Effect of Corneal Preservation Time on Long-Term Graft Success (CPTS)

描述(由申请人提供)：在2004年至2006年间，美国的角膜成形术数量下降了12%，但在短短两年内，角膜成形术的数量增加了37%。与10年前的角膜捐赠者研究(CDS)一样，关于捐赠者池未来的充分性，再次提出了一个重要的公共卫生问题。最近的增长在很大程度上是由内皮角膜移植手术的出现推动的，内皮角膜移植手术几乎增加了两倍，占2008年角膜成形术的33%。再加上术后初期失败率高于穿透性角膜移植，人口老龄化和内皮功能障碍病例数量增加，以及角膜评估过程中潜在的变化，法规的增加和更广泛的实验室测试要求以检测新出现的感染，除了使用老年供体组织外，还需要其他手段来扩大供体池以保证未来的供应。一个主要的机会是将供体组织的使用延长到FDA批准的在40℃的中间存储介质的14天的完整保存时间。保存超过7天的角膜在美国很少用于移植，但经常出口到国际上成功使用。虽然现有数据不支持这种偏见，但需要一项循证研究来改变这种做法模式。因此，我们的主要目标是通过一项随机、前瞻性、隐蔽性的临床试验，确定内皮角膜移植成功的两个最公认的衡量标准--移植物透明度和内皮细胞丢失，在术后3年内，供体角膜保存最多7天与手术前8-14天保存的供体角膜是否具有可比性。已经提交了两份不同的拨款申请。指导CDS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协调的方方面面。凯斯西储大学和大学医院眼科研究所的协调中心由研究主席指导，将为临床地点和角膜图像分析阅读中心的活动提供科学指导和协调。

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.