NCT05710458

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 12, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 25, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 2, 2023

Completed
Last Updated

February 2, 2023

Status Verified

January 1, 2023

Enrollment Period

1.3 years

First QC Date

January 25, 2023

Last Update Submit

February 1, 2023

Conditions

VitrectomyEpiretinal MembraneMacular HoleVitreous HemorrhageRetinal Detachment

Outcome Measures

Primary Outcomes (1)

  • Duration of Core 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 Outcomes (1)

  • Non-inferiority of intraoperative and postoperative complication

    3 months

Study Arms (2)

25 gauge 20,000 cpm Hypervit Dual Blade

EXPERIMENTAL

New vitrectomy blade with higher cutting rate

Device: 25 gauge 20,000 cpm Hypervit Dual Blade

25 gauge 10,000 Ultravit vitrectomy cutter

ACTIVE COMPARATOR

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

Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

Interventions

25 gauge 20,000 cpm Hypervit Dual BladeDEVICE

Vitrectomy blade with increased cutting rate to 20,000 cut/min

Also known as: 20K
25 gauge 20,000 cpm Hypervit Dual Blade
25 gauge 10,000 cpm Ultravit Vitrectomy CutterDEVICE

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

Also known as: 10K
25 gauge 10,000 Ultravit vitrectomy cutter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient over 18 years of age who are undergoing vitrectomy for the following conditions:
  • Macular hole
  • Epimacular membrane
  • Vitreous hemorrhage
  • Primary retinal detachment

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Grantham Hospital

Hong Kong, Hong Kong

Location

Related Publications (2)

  • O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4.

    PMID: 1147502BACKGROUND

  • 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.

    PMID: 21685823BACKGROUND

MeSH Terms

Conditions

Epiretinal MembraneRetinal PerforationsVitreous HemorrhageRetinal Detachment

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesEye HemorrhageHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Patients are randomised and masked from the treatment
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Asst Professor

Study Record Dates

First Submitted

January 25, 2023

First Posted

February 2, 2023

Study Start

July 1, 2021

Primary Completion

October 12, 2022

Study Completion

November 30, 2022

Last Updated

February 2, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will share

By direct contact to the corresponding author or PI

Shared Documents
STUDY PROTOCOL, CSR
Time Frame
5 Years after the study ends
Access Criteria
Case by case

Locations

HK(1)