Cornea Donor Study-Morphometric Study Competitive Revision

角膜捐赠者研究-形态测量研究竞争性修订

• 批准号: 7814671
• 负责人: ROY W. BECK
• 金额: $ 69.35万
• 依托单位: JAEB CENTER FOR HEALTH RESEARCH, INC.
• 依托单位国家: 美国
• 财政年份: 1999
• 资助国家: 美国
• 起止时间: 1999-08-01 至 2012-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7814671
• 关键词: Age; Ancillary Study; Area; Cell Density; Cell Shape; Cell Size; Cells; Cellular Morphology; Cornea; Corneal edema; Data; Data Set; Endothelial Cells; Enrollment; Fuchs' Endothelial Dystrophy; Functional disorder; Funding; Graft Survival; Health; Image; Image Analysis; Keratoplasty; Longitudinal Studies; Methods; Microscopy; Natural History; Patients; Penetrating Keratoplasty; Pilot Projects; Pleomorphism; Postoperative Period; Predictive Value; Procedures; Reading; Recovery; Risk; Shapes; Time; United States; United States National Institutes of Health; Universities; Variant; base; clinical research site; flexibility; graft failure; human old age (65+); response

DESCRIPTION (provided by applicant): This application is in response to NOT-OD-09-058: NIH announces the Availability of Recovery Act Funds for Competitive Revision Applications. The Cornea Donor Study (CDS) and its ancillary study, the Specular Microscopy Ancillary Study (SMAS), are examining the effect of donor age and the predictive value of endothelial cell density (ECD) on cornea graft survival. The study enrolled 1,101 subjects undergoing penetrating keratoplasty at 80 clinical sites in the United States between January 10, 2000 and August 2, 2002; the SMAS included 596 subjects from 45 clinical sites. Changes in the morphometric parameters of cell area, coefficient of variation reflecting variation in cell size (polymegathism), and percentage of hexagonal cells reflecting variation in cell shape (pleomorphism), may be more sensitive than endothelial cell density in assessing endothelial health and dysfunction. As a result, a pilot study, which is currently in progress was developed to determine the feasibility and reliability of implementing established morphometric analysis methods to determine morphometric parameters on a select set of the SMAS images of varying quality. As part of the pilot study, the Case Western Reserve University Specular Microscopy Reading Center (SMRC), which serves as the central reading center for the SMAS, is defining the procedures for morphometric analyses of images received in the SMAS. To date, we have found that a flexible application of these available methods based upon image quality will enable us to acquire these data on the majority of images encountered in the first 5 years of the SMAS. We propose that the morphometric analysis should be expanded to include all images received in the first five years of the SMAS. This is a unique opportunity to obtain additional data from this ongoing longitudinal study which will allow us to determine the value of changes in the various endothelial parameters over a 5-year period after penetrating keratoplasty on endothelial function and ultimate decompensation.

描述（由申请人提供）：此申请是响应于NOT-OD-09-058：NIH宣布为竞争性修订申请提供恢复法案资金。角膜供体研究（CDS）及其辅助研究镜头显微镜辅助研究（SMA）正在研究供体年龄的影响以及内皮细胞密度（ECD）对角膜移植生存的影响。这项研究招募了1,101名在2000年1月10日至2002年8月2日之间在美国80个临床部位进行穿透性角化术的受试者； SMA包括来自45个临床部位的596名受试者。细胞面积的形态计量参数的变化，反映细胞大小变化（多聚体）的变异的变异系数以及反映细胞形状变化（多态性）的六边形细胞的百分比，在评估内皮细胞密度评估内皮细胞密度时可能更敏感。结果，目前正在进行的一项试验研究是为了确定实施已建立的形态计量分析方法的可行性和可靠性，以确定一组不同质量的SMAS图像集中的形态计量参数。作为试点研究的一部分，西方储备大学镜头显微镜阅读中心（SMRC）是SMA中央阅读中心，它确定了SMA中收到的图像的形态分析程序。迄今为止，我们发现，基于图像质量的这些可用方法的灵活应用将使我们能够在SMA的前5年中获取大多数图像。我们建议应扩展形态分析，以包括在SMA的前五年中收到的所有图像。这是从这项正在进行的纵向研究中获取其他数据的独特机会，这将使我们能够在穿透性角化膜对内皮功能和最终失去负担后的5年期间确定各种内皮参数变化的价值。