Non-genetic Risk Factors of Congenital Cataracts

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

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.

Study Overview

• Status: Unknown
• Conditions: Cataract
• Intervention / Treatment: Other: observational study

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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jing Li, M.D.; Phone Number: +86-20-87330341

Study Locations

• China
  • Guangdong
    • Guangzhou, Guangdong, China, 510060
      • Recruiting
      • Zhognshan Ophthalmic Center, Sun Yat-sen University
      • Contact: Haotian Lin, M.D., Ph.D.; Phone Number: 8613802793086; Email: haot.lin@hotmail.com
      • Contact: Jing Li, M.D.; Phone Number: +86-20-87330341; Email: Reviewborad_SYsU@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Sun Yat-sen University
• Collaborators: Ministry of Health, China
• Investigators: Principal Investigator: Haotian Lin, M.D. Ph.D, Zhongshan Ophthalmic Center, Sun Yat-sen University

Publications and helpful links

General Publications

• 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.

Helpful Links

• Description Description Home page of Zhongshan Ophthalmic Center

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2011
• Primary Completion (Anticipated): February 28, 2018
• Study Completion (Anticipated): June 30, 2018

Study Registration Dates

• First Submitted: July 6, 2017
• First Submitted That Met QC Criteria: July 9, 2017
• First Posted (Actual): July 12, 2017

Study Record Updates

• Last Update Posted (Actual): July 12, 2017
• Last Update Submitted That Met QC Criteria: July 9, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: risk factor; congenital cataract; mathematic model
• Additional Relevant MeSH Terms: Eye Diseases; Lens Diseases; Cataract
• Other Study ID Numbers: CCPMOH2017-China-2