Structural and Functional Progression of Glaucomatous Damage to the Macula

青光眼黄斑损伤的结构和功能进展

• 批准号: 9050683
• 负责人: Carlos Gustavo De Moraes
• 金额: $ 40万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-05-01 至 2018-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9050683
• 关键词: Affect; Agreement; Area; Bayesian Analysis; Bayesian Modeling; Biometry; Clinical; Clinical Trials; Collaborations; Computer software; Data; Data Set; Databases; Decision Making; Disease; Doctor of Medicine; Doctor of Philosophy; Glaucoma; Goals; Health; Institution; Joints; Knowledge; Length; Letters; Literature; Measures; Methods; Modeling; Monitor; Nature; Noise; Optical Coherence Tomography; Paper; Patients; Performance; Perimetry; Peripheral; Process; Prospective Studies; Publishing; Recruitment Activity; Research; Resolution; Retinal; Retinal Ganglion Cells; Scanning; Sensitivity and Specificity; Source; Specialist; Staging; Statistical Methods; Structure; Techniques; Technology; Testing; Time; Training; Translating; Universities; Vision; Visual Cortex; Visual Fields; Work; area striata; clinical practice; clinically significant; density; experience; field study; follow-up; health related quality of life; improved; indexing; innovation; longitudinal database; macula; patient population; prospective; rate of change; tool; trend analysis

 DESCRIPTION (provided by applicant): There is compelling evidence that glaucomatous damage to the macula occurs even in early stages of the disease. The macula comprises about 30% of all retinal ganglion cells and its information corresponds to over 50% of the visual cortex. However, glaucomatous damage to the macula is often missed in clinical practice. Some of the reasons are: 1) traditional glaucoma knowledge supports that glaucoma is fundamentally a peripheral disease; 2) inherent limitations of conventional clinical tests to detect damage to the macula; and 3) the paucity of large, prospective studies that describe the nature of glaucomatous damage to the macula. Our group has published numerous papers in the past two years showing that macular damage is prevalent among patients with early glaucoma if one employs the appropriate tools to assess it, namely 10-2 visual fields and high-resolution optical coherence tomography (OCT). This information comes from a unique prospective cross- sectional database and techniques we developed to produce objective metrics of structure and function. Now that we understand the cross-sectional nature of macular damage, this proposal aims to: 1) develop a longitudinal database including patients with early glaucoma and healthy controls, 2) to test models that explain progression of macular damage, and 3) to apply new statistical methods combining structural and functional tests which could improve the accuracy to detect progression and shorten the length of clinical trials. Our main hypothesis is that incorporating 10-2 visual field testing and high-resolution OCT scans of the macula to the conventional repertoire of technologies used in clinical practice, in addition to translating recently described statistical methods into softwares that can be used in daily practice, enhances the performance and confidence to detect glaucoma progression. In Aim 1 we plan to follow healthy subjects and glaucoma patients at regular intervals with 10-2, 24-2 visual fields, and swept source (ss) OCT tests and define metrics of short- and long-term test variability that are needed to differentiate true progression from 'noise'. To date, there is no such database combining these technologies. In Aim 2 we plan to combine metrics of structure and function from this longitudinal database using two methods: a spatial approach, which will ultimately produce a joint structure-function index using 10-2 and ssOCT data; and a temporal approach, which will employ Bayesian statistics to measure rates of progression using trend analysis. By the end of the study, our contributions to the field should be: 1) to make available a unique and pristine longitudinal database that could be used for other hypotheses testing, 2) to translate techniques recently described in the literature into objective tools to be readily useful in clinicl practice, and 3) to mitigate the burdens of progressive loss of central vision in glaucoma.

 描述（由申请人提供）：有令人信服的证据表明，即使在疾病的早期阶段，黄斑部也会出现青光眼损伤。黄斑约占所有视网膜神经节细胞的 30%，其信息对应超过 50% 的视觉皮层。 然而，在临床实践中，青光眼对黄斑的损伤经常被忽视。一些原因是：1）传统的青光眼知识支持青光眼从根本上来说是一种周围性疾病； 2）常规临床测试检测黄斑损伤的固有局限性； 3）缺乏描述青光眼黄斑损伤性质的大型前瞻性研究。我们小组在过去两年中发表了大量论文，表明如果使用适当的工具（即 10-2 视野和高分辨率光学相干断层扫描 (OCT)）进行评估，早期青光眼患者中黄斑损伤很普遍。这些信息来自我们开发的独特的前瞻性横截面数据库和技术，用于生成结构和功能的客观指标。既然我们了解了黄斑损伤的横截面性质，该提案的目的是：1）开发一个包括早期青光眼患者和健康对照的纵向数据库，2）测试解释黄斑损伤进展的模型，3）应用结合结构和功能测试的新统计方法，这可以提高检测进展的准确性并缩短临床试验的时间。我们的主要假设是，除了将最近描述的统计方法转化为可在日常实践中使用的软件之外，将黄斑的 10-2 视野测试和高分辨率 OCT 扫描纳入临床实践中使用的常规技术，还可以增强检测青光眼进展的性能和信心。在目标 1 中，我们计划定期使用 10-2、24-2 视野和扫频 (ss) OCT 测试跟踪健康受试者和青光眼患者，并定义区分真实进展与“噪声”所需的短期和长期测试变异性指标。迄今为止，还没有这样的数据库结合了这些技术。在目标 2 中，我们计划使用两种方法结合该纵向数据库中的结构和功能指标：空间方法，最终将使用 10-2 和 ssOCT 数据产生联合结构功能索引；以及时间方法，该方法将利用贝叶斯统计通过趋势分析来衡量进展率。在研究结束时，我们对该领域的贡献应该是：1）提供一个独特且原始的纵向数据库，可用于其他假设检验，2）将文献中最近描述的技术转化为易于在临床实践中使用的客观工具，以及3）减轻青光眼中心视力逐渐丧失的负担。