Ocular Complications of AIDS-Photograph Reading Center

艾滋病眼部并发症-图片阅读中心

• 批准号: 7281196
• 负责人: Ronald Danis
• 金额: $ 25.13万
• 依托单位: UNIVERSITY OF WISCONSIN-MADISON
• 依托单位国家: 美国
• 财政年份: 1988
• 资助国家: 美国
• 起止时间: 1988-08-15 至 2008-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7281196
• 关键词: Ocular; Complications; AIDS; Photograph; Reading

DESCRIPTION (provided by applicant): Cytomegalovirus (CMV) retinitis and other ocular opportunistic infections (OIs) are a major cause of visual loss and morbidity among patients with AIDS. Although the epidemiology of CMV retinitis has been altered by highly active antiretroviral therapy (HAART), CMV retinitis remains among the most common OIs in patients with AIDS. Furthermore, there appear to be subtle abnormalities of vision (detected on contrast sensitivity and visual field testing) among patients with AIDS without ocular OIs, the long-term consequences of which are unknown. The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is a multicenter, prospective, observational study of patients with AIDS. As of June 1,2002, 1,337 patients with a diagnosis of AIDS have been enrolled, of whom 348 (26%) had a major ocular complication (94% of which were CMV retinitis). Projected enrollment by August 2003 is 1,700 patients. The objectives of this study are: 1) to determine the characteristics (clinical, virologic, and immunologic) of and risk factors for CMV retinitis and other ocular complications of AIDS in the era of HAART; 2) to monitor trends in the incidence and prevalence of CMV retinitis and other ocular complications of AIDS; and 3) to evaluate the outcomes of CMV retinitis and other ocular complications of AIDS and determine risk factors for adverse outcomes. Over the next five years an additional 500 patients will be enrolled in the study, to replace those lost to mortality and withdrawal, thereby maintaining a stable population of patients under follow up. Participants will continue in follow-up for the duration of the study. All patients will be on a 3-month follow-up schedule. For patients with a major ocular complication, all follow-up visits will be clinic visits. For patients without a major complication, follow-up visits will alternate between clinic follow-up visits and telephone follow-up visits. Data will be collected from medical history, visual function testing, eye examinations, fundus photographs, quality of life assessment, laboratory studies, and collection of plasma and blood cells for banking. Banked specimens also will be analyzed for CMV DNA levels. Outcomes of interest include incidence of CMV retinitis, incidences of other ocular complications, visual outcomes, and mortality. Other outcomes of interest include sequelae of AIDS-related eye disease (e.g., retinal detachment), quality of life, and the effect of therapies on ocular disease. With an estimated 11,250 person-years of follow-up by 2008, LSOCA will be adequately powered to detect clinically meaningful relative risks even for uncommon events. This application is for the Fundus Photograph Reading Center.

描述（由申请人提供）：巨细胞病毒（CMV）视网膜炎和其他眼部机会性感染（OIs）是艾滋病患者视力丧失和发病的主要原因。尽管高效抗逆转录病毒治疗 (HAART) 改变了 CMV 视网膜炎的流行病学，但 CMV 视网膜炎仍然是 AIDS 患者最常见的 OIs 之一。 此外，在没有眼部成骨不全的艾滋病患者中，似乎存在轻微的视力异常（通过对比敏感度和视野测试检测到），其长期后果尚不清楚。艾滋病眼部并发症的纵向研究 (LSOCA) 是一项针对艾滋病患者的多中心、前瞻性、观察性研究。 截至2002年6月1日，已登记了1,337名被诊断为艾滋病的患者，其中348名（26%）患有严重眼部并发症（其中94%为CMV视网膜炎）。预计到 2003 年 8 月登记的患者人数为 1,700 名。本研究的目的是：1）确定HAART时代CMV视网膜炎和艾滋病其他眼部并发症的特征（临床、病毒学和免疫学）和危险因素； 2) 监测巨细胞病毒视网膜炎和艾滋病其他眼部并发症的发病率和流行趋势； 3) 评估巨细胞病毒视网膜炎和艾滋病其他眼部并发症的结果，并确定其危险因素 不良后果。 在接下来的五年中，将另外招募 500 名患者参加该研究，以补充那些因死亡和退出而流失的患者，从而保持稳定的随访患者群体。 参与者将在研究期间继续进行随访。 所有患者都将接受为期 3 个月的随访。 对于患有主要眼部并发症的患者，所有随访都将是门诊就诊。对于没有重大并发症的患者，随访将采用门诊随访和电话随访交替进行。 数据将从病史、视功能测试、眼科检查、眼底照片、生活质量评估、实验室研究以及血浆和血细胞的收集中收集。 还将对储存的样本进行 CMV DNA 水平分析。 感兴趣的结果包括巨细胞病毒视网膜炎的发生率、其他眼部并发症的发生率、视力结果和死亡率。其他令人感兴趣的结果包括艾滋病相关眼病的后遗症（例如视网膜脱离）、生活质量以及眼病治疗的效果。预计到 2008 年，LSOCA 将进行 11,250 人年的随访，即使对于不常见的事件，LSOCA 将有足够的能力检测具有临床意义的相对风险。 此应用程序适用于眼底照片阅读中心。