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

Not Applicable

Completed

• Conditions: Epiretinal Membrane; Retinal Detachment; Vitrectomy; Macular Hole; Vitreous Hemorrhage
• Interventions: Device: 25 gauge 20,000 cpm Hypervit Dual Blade; Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

• Registration Number: NCT05710458
• Lead Sponsor: The University of Hong Kong

Brief 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.

Study Timeline

• Study Start: 2021-07-01
• Primary Completion: 2022-10-12
• Study Completion: 2022-11-30
• Status Verified: 2023-01
• Study First Submitted: 2023-01-25
• Study First Submitted QC: 2023-02-01
• Last Update Submitted: 2023-02-01
• Study First Posted: 2023-02-02
• Last Update Posted: 2023-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patient over 18 years of age who are undergoing vitrectomy for the following conditions:

  • Macular hole
  • Epimacular membrane
  • Vitreous hemorrhage
  • Primary retinal detachment

Exclusion Criteria

• Patient who is

  • unable to give proper consent
  • previous vitrectomy or scleral buckle surgery
  • cases requiring silicone oil tamponed
  • undergoing repeated retinal detachment surgery
  • undergoing surgery for tractional diabetic retinopathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
25 gauge 20,000 cpm Hypervit Dual Blade	25 gauge 20,000 cpm Hypervit Dual Blade	New vitrectomy blade with higher cutting rate
25 gauge 10,000 Ultravit vitrectomy cutter	25 gauge 10,000 cpm Ultravit Vitrectomy Cutter	Existing vitrectomy blade with cutting rate 10,000 cut/min

Primary Outcome Measures

Name	Time	Method
Duration of Core vitrectomy	intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)	Measurement of core vitrectomy duration by Constellation Vision System

Secondary Outcome Measures

Name	Time	Method
Non-inferiority of intraoperative and postoperative complication	3 months	Safety and Efficacy

Trial Locations

Locations (1)

Grantham Hospital; 🇭🇰 Hong Kong, Hong Kong