Trends of Vitreoretinal Surgery in Children

Vitreoretinal Disease Clinical Trial

Official title:

Contemporary Patterns and Underlying Causes of Vitrectomy in Pediatric and Adolescent Patients: A Nationwide, Population-Based Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06123923
• Other study ID #: IRB No. 2022-07-010
• Status: Completed
• 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
• 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
• 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.

Related Conditions & MeSH terms

• Vitreoretinal Disease

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