Comparison of AMD Treatment Trials-OCT Reading Center

AMD治疗试验比较-OCT阅片中心

• 批准号: 7295914
• 负责人: GLENN JAFFE
• 金额: $ 30.3万
• 依托单位: DUKE UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-09-30 至 2010-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7295914
• 关键词: Age related macular degeneration; Archives; Back; Blindness; Certification; Characteristics; Classification; Clinical; Clinical Investigator; Clinical Research; Clinical Trials; Color; Complex; Custom; Data; Electronics; End Point; Ensure; Exudative age-related macular degeneration; Eye; Fluorescein; Fluorescein Angiography; Fluoresceins; Fundus; Fundus photography; Goals; Group Meetings; Human Resources; Image; Imaging Techniques; Internet; Lesion; Methods; Morphology; Online Systems; Ophthalmologist; Optical Coherence Tomography; Optics; Outcome; Pathology; Preparation; Process; Protocols documentation; Publications; Reading; Relative (related person); Reproducibility; Research Infrastructure; Resolution; Resources; Retinal; Safety; Scanning; Secure; Site; System; Therapeutic; Thick; To specify; Training; Training Programs; Training Support; Visual Acuity; design; improved; macula; macular edema; prevent; quality assurance; size; therapy design; transmission process; treatment trial

DESCRIPTION (provided by applicant): The primary objective of the activities proposed in this application is to provide optical coherence tomography (OCT) Reading Center support to the Comparison of Age Related Macular Degeneration Treatment trials (CATT). The long term goals of this project, that will be accomplished through conduct of specific CATT studies are 1) to identify by OCT those eyes that are most likely to benefit from preventative strategies or treatments designed to prevent vision loss, or improve visual acuity in eyes with AMD, 2) to determine by OCT when treatment is effective or re-treatment is required and 3) to standardize OCT protocols and grading methods in eyes with AMD. The primary objective will be accomplished through the following specific aims: Specific Aim 1: Establish the infrastructure to process OCT images that will be submitted by CATT clinical centers to the CATT OCT Reading Center. Specific Aim 2: Collaborate with the Coordinating Center to establish and implement OCT certification and training programs for CATT clinical study investigators, clinical coordinators and OCT technicians in preparation for CATT. Specific Aim 3: Provide reliable, timely, reproducible, and systematic grading of submitted OCT materials. To achieve these aims, The OCT Reading Center will use a custom, stand-alone web-based system that we have developed to establish and implement secure methods for electronic OCT data submission from the CATT clinical study sites to the CATT OCT Reading Center, and to store and back-up submitted data. We will establish secure methods to transmit data from the OCT Reading Center to the Coordinating Center. The Reading Center will also implement materials and methods for grader, photographer, clinical coordinator and ophthalmologist certification and training, and support study goals as an image resource for recruitment, Study Group meetings, presentations and publications.

描述（由申请人提供）：本申请中提出的活动的主要目标是为年龄相关性黄斑变性治疗试验的比较（CATT）提供光学相干断层扫描（OCT）阅读中心支持。该项目的长期目标将通过进行特定的 CATT 研究来实现，其目标是 1) 通过 OCT 识别最有可能受益于旨在预防视力丧失或提高眼睛视力的预防策略或治疗的眼睛2) 通过 OCT 确定治疗有效或需要重新治疗，3) 标准化 AMD 眼睛的 OCT 方案和分级方法。主要目标将通过以下具体目标来实现： 具体目标 1：建立处理 OCT 图像的基础设施，这些图像将由 CATT 临床中心提交给 CATT OCT 阅片中心。具体目标2：与协调中心合作，为CATT临床研究研究者、临床协调员和OCT技术人员建立并实施OCT认证和培训计划，为CATT做准备。具体目标 3：对提交的 OCT 材料提供可靠、及时、可重复和系统的评分。 为了实现这些目标，OCT 阅读中心将使用我们开发的定制的独立网络系统来建立和实施从 CATT 临床研究站点向 CATT OCT 阅读中心提交电子 OCT 数据的安全方法，以及存储和备份提交的数据。我们将建立安全的方法将数据从OCT阅读中心传输到协调中心。阅读中心还将实施分级师、摄影师、临床协调员和眼科医生认证和培训的材料和方法，并支持研究目标，作为招募、研究组会议、演示和出版物的图像资源。