Correction of Myopia Evaluation Trial Phase II

描述（由申请人提供）：这是一项临床试验，旨在评价立即降低眼内压（IOP）与不治疗对早期开角型青光眼（OAG）进展的影响，始于1993年。该试验将OAG患者随机分为立即降低IOP治疗组和未进行初始治疗组。EMGT-2建议继续随访这些患者，以确定治疗的长期效果，并评估进展模式及其相关因素。这个独特的，定义明确的队列现在平均随访时间为7年，包括广泛的疾病。采用相同方案在EMGT-2中额外收集4.5年的数据将为所有患者提供至少11年的观察，平均随访时间约为12.5年。 EMGT-2中的方法将与第一阶段相同，除了：1）研究访视将从每季度减少到每半年; 2）海德堡视网膜断层扫描（HRT-II）图像将用于评价椎间盘变化。由于两个研究组中的良好保留，可行性增强：在255名EMGT患者中，32名死亡，仅9名（4%）失访。EMGT-2的主要目的是：1-通过一系列子目的确定长期眼部和一般结局的频率和趋势（例如，视野（VF）、白内障、死亡率、视功能相关的生活质量）; 2-评估和量化EMGT治疗和其他因素对长期进展的独立影响（例如，初始IOP降低的程度和随访时的程度;疾病严重程度;椎间盘突出;角膜厚度，全身变量）;和3-基于Humphrey C30-2阈值测试和HRT-II图像，评估和比较VF和椎间盘中与青光眼相关的变化率。次要目标是：1）获得未接受治疗的对照患者的长期自然病史数据; 2）确定只有一只初始合格眼睛的患者的对侧眼睛中青光眼相关变化的发展;和3）描述椎间盘突出的时间和空间分布及其与青光眼损伤的其他指标的关系。EMGT-2将继续遵循相同的临床试验设计和方案。每个目标的具体成果已经确定。估计表明，EMGT-2分析将有足够的能力来实现拟议的目标。本申请寻求对EMGT-2数据中心活动的持续支持。还提交了一份单独的申请，寻求对临床中心活动的支持。

DESCRIPTION (provided by applicant): This is a clinical trial to evaluate the effect of immediate reduction of intraocular pressure (lOP) vs. no treatment, on progression of early open-angle glaucoma (OAG), initiated in 1993. The trial randomized OAG patients to immediate lOP-lowering treatment vs. no initial treatment. EMGT-2 proposes to continue following these patients to determine the long-term effects of treatment, as well as to evaluate patterns of progression and their related factors. This unique, well-defined cohort now has an average follow-up time of 7 years and includes a wide spectrum of disease. An additional 4.5 yrs of data collection in EMGT-2 with the same protocol would provide at least 11 years of observation for all patients, with an average follow-up time of about 12.5 years. Methods in EMGT-2 will remain the same as in the first phase except that:1) study visits will be reduced from quarterly to semiannual; and, 2) Heidelberg Retina Tomograph (HRT-II) images will be used to evaluate disc changes. Feasibility is enhanced because of the excellent retention in both study groups: of the 255 EMGT patients, 32 have died and only 9 (4%) have been losses to follow-up. The primary aims of EMGT-2 are: 1- To determine, through a series of subaims, the frequency and trends of long-term ocular and general outcomes (e.g., visual field (VF), cataract, mortality, visual function-related quality of life) of glaucoma patients randomized to immediate treatment or no treatment; 2- To evaluate and quantify the independent effect of EMGT treatment and other factors on long-term progression (e.g., extent of initial lOP reduction and at follow-up; disease severity; disc hemorrhages; corneal thickness, systemic variables); and 3- To evaluate and compare the rates of glaucoma-related changes in VF and discs, based on Humphrey C30-2 threshold tests and HRT-II images. Secondary aims are: 1) To obtain long-term natural history data on control patients who remain untreated; 2) To determine the development of glaucoma-related changes in fellow eyes of patients who had only one initially eligible eye; and 3) To describe the temporal and spatial distribution of disc hemorrhages and their relationship to other indicators of glaucoma damage. EMGT-2 will continue to follow the same clinical trial design and protocol. Specific outcomes for each aim have been defined. Estimates indicate that EMGT-2 analyses will have sufficient power to meet the proposed aims. This application seeks continued support for the activities of the Data Center for EMGT-2. A separate application seeking support for the activities of the Clinical Center has also been submitted.