Childhood CataractNCT03640780
Practical Pattern of Surgical Timing of Childhood Cataract in China
An observational study of Childhood Cataract, run by Sun Yat-sen University at 1 site in China.
Trial summary
In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL… Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood Cataract
- What is being tested?
- observation
- How many people
- 2,421 participants
- Where
- 1 siteChina
- Study dates
- Jan 2005to Dec 2014
- How long will I take part?
- 3 Years
- 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
- No healthy volunteers
- Child, Adult
Study population: hospital-based
Who may be able to join
- childhood cataracts present at the ZOC at the first time age: 0-18 years
Who cannot join
- complicated with other type of cataracts
Trial locations and contacts
1 site in 1 country.
China1 site
Zhognshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, Guangdong, 510060
About this study
In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.
- Conditions
- Childhood Cataract
- Being tested
- observation
- Keywords
- surgical timing, cataract extraction, IOL implantation, childhood cataract, real-world data
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
The surgical ages and other information between two groups were compared.
| Study group | Role | What they receive |
|---|---|---|
| cataract extraction (CE) | Patients received CE without IOL implantation in the first surgical stage, and received IOL implantation at secondary surgical stage. Receives: Other: observation | |
| cataract extraction and IOL implantation | Patients received CE and IOL implantation in the first surgical stage. Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Surgical age
the surgical ages of two groups
Measured: 2005-2014
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2018
- Study startJan 2005
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood 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
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 2,421 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haotian Lin, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03640780
- Sponsor's protocol ID
- CCPMOH2018- China8
- Status last verified
- Aug 2018
- First submitted
- 18 Aug 2018
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Practical Pattern of Surgical Timing of Childhood Cataract in China
- ClinicalTrials.gov ID
- NCT03640780
- Acronym / sponsor ID
- CCPMOH2018- China8
- Conditions
- Childhood Cataract
- Keywords
- surgical timing, cataract extraction, IOL implantation, childhood cataract, real-world data
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,421 participants (actual)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2005 (actual)
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 21 Aug 2018 (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.
In the current study, the investigators analyzed the surgical RWD of 2,421 children with childhood cataracts from the Childhood Cataract Program of the Chinese Ministry of Health (CCPMOH) at the Zhognshan Ophthalmic Center and proposed data-based clinical experience for the timings of cataract extraction and IOL implantation.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| cataract extraction (CE) | – | Other: observationPatients received CE without IOL implantation in the first surgical stage, and received IOL implantation at secondary surgical stage. |
| cataract extraction and IOL implantation | – | Other: observationPatients received CE and IOL implantation in the first surgical stage. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- hospital-based
Key inclusion criteria (1 listed)
- childhood cataracts present at the ZOC at the first time age: 0-18 years
Key exclusion criteria (1 listed)
- complicated with other type of cataracts
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 |
|---|---|---|
| observationThe surgical ages and other information between two groups were compared. | Other | cataract extraction (CE), cataract extraction and IOL implantation |
Primary outcome
Surgical age
Time frame: 2005-2014
the surgical ages of two groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Childhood 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 27 Aug 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Surgical age (time frame: 2005-2014). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Aug 2018.