Using a short vitrectomy probe for pediatric eye surgeries
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
PHASE4 · Chang Gung Memorial Hospital · NCT06520410
This study tests a new shorter tool for eye surgery in children to see if it makes the surgery safer and easier for doctors.
Quick facts
| Phase | PHASE4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 0 Years to 18 Years |
| Sex | All |
| Sponsor | Chang Gung Memorial Hospital (other) |
| Locations | 1 site (Taoyuan) |
| Trial ID | NCT06520410 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and effectiveness of an 18 mm short vitrectomy probe specifically designed for pediatric vitreoretinal surgeries. It addresses the unique challenges faced in pediatric eye surgery, such as the need for greater stability and ease of manipulation during procedures. The study aims to enhance surgeon comfort and reliability when using this shorter probe, which could lead to fewer complications and improved surgical outcomes for children. By focusing on various pediatric retinal diseases, the research seeks to provide insights into the benefits of this innovative surgical tool.
Who should consider this trial
Good fit: Ideal candidates for this study are patients under 18 years old who require vitrectomy for conditions like retinopathy of prematurity or other vitreoretinal diseases.
Not a fit: Patients who are unable to cooperate with detailed ophthalmic examinations may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to safer and more effective surgical outcomes for children undergoing vitreoretinal procedures.
How similar studies have performed: While there have been advancements in pediatric vitreoretinal surgery, this specific approach using a short vitrectomy probe is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Patients who cannot cooperate fully with detailed ophthalmic examinations.
Where this trial is running
Taoyuan
- Chang Gung Memorial Hospital — Taoyuan, Taiwan (RECRUITING)
Study contacts
- Study coordinator: Wei-Chi Wu, MD, PhD
- Email: weichi666@gmail.com
- Phone: 886975365848
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Retinopathy of Prematurity Both Eyes, Retinal Disease, Persistent Fetal Vasculature, Coats Disease, Coats Retinopathy, Familial Exudative Vitreoretinopathies, Vitreous Disorder, Vitreous Anomalies