Secondary Analysis of Four Trichiasis Surgery Clinical Trials to Inform Managemen

四项倒睫手术临床试验的二次分析，为管理人员提供信息

• 批准号: 8635352
• 负责人: EMILY W GOWER
• 金额: $ 18.62万
• 依托单位: WAKE FOREST UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-04-01 至 2016-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8635352
• 关键词: Address; Affect; Blindness; Chronic Conjunctivitis; Cicatrix; Clinical; Clinical Trials; Cornea; Corneal Opacity; Data; Data Analyses; Data Element; Decision Making; Development; Disease; Epidemiology; Etiology; Excision; Eye; Eyelash; Eyelid structure; Forcep; Foreign-Body Reaction; Funding; Goals; Granuloma; Growth; Guidelines; Hair Removal; Hunger; Knowledge; Location; Manuscripts; National Eye Institute; Natural History; Operative Surgical Procedures; Outcome; Pain; Pattern; Peripheral; Postoperative Period; Poverty; Prevalence; Probability; Recommendation; Recurrence; Repeat Surgery; Research; Research Project Grants; Resources; Risk; Risk Factors; Severities; Silk; Surgical sutures; Time; Touch sensation; Trachoma; United Nations; Update; Work; World Health Organization; arm; base; case-based; design; improved; interest; modifiable risk; pathogen; prevent; programs; public health relevance; response; trial comparing

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.

描述（由申请人提供）：本申请是对PAR-09-252，“二级数据分析研究项目赠款”的回应，对NEI来说具有“最高的项目兴趣”，因为它利用了NEI资助的临床试验的数据。 沙眼性倒睫（TT）是世界范围内导致失明的主要传染性原因，影响超过800万人。 虽然TT可以通过手术纠正，但在程序设置中的复发率范围为30- 60%。 世界卫生组织制定了到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1500万次TT手术。 目前迫切需要更新TT管理指南，特别是针对复发性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进一步的了解。 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倒睫手术试验的数据，以研究直接影响TT管理的流行病学问题。 这些已完成的试验包括NEI资助的星星试验、PRET手术、可吸收缝线与丝线缝线以及手术与脱毛。 每项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标：目的1：确定不同倒睫睫毛模式的复发性倒睫进展的风险。假设：复发性倒睫，仅是周边是不太可能进展比复发性倒睫中央睫毛受累。目标2：根据倒睫发生的睫毛位置计算脱毛者角膜混浊进展的概率，并使用此信息预测复发性倒睫病例角膜混浊进展的概率。 假设条件： 角膜混浊进展的可能性大大降低 轻度周边倒睫的患眼比中央倒睫的患眼更易发生角膜混浊，因此，周边复发性倒睫病例中角膜混浊进展的可能性也较小。 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：肉芽肿是造成轮廓异常的主要原因。 术后即刻明显的轮廓异常不太可能消退。 该项目的数据具有强大的潜力，通过指导TT管理决策，对全球国家沙眼控制计划的决策产生直接和深远的影响。 此外，该项目与联合国千年发展目标保持一致，该目标侧重于减少贫困、饥饿和疾病。