Infant Aphakia Treatment Study

婴儿无晶体眼治疗研究

基本信息

批准号：
8293270
负责人：
SCOTT R LAMBERT
金额：
$ 84.63万
依托单位：
EMORY UNIVERSITY
依托单位国家：
美国
项目类别：
财政年份：
2004
资助国家：
美国
起止时间：
2004-07-01 至 2013-09-29
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8293270
关键词：
Affect Age Age-Months Anterior Aphakia Bilateral Caring Cataract Cataract Extraction Child Childhood Clinical Clinical Trials Contact Lenses Control Groups Coupled Crystalline Lens Data Eligibility Determination Ensure Examination Under Anesthesia Eye Eyeglasses Funding Implant Incidence Infant Inferior Intraocular Lens Implantation Intraocular lens implant device Literature Methods Multi-Institutional Clinical Trial Operative Surgical Procedures Ophthalmologist Optics Outcome Outcome Measure Parenting behavior Parents Patients Pilot Projects Public Health Randomized Randomized Clinical Trials Recruitment Activity Refractive Errors Regimen Relative (related person)Repeat Surgery Reporting Residual state Resolution Safety Sample Size Schedule Series Strabismus Stress Surveys Testing Time United States Visual Visual Acuity Vitrectomy cell motility congenital cataract conventional therapy design early childhood experience improved infancy legally blind primary outcome secondary outcome sound trend

项目摘要

DESCRIPTION (provided by applicant): Intraocular lenses (IOLs) are now accepted treatment for cataracts in older children and are being used increasingly in younger children and even infants, but little is known about the safety or the appropriate power to implant in a rapidly growing eye. Available data suggest that a fair-to-good visual acuity outcome can be more consistently obtained in infants with a unilateral congenital cataract who undergo IOL implantation at the time of cataract surgery, but the methods used to assess the visual outcome in these series have been nonstandardized and may have overestimated the visual acuity of the pseudophakic eyes. Moreover, these series have generally reported more complications in pseudophakic than aphakic eyes. Therefore, the question - What is the best way to treat infants with unilateral aphakia? - remains unanswered. The objective of this randomized multicenter clinical trial is to compare two treatments for infants with a unilateral congenital cataract. The control group will receive the conventional treatment that involves cataract surgery followed by optical treatment with a contact lens and later coupled with spectacle treatment. The experimental group will also undergo cataract surgery but in addition will have an IOL implanted during the same surgery. The IOL will serve as the primary optical treatment any residual refractive error will be corrected with spectacles. This randomized, multi-center clinical trial will: 1) determine whether infants with a unilateral congenital cataract are more likely to have an interocular acuity difference of less than 0.2 LogMAR when 12 months of age if they undergo primary implantation of an IOL or if they are corrected primarily with a contact lens; 2) determine whether more complications develop and reoperations are necessary in eyes undergoing the primary implantation of an IOL; and 3) determine whether parents of infants with a unilateral congenital cataract experience less parenting stress if their child is primarily treated with an IOL. The public health importance of this trial not only involves the approximately 300 children born each year in the United States with a unilateral congenital cataract, but also the many more children born each year with bilateral cataracts or who acquire a cataract during early childhood.

描述（由申请人提供）：人工晶状体（IOL）现已被接受为年龄较大儿童的白内障治疗方法，并且越来越多地用于年幼的儿童甚至婴儿，但对于植入快速生长的儿童的安全性或适当的能力知之甚少。眼睛。现有数据表明，在白内障手术时接受人工晶状体植入的单侧先天性白内障婴儿可以更一致地获得中等至良好的视力结果，但这些系列中用于评估视力结果的方法一直没有得到证实。非标准化，可能高估了人工晶状体眼的视力。此外，这些系列报告普遍显示，人工晶状体眼的并发症多于无晶状体眼。因此，问题是——治疗单侧无晶状体婴儿的最佳方法是什么？ - 仍未得到答复。这项随机多中心临床试验的目的是比较对患有单侧先天性白内障的婴儿的两种治疗方法。对照组将接受常规治疗，包括白内障手术、隐形眼镜光学治疗以及眼镜治疗。实验组还将接受白内障手术，但在同一手术中还将植入人工晶状体。 IOL 将作为主要的光学治疗，任何残余屈光不正都将通过眼镜进行矫正。这项随机、多中心临床试验将：1) 确定患有单侧先天性白内障的婴儿在 12 个月大时，如果接受人工晶状体初次植入，或者如果他们接受人工晶状体植入术，眼间视力差异是否更有可能小于 0.2 LogMAR主要通过隐形眼镜矫正； 2) 确定初次植入人工晶状体的眼睛是否出现更多并发症以及是否需要再次手术； 3) 确定患有单侧先天性白内障的婴儿的父母如果他们的孩子主要接受人工晶状体治疗，他们的养育压力是否会减轻。这项试验对公共卫生的重要性不仅涉及美国每年出生的大约 300 名患有单眼先天性白内障的儿童，而且还涉及每年出生的双侧白内障或在儿童早期患上白内障的更多儿童。