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

基本信息

批准号：
8334468
负责人：
JONATHAN H LASS
金额：
$ 93.18万
依托单位：
CASE WESTERN RESERVE UNIVERSITY
依托单位国家：
美国
项目类别：
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/8334468
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

项目摘要

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

2004 年至 2006 年间，美国的角膜移植手术数量下降了 12%，而美国的角膜移植手术数量却增加了 37%。过去 2 年，2009 年进行了近 60,000 例手术。与角膜捐赠者研究 (CDS) 10 一样几年前，关于捐助池未来是否充足的公共卫生问题再次被提出。内皮角膜移植术（EK）的出现推动了这一增长，该术已成为治疗内皮衰竭情况的首选手术，2006-09 年间病例数量增加了两倍，占 30% 去年角膜移植术的主要供体失败率高于穿透性角膜移植术（PKP），这是一种老龄化现象。患有更多病理学的人群，随着法规的增加，角膜评估过程发生变化针对新出现的感染以及这些感染对捐赠者库的威胁提出了更多的检测要求，除了使用较旧的供体组织外，还需要采取其他措施来扩大供体库。机会是将供体组织的使用延长至 FDA 批准的 14 天保存时间中间存储介质为 4¿ C（Optisol GS 和 Life 4"C）。保存超过 7 天的角膜很少见在美国用于 PKP 或 EK，但定期出口并在国际上成功使用。现有数据并不支持这种偏见，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受者角膜基质透明度和内皮细胞是否细胞损失是 EK 成功的两个最佳衡量标准，对于供体角膜术后 3 年具有可比性与利用随机、保存8至14天的保存时间相比，保存时间为7天或更短，前瞻性、隐蔽的临床试验设计已提交。指导 CDS 的 Jaeb 健康研究中心的管理和分析中心将监督眼库参与研究、多功能网站开发、统计的各个方面 CWRU 协调中心的计划、数据管理和分析以及协调。夏威夷大学眼科研究所在 PI 和所长的领导下，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（参见说明）：如果可以证明延长保存时间（达到 FDA 14 天的限制）不会对移植成功产生不利影响 3 年后内皮细胞损失，更多的供体组织将可有效地分布在美国对于所有角膜移植手术来说，在时间上都会有更大的灵活性，可以进行延长测试疑似新出现感染，由于超过了 7 个感知限制，出口的组织将会减少存储中的 davs