Coordinating Center for Infant Aphakia Treatment Study (IATS)

描述（由申请人提供）：人工晶状体（lol）现在是大龄儿童白内障手术后接受的治疗方法，并且越来越多地用于年幼的儿童和婴儿，但是对于快速生长的眼睛，人工晶状体的安全性和有效性知之甚少。婴儿无晶状体治疗研究（lATS）的目的是比较lOL矫正与隐形眼镜矫正在1至7个月大的婴儿单侧先天性白内障摘除中的相对疗效和安全性。临床试验的主要结果是视力。2004年12月至2009年1月，我们在lATS中招募了114名患者。lATS的第一阶段包括跟踪所有患者至一岁，以便使用泰勒视力卡评估光栅视力，并于2010年1月完成。lATS的第二阶段包括跟踪所有患者至5岁，并在4岁半测试时使用HOTV测试评估视型视力，该测试将于2014年初完成。我们现在正在申请额外的资金，对这些患者在10岁时进行更多的临床检查，以便在两个治疗组之间比较以下因素：1)主要结果，使用E-ETDRS logMAR图表的视力；2)青光眼的发病率经过较长时间的随访。这项临床试验的公共卫生重要性不仅影响到美国每年出生的大约400名患有单侧先天性白内障的儿童，而且影响到全世界因白内障而失明的20万儿童。lATS由两笔赠款资助，一笔用于主席办公室（U10 EY013272, Scott Lambert， PI），另一笔用于数据协调中心（DCC） （U10 EY013287, Michael Lynn， PI）。本赠款申请的目的是为DCC请求额外的资金。DCC将开展lATS的以下方面工作：研究设计、数据管理、不良事件和患者安全监测、统计报告和分析、临床中心监测、患者跟踪和试验管理。

DESCRIPTION (provided by applicant): Intraocular lenses (lOLs) are now the accepted treatment following cataract surgery in older children and are being used increasingly in younger children and infants, but little is known about the safety or efficacy of lOLs for a rapidly growin eye. The objective of the Infant Aphakia Treatment Study (lATS) is to compare the relative efficacy and safety of lOL correction versus contact lens correction in infants with a unilateral congenital cataract removed between the ages of 1 to 7 months. The primary outcome of the clinical trial is visual acuity. We enrolled 114 patients in lATS between December 2004 and January 2009. Phase 1 of the lATS involved following all patients to one year of age so that grating acuity could be assessed with Teller Acuity cards and was completed in January 2010. Phase 2 of lATS involved following all patients to 5 years of age and assessing optotype acuity with the HOTV test at age 4 1/2 years test and will be completed in early 2014. We are now requesting additional funding to perform one more clinical examination of these patients at age 10 years so that the following factors can be compared between the two treatment groups: 1) the primary outcome, visual acuity using the E-ETDRS logMAR chart; and 2) the incidence of glaucoma after a longer-term follow-up. The public health importance of this clinical trial not onl impacts the approximately 400 children born each year in the United States with a unilateral congenital cataract, but also the 200,000 children worldwide who are blind from cataracts. lATS is funded through two grants, one for the Chairman's Office (U10 EY013272, Scott Lambert, PI) and one for the Data Coordinating Center (DCC) (U10 EY013287, Michael Lynn, PI). The purpose of this grant application is to request the additional funding for the DCC. The DCC will carry out the following aspects of lATS: study design, data management, adverse event and patient safety monitoring, statistical reporting and analysis, clinical center monitoring, patient tracking, and trial administration.