The Steroids for Cornea Ulcers Trial

类固醇治疗角膜溃疡试验

• 批准号: 7122360
• 负责人: THOMAS M LIETMAN
• 金额: $ 49.33万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2005
• 资助国家: 美国
• 起止时间: 2005-09-30 至 2009-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7122360
• 关键词: India; antibiotics; artificial immunosuppression; clinical research; clinical trials; combination therapy; cooperative study; cornea ulcer; corticosteroids; drug adverse effect; eye infections; hormone therapy; human subject; human therapy evaluation; immunosuppressive; longitudinal human study; microorganism disease chemotherapy; patient oriented research; topical drug application; visual perception

DESCRIPTION (provided by applicant): Antimicrobial treatment of a bacterial corneal ulcer is generally effective in eradicating infection. However, "successful" treatment is not always associated with a good visual outcome. The scarring that accompanies the resolution of infection leaves many eyes blind. Some corneal specialists advocate the use of topical corticosteroids along with antibiotics in an effort to reduce immune mediated tissue damage, and thus scarring. Others fear that using steroids to reduce the cornea's immune response will prolong or even exacerbate infection. Evidence from animal and human reports is mixed. No single referral center in the United States has the volume necessary to support an adequate trial. We propose to perform a clinical trial evaluating the efficacy of steroids at the Aravind Eye Hospital in Madurai, India. This center receives 3-7 bacterial cornea ulcers per day and has the administrative, medical, and microbiological facilities necessary to perform the study. Since the bacterial pathogens seen in corneal ulcer patients at Aravind are similar to those seen in the United States, we believe that Aravind is a logical and cost-effective site to study the role of steroids in the treatment of bacterial keratitis, and will provide results relevant to the treatment of patients in both India and the United States. At the advice of reviewers, two parallel sites in the U.S. (the Proctor Foundation and Dartmouth Medical School) will be added to provide confirmatory data, and to highlight the differences in American and South Indian ulcers. Long-term goal: Can immunosuppressive agents improve outcomes in infectious corneal ulcers? The Specific Aims (and short-term goals), a randomized, placebo-controlled clinical trial: 1) To determine whether the addition of topical steroids to the treatment of a bacterial corneal ulcer improves post-treatment visual acuity. 2) To determine whether the addition of topical steroids results in a higher frequency of adverse outcomes. 3) To determine whether outcomes depend on the organism.

描述（由申请人提供）：细菌性角膜溃疡的抗菌治疗通常可有效根除感染。然而，“成功”的治疗并不总是与良好的视力结果相关。感染消退后留下的疤痕使许多人失明。一些角膜专家主张使用局部皮质类固醇和抗生素，以减少免疫介导的组织损伤，从而减少疤痕。其他人担心使用类固醇来降低角膜的免疫反应会延长甚至加剧感染。来自动物和人类报告的证据是混杂的。美国没有一个转诊中心拥有足够的数量来支持充分的试验。我们建议在印度马杜赖的阿拉文眼科医院进行一项评估类固醇功效的临床试验。该中心每天接收 3-7 个细菌性角膜溃疡，并拥有进行研究所需的行政、医疗和微生物设施。由于在阿拉文德角膜溃疡患者中看到的细菌病原体与在美国看到的细菌病原体相似，我们相信阿拉文德是研究类固醇在细菌性角膜炎治疗中的作用的合乎逻辑且具有成本效益的地点，并将提供结果与印度和美国患者的治疗相关。根据审稿人的建议，将添加美国的两个平行站点（普罗克特基金会和达特茅斯医学院）以提供验证性数据，并强调美国和南印度溃疡的差异。长期目标：免疫抑制剂能否改善感染性角膜溃疡的预后？具体目标（和短期目标）是一项随机、安慰剂对照临床试验：1) 确定在细菌性角膜溃疡的治疗中添加局部类固醇是否可以提高治疗后的视力。 2) 确定添加外用类固醇是否会导致不良后果发生率更高。 3) 确定结果是否取决于生物体。