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 年间，美国的角膜移植手术数量下降了 12%，但最近两年却增加了 37%，2009 年进行了近 60,000 例手术。与角膜捐赠者研究 (CDS) 一样十年前，关于捐助池未来是否充足的公共卫生问题再次被提出。这一增长是由内皮角膜移植术 (EK) 的出现推动的，该术已成为治疗内皮衰竭病症的首选手术，2006-09 年间病例数增加了两倍，去年占角膜移植术的 30%。与穿透性角膜移植术 (PKP) 相比，初次供体失败率更高，人口老龄化，病理增多，角膜评估过程发生变化，法规增加，对新发感染的检测要求增加，以及这些感染对供体库的威胁，需要其他手段除了使用较旧的供体组织外，还需要扩大供体库。一个主要机会是将供体组织的使用延长至 FDA 批准的 4oC 中间存储介质（Optisol GS 和 Life 4oC）的 14 天保存时间。在美国，保存超过 7 天的角膜很少用于 PKP 或 EK，但经常出口到国际上以成功使用。虽然现有数据不支持这种偏见，但需要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保存 7 天或更短时间的供体角膜与保存 8 到 14 天之间的供体角膜在术后 3 年的受者角膜基质透明度和内皮细胞损失（EK 成功的两个最佳衡量标准）是否具有可比性利用随机、前瞻性、隐蔽临床试验设计的天数。已提交两份单独的拨款申请。 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、多功能网站开发、统计计划、数据管理和分析以及 DSMC 协调的各个方面。 CWRU 和夏威夷大学眼科研究所的协调中心由 PI 和主任领导，将为临床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：如果可以证明延长保存时间（达到 FDA 14 天的限制）不会对移植成功和 3 年后内皮细胞损失产生不利影响，则更多的供体组织将可在美国境内有效分配用于所有角膜移植手术，对疑似新发感染进行延长检测的时间将更加灵活，并且由于超过 7 天的储存限制，出口的组织将减少