Coordinating Center for Infant Aphakia Treatment Study (IATS)

 描述(申请人提供)：人工晶状体(IOL)现在是年龄较大的儿童白内障手术后公认的治疗方法，越来越多地用于年幼的儿童和婴儿，但对IOL对快速生长的眼睛的安全性或有效性知之甚少。婴儿无晶状体眼治疗研究(IATS)的目的是比较人工晶状体矫正术和隐形眼镜矫正术在1至7个月大的婴儿单眼先天性白内障手术中的相对有效性和安全性。我们在2004年12月至2009年1月期间在IATS招募了114名患者。IATS的第一阶段包括跟踪所有患者至一岁，以便可以使用Teller Acuity卡评估光栅视力，并于2010年1月完成。IATS第二阶段包括跟踪所有患者至5岁，并在4岁半时用HOTV测试评估视力，并于2014年初完成。我们现在正在申请额外的资金，以便在这些患者10岁时再进行一次临床检查，以便可以比较两个治疗组在较长期随访后的青光眼发病率。此外，我们将确定人工晶状体组近视移位10年的特征，并确定基线风险因素，如白内障手术年龄和眼轴长度，以及儿童时期出现的其他因素，如弱视和青光眼，这些因素与比预期更大的近视移位有关。这项临床试验的公共卫生重要性不仅影响到美国每年约400名出生时患有单侧先天性白内障的儿童，也影响到全球20万因白内障而失明的儿童。IATS的第一阶段和第二阶段通过两笔赠款提供资金，一笔用于主席办公室，一笔用于数据协调中心。这项拨款申请的目的是为DCC申请第三阶段的额外资金。DCC将执行IATS的以下方面：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 (IOLs) 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 IOLs for a rapidly growin eye. The objective of the Infant Aphakia Treatment Study (IATS) is to compare the relative efficacy and safety of IOL correction versus contact lens correction in infants with a unilateral congenital cataract removed between the ages of 1 to 7 months. We enrolled 114 patients in IATS between December 2004 and January 2009. Phase 1 of the IATS 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 IATS 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 was 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 incidence of glaucoma after a longer- term follow-up can be compared between the two treatment groups. In addition, we will characterize myopic shift by 10 years in IOL group and identify baseline risk factors such as age of cataract surgery and axial length and other factors that arise during childhood, such as amblyopia and glaucoma, that are associated with a larger than expected myopic shift. The public health importance of this clinical trial not only 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. Phases 1 and 2 of the IATS are funded through two grants, one for the Chairman's Office and one for the Data Coordinating Center (DCC). The purpose of this grant application is to request the additional funding for the DCC for Phase 3. The DCC will carry out the following aspects of IATS: study design, data management, adverse event and patient safety monitoring, statistical reporting and analysis, clinical center monitoring, patient tracking, and trial administration.