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临床试验/NCT04872829
NCT04872829已完成不适用

Comparative Analysis of Visual Outcomes of Multifocal and Monofocal Intraocular Lenses in Congenital Cataract Surgery

Bambino Gesù Hospital and Research Institute0 个研究点目标入组 43 人开始时间: 2008年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
43
主要终点
Mean CDVA

研究概览

简要总结

The aim of this study is to evaluate long-term outcome after congenital cataract surgery comparing results achieved with multifocal and monofocal IOLs.

详细描述

PURPOSE: To assess the impact on visual development of multifocal versus monofocal intraocular lenses (IOLs) implantation in children following congenital cataract surgery.

DESIGN: Retrospective interventional consecutive case series. METHODS: We reviewed the records of 56 eyes of 43 pediatric patients who underwent congenital cataract surgery with phacoaspiration and simultaneous implantation of IOL under one year of age. Corrected distance visual acuity (CDVA), refractive error and ocular motility disorders were evaluated after a follow-up greater than 4 years.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
6 Months 至 12 Months(Child)
性别
All
接受健康志愿者

入选标准

  • unilateral congenital cataract
  • bilateral congenital cataract

排除标准

  • other ocular pathologies (such as glaucoma, microphthalmia, micro - or megalocornea, persistent fetal vasculature, retinal congenital disease, corneal scar, traumatic cataracts)
  • systemic diseases (such as chromosomal abnormalities, prematurity or mental retardation)

结局指标

主要结局

Mean CDVA

时间窗: CDVA was evaluated after 4 years of age.

Corrected distance visual acuity (CDVA), calculated in logarithm of the minimum angle of resolution (logMAR), using standard Snellen charts

次要结局

未报告次要终点

研究者

发起方
Bambino Gesù Hospital and Research Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Luca Buzzonetti

Head of the Ofthalmology Departement

Bambino Gesù Hospital and Research Institute

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