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: 8728245
• 负责人: JONATHAN H LASS
• 金额: $ 87.31万
• 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/8728245
• 关键词: Address; Applications Grants; Area; Biological Preservation; Certification; Chagas Disease; Clinical Trials; Clinical Trials Design; Communities; Cornea; Corneal Stroma; Corneal dystrophy; Corneal edema; Data; Data Analyses; Development; Endothelial Cells; Evaluation; Eye; Eye Banks; FDA approved; Failure; Future; Goals; Health; Image Analysis; Infection; Institutes; International; Keratoplasty; Laboratories; Life; Masks; Measures; Methods; Monitor; Multi-Institutional Clinical Trial; Optisol; Pathology; Patient Recruitments; Patients; Pattern; Penetrating Keratoplasty; Principal Investigator; Procedures; Process; Public Health; Randomized; Reading; Regulation; Research; Risk; Safety; Secure; Surgeon; Techniques; Testing; Time; Tissue Donors; Tissues; Transplantation; United States; Universities; University Hospitals; West Nile virus; acronyms; aging population; base; clinical research site; data management; endothelial dysfunction; evidence base; experience; flexibility; high standard; meetings; operation; prospective; success; web site

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 4¿C (Optisol GS and Life 4 "C). 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 paftern. 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 (See instmctions): 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 davs in storage

在2004年至2006年之间，美国的角膜体下降了12％之后，增加了37％ 最近两年，在2009年进行了近60,000例病例。与角膜供体研究（CDS）10一样 几年前，关于捐助者池的未来充分性，再次提出了一个公共卫生问题。这 增长是由内皮角膜成形术（EK）的出现驱动的 对于内皮失败条件的首选程序，在2006 - 09年之间的病例和30％ 去年的角膜体。与穿透性角膜成形术（PKP）相比，主要的供体失败高（PKP） 人口具有更多病理学，角膜评估过程的变化随法规的增加和 对新兴感染的更多测试要求以及这些感染对供体池的威胁， 除了使用老供体组织外，还需要扩大供体池的其他方法。一个主要 机会是将供体组织的使用扩展到FDA批准的14天的保存时间 在4¿C处的中间存储介质（optiso gs and life 4“ c）。保持7天以上的角膜很少 在美国用于PKP或EK，但经常出口在国际上成功使用。尽管 现有数据不支持这种偏见，需要基于证据的研究来改变这种做法。 我们研究的主要目的是确定接受者角膜基质清晰度和内皮是否是否 细胞损失是EK成功的两个最佳措施，术后3年与供体角膜相当 与使用随机的随机保存在8到14天之间的保留7天或更短的时间相比 前瞻性，掩盖的临床试验设计。提交了两个单独的赠款申请。数据 导演CD的JAEB健康研究中心的管理与分析中心将 监督眼库参与研究的各个方面，多功能网站开发，统计 DSMC的计划，数据管理和分析以及协调。 CWRU的协调中心 由PI和董事执导的UH眼科研究所将提供科学方向和协调 临床部位以及监督角膜图像分析阅读中心。 相关性（请参阅Instmctions）： 如果更长的保存时间至FDA限制为14天 和3年的内皮细胞损失，将有效分布在3年中 美国进行所有角化术程序，将有更多的灵活性进行扩展测试的时间 可疑的新兴感染，由于超过七个的限制，将出口较少的组织将出口 davs在存储中