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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06123923
Other study ID # IRB No. 2022-07-010
Secondary ID
Status Completed
Phase
First received
Last updated
Start date October 16, 2022
Est. completion date October 30, 2023

Study information

Verified date November 2023
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


Recruitment information / eligibility

Status Completed
Enrollment 3509
Est. completion date October 30, 2023
Est. primary completion date December 17, 2022
Accepts healthy volunteers
Gender All
Age group 0 Years to 19 Years
Eligibility Inclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Other:
no intervention
no intervention, just retrospective observation

Locations

Country Name City State
Korea, Republic of Seoul National University Hospital Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary number of vitreoretinal surgery vitreoretinal surgeries that had already performed during the retrospective study period 2009-2020
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