NCT06520410

Brief 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.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
23mo left

Started Mar 2024

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

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 Progress55%
Mar 2024Feb 2028

First Submitted

Initial submission to the registry

February 29, 2024

Completed
5 days until next milestone

Study Start

First participant enrolled

March 5, 2024

Completed
5 months until next milestone

First Posted

Study publicly available on registry

July 25, 2024

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2028

Expected
Last Updated

July 25, 2024

Status Verified

February 1, 2024

Enrollment Period

2 years

First QC Date

February 29, 2024

Last Update Submit

July 21, 2024

Conditions

Retinopathy of Prematurity Both EyesRetinal DiseasePersistent Fetal VasculatureCoats DiseaseCoats RetinopathyFamilial Exudative VitreoretinopathiesVitreous DisorderVitreous AnomaliesRetinal Vascular Disorder

Outcome Measures

Primary Outcomes (2)

  • SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

    Incidence of iatrogenic injury as assessed by the percentage of surgery with iatrogenic injury event

    Intraoperatively

  • SAFETY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

    Incidence of intraoperative instrument bending as assessed by the percentage of surgery with instrument bending event

    Intraoperatively

Secondary Outcomes (3)

  • EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

    6, 12, and 24 months postoperatively

  • EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery

    6, 12, and 24 months postoperatively

  • SATISFACTION of surgeon while using 18 mm short vitrectomy probe for pediatric vitreoretinal surgery

    Intraoperatively

Study Arms (1)

Short vitrector group

EXPERIMENTAL

All enrolled patients will receive vitrectomy with the 18 mm short vitrectomy probe (25+ Short TOTALPLUS Vit Pak, 7500 CPM, Str Endoillum. w/ RFID, Alcon Laboratories Inc., Fort Worth, TX, USA.) for various vitreoretinopathies.

Device: Pars plana vitrectomy with a 18 mm short vitrector

Interventions

Pars plana vitrectomy with a 18 mm short vitrectorDEVICE

Using the shorter 18 mm vitrector for various pediatric vitreoretinal surgeries

Short vitrector group

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients less than 18 years old
  • Need vitrectomy due to various etiologies, including retinopathy of prematurity, familial exudative vitreoretinopathy, persistent fetal vasculature, congenital cataract, lens dislocation, open-globe injury, vitreous hemorrhage, or other vitreoretinal diseases.

You may not qualify if:

  • Patients who cannot cooperate fully with detailed ophthalmic examinations.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chang Gung Memorial Hospital

Taoyuan District, 333, Taiwan

RECRUITING

Related Publications (4)

  • Gan NY, Lam WC. Special considerations for pediatric vitreoretinal surgery. Taiwan J Ophthalmol. 2018 Oct-Dec;8(4):237-242. doi: 10.4103/tjo.tjo_83_18.

    PMID: 30637195BACKGROUND

  • Yeh CT, Chen KJ, Liu L, Wang NK, Hwang YS, Chao AN, Chen TL, Lai CC, Wu WC. Visual and Anatomical Outcomes With Vitrectomy in Posterior or Combined Persistent Fetal Vasculature in an Asian Population. Ophthalmic Surg Lasers Imaging Retina. 2019 Jun 1;50(6):377-384. doi: 10.3928/23258160-20190605-06.

    PMID: 31233155BACKGROUND

  • Huang YC, Chu YC, Wang NK, Lai CC, Chen KJ, Hwang YS, Wu WC. IMPACT OF ETIOLOGY ON THE OUTCOME OF PEDIATRIC RHEGMATOGENOUS RETINAL DETACHMENT. Retina. 2019 Jan;39(1):118-126. doi: 10.1097/IAE.0000000000001908.

    PMID: 29190237BACKGROUND

  • Wang NK, Tsai CH, Chen YP, Yeung L, Wu WC, Chen TL, Lin KK, Lai CC. Pediatric rhegmatogenous retinal detachment in East Asians. Ophthalmology. 2005 Nov;112(11):1890-5. doi: 10.1016/j.ophtha.2005.06.019.

    PMID: 16271317BACKGROUND

MeSH Terms

Conditions

Retinal DiseasesPersistent Hyperplastic Primary VitreousRetinal TelangiectasisFamilial Exudative Vitreoretinopathies

Condition Hierarchy (Ancestors)

Eye DiseasesEye AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesTelangiectasisVascular DiseasesCardiovascular DiseasesEye Diseases, HereditaryGenetic Diseases, Inborn

Study Officials

  • Wei-Chi Wu, MD, PhD

    Chang Gung Medical Foundation

    STUDY CHAIR

Central Study Contacts

Wei-Chi Wu, MD, PhD

CONTACT

886975365848weichi666@gmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 29, 2024

First Posted

July 25, 2024

Study Start

March 5, 2024

Primary Completion

February 28, 2026

Study Completion (Estimated)

February 28, 2028

Last Updated

July 25, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)