Vitreoretinal DiseaseNCT06123923
Trends of Vitreoretinal Surgery in Children
An observational study of Vitreoretinal Disease, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Purpose: We determined the incidence, etiology, and longitudinal trends of vitreoretinal diseases necessitating pars plana vitrectomy (PPV) in the pediatric and adolescent population. Read more about this study
- Who is it for?
- Ages 0 to 19 years
- Conditions the study is for
- Vitreoretinal Disease
- How many people
- 3,509 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Oct 2022to 30 Oct 2023
- 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 0 to 19 years
- All sexes
- Child, Adult
Study population: all pediatric and adolescent subjects under 20 years of age in Korean population
Who may be able to join
- We included all pediatric and adolescent patients who underwent complete PPV (registered under code S5121) during the study period from January 2009 to December 2020, and who were continuously enrolled in a medical plan, in our estimates.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contemporary Patterns and Underlying Causes of Vitrectomy in Pediatric and Adolescent Patients: A Nationwide, Population-Based Analysis
Purpose: We determined the incidence, etiology, and longitudinal trends of vitreoretinal diseases necessitating pars plana vitrectomy (PPV) in the pediatric and adolescent population.
Design: This was a nationwide, population-based cohort study, utilizing data from the Korean National Health Claims database spanning from 2009 to 2020.
Read more
Given the retrospective design of the study and the anonymized nature of the data, the requirement for informed consent was waived.
Methods: All pediatric and adolescent patients (under 20 years of age) who underwent PPV across the Korean population were included. The cumulative incidence of PPV was estimated from 2009 to 2020, with 2009 to 2011 as the washout period. The annual trends of PPV incidence, the proportion of each etiology, and comorbidity were estimated based on sex and specific age groups.
- Conditions
- Vitreoretinal Disease
- Being tested
- no intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention, just retrospective observation
What is being measured
The primary outcome is the main question the study is designed to answer.
number of vitreoretinal surgery
vitreoretinal surgeries that had already performed during the retrospective study period
Measured: 2009-2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2023
- Study start16 Oct 2022
- Primary completion17 Dec 2022
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vitreoretinal DiseaseStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Retrospective
- Enrolment
- 3,509 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kunho Bae, Seoul National University Hospital
- Investigators
- Kunho Bae, MD, Study chair, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06123923
- Sponsor's protocol ID
- IRB No. 2022-07-010
- Status last verified
- Nov 2023
- First submitted
- 3 Nov 2023
- Last updated
- 9 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contemporary Patterns and Underlying Causes of Vitrectomy in Pediatric and Adolescent Patients: A Nationwide, Population-Based Analysis
- ClinicalTrials.gov ID
- NCT06123923
- Acronym / sponsor ID
- IRB No. 2022-07-010
- Conditions
- Vitreoretinal Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,509 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 16 Oct 2022 (actual)
- Primary completion
- 17 Dec 2022 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 9 Nov 2023 (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.
Purpose: We determined the incidence, etiology, and longitudinal trends of vitreoretinal diseases necessitating pars plana vitrectomy (PPV) in the pediatric and adolescent population.
Design: This was a nationwide, population-based cohort study, utilizing data from the Korean National Health Claims database spanning from 2009 to 2020.
Given the retrospective design of the study and the anonymized nature of the data, the requirement for informed consent was waived.
Methods: All pediatric and adolescent patients (under 20 years of age) who underwent PPV across the Korean population were included. The cumulative incidence of PPV was estimated from 2009 to 2020, with 2009 to 2011 as the washout period. The annual trends of PPV incidence, the proportion of each etiology, and comorbidity were estimated based on sex and specific age groups.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 0 to 19 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- all pediatric and adolescent subjects under 20 years of age in Korean population
Key inclusion criteria (1 listed)
- We included all pediatric and adolescent patients who underwent complete PPV (registered under code S5121) during the study period from January 2009 to December 2020, and who were continuously enrolled in a medical plan, in our estimates.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| no interventionno intervention, just retrospective observation | Other | – |
Primary outcome
number of vitreoretinal surgery
Time frame: 2009-2020
vitreoretinal surgeries that had already performed during the retrospective study period
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 9 Nov 2023.
- Individual participant dataSharing planned: Undecided
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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.
Kunho Bae, MD study chair
Seoul National University Hospital
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 Vitreoretinal Disease, run by Seoul National University Hospital at 1 site in South Korea.
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 0 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 9 Nov 2023. 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 South Korea. 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?
number of vitreoretinal surgery (time frame: 2009-2020). 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 9 Nov 2023.