CIGTS-2 Optic Disc Reading Center

描述(由申请人提供)：协作性青光眼风险和结果研究(CIGTS-2)是一项前瞻性的纵向观察研究，旨在确定在纳入协作性初始青光眼治疗研究(CIGTS)的参与者中，降低眼压在预防或延缓开角型青光眼(OAG)引起的进一步视野丧失或视神经进展方面的长期效果。CIGTS-2的光盘阅读中心(ODRC)将通过对现有CIGTS基线和五年后续立体光盘照片提供统一的掩蔽解释，支持这项研究的使命。迈阿密大学的研究人员是一支经验丰富的团队，他们自1994年以来一直担任眼压治疗研究的ODRC。 CIGTS-2 ODRC的目标是： 1.建立基线和随访时的视盘特征分级方案 2.评估照片质量 3.以统一掩蔽方式评估视盘进展的发展 4.对研究摄影师进行再培训和再认证 5.培训和认证初级阅读器对立体视盘照片进行分级，以确定视盘进展 6.开发ODRC基础设施，以接收、登录、跟踪和存档CIGTS和CIGTS-2的所有立体光盘照片 7.制定和实施及时、安全和可靠的数据输入和传输协议，将数据库从对外数据中心传输到密歇根大学协调中心 8.在ODRC执行质量保证程序，以确保杯/盘(C/D)比率和视盘进展的可重复性、高质量分级 9.协助协调中心制定临床评估委员会方案，以确定ODRC判断的变化是否是OAG引起的视盘进展 10.制定一项协议，对所有CIGTS和CIGTS-2光盘图像进行数字存档，并建立一个关系数据库，供今后感兴趣的研究人员使用 11.向协调中心提供视盘进展率

DESCRIPTION (provided by applicant): The Collaborative Glaucoma Risks and Outcomes Study (CIGTS-2) is a prospective longitudinal observation study designed to determine the long-term effects of intraocular pressure lowering in preventing or delaying further visual field loss or optic nerve progression due to open angle glaucoma (OAG) in participants recruited into the Collaborative Initial Glaucoma Treatment Study (CIGTS). The Optic Disc Reading Center (ODRC) of CIGTS-2 will support the mission of the study by providing uniform masked interpretation of existing CIGTS baseline and five-year follow-up stereoscopic optic disc photographs. The investigators at the University of Miami are an experienced team, who have been the ODRC for the Ocular Hypertension Treatment Study since 1994. The aims of the CIGTS-2 ODRC are: 1. To establish a protocol for grading optic disc characteristics at baseline and follow-up 2. To evaluate photographic quality 3. To assess development of optic disc progression in a uniform masked manner 4. To re-train and re-certify study photographers 5. To train and certify Primary Readers to grade stereoscopic optic disc photographs for determination of optic disc progression 6. To develop an ODRC infrastructure to receive, log in, track, and archive all stereoscopic optic disc photographs of the CIGTS and CIGTS-2 7. To develop and implement a timely, secure, and reliable data entry and transmittal protocol to transmit databases from the ODRC to the Coordinating Center at the University of Michigan 8. To perform quality assurance procedures at the ODRC to assure reproducible, high quality grading of cup/disc (C/D) ratio and optic disc progression 9. To assist the Coordinating Center to establish a Clinical Assessment Committee protocol to determine if the changes judged by the ODRC are optic disc progression caused by OAG 10. To develop a protocol for the digital archiving of all CIGTS and CIGTS-2 optic disc images and for the construction of a relational database for use by interested researchers in the future 11. To provide the Coordinating Center with optic disc progression rates