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

Primary Purpose

Vitrectomy, Epiretinal Membrane, Macular Hole

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
25 gauge 20,000 cpm Hypervit Dual Blade
25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitrectomy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Grantham Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

25 gauge 20,000 cpm Hypervit Dual Blade

25 gauge 10,000 Ultravit vitrectomy cutter

Arm Description

New vitrectomy blade with higher cutting rate

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

Outcomes

Primary Outcome Measures

Duration of Core vitrectomy
Measurement of core vitrectomy duration by Constellation Vision System

Secondary Outcome Measures

Non-inferiority of intraoperative and postoperative complication
Safety and Efficacy

Full Information

First Posted
January 25, 2023
Last Updated
February 1, 2023
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT05710458
Brief Title
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Official Title
Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
October 12, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of Hong Kong

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitrectomy, Epiretinal Membrane, Macular Hole, Vitreous Hemorrhage, Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Patients are randomised and masked from the treatment
Allocation
Randomized
Enrollment
72 (Actual)

8. Arms, Groups, and Interventions

Arm Title
25 gauge 20,000 cpm Hypervit Dual Blade
Arm Type
Experimental
Arm Description
New vitrectomy blade with higher cutting rate
Arm Title
25 gauge 10,000 Ultravit vitrectomy cutter
Arm Type
Active Comparator
Arm Description
Existing vitrectomy blade with cutting rate 10,000 cut/min
Intervention Type
Device
Intervention Name(s)
25 gauge 20,000 cpm Hypervit Dual Blade
Other Intervention Name(s)
20K
Intervention Description
Vitrectomy blade with increased cutting rate to 20,000 cut/min
Intervention Type
Device
Intervention Name(s)
25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
Other Intervention Name(s)
10K
Intervention Description
Existing Vitrectomy blade with cutting rate 10,000 cut/min
Primary Outcome Measure Information:
Title
Duration of Core vitrectomy
Description
Measurement of core vitrectomy duration by Constellation Vision System
Time Frame
intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy)
Secondary Outcome Measure Information:
Title
Non-inferiority of intraoperative and postoperative complication
Description
Safety and Efficacy
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Grantham Hospital
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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
Citations:
PubMed Identifier
1147502
Citation
O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4.
Results Reference
background
PubMed Identifier
21685823
Citation
Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a.
Results Reference
background

Learn more about this trial

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

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