Non-genetic Risk Factors of Congenital Cataracts

• Conditions: Cataract
• Interventions: Other: observational study

• Registration Number: NCT03215186
• Lead Sponsor: Sun Yat-sen University

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2011-02-01
• Status Verified: 2017-07
• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-09
• Last Update Submitted: 2017-07-09
• Study First Posted: 2017-07-12
• Last Update Posted: 2017-07-12
• Primary Completion: 2018-02-28
• Study Completion: 2018-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cataract children	observational study	All children in this group were diagnosed as congenital cataracts. The four respects of following information of CC patients were collected and confirmed: 1) demography: including age, sex, and laterality; 2) family and pregnancy-labor histories: including family history, mothers' disease and medication histories during pregnancy, premature or term infant, cesarean or eutocia, and history of oxygen inspiration/infant incubator; 3) complicated systemic diseases; 4) living environment: including radiation/pollution exposure, parental smoking, parental education level, and family income.

Primary Outcome Measures

Name	Time	Method
Demography (age, sex, and laterality)	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)	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)	Baseline	Measured by using a semi-structured questionnaire.
Complicated systemic diseases (congenital heart diseases, brain diseases, favism, etc.)	Baseline	Measured by using a semi-structured questionnaire.

Trial Locations

Locations (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China