NCT06729333已完成不适用
A Multicenter and Prospective Study of Screening Retinopathy of Prematurity in China
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine1 个研究点 分布在 1 个国家目标入组 4,841 人开始时间: 2024年12月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 4,841
- 试验地点
- 1
- 主要终点
- The incidence rate of ROP
研究概览
简要总结
The purpose of the study is to explore the current incidence rate of retinopathy of prematurity (ROP) in China and to explore more appropriate screening criteria for ROP.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •From December 2024 to May 2025, preterm infants (gestational age <37 weeks) or low birth weight infants (birth weight <2500 g) who receive their first ROP screening at Xinhua Hospital or partner institutions will be included.
排除标准
- •Death before the first screening;
- •Death or loss to follow-up before complete retinal vascularization;
- •Presence of other diseases causing incomplete retinal vascularization, such as familial exudative vitreoretinopathy, incontinentia pigmenti, or Coats disease;
- •Coexisting conditions affecting the classification or staging of ROP, such as corneal opacity, congenital cataract, persistent fetal vasculature, retinoblastoma, anophthalmia, Terson syndrome, or other ocular infections or diseases;
- •Poor systemic condition preventing fundus examination;
- •History of ocular trauma or surgery (excluding treatments for ROP);
- •Poor-quality fundus images;
- •Other conditions deemed exclusionary by the investigators.
结局指标
主要结局
The incidence rate of ROP
时间窗: 6 months after the first screening
Gestational age at which treatment-requiring ROP develops
时间窗: 6 months after the first screening
Birthweight at which treatment-requiring ROP develops
时间窗: 6 months after the first screening
次要结局
- Gestational age of infants developing any ROP lesion(6 months after the first screening)
- Birthweight of infants developing any ROP lesion(6 months after the first screening)
- Postmenstrual age (PMA) at which ROP lesions occur(6 months after the first screening)
- PMA at which treatment-requiring ROP occurs(6 months after the first screening)
- Screening and treatment costs(6 months after the first screening)
研究者
Peiquan Zhao
Director of the Department of Ophthalmology
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
研究点 (1)
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