CataractNCT03215186
Non-genetic Risk Factors of Congenital Cataracts
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages Up to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Cataract
- What is being tested?
- observational study
- How many people
- 2,000 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2011to 30 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
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.
Who may be able to join
- Diagnosis of congenital cataract.
- Less than 18 years old.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jing Li, M.D. contact
China1 site, 1 recruiting
- Recruiting
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
Haotian Lin, M.D., Ph.D., 8613802793086, haot.lin@hotmail.com
Jing Li, M.D., +86-20-87330341, Reviewborad_SYsU@163.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Cataract
- Being tested
- observational study
- Keywords
- congenital cataract, risk factor, mathematic model
- Medical subject headings
- Cataract
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational studyOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 being measured
The primary outcome is the main question the study is designed to answer.
Demography (age, sex, and laterality)
The demography of cataract and healthy children were recorded by using a semi-structured questionnaire.
Measured: 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.
Measured: Baseline
Complicated systemic diseases (congenital heart diseases, brain diseases, favism, etc.)
Measured by using a semi-structured questionnaire.
Measured: Baseline
Living environment (radiation/pollution exposure, parental smoking, parental education)
Measured by using a semi-structured questionnaire.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2017
- Study start1 Feb 2011
- Primary completion28 Feb 2018 (estimated)
- Study completion30 Jun 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CataractStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, China
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
- Investigators
- Haotian Lin, M.D. Ph.D, Principal investigator, Zhongshan Ophthalmic Center, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03215186
- Sponsor's protocol ID
- CCPMOH2017-China-2
- Status last verified
- Jul 2017
- First submitted
- 6 Jul 2017
- Last updated
- 12 Jul 2017
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26339020
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of the Mathematic Model of Non-genetic Risk Factors of Congenital Cataracts
- ClinicalTrials.gov ID
- NCT03215186
- Acronym / sponsor ID
- CCPMOH2017-China-2
- Conditions
- Cataract
- Keywords
- congenital cataract, risk factor, mathematic model
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Collaborators
- Ministry of Health, China
- Study start
- 1 Feb 2011 (actual)
- Primary completion
- 28 Feb 2018 (estimated)
- Study completion
- 30 Jun 2018 (estimated)
- First posted
- 12 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cataract children | – | Other: observational studyAll 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. |
| 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. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (2 listed)
- Diagnosis of congenital cataract.
- Less than 18 years old.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational study | Other | Cataract children |
Primary outcome
Demography (age, sex, and laterality)
Time frame: Baseline
The demography of cataract and healthy children were recorded 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.
Living environment (radiation/pollution exposure, parental smoking, parental education)
Time frame: Baseline
Measured by using a semi-structured questionnaire.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2017.
- Results publication: PubMed 26339020Lin 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.
- Description Description Home page of Zhongshan Ophthalmic CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jing Li, M.D. contact
Haotian Lin, M.D. Ph.D principal investigator
Zhongshan Ophthalmic Center, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cataract, run by Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jing Li, M.D. (+86-20-87330341), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demography (age, sex, and laterality) (time frame: Baseline). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03215186, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2017.