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临床试验/NCT04342052
NCT04342052Enrolling By Invitation不适用

Glaucoma After Congenital Cataract Surgery

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 351 人开始时间: 2011年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
351
试验地点
1
主要终点
the incidence of glaucoma after congenital cataract surgery

研究概览

简要总结

To determine the incidence of glaucoma following bilateral congenital cataract removal and estimate the associated risk factors in a large cohort to provide guidance for clinical practice.

详细描述

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2025 was performed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • a diagnosis of bilateral congenital cataracts, the etiologies include congenital idiopathic cataract and congenital cataract associated with a systemic syndrome or ocular anomalies;
  • cataract surgery performed in ZOC;
  • age at cataract removal younger than 16 years;

排除标准

  • the preoperative IOP was above 21 mm Hg;
  • family history of glaucoma;
  • signs of preoperative glaucoma were present, such as corneal clouding, corneal enlargement, excessive cup-disc ratio and myopic shift;
  • ocular trauma history;
  • previous surgery intervention and
  • they were noncompliant with our follow-up protocol to monitor the occurrence of glaucoma and glaucoma suspect.

结局指标

主要结局

the incidence of glaucoma after congenital cataract surgery

时间窗: baseline

A Kaplan-Meier analysis was used

次要结局

  • Risk factors of glaucoma after congenital cataract surgery(baseline)

研究者

发起方
Sun Yat-sen University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Haotian Lin

Principal Investigator

Sun Yat-sen University

研究点 (1)

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