Secondary Analyses of data from the Infant Aphakia Treatment Study: Patching in Children with Unilateral Congenital Cataracts and Poor Visual Acuity

婴儿无晶体眼治疗研究数据的二次分析：单侧先天性白内障和视力不佳儿童的修补

• 批准号: 10373231
• 负责人: MARIANNE CELANO
• 金额: $ 22.68万
• 依托单位: GEORGE MASON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-02-01 至 2024-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10373231
• 关键词: 3 year old; Address; Adherence; Affect; Age; Aphakia; Caregivers; Cataract Extraction; Child; Child Behavior; Child Rearing; Childhood; Costs and Benefits; Coupled; Cues; Data; Data Analyses; Effectiveness; Eye; Goals; Habits; Hour; Implant; Infant; Intraocular lens implant device; Knowledge; Life; Longterm Follow-up; Measures; Medical; Nursery Schools; Operative Surgical Procedures; Ophthalmologist; Ophthalmology; Optics; Outcome; Parents; Participant; Population; Problem behavior; Protocols documentation; Provider; Quality of life; Randomized Controlled Trials; Reporting; Schools; Selection Bias; Source; Stress; Time; Translating; Treatment Protocols; Vision; Visual; Visual Acuity; aged; base; cohort; congenital cataract; cost; elementary school; evidence base; evidence based guidelines; follow-up; improved; improved outcome; infancy; negative affect; secondary analysis; therapy development; tool; trial comparing; trial design

Project Title: Secondary Analyses of data from the Infant Aphakia Treatment Study: Patching in Children with Unilateral Congenital Cataracts and Poor Visual Acuity Project Summary: Unilateral congenital cataracts (UCC) are one of the most difficult problems in pediatric ophthalmology. Early surgical intervention, and consistent optical correction and patching therapy are necessary to allow for the possibility of achieving good vision in this eye. Currently, children treated for UCC are advised to patch the unaffected eye for 50% of waking hours throughout the first five years of life, and often into the elementary school years. Even with early surgery and consistent patching relatively few of these eyes develop good visual acuity (VA) by the time the children enter school. A high proportion of children who do not develop useable vision in the treated eye and many caregivers have difficulty patching their children for the prescribed amount of time. Therefore, the utility of extended patching in eyes destined to have poor vision is unclear, and the costs of therapy need to be weighed against possible benefits. However, few data are available regarding how to help caregivers adhere to prescribed patching protocols or to help providers and caregivers determine when the costs of such patching outweigh the potential benefits. These gaps have limited the development of treatment protocols to address the needs of this population. Therefore, there is little evidence which can be used to guide clinicians and caregivers in deciding how much patching to provide and when to discontinue patching. The proposed project will leverage unique secondary data collected in the Infant Aphakia Treatment Study (IATS) in order to provide guidance on establishing patching habits that may improve outcomes. We will also conduct analyses that will improve understanding of the costs and benefits of patching in the latter part of the preschool period in children treated for UCC. Specifically, we will determine whether it is possible to accurately identify children who will ultimately have little usable vision in their affected eye using information collected in the first four years of life, and if quality of life is impacted by prolonged patching in children who ultimately will not see well. The IATS is a randomized controlled trial designed to compare two treatments for UCC: leaving children aphakic versus implanting an intraocular lens (IOL) at the time of cataract surgery. The primary study is one of the largest currently-available cohorts of children treated for UCC, and has provided important evidence about outcomes in these children prior to school-entry. The proposed R21 will leverage data from this unique, well- characterized cohort of children treated for UCC who have been followed for more than 10 years to generate new knowledge about important questions related to treatment of UCC.

项目名称：婴儿无晶体眼治疗研究数据的二次分析：患有以下疾病的儿童进行修补 单眼先天性白内障和视力不佳 项目概要：单侧先天性白内障（UCC）是儿科最棘手的问题之一 眼科。早期手术干预以及持续的光学矫正和修补治疗是 为了使这只眼睛能够获得良好的视力，这是必要的。目前，接受 UCC 治疗的儿童 建议在生命的头五年中，用 50% 的醒着时间来遮盖未受影响的眼睛，并且经常 进入小学阶段。即使进行了早期手术并持续进行遮盖，这些眼睛的数量也相对较少 当孩子们进入学校时，培养良好的视力（VA）。很大比例的孩子不 接受治疗的眼睛发展出可用的视力，许多护理人员很难为孩子戴上眼罩 规定的时间。因此，对注定视力不佳的眼睛进行长期遮盖的效用是 尚不清楚，并且需要权衡治疗成本与可能的益处。然而，很少有数据 有关如何帮助护理人员遵守规定的修补方案或帮助提供者和 护理人员会确定此类修补的成本何时超过潜在收益。这些差距有 限制了治疗方案的制定以满足该人群的需求。因此，很少有 可用于指导临床医生和护理人员决定提供多少补丁和 何时停止修补。 拟议的项目将利用婴儿无晶状体治疗研究中收集的独特二手数据 (IATS)，以便为建立可能改善结果的修补习惯提供指导。我们也会 进行分析，以提高对后期修补的成本和收益的了解 接受 UCC 治疗的儿童的学龄前时期。具体来说，我们将确定是否可以准确地 使用收集到的信息来识别受影响眼睛最终几乎没有可用视力的儿童 生命的头四年，如果儿童的生活质量受到长期修补的影响，他们最终将 没看清楚。 IATS 是一项随机对照试验，旨在比较 UCC 的两种治疗方法： 无晶状体眼与白内障手术时植入人工晶状体 (IOL) 的比较。主要研究是其中之一 目前最大的接受 UCC 治疗的儿童队列，并提供了重要的证据 这些儿童入学前的结果。拟议的 R21 将利用来自这个独特的、良好的数据 对接受 UCC 治疗的儿童进行了 10 多年的跟踪研究，以产生 有关 UCC 治疗相关重要问题的新知识。