NCT06123923

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,509

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 16, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 17, 2022

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 3, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 9, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

2 months

First QC Date

November 3, 2023

Last Update Submit

November 3, 2023

Conditions

Vitreoretinal Disease

Outcome Measures

Primary Outcomes (1)

  • number of vitreoretinal surgery

    vitreoretinal surgeries that had already performed during the retrospective study period

    2009-2020

Interventions

no interventionOTHER

no intervention, just retrospective observation

Eligibility Criteria

Age0 Years - 19 Years
Sexall
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodProbability Sample
Study Population

all pediatric and adolescent subjects under 20 years of age in Korean population

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Study Officials

  • Kunho Bae, MD

    Seoul National University Hospital

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 3, 2023

First Posted

November 9, 2023

Study Start

October 16, 2022

Primary Completion

December 17, 2022

Study Completion

October 30, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Locations

KR(1)