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: 8541860
• 负责人: Allison Renee Ayala
• 金额: $ 107.42万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 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/8541860
• 关键词: Adherence; Ancillary Study; Applications Grants; Biological Preservation; Clinical; Clinical Trials; Conduct Clinical Trials; Cornea; Coupled; Data; Data Analyses; Data Collection; Development; Endothelial Cells; Evaluation; Eye; Eye Banks; Eye diseases; FDA approved; Failure; Functional disorder; Future; Generic Drugs; Health; Image Analysis; Infection; Institutes; Institutional Review Boards; International; Internet; Keratoplasty; Laboratories; Manuscripts; Masks; Measures; Monitor; Online Systems; Operative Surgical Procedures; Pattern; Penetrating Keratoplasty; Postoperative Period; Preparation; Principal Investigator; Procedures; Process; Protocols documentation; Public Health; Publications; Quality Control; Randomized; Reading; Regulation; Research; Research Personnel; Review Committee; Robin bird; Role; Safety; Statistical Data Interpretation; Structure; System; Testing; Time; Tissue Donors; Tissues; Training; Transplantation; United States; Universities; University Hospitals; Work; abstracting; aging population; clinical research site; data management; evidence base; experience; flexibility; innovation; prospective; success; web site

DESCRIPTION (provided by applicant): After a 12% decline in the number of keratoplasties in the U.S. between 2004 and 2006 there has been a 37% increase in the number of keratoplasties in just two years. As with the Cornea Donor Study (CDS) 10 years ago, an important public health issue is again raised regarding the future adequacy of the donor pool. This recent increase has been largely driven by the advent of endothelial keratoplasty procedures which have nearly tripled, representing 33% of the keratoplasties in 2008. Coupled with a higher failure rate in the initial postoperative period than penetrating keratoplasty, an aging population with a greater number of endothelial dysfunction cases, and potential changes in the cornea evaluation process with increased regulations and more extensive laboratory testing requirements to test for emerging infections, other means to expand the donor pool besides the use of older donor tissue are needed to guarantee future supply. One major opportunity is to extend the use of donor tissue to the full FDA approved preservation time of 14 days for intermediate storage media at 40C. Corneas preserved beyond 7 days are rarely used for transplantation in the U.S. but are often exported for successful international use. While existing data do not support this bias, an evidence-based study is needed to change this practice pattern. Thus, our primary objective is to determine whether graft clarity and endothelial cell loss, the two most recognized measures of endothelial keratoplasty success, are comparable three years postoperatively for donor corneas preserved up to 7 days vs. those preserved from 8 to 14 days prior to surgery utilizing a randomized, prospective, masked clinical trial. Two separate grant applications have been submitted. The Data Management and Analysis Center (DMAC) 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, data management, statistical analysis, and DSMC coordination. The Coordinating Center at Case Western Reserve University and University Hospitals Eye Institute, directed by the Study Chair, will provide scientific direction and coordination of the clinical sites and Cornea Image Analysis Reading Center activities. 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, 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）：在2004年至2006年之间，美国的角膜变质数量下降了12％之后，短短两年内的角膜体数量增加了37％。与10年前的角膜捐助者研究（CDS）一样，关于捐助者池的未来充分性，再次提出了一个重要的公共卫生问题。 This recent increase has been largely driven by the advent of endothelial keratoplasty procedures which have nearly tripled, representing 33% of the keratoplasties in 2008. Coupled with a higher failure rate in the initial postoperative period than penetrating keratoplasty, an aging population with a greater number of endothelial dysfunction cases, and potential changes in the cornea evaluation process with increased regulations and more extensive laboratory为了测试新兴感染的测试要求，除了使用较老的供体组织以外，还需要扩大供体池的其他方法来保证未来的供应。一个主要的机会是将供体组织的使用扩展到FDA批准的整个保存时间为14天，用于40c的中间存储介质。在美国，很少使用7天以上的角膜用于移植，但经常出口以成功地用于国际使用。尽管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练习模式。因此，我们的主要目标是确定移植物的清晰度和内皮细胞损失，这是内皮性角膜成形术成功的两种最公认的措施，在术后三年可比保留了7天的供体角膜相当，而在手术前的8天到14天，利用随机的，前瞻性的，前瞻性的，前瞻性的，掩盖的临床试验。提交了两个单独的赠款申请。指示CD的JAEB健康研究中心的数据管理和分析中心（DMAC）将监督眼库参与研究，多功能网站开发，数据管理，统计分析和DSMC协调的各个方面。由研究主席执导的Case Western Reserve University和University Hospitals Eye Institute的协调中心将提供临床站点和角膜图像分析阅读中心活动的科学方向和协调。相关性：如果可以证明更长的保留时间至FDA限制的限制不会对3年时的嫁接成功和内皮细胞损失产生不利影响，那么在美国内将有效分布更多的供体组织，将有更多的时间灵活性地用于延长的时间，以使可疑的感染较少，并且较少的组织会超过七个日期的限制。