Correction of Myopia Evaluation Trial Phase II

描述（由申请人提供）：这是一项临床试验，旨在评估立即降低眼压（lOP）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lop治疗和不进行初始治疗。EMGT-2建议继续对这些患者进行随访，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。在EMGT-2中使用相同的方案额外收集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的方法将与第一阶段相同，除了：1)研究访问将从每季度减少到每半年；2)使用海德堡视网膜断层扫描（HRT-II）图像评估椎间盘的变化。由于两个研究组的保留情况都很好，可行性得到了提高：在255例EMGT患者中，32例死亡，只有9例（4%）随访失败。EMGT-2的主要目的是：1-通过一系列子目标，确定随机分配到立即治疗或不治疗的青光眼患者的长期眼部和一般结局（如视野（VF）、白内障、死亡率、视觉功能相关生活质量）的频率和趋势；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lOP降低程度和随访；疾病严重程度；椎间盘出血；角膜厚度，全身变量）；基于Humphrey C30-2阈值试验和HRT-II图像，评估和比较VF和椎间盘青光眼相关改变的发生率。次要目的是：1)获得未接受治疗的对照患者的长期自然病史数据；2)确定最初只有一只眼的患者同眼青光眼相关变化的发展情况；3)分析青光眼椎间盘出血的时空分布及其与其他青光眼损伤指标的关系。EMGT-2将继续遵循相同的临床试验设计和方案。每个目标的具体结果都已确定。估计表明，EMGT-2分析将有足够的能力满足拟议的目标。该应用程序寻求对EMGT-2数据中心活动的持续支持。另一份寻求支持临床中心活动的申请也已提交。

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.