Effect of Corneal Preservation Time on Long-Term Graft Success - Study Chair

角膜保存时间对长期移植成功的影响 - 研究主席

• 批准号: 8332366
• 负责人: JONATHAN H LASS
• 金额: $ 18.46万
• 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/8332366
• 关键词: Applications Grants; Biological Preservation; Clinical Trials Design; Cornea; Corneal Stroma; Data; Data Analyses; Development; Endothelial Cells; Evaluation; Eye; Eye Banks; FDA approved; Failure; Future; Health; Image Analysis; Infection; Institutes; Keratoplasty; Life; Masks; Measures; Optisol; Pathology; Penetrating Keratoplasty; Procedures; Process; Public Health; Randomized; Reading; Regulation; Research; Testing; Time; Tissue Donors; United States; aging population; clinical research site; data management; evidence base; 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.

2004年至2006年间，美国的角膜移植术数量下降了12%，而同期却增加了37%。 在过去两年中，2009年进行了近60，000例手术。与角膜供体研究（CDS）10一样 几年前，人们再次提出了一个公共卫生问题，即今后是否有足够的捐助者。这 角膜内皮移植术（EK）的出现推动了这一增长， 2006- 2009年间，病例增加了三倍，30%的 去年做了角膜移植手术与穿透性角膜移植术（PKP）相比， 患有更多病理学的人群，角膜评价过程中的变化以及法规的增加， 对新出现的感染以及这些感染对供体库的威胁提出了更多的检测要求， 除了使用较老的供体组织之外，还需要其它方法来扩大供体库。一个主要 机会是将供体组织的使用延长到FDA批准的14天保存时间， 在4 ° C下的中间储存介质（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，但经常出口以在国际上成功使用。而 现有的数据不支持这种偏见，需要进行循证研究来改变这种做法模式。 我们研究的主要目的是确定受体角膜基质的透明度和内皮细胞的数量是否与受体角膜基质的透明度和内皮细胞的数量有关。 角膜移植成功的两个最佳指标--角膜细胞丢失率在术后3年对供体角膜来说是相当的 保存7天或更短的那些与使用随机， 前瞻性、设盲临床试验设计。已经提交了两份单独的赠款申请。数据 Jaeb健康研究中心的管理和分析中心负责CDS， 监督眼库参与研究的各个方面，多功能网站开发，统计 计划、数据管理和分析以及DSMC的协调。CWRU协调中心 和UH眼科研究所，由PI和主任指导，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。