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

February 1, 2023 updated by: Dr. Nicholas Fung, The University of Hong Kong
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • Grantham Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of Core vitrectomy
Time Frame: 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
intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Non-inferiority of intraoperative and postoperative complication
Time Frame: 3 months
Safety and Efficacy
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Hong Kong

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2021

Primary Completion (ACTUAL)

October 12, 2022

Study Completion (ACTUAL)

November 30, 2022

Study Registration Dates

First Submitted

January 25, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (ACTUAL)

February 2, 2023

Study Record Updates

Last Update Posted (ACTUAL)

February 2, 2023

Last Update Submitted That Met QC Criteria

February 1, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20K

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

By direct contact to the corresponding author or PI

IPD Sharing Time Frame

5 Years after the study ends

IPD Sharing Access Criteria

Case by case

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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