NCT05710458

Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.

Detailed description

In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.

Conditions

• Vitrectomy
• Epiretinal Membrane
• Macular Hole
• Vitreous Hemorrhage
• Retinal Detachment

Interventions

Type	Name	Description
DEVICE	25 gauge 20,000 cpm Hypervit Dual Blade	Vitrectomy blade with increased cutting rate to 20,000 cut/min
DEVICE	25 gauge 10,000 cpm Ultravit Vitrectomy Cutter	Existing Vitrectomy blade with cutting rate 10,000 cut/min

Timeline

• Start date: 2021-07-01
• Primary completion: 2022-10-12
• Completion: 2022-11-30
• First posted: 2023-02-02
• Last updated: 2023-02-02

Locations

1 site across 1 country: Hong Kong