龄组之间没有差异。结论：中等失败风险角膜移植的5年移植存活率与供体角膜移植（>= 66.0年）和供体角膜移植（< 66.0年）相似。外科医生和患者现在有证据表明，来自75岁以下捐赠者的角膜质量与本研究中使用的角膜相当，适合移植。
Objective: To determine whether graft survival over a 5-year follow-up period using corneal tissue from donors older than 65 is similar to graft survival using corneas from younger donors.Design: Multicenter prospective, double-masked, controlled clinical trial.Participants: One thousand ninety subjects undergoing corneal transplantation for a moderate-risk condition (principally Fuchs' dystrophy or pseuclophakic corneal edema); 11 subjects with ineligible diagnoses were not included.Methods: Forty-three participating eye banks provided corneas from donors in the age range of 12 to 75 with endothelial cell densities of 2300 to 3300 cells/mm(2), using a random approach without respect to recipient factors. The 105 participating surgeons at 80 sites were masked to information about the donor cornea including donor age. Surgery and postoperative care were performed according to the surgeons' usual routines. Subjects were observed for 5 years.Main Outcome Measures: Graft failure, defined as a regraft or a cloudy cornea that was sufficiently opaque as to compromise vision for a minimum of 3 consecutive months.Results: The 5-year cumulative probability of graft survival was 86% in both the < 66.0 donor age group and the; >= 66.0 donor age group (difference = 0%, upper limit of 1 -sided 95% confidence interval = 4%). In a statistical model with donor age as a continuous variable, there was no significant relationship between donor age and outcome (P = 0.11). Three graft failures were due to primary donor failure, 8 to uncorrectable refractive error, 48 to graft rejection, 46 to endothelial decompensation (23 of which had a prior, resolved episode of probable or definite graft rejection), and 30 to other causes. Distributions of the causes of graft failure did not differ between donor age groups.Conclusions: Five-year graft survivals for cornea transplants at moderate risk for failure are similar using corneas from donors >= 66.0 years and donors < 66.0. Surgeons and patients now have evidence that corneas comparable in quality to those used in this study from donors through age 75 are suitable for transplantation.