Actively Recruiting

Phase 4
Age: 0Years - 18Years
All Genders
ID06520410

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

Led by Chang Gung Memorial Hospital · Updated on 2024-07-25

60

Participants Needed

1

Research Sites

104 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of using an 18 mm short vitrectomy probe in eye surgeries for children with various retinal diseases. The study focuses on pediatric vitreoretinal surgeries, where smaller, stiffer instruments may improve surgical control and reduce complications compared to traditional longer probes. Researchers also want to assess how comfortable and confident surgeons feel using this shorter probe during operations. Participants will receive vitrectomy surgery using the 18 mm short vitrectomy probe designed specifically for pediatric eyes. This device is shorter and stiffer than the usual adult probes, which may help surgeons better handle delicate eye tissues and avoid injury. The study will track intraoperative complications, probe bending, and surgical outcomes, including anatomical and functional results after surgery. Surgeons will complete questionnaires about their experience using the probe. During the study, patients under 18 undergoing vitrectomy will be closely monitored. Data will be collected on surgical safety, effectiveness at 6, 12, and 24 months post-surgery, and surgeon satisfaction. Researchers will compare these findings to previous cases using longer probes. Follow-up assessments will include detailed eye exams to evaluate healing and success of the surgery, with ongoing observation to identify any need for additional procedures.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 0Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients less than 18 years old
  • Need vitrectomy due to various causes including retinopathy of prematurity, familial exudative vitreoretinopathy, persistent fetal vasculature, congenital cataract, lens dislocation, open-globe injury, vitreous hemorrhage, or other vitreoretinal diseases
Not Eligible

You will not qualify if you...

  • Patients who cannot fully cooperate with detailed eye examinations

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - 1 day

Participants undergo vitrectomy surgery using the 18 mm short vitrectomy probe. Intraoperative safety and surgeon satisfaction are assessed during this stage.

1 surgical visit (in-person)

Post-operative Follow-up

Duration - 24 months

Participants are monitored to evaluate anatomical and functional outcomes and the rate of additional surgeries after the vitrectomy procedure.

Follow-up visits at 6, 12, and 24 months post-surgery

Trial Site Locations

Total: 1 location

1

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Actively Recruiting

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Research Team

W

Wei-Chi Wu, MD, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DEVICE_FEASIBILITY

Number of Arms

1

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Published Research Related To This Trial

Visual and Anatomical Outcomes With Vitrectomy in Posterior or Combined Persistent Fetal Vasculature in an Asian Population.

Chun-Ting Yeh, Kuan-Jen Chen, Laura Liu...

https://pubmed.ncbi.nlm.nih.gov/31233155