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: 8542853
• 负责人: JONATHAN H LASS
• 金额: $ 89.66万
• 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/8542853
• 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; Functional disorder; 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; 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至2006年间，美国的角膜成形术下降了12%，但在2004年至2006年期间， 在过去的两年中，2009年执行了近60,000起案件。与角膜捐赠者研究(CDS)10一样 几年前，再次提出了一个公共卫生问题，涉及捐赠者池未来的充分性。这 增长是由内皮角膜移植(EK)的出现推动的，EK已经成为 内皮衰竭情况的首选程序，2006-09年间病例增加了两倍，30%的 去年做了角膜成形术。与穿透性角膜移植(PKP)相比，初级供体衰竭更严重，老年患者 有更多病理的人群，角膜评估过程中的变化随着规则的增加和 对新出现的感染和这些感染对捐赠者池的威胁提出了更多的检测要求， 除了使用较老的捐赠者组织外，还需要其他手段来扩大捐赠者池。一大专业 机会是将供体组织的使用期限延长到FDA批准的14天保存时间 4℃的中间存储介质(Optisol GS和Life 4“C)。保存超过7天的角膜很少 在美国用于PKP或EK，但经常出口，在国际上成功使用。而当 现有的数据不支持这种偏见，需要一项基于证据的研究来改变这种做法。 我们研究的主要目标是确定受者的角膜基质透明度和内皮细胞 细胞丢失是EK成功的两个最好的衡量标准，对于供体角膜来说，术后3年的细胞丢失是相似的。 保存7天或更短时间与使用随机的， 前瞻性、隐蔽性临床试验设计。已经提交了两份不同的拨款申请。数据 指导CDS的Jaeb卫生研究中心的管理和分析中心将 监督眼库各方面参与研究，多功能网站开发，统计 计划、数据管理和分析，以及数据管理和协调。CWRU的协调中心 而由PI和主任指导的UH眼科研究所将提供科学指导和协调 临床站点，以及监督角膜图像分析阅读中心。 相关性(请参阅说明)： 如果FDA规定的长达14天的保存时间不会对移植物的成功率产生不利影响 在3年内，更多的供体组织将被有效地分布在 对于美国所有的角膜移植手术，将有更多的灵活性在时间上延长检测 疑似新出现的感染，由于超过七个组织的感知限制，出口的组织将减少 存储中的DAV