Non-genetic Risk Factors of Congenital Cataracts

Cataract Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03215186
• Other study ID #: CCPMOH2017-China-2
• Status: Recruiting
• Phase: N/A
• First received: July 6, 2017
• Last updated: July 9, 2017
• Start date: February 1, 2011
• Est. completion date: June 30, 2018

Study information

• Verified date: July 2017
• Source: Sun Yat-sen University
• Contact: Jing Li, M.D.
• Phone: +86-20-87330341
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2000
• Est. completion date: June 30, 2018
• Est. primary completion date: February 28, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cataract

Intervention

Other:
• observational study

Locations

Country	Name	City	State
China	Zhognshan Ophthalmic Center, Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (2)

Lead Sponsor	Collaborator
Sun Yat-sen University	Ministry of Health, China

Country where clinical trial is conducted

China, 

References & Publications (1)

Lin H, Long E, Chen W, Liu Y. Documenting rare disease data in China. Science. 2015 Sep 4;349(6252):1064. doi: 10.1126/science.349.6252.1064-b. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demography (age, sex, and laterality)	The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.	Baseline
Primary	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)	Measured by using a semi-structured questionnaire.	Baseline
Primary	Complicated systemic diseases (congenital heart diseases, brain diseases, favism, etc.)	Measured by using a semi-structured questionnaire.	Baseline
Primary	Living environment (radiation/pollution exposure, parental smoking, parental education)	Measured by using a semi-structured questionnaire.	Baseline

External Links

•   Description Description Home page of Zhongshan Ophthalmic Center