Infant Aphakia Treatment Study

婴儿无晶体眼治疗研究

• 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
• 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

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）：现在的眼内镜头（IOL）已被接受的年龄较大儿童的白内障治疗，并且越来越多地用于年幼的儿童甚至婴儿中，但对在快速生长的眼睛中植入的安全性或适当的能力知之甚少。 可用的数据表明，在白内障手术时接受IOL植入的婴儿可以更稳定地获得良好的视力结果，但是在白内障手术时进行了IOL植入，但是用于评估这些系列视觉结果的方法已被化为未标准化，并且可能已被高估了Pseudophophapic of peceudophophapic of Eyes的视觉结果。 此外，这些系列通常报道了假性摇摆的并发症比出色的眼睛更多。 因此，问题 - 治疗单方面阿法基亚的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单侧白内障的婴儿的两种治疗方法。 对照组将接受常规治疗，该治疗涉及白内障手术，然后通过隐形眼镜进行光学处理，然后再与眼镜治疗结合。实验组也将接受白内障手术，但此外，在同一手术期间还将植入IOL。 IOL将用作主要的光学处理。任何残留折射误差都将通过眼镜校正。 这项随机，多中心的临床试验将：1）确定单侧白内障的婴儿在12个月大的年龄时是否更有可能具有少于0.2 logmar的眼部敏锐度差异，如果他们经过IOL的原发性植入或主要使用隐形眼镜进行校正； 2）确定在经历IOL的主要植入的眼中是否需要更多的并发症发生； 3）确定单侧先天性白内障婴儿的父母是否主要接受IOL治疗，是否会减少育儿压力。 该试验的公共健康重要性不仅涉及每年在美国出生的大约300名儿童，具有单侧的先天性白内障，而且每年出生的儿童每年都有双侧白内障或在童年时期获得白内障的儿童。