Coordinating Center for Infant Aphakia Treatment Study (IATS)

婴儿无晶体眼治疗研究协调中心 (IATS)

• 批准号: 8552196
• 负责人: MICHAEL J LYNN
• 金额: --
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-06-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8552196
• 关键词: 1 year old; 10 year old; 5 year old; Adverse event; Age; Age-Months; Age-Years; Amblyopia; Aphakia; Applications Grants; Blindness; Cataract; Cataract Extraction; Cell Count; Chairperson; Child; Childhood; Clinical; Clinical Trials; Contact Lenses; Cornea; Data; Data Coordinating Center; Diagnosis; Early treatment; Endothelial Cells; Enrollment; Excision; Eye; Eyeglasses; Funding; Glass; Glaucoma; Goals; Grant; Incidence; Infant; Intraocular lens implant device; Length; Measures; Monitor; Newly Diagnosed; Operative Surgical Procedures; Optics; Outcome; Patient Monitoring; Patients; Phase; Physiologic Intraocular Pressure; Principal Investigator; Public Health; Randomized; Recommendation; Refractive Errors; Relative (related person); Reporting; Research; Research Design; Risk; Safety; Sample Size; Testing; Thick; Time; United States; Vision; Visual; Visual Acuity; Work; base; blind; cohort; congenital cataract; data management; design; follow-up; implantation; infancy; lens; non-compliance; patient safety; primary outcome; public health relevance; success

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.

描述（由申请人提供）：眼内镜头（LOL）是白内障手术后大儿童的接受治疗，并且越来越多地用于年幼的儿童和婴儿中，但对LOLS快速生长的眼睛的安全性或功效知之甚少。婴儿阿法基亚治疗研究（LATS）的目的是比较儿童在1至7个月之间去除单侧先天性白内障的婴儿的相对疗效和安全性与隐形眼镜校正的相对疗效和安全性。临床试验的主要结果是视力。我们在2004年12月至2009年1月之间招募了114名患者。涉及所有患者的LATS的第1阶段，以便使用Teller Acuity卡评估光栅敏锐度，并于2010年1月完成。涉及所有患者的LATS的2阶段2阶段，每年5岁，并在5岁时进行了调查，并在4 1/2年度进行了临时测试。在10岁的这些患者中，可以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）长期随访后青光眼的发生率。这项临床试验的公共卫生重要性不是一定会影响美国每年出生的大约400名儿童，其单方面白内障，但全世界有200,000名因白内障而失明的儿童。 LATS通过两项赠款资助，一项用于董事长办公室（U10 EY013272，Scott Lambert，pi），一项用于数据协调中心（DCC）（U10 EY013287，Michael Lynn，PI）。本赠款申请的目的是为DCC索取额外的资金。 DCC将执行LATS的以下方面：研究设计，数据管理，不良事件和患者安全监控，统计报告和分析，临床中心监测，患者跟踪和试验管理。