Secondary Analysis of Four Trichiasis Surgery Clinical Trials to Inform Managemen

描述（由申请人提供）：该申请是对PAR-09-252“二次数据分析研究项目资助”的回应，并且对NEI具有“最高的编程兴趣”，因为它使用了NEI资助的临床试验的数据。沙眼倒睫（TT）是全世界致盲的主要传染性原因，影响到800多万人。虽然TT可以通过手术矫正，但程序性设置的复发率在30-60%之间。世卫组织设定了到2020年消除致盲性沙眼的目标，这将需要在未来7年内成功进行1.5亿例沙眼手术。迫切需要更新的TT治疗指南，特别是复发性TT和眼睑轮廓异常，以帮助制定手术计划。最近的四项临床试验对成功的实践有了先进的认识。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四项互补倒睫手术试验的数据，以研究直接影响倒睫治疗的流行病学问题。这些已完成的试验包括nei资助的STAR试验、PRET手术、可吸收缝合线与丝性缝合线、手术与脱毛。每次试验收集的数据元素基本相同。这些试验将用于解决以下具体目的：目的1：确定复发性倒睫进展的风险为不同的倒睫模式。假设：仅外周复发性倒睫比累及中央鞭的复发性倒睫进展的可能性要小。目的2：计算脱毛者中角膜混浊进展的概率，基于事件倒睫的睫毛位置，并利用该信息预测复发性倒睫患者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

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.