The infant aphakia treatment study: design and clinical measures at enrollment.

The infant aphakia treatment study: design and clinical measures at enrollment.
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DOI:
10.1001/archophthalmol.2009.350
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发表时间:
2010-01
影响因子:
--
通讯作者:
Wilson, M. Edward
Wilson, M. Edward
中科院分区:
其他
文献类型:
--
作者:
Lambert, Scott R.;Buckley, Edward G.;Drews-Botsch, Carolyn;DuBois, Lindreth;Hartmann, Eugenie;Lynn, Michael J.;Plager, David A.;Wilson, M. Edward

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比较婴儿期单侧无晶状体眼的光学矫正中隐形眼镜和人工晶状体(IOL)的效果。 在一项随机、多中心(12个地点)的临床试验中,114名患有单侧先天性白内障的婴儿被分配接受白内障手术,手术时有的植入人工晶状体,有的不植入。随机接受人工晶状体治疗的儿童其剩余屈光不正用眼镜矫正。随机不植入人工晶状体的儿童其无晶状体眼用隐形眼镜治疗。 12个月龄时的光栅视力和4.5岁时的HOTV视力 招募于2004年12月开始,2009年1月完成。白内障手术时的中位年龄为1.8个月。50名患者在招募时年龄为4 - 6周,32名患者年龄在49天至3个月之间,其余32名儿童年龄在3至7个月之间。57名儿童被随机分配到人工晶状体植入组或无晶状体眼组(每组各57人)。患白内障的眼睛平均比对侧眼轴长更短且角膜更陡。 婴儿无晶状体眼的最佳光学治疗方法尚不清楚。婴儿无晶状体眼治疗研究(IATS)旨在提供实证,以确定婴儿期单侧白内障手术后使用人工晶状体或隐形眼镜进行光学治疗是否与更好的视力结果相关。
To compare contact lenses and intraocular lenses (IOLs) for the optical correction of unilateral aphakia during infancy. In a randomized, multicenter (12 sites) clinical trial, 114 infants with a unilateral congenital cataract were assigned to undergo cataract surgery either with or without IOL implantation. Children randomized to IOL treatment had their residual refractive error corrected with spectacles. Children randomized to no IOL had their aphakia treated with a contact lens Grating acuity at 12 months of age and HOTV visual acuity at 4.5 years of age Enrollment began in December 2004 and was completed in January 2009. The median age at the time of cataract surgery was 1.8 months. Fifty patients were 4–6 weeks of age at the time of enrollment, 32 patients were between 49 days and 3 months of age and the remaining 32 children were 3 to 7 months of age. Fifty-seven children were randomized to each treatment group with either IOL placement or aphakia. The eyes with cataracts had shorter axial lengths and steeper corneas on average than the fellow eyes. The optimal optical treatment of aphakia in infants is unknown. IATS was designed to provide empirical evidence whether optical treatment with an IOL or a contact lens following unilateral cataract surgery during infancy is associated with a better visual outcome.
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