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Clinical Trials/NCT03215186
NCT03215186
Unknown
Not Applicable

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

Sun Yat-sen University1 site in 1 country2,000 target enrollmentFebruary 1, 2011
ConditionsCataract

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cataract
Sponsor
Sun Yat-sen University
Enrollment
2000
Locations
1
Primary Endpoint
Demography (age, sex, and laterality)
Last Updated
8 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2011
End Date
June 30, 2018
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Sun Yat-sen University
Responsible Party
Principal Investigator
Principal Investigator

Haotian Lin

Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Sun Yat-sen University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Demography (age, sex, and laterality)

Time Frame: 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)

Time Frame: 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)

Time Frame: Baseline

Measured by using a semi-structured questionnaire.

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

Time Frame: Baseline

Measured by using a semi-structured questionnaire.

Study Sites (1)

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