NCT06520410|RecruitingPhase 4FDA Device
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Sponsor study identifier
interventional
60
1 country
1
Study Start
March 5, 2024
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 29, 2024
Actual (reported)March 5, 2024
Actual (reported)July 25, 2024
Actual (reported)February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
EFFICACY of 18 mm vitrectomy probe in pediatric vitreoretinal surgery
6, 12, and 24 months postoperatively
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.
Using the shorter 18 mm vitrector for various pediatric vitreoretinal surgeries
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Chang Gung Memorial Hospital
Taoyuan, 333, Taiwan
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.
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.
Wei-Chi Wu, MD, PhD
Chang Gung Medical Foundation
First Submitted
February 29, 2024
First Posted
July 25, 2024
Study Start
March 5, 2024
Actual (reported)Primary Completion
February 28, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Cpap at Delivery Room for Preterm Infants
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
Contact the study team to confirm eligibility.
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.
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.
Study Completion
February 28, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
July 25, 2024
Record last verified: 2024-02
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Source: ClinicalTrials.gov.
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