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临床试验/NCT03334513
NCT03334513已完成不适用

Refractive and Biometric Outcomes in Patients With Retinopathy of Prematurity Treated With Intravitreal Injection of Ranibizumab as Compared With Bevacizumab - a Clinical Study of Correction at Three Years of Age

San Ni Chen0 个研究点目标入组 35 人开始时间: 2011年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
35
主要终点
spherical equivalent

研究概览

简要总结

The investigators compared long-term refractive and biometric outcomes in children with retinopathy of prematurity who received two different anti-vascular endothelial growth factor agents.

详细描述

Purpose:

To compare refractive and biometric outcomes in patients with type 1 retinopathy of prematurity (ROP) treated with intravitreal injection of Ranibizumab (IVR), versus bevacizumab (IVB), at a corrected age of 3 years.

Methods:

A retrospective case series compared cycloplegic refractive statuses and biometric statuses in patients who received either IVR or IVB for Type 1 ROP, from April 2011 to April 2014.

Comparison of refractive errors and biometric findings between the two groups was performmed and multivariate analysis of possible factors contributive to visual acuity was also performmed

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
3 Years 至 3 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children with type 1 retinopathy of prematurity
  • children received anti-vascular endothelial growth factors (bevacizumab or ranibizumab)

排除标准

  • children withour retinopathy of prematurity
  • children with retinopathy of prematurity received laser therapy

研究组 & 干预措施

ROP group

children with retinopathy of prematurity received either bevacizumab or ranibizumab

干预措施: Bevacizumab (Drug)

ROP group

children with retinopathy of prematurity received either bevacizumab or ranibizumab

干预措施: Ranibizumab (Drug)

结局指标

主要结局

spherical equivalent

时间窗: at corrected age of 3 year-old

spherical power + half of cylinder power

astigmatism

时间窗: at corrected age of 3 year-old

in cylinder power

次要结局

  • axial length(at corrected age of 3 year-old)
  • lens thickness(at corrected age of 3 year-old)
  • cornea radius(at corrected age of 3 year-old)
  • anterior chamber depth(at corrected age of 3 year-old)

研究者

发起方
San Ni Chen
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

San Ni Chen

medical doctor

Changhua Christian Hospital

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