LONGITUDINAL STUDY OF OCULAR COMPLICATIONS OF AIDS

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。艾滋病眼部并发症纵向研究（LSOCA）是一项针对艾滋病患者的多中心前瞻性观察性研究。根据1993年疾控中心标准诊断为艾滋病的患者，不论有无眼部并发症，都将被纳入研究对象。本研究的目的是：1)监测艾滋病眼部并发症发生率的长期趋势；2)确定haart诱导的免疫状态变化对艾滋病眼部并发症发生率和病程的影响；3)确定眼部并发症高危患者的特征；4)评价巨细胞病毒性视网膜炎及其他眼部并发症的治疗对视功能、生活质量和生存的影响。大约2000名患者将参加这项研究。在基线时，CMV视网膜炎患者的入组将在300 - 600例之间。所有患者将进行为期3个月的随访。对于有重大眼部并发症的患者，所有随访均为门诊。对于无重大眼部并发症的患者，随访将在电话随访和门诊随访之间交替进行。数据将从以下方面收集：眼科检查、眼底照片、视觉功能测试、病史、生活质量评估、实验室研究和收集血浆和血细胞以供储存。将分析储存的标本的HIV RNA水平和CMV DNA水平。主要关注的结局是巨细胞病毒性视网膜炎的发生率、其他眼部并发症的发生率和死亡率。其他值得关注的结局包括眼外巨细胞病毒疾病的发生率、艾滋病相关眼病的后遗症（如视网膜脱离）、视觉功能、生活质量和眼部并发症治疗的并发症发生率。

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. The Longitudinal Study of Ocular Complications of AIDS (LSOCA) is a multi-center prospective, observational study of patients with AIDS. Patients with a diagnosis of AIDS according to the 1993 CDC criteria, with or without ocular complications, will be enrolled. The objectives of the study are: 1) to monitor secular trends in the incidence of ocular complications of AIDS; 2) to determine the effect of HAART-induced changes in immune status on the incidence and course of ocular complications of AIDS; 3) to determine the characteristics of patients that place them at high risk for ocular complications; and 4) to evaluate the effects of treatments for CMV retinitis and other ocular complications on visual functions, quality of life and survival. Approximately 2,000 patients will be enrolled in this study. Enrollment of patients with CMV retinitis at baseline will be between 300 and 600 patients. 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 ocular complication, follow-up visits will alternate between telephone follow-up visits and clinic follow-up visits. Data will be collected from eye examinations, fundus photographs, visual function testing, medical history, quality of life assessments, laboratory studies and collection of plasma and blood cells for banking. Banked specimens will be analyzed for HIV RNA levels and CMV DNA levels. Outcomes of primary interest are incidence of CMV retinitis, incidence of other ocular complications and mortality. Other outcomes of interest include incidence of extra-ocular CMV disease, sequelae of AIDS-related eye disease ( e.g., retinal detachment), visual function, quality of life, and incidence of complications of therapies for ocular complications.