跳至主要内容
临床试验/NCT04131114
NCT04131114Unknown不适用

Suspected Glaucoma and Glaucoma After Congenital and Infantile Cataract Surgery: A Longitudinal Study in China

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 241 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
发起方
入组人数
241
试验地点
1
主要终点
the incidence of suspected glaucoma/glaucoma after congenital cataracts

研究概览

简要总结

Pediatric patients who have undergone surgery for congenital or infantile cataracts have a risk of developing suspected glaucoma and glaucoma, but the current evidence does not address our understanding of the incidence and associated risk factors of suspected glaucoma/glaucoma for application in clinical standard care. Therefore, this study investigated the incidence of and risk factors for suspected glaucoma/glaucoma in patients who have undergone surgery for congenital/infantile cataracts.

详细描述

A prospective longitudinal cohort study of pediatric patients who underwent surgery for congenital/infantile cataracts between January 2011 and December 2021 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 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • a diagnosis of congenital/infantile cataracts without any surgical intervention;
  • age younger than 10 years;
  • cataract surgery performed at the Zhongshan Ophthalmic Center after enrollment

排除标准

  • a preoperative IOP above 21 mm Hg;
  • the presence of any preoperative sign of glaucoma, such as corneal enlargement, corneal clouding, excessive optic nerve cupping, or a family history of glaucoma;
  • the presence of ocular trauma or other abnormalities, such as microcornea, microphthalmia, persistent hyperplastic primary vitreous, Peters anomaly, congenital aniridia, Marfan syndrome, lens dislocation, retinitis pigmentosa, high myopia, fundus lesions, rubella, and Lowe syndrome.

结局指标

主要结局

the incidence of suspected glaucoma/glaucoma after congenital cataracts

时间窗: 3 years

A Kaplan-Meier analysis was used.

Risk Factors of suspected glaucoma/glaucoma after congenital cataracts

时间窗: 3 years

Cox regression analysis was assessed

次要结局

未报告次要终点

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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