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

Sponsor
The University of Hong Kong (Other)
Overall Status
Completed
CT.gov ID
NCT05710458
Collaborator
(none)
72
Enrollment
1
Location
2
Arms
17
Actual Duration (Months)
4.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: 25 gauge 20,000 cpm Hypervit Dual Blade
  • Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
72 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Masking Description:
Patients are randomised and masked from the treatment
Primary Purpose:
Treatment
Official Title:
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Actual Study Start Date :
Jul 1, 2021
Actual Primary Completion Date :
Oct 12, 2022
Actual Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: 25 gauge 20,000 cpm Hypervit Dual Blade

New vitrectomy blade with higher cutting rate

Device: 25 gauge 20,000 cpm Hypervit Dual Blade
Vitrectomy blade with increased cutting rate to 20,000 cut/min
Other Names:
  • 20K

    		•
    Active Comparator: 25 gauge 10,000 Ultravit vitrectomy cutter

    Existing vitrectomy blade with cutting rate 10,000 cut/min

    Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
    Existing Vitrectomy blade with cutting rate 10,000 cut/min
    Other Names:
  • 10K

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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

    1. Non-inferiority of intraoperative and postoperative complication [3 months]

      Safety and Efficacy

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Grantham Hospital Hong Kong Hong Kong

    Sponsors and Collaborators

    • The University of Hong Kong

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Dr. Nicholas Fung, Clinical Asst Professor, The University of Hong Kong
    ClinicalTrials.gov Identifier:
    NCT05710458
    Other Study ID Numbers:
    • 20K
    First Posted:
    Feb 2, 2023
    Last Update Posted:
    Feb 2, 2023
    Last Verified:
    Jan 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Retinal Detachment
    Retinal Perforations
    Epiretinal Membrane
    Vitreous Hemorrhage
    Hemorrhage

    Study Results

    No Results Posted as of Feb 2, 2023