Infant Aphakia Treatment Study

婴儿无晶体眼治疗研究

• 批准号: 8554493
• 负责人: SCOTT R LAMBERT
• 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: 2004-07-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8554493
• 关键词: 1 year old; 10 year old; 4 year old; 5 year old; Age; Age-Months; Age-Years; Amblyopia; Aphakia; Blindness; Cataract; Cataract Extraction; Cell Count; Chairperson; Child; Childhood; Clinical; Clinical Trials; Contact Lenses; Cornea; Data; Data Coordinating Center; Diagnosis; Endothelial Cells; Enrollment; Excision; Eye; Eyeglasses; Funding; Glass; Glaucoma; Goals; Grant; Incidence; Infant; Intraocular Lens Implantation; Intraocular lens implant device; Length; Measures; Newly Diagnosed; Operative Surgical Procedures; Optics; Outcome; Patients; Phase; Physiologic Intraocular Pressure; Pongidae; Public Health; Randomized; Recommendation; Refractive Errors; Relative (related person); Reporting; Research; Risk; Safety; Sample Size; Testing; Thick; Time; United States; Vision; Visual; Visual Acuity; Work; base; blind; cohort; congenital cataract; design; follow-up; improved; infancy; lens; non-compliance; 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 years. 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 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. lATS is funded through two grants, one for the Chairman's Office (U10 EY013272, Scott Lambert, PI) and one for the Data Coordinating Center (U10 EY013287, Michael Lynn, PI).

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LATS患者。所有患者涉及的LATS的第1阶段至一岁，因此可以用teller敏锐的卡评估光栅敏锐度，并于2010年1月完成。涉及所有患者的LATS的第2阶段与5岁的患者相关，并在4岁时通过HOTV测试评估了Optotype敏锐度。现在，我们要求额外的资金在10岁时对这些患者进行另一次临床检查，以便可以在两个治疗组之间比较以下因素：1）使用E-ETDRS logmar图表的主要结果，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仅影响了美国每年大约400名儿童，并具有单方面的先天性白内障，而且还影响了全球范围内有200,000名儿童。 LATS是通过两项赠款资助的，一项是为董事长办公室（U10 EY013272，Scott Lambert，PI）提供资金，另一个用于数据协调中心（U10 EY013287，Michael Lynn，PI）。