Infant Aphakia Treatment Study-Clinical Centers

婴儿无晶体眼治疗研究-临床中心

• 批准号: 9354491
• 负责人: CAROLYN Dawson DREWS-BOTSCH
• 金额: $ 24.54万
• 依托单位: EMORY UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-09-01 至 2019-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9354491
• 关键词: 10 year old; 5 year old; Adverse event; Affect; Age; Aphakia; Blindness; Cataract; Cataract Extraction; Child; Clinical; Clinical assessments; Companions; Contact Lenses; Diagnosis; Enrollment; Event; Eye; Family; Follow-Up Studies; Funding; Glaucoma; Grant; Incidence; Infant; Intraocular Lens Implantation; Intraocular lens implant device; Leadership; Operative Surgical Procedures; Ophthalmic examination and evaluation; Optics; Parents; Patients; Phase; Randomized; Reporting; Risk Factors; Sample Size; Serious Adverse Event; Suspect Glaucomas; Testing; Time; Touch sensation; Travel; Vision; Vision research; Visit; Visual; Visual Acuity; Work; base; clinical research site; congenital cataract; design; follow-up; infancy; primary outcome; public health relevance; research study; response; social media; treatment group; trend

 DESCRIPTION (provided by applicant): Congenital cataracts are one of the leading causes of blindness among children. For children born with a unilateral cataract, early surgical intervention and consistent optical correction and patching therapy are critical to achieve good vision in this eye. Glaucoma continues to be one of the most serious long term complications in eyes undergoing cataract surgery during early infancy. The Infant Aphakia Treatment Study (IATS) was designed to compare the visual acuity of children after unilateral congenital cataract surgery randomized to either intraocular lens (IOL) or contact lens (CL) correction. Enrollment and randomized treatment of the target sample size of 114 patients (IOL, n=57; CL, n=57) began in December 2004 and was completed in January 2009. We found that the optotype acuity was not significantly different between the study eyes in the two treatment groups at age 41/2 years (p=.54). However, at the full clinical assessment performed at age 5 years, we found that significantly more study eyes in the IOL group had had at least 1 adverse event (p=.02) and at least 1 additional intraocular surgery (p<.001). We also noted that the cumulative incidence of a diagnosis of glaucoma was similar in study eyes in both treatment groups at age 5 years (IOL group, 19%; CL group, 16%). However, using the combined diagnosis glaucoma or glaucoma suspect status, there was a trend noted for more study eyes in the CL group to be affected between ages 1 and 5 years compared to the IOL group (IOL group, 28%; CL group, 35%). In this renewal application for years 13-16 of the IATS, we are proposing to examine these children one more time, in their 10th year (Phase 3), to further elucidate the relationship between initial optical correction, an IOL or a CL, and the incidence of glaucoma. In addition, we will better characterize the longer term myopic shift that occurs in the eyes randomized to primary IOL implantation.

 描述（应用程序提供）：先天性白内障是儿童失明的主要原因之一。对于患有单侧白内障的儿童，早期手术干预 一致的光学校正和修补疗法对于在这只眼中实现良好的视力至关重要。青光眼仍然是在婴儿早期接受白内障手术的眼睛中最严重的长期并发症之一。婴儿阿法基亚治疗研究（IAT）的设计是为了比较单侧先天性白内障手术随机与眼内透镜（IOL）或隐形眼镜（CL）校正后的儿童视力。对目标样本量的入学和随机治疗114例患者（IOL，n = 57; Cl，n = 57）于2004年12月开始，并于2009年1月完成。我们发现，在41/2岁年龄段的两个治疗组中，研究眼睛之间的选择性型敏锐度没有显着差异（p = .54）。但是，在5岁时进行的完整临床评估中，我们发现IOL组的研究眼至少有1个对抗事件（P = .02），至少另外1个眼内手术（P <.001）。我们还指出，在5岁时的两个治疗组中，研究眼的诊断青光眼的累积事件相似（IOL组，19％； CL组为16％）。但是，使用诊断性青光眼或青光眼可疑状态的综合，与IOL组相比，CL组的更多研究眼有一种趋势（IOL组，28％； CL组，35％）。在IAT的13 - 16年的这种续签应用中，我们提议在第10年（第3阶段）再检查这些儿童，以进一步阐明初始光学校正，IOL或CL与青光眼的发生之间的关系。此外，我们将更好地表征随机分配给主要IOL植入的长期近视转移。