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Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries

NCT06520410 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2024-07-25

No results posted yet for this study

Summary

This study aims to study the safety and efficacy of using an 18 mm short vitrectomy probe for pediatric vitreoretinal surgeries and to investigate the surgeon's comfort and reliability of using the shorter probe.

Conditions

  • Retinopathy of Prematurity Both Eyes
  • Retinal Disease
  • Persistent Fetal Vasculature
  • Coats Disease
  • Coats Retinopathy
  • Familial Exudative Vitreoretinopathies
  • Vitreous Disorder
  • Vitreous Anomalies
  • Retinal Vascular Disorder

Interventions

DEVICE

Pars plana vitrectomy with a 18 mm short vitrector

Using the shorter 18 mm vitrector for various pediatric vitreoretinal surgeries

Sponsors & Collaborators

  • Chang Gung Memorial Hospital

    lead OTHER

Principal Investigators

  • Wei-Chi Wu, MD, PhD · Chang Gung Medical Foundation

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-05
Primary Completion
2026-02-28
Completion
2028-02-28
FDA Device
Yes

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06520410 on ClinicalTrials.gov