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中文摘要
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这项建议是为了继续对1988至1991年间参加视神经炎治疗试验(ONTT)的患者进行长期随访研究,并自1992年以来一直作为纵向视神经炎研究(LONS)的一部分进行跟踪。ONTT的主要目标是评估皮质类固醇在急性视神经炎治疗中的疗效。LONS的主要目标是(1)评估视神经炎后的长期视觉功能进程,以及(2)研究视神经炎和多发性硬化症(MS)之间的关系。这一应用是对Lons的延续,以获得关于这一独特患者队列中的视觉过程和神经学过程的额外的有价值的长期随访信息。Lons为研究一群特征良好的视神经炎患者提供了一个独特的机会。没有其他研究用标准化的方法如此广泛地收集和评估过如此大量的视神经炎患者。从ONTT方案的开发开始,就认识到该治疗试验在提供一组可以纵向跟踪回答许多有关视神经炎的关键视觉和神经学问题的患者方面的重要性。这群患者是通过相当大的努力和成本聚集在一起的。与整体研究成本相比,目前拟议的五年延期所涉及的成本较小。这项研究产生的信息将对视神经炎患者的治疗和生活质量具有相关性。在该提案的头四年,患者将通过数据协调中心的电话和邮件保持联系。在第五年,14家Lons诊所将重新获得认证,每个患者都将接受眼科检查、视觉功能测试和神经学检查,这是Lons目前使用的方案。这次访问将与每个患者15-17年的随访时间相吻合。眼科和神经学结果的主要手稿都计划进行。80%以上的原始队列仍在跟进中,并建立了机制,以确保这一高比率将继续下去,以便为长期研究提供有效的结果。
英文摘要
This proposal is to continue a long-term follow-up study of the cohort of patients who were entered into the Optic Neuritis Treatment Trial (ONTT) between 1988 and 1991 and have been followed as part of the Longitudinal Optic Neuritis Study (LONS) since 1992. The ONTT's primary objective was to assess the efficacy of corticosteroids in the treatment of acute optic neuritis. The LONS' primary objectives are (1) the evaluation of the long-term course of visual function after optic neuritis and (2) investigation of the relationship between optic neuritis and multiple sclerosis (MS). This application is for a continuation of the LONS to acquire additional valuable long-term follow-up information about both the visual course and the neurologic course in this unique patient cohort. The LONS provides a unique opportunity to study a cohort of well- characterized patients with optic neuritis. No other study has ever assembled and evaluated so extensively with standardized methodology such a large number of patients with optic neuritis. The importance of the treatment trial in providing a cohort of patients which could be followed longitudinally to answer many key visual and neurologic questions concerning optic neuritis was recognized from the onset of development of the ONTT protocol. This cohort of patients was assembled through considerable effort and cost. The costs involved in the current proposed five-year extension are small compared to the overall study costs. The information emanating from this study will have both therapeutic and quality of life relevance for patients with optic neuritis. For the first four years of the proposal, patient contact will be maintained through phone calls and mailings from the Data Coordinating Center. In the fifth year, the 14 LONS clinics will be recertified and each patient will be seen for an ocular examination, visual function testing, and neurologic examination by protocols currently utilized in the LONS. This visit will coincide with 15-17 years of follow up for each patient. Major manuscripts are planned for both the ophthalmic and neurologic results. More than 80% of the original cohort remains in follow up and mechanisms are in place to assure that this high rate will continue so as to provide valid results for the long-term study.
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WEB-BASED METHODS RESOURCE CENTER FOR EYE DISEASE TRIALS
WEB-BASED METHODS RESOURCE CENTER FOR EYE DISEASE TRIALS
Web-Based Methods Resource Center for Eye Disease Trials
Web-Based Methods Resource Center for Eye Disease Trials
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