Skip to main content
OpenTrials
Completed

NCT Number: NCT05710458

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vitrectomy Epiretinal Membrane Eye Diseases Eye Hemorrhage Hemorrhage Macular Hole Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Detachment Retinal Diseases Retinal Perforations Vitreous Hemorrhage

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Grantham Hospital

Hong Kong

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

25 gauge 20,000 cpm Hypervit Dual Blade

Device

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

Other names: 20K

25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

Device

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

Other names: 10K

Primary outcomes

  1. 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

Secondary outcomes

  1. Non-inferiority of intraoperative and postoperative complication

    Time frame: 3 months

    Safety and Efficacy

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 2, 2023
Registry last updated
Feb 2, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.