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临床试验/NCT03215186
NCT03215186Unknown不适用

Establishment of the Mathematic Model of Non-genetic Risk Factors of Congenital Cataracts

Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 2,000 人开始时间: 2011年2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
2,000
试验地点
1
主要终点
Demography (age, sex, and laterality)

研究概览

简要总结

Prevention and treatment of the reversible childhood blindness, including congenital cataracts (CC), has been listed as a significant component of the international programme "VISION 2020 - the Right to Sight" launched by WHO in 1999. However, there is still a lot of unsolved problems regarding to CC, especially in developing countries, such as the delayed presentation and treatment to the hospitals, the lack of specialized treatment departments, and the poor treatment prognosis. With the two children policy opened in China in 2016, many CC parents hesitate to have a second child due to the potential high risk of CC. Date on detailed clinical characteristics of the CC children, including the demography, pregnancy-labor history, and living condition, are crucial for developing the national screening strategies of CC in Pregnant women. However, to our knowledge, it still lacks of thus large population-based and comprehensive investigations of the characteristics of CC children in developing countries.

详细描述

Prevention and treatment of the reversible childhood blindness, including congenital cataracts (CC), has been listed as a significant component of the international programme "VISION 2020 - the Right to Sight" launched by WHO in 1999. However, there is still a lot of unsolved problems regarding to CC, especially in developing countries, such as the delayed presentation and treatment to the hospitals, the lack of specialized treatment departments, and the poor treatment prognosis. With the two children policy opened in China in 2016, many CC parents hesitate to have a second child due to the potential high risk of CC. Date on detailed clinical characteristics of the CC children, including the demography, pregnancy-labor history, and living condition, are crucial for developing the national screening strategies of CC in Pregnant women. However, to our knowledge, it still lacks of thus large population-based and comprehensive investigations of the characteristics of CC children in developing countries. Supporting by the National Ministry of Health and the Zhongshan Ophthalmic Center (ZOC), a specialized eye facility with the largest CC database in China, we therefore comprehensively investigated the demography, pregnancy-labor history, and living condition of CC children with their first visits to the hospital. We also further established a mathematic model of non-genetic risk factors of congenital cataracts. The implications of this study will be of clinical importance to roughly predict the risk of CC in pregnant women.

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

  • Diagnosis of congenital cataract.
  • Less than 18 years old.

排除标准

  • The children with definite or suspected ocular trauma (including blunt trauma) history and those with regular ocular or systemic steroid history were excluded from this study.
  • The children came from the welfare homes with unclear family heredity and gestation history information were also excluded.

结局指标

主要结局

Demography (age, sex, and laterality)

时间窗: Baseline

The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.

Living environment (radiation/pollution exposure, parental smoking, parental education)

时间窗: Baseline

Measured by using a semi-structured questionnaire.

Family and pregnancy-labor histories (family history, mothers' disease and medication histories during pregnancy, premature or term infant, cesarean or eutocia, and history of oxygen inspiration/infant incubator)

时间窗: Baseline

Measured by using a semi-structured questionnaire.

Complicated systemic diseases (congenital heart diseases, brain diseases, favism, etc.)

时间窗: Baseline

Measured by using a semi-structured questionnaire.

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, Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

研究点 (1)

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