Effect of Corneal Preservation Time on Long-Term Graft Success (CPTS)

角膜保存时间对长期移植成功率 (CPTS) 的影响

• 批准号: 8150037
• 负责人: JONATHAN H LASS
• 金额: $ 120.03万
• 依托单位: CASE WESTERN RESERVE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-30 至 2016-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8150037
• 关键词: Effect; Corneal; Preservation; Time; Long

DESCRIPTION (provided by applicant): After a 12% decline in keratoplasties in the USA between 2004 and 2006, a 37% increase has occurred in the last 2 years with nearly 60,000 cases performed in 2009. As with the Cornea Donor Study (CDS) 10 years ago, a public health issue is again raised regarding the future adequacy of the donor pool. This increase has been driven by the emergence of endothelial keratoplasty (EK) which has become the procedure of choice for endothelial failure conditions, tripling in cases between 2006-09, and 30% of the keratoplasties last year. With a higher primary donor failure than penetrating keratoplasty (PKP), an aging population with more pathology, changes in the cornea evaluation process with increased regulations and more testing requirements for emerging infections and the threat to the donor pool from these infections, additional means to expand the donor pool besides the use of older donor tissue are needed. One major opportunity is to extend the use of donor tissue to the FDA approved preservation time of 14 days for intermediate storage media at 4oC (Optisol GS and Life 4oC). Corneas preserved beyond 7 days are rarely used for PKP or EK in the United States, but are regularly exported for successful use internationally. While existing data do not support this bias, an evidence based study is needed to change this practice pattern. The primary objectives of our study are to determine whether recipient corneal stroma clarity and endothelial cell loss, the two best measures for EK success, are comparable 3 years postoperatively for donor corneas preserved for 7 days or less compared to those preserved for between 8 and 14 days utilizing a randomized, prospective, masked clinical trial design. Two separate grant applications have been submitted. The Data Management and Analysis Center at the Jaeb Center for Health Research, which directed the CDS, will oversee all aspects of eye bank participation in the study, multi-functional website development, statistical plan, data management and analysis, and coordination of the DSMC. The Coordinating Center at CWRU and the UH Eye Institute, directed by the PI and Director, will provide scientific direction and coordination of the clinical sites, as well as oversee the Cornea Image Analysis Reading Center. RELEVANCE: If longer preservation time up to the FDA limit of 14 days can be shown to not adversely impact graft success and endothelial cell loss at 3 years, more donor tissue will be available to be efficiently distributed within the United States for all keratoplasty procedures, there will be more flexibility in time for extended testing for a suspected emerging infection, and less tissue will be exported due to exceeding a perceived limit of seven days in storage

描述（由申请人提供）：2004年至2006年，美国角膜移植术下降了12%，但在过去2年中增加了37%，2009年进行了近60，000例。与10年前的角膜供体研究（CDS）一样，关于供体库的未来充足性的公共卫生问题再次被提出。这一增长是由内皮角膜移植术（EK）的出现推动的，EK已成为内皮衰竭条件的首选手术，2006-09年间病例增加了两倍，去年占角膜移植术的30%。由于初次供体失败率高于穿透性角膜移植术（PKP），老龄化人群的病理情况更多，角膜评估过程的变化以及对新发感染的法规和更多检测要求的增加，以及这些感染对供体库的威胁，除了使用较旧的供体组织外，还需要其他方法来扩大供体库。一个主要的机会是将供体组织的使用延长至FDA批准的中间储存介质在4 ℃下保存14天的时间（Optisol GS和Life 4 ℃）。保存超过7天的角膜在美国很少用于PKP或EK，但经常出口到国际上成功使用。虽然现有数据不支持这种偏见，但需要进行基于证据的研究来改变这种实践模式。我们研究的主要目的是确定受体角膜基质透明度和内皮细胞损失，EK成功的两个最佳指标，是否与保存7天或更短时间的供体角膜相比，使用随机、前瞻性、设盲的临床试验设计，保存8 - 14天的供体角膜在术后3年具有可比性。已经提交了两份单独的赠款申请。Jaeb健康研究中心的数据管理和分析中心负责指导CDS，将监督眼库参与研究的各个方面、多功能网站开发、统计计划、数据管理和分析以及DSMC的协调。CWRU和UH眼科研究所的协调中心由PI和主任指导，将为临床研究中心提供科学指导和协调，并监督角膜图像分析阅读中心。相关性：如果可以证明长达14天的FDA限制的更长保存时间在3年时不会对移植成功和内皮细胞损失产生不利影响，则更多的供体组织将可用于在美国境内有效地分布用于所有角膜移植手术，对于疑似新发感染的延长测试，时间上将有更大的灵活性，由于超过了7天的储存限制，