Special considerations for pediatric vitreoretinal surgery.
Nicola Y Gan, Wai-Ching Lam
https://pubmed.ncbi.nlm.nih.gov/30637195Actively Recruiting
Led by Chang Gung Memorial Hospital · Updated on 2024-07-25
60
Participants Needed
1
Research Sites
104 weeks
Total Duration
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
Safety and Efficacy of 18 mm Short Vitrectomy Probe for Pediatric Vitreoretinal Surgeries
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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)
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
Total: 1 location
1
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 333
Actively Recruiting
W
Wei-Chi Wu, MD, PhD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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