Secondary Analysis of Four Trichiasis Surgery Clinical Trials to Inform Managemen

描述(由申请人提供)：本申请是对PAR-09-252“二次数据分析研究项目拨款”的回应，由于它使用了NEI资助的临床试验的数据，因此对NEI具有“最高的计划兴趣”。沙眼倒睫是世界范围内导致失明的主要传染病，影响着800多万人。虽然TT可以通过手术矫正，但程序性环境中的复发率从30%到60%不等。世界卫生组织制定了到2020年消除致盲沙眼的目标，这将需要在未来7年内成功进行1500万例TT手术。迫切需要更新TT处理指南，特别是针对复发性TT和眼睑轮廓异常的指南，以帮助制定手术计划。最近的四项临床试验有关于成功实践的先进知识。然而，尽管从这些试验中获得了宝贵的知识，但仍然存在其他问题。该项目的总体目标是整合来自四个互补的倒立手术试验的数据，以检查直接影响TT管理的流行病学问题。这些已完成的试验包括NEI资助的STAR试验、Pret手术、可吸收缝合与真丝缝合以及手术与脱毛。收集的每个试验的数据元素基本相同。这些试验将用于解决以下具体目标：目标1：确定不同睫毛类型的倒睫复发进展的风险。假设：仅为外周性的复发性倒睫比累及中枢性睫毛的复发性倒睫更有可能进展。目的2：根据倒睫睫毛发生的位置，计算外固定器之间角膜混浊进展的概率，并利用这些信息预测复发性倒立病例中角膜混浊进展的概率。假设：角膜混浊进展的可能性大大降低 在轻度周围性倒睫患者中，角膜混浊进展的可能性也低于周围性复发性倒睫患者。目的3：描述眼睑轮廓异常严重程度的变化，并调查可改变的危险因素。假设：肉芽肿是轮廓异常的主要原因。术后立即明显的轮廓异常不太可能消退。来自该项目的数据有很强的潜力，通过指导TT管理决策，对世界各地的国家沙眼控制计划的决策产生直接和深远的影响。此外，该项目与联合国的千年发展目标保持一致，千年发展目标的重点是减少贫困、饥饿和疾病。

DESCRIPTION (provided by applicant): This application is in response to PAR-09-252, "Research Project Grants for Secondary Data Analyses," and is of "highest programmatic interest" to NEI because it utilizes data from an NEI-funded clinical trial. Trachomatous trichiasis (TT) is the leading infectious cause of blindness worldwide, affecting more than 8 million people. Although TT can be corrected surgically, recurrence rates in programmatic settings range from 30-60%. The WHO has set a goal of eliminating blinding trachoma by the year 2020, which will require >15 million successful TT surgeries over the next 7 years. Updated guidelines for TT management, specifically for recurrent TT and eyelid contour abnormalities, are urgently needed to help with surgical planning. Four recent clinical trials have advanced knowledge regarding successful practices. However, despite the valuable knowledge derived from these trials, additional questions remain. The overarching goal of this project is to integrate data from four complementary trichiasis surgery trials to examine epidemiologic questions that directly impact TT management. These completed trials include the NEI-funded STAR trial, PRET surgery, absorbable vs. silk sutures, and surgery vs. epilation. Data elements collected are mostly the same for each trial. These trials will be used to address the following specific aims: AIM 1: Determine the risk of recurrent trichiasis progression for different trichiatic lash patterns. Hypothesis: Recurrent trichiasis that is peripheral only is les likely to progress than recurrent trichiasis with central lash involvement. AIM 2: Calculate the probability of corneal opacity progression among epilators based on incident trichiasis lash locations and use this information to predict the probability of corneal opacity progression in recurrent trichiasis cases. Hypotheses: Corneal opacity progression is substantially less likely among eyes with mild peripheral trichiasis than eyes with central trichiasis~ hence; corneal opacity progression is also less likely in peripheral recurrent trichiasis cases. AIM 3: Characterize changes in eyelid contour abnormality severity and investigate modifiable risk factors. Hypotheses: Granulomas are responsible for a substantial portion of contour abnormalities. Contour abnormalities that are evident immediately post-operatively are less likely to regress. Data from this project have strong potential to make an immediate and profound impact on decision making for National Trachoma Control programs worldwide by guiding TT management decisions. In addition, this project is aligned with the United Nations' Millennium Development Goals, which focuses on reducing poverty, hunger, and disease.