Non-genetic Risk Factors of Congenital Cataracts

NCT03215186 | Unknown DMC

• 1 other identifier: CCPMOH2017-China-2
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Cataract

Keywords

congenital cataract; risk factor; mathematic model

Outcome Measures

Primary Outcomes (4)

• Demography (age, sex, and laterality)

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

  Baseline

• 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

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

  Measured by using a semi-structured questionnaire.

  Baseline

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

  Measured by using a semi-structured questionnaire.

  Baseline

Study Arms (2)

Cataract children

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.

Other: observational study

Healthy children

All children in this group were healthy and without 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.

Interventions

observational study OTHER

Cataract children

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

The prospective study included congenital cataract (CC) patients ≤ 18 years old and firstly present to the ZOC in Guangzhou from 2011 to 2017. The included patients registered in the CC database after being diagnosed as CC by at least two experienced pediatric ophthalmologists based on the slit-lamp and Pentacam examinations. The detailed basic information of each CC patient including the demography, family heredity, gestation history, complicated systemic disease, living condition and the family environment were investigated to parents by a structured questionnaire and were recorded in the CC database. The healthy children without CC were set as control. More than 1000 subjects should be included in each group.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead
• Ministry of Health, China: collaborator

Study Sites (1)

Zhognshan Ophthalmic Center, Sun Yat-sen University

Guangzhou, Guangdong, 510060, China

RECRUITING

Related 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. No abstract available.

  PMID: 26339020 RESULT

Related Links

• Description Description Home page of Zhongshan Ophthalmic Center

MeSH Terms

Conditions

Cataract

Interventions

Observation

Condition Hierarchy (Ancestors)

Lens Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Study Officials

• Haotian Lin, M.D. Ph.D

  Zhongshan Ophthalmic Center, Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jing Li, M.D.

CONTACT

+86-20-87330341

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Home for Cataract Children, Zhongshan Ophthalmic Center

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 12, 2017
• Study Start: February 1, 2011
• Primary Completion: February 28, 2018
• Study Completion: June 30, 2018
• Last Updated: July 12, 2017

Record last verified: 2017-07

Locations

CN (1)