Skip to main content
OpenTrials
Completed

NCT Number: NCT04859556

Performance, Safety and Efficiency Comparison Between 10,000 and 5,000 Cuts Per Minute Vitrectomy Using a 25G Cutter - A Prospective Randomized Controlled Study

As technology advances, vitrectomy cutters are smaller and cut rates have become faster. In this prospective study, the vitrectomy efficiency and safety between 5,000 cuts per minute with 10,000 cuts per minute are compared

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Hong Kong

Hong Kong

About this study

Purpose:

This study aims to compare the performance of the Alcon 25+® UltraVit® 5000 cpm vitrectomy probe versus the 25+® Ultravit 10,000 cpm® beveled tip, dual drive vitrectomy probe. The safety profile and efficiency were compared.

Method:

Prospective, randomised study. Consecutive patients from January 2019 to August 2019 requiring vitrectomy for retinal detachment, epiretinal membrane, vitreous haemorrhage, and macula hole were randomized into either the 10K or 5K vitrectomy group. Both groups underwent vitrectomy using the proportional vacuum mode with the cut rate set at the fastest rate. Patients with previous vitrectomy, other ocular diseases (glaucoma, corneal disease, or significant corneal opacities), or trauma were excluded from the study. The primary endpoint was vitrectomy time, while secondary endpoints included posterior vitreous detachment time, intraoperative complications, and number of instruments used. The preoperative, postoperative 1 month and 3 month best corrected visual acuity (BCVA), and complications were recorded.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Consecutive patients over the age of 18 requiring vitrectomy for vitreous haemorrhage (VH), epiretinal membrane (ERM), macular hole (MH), dislocated lens, rhegmatogenous retinal detachment and diabetic tractional retinal detachment were randomized into the study from January 2019 till August 2019

Exclusion criteria

  • Patients with ocular comorbidities affecting surgical view including corneal opacities or scar, previous vitrectomy, history of trauma or requiring silicone oil were excluded from the study

Treatment and study plan

Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter

Device

a proprietary Vitrector from Alcon for the use on the Constellation system

Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter

Device

a proprietary Vitrector from Alcon for the use on the Constellation system

Primary outcomes

  1. Vitrectomy time

    Time frame: 1 day

    The time needed to remove all vitreous

Secondary outcomes

  1. Safety and complications

    Time frame: up to 6 months

    Associated Intraoperative and post operative complications

  2. Number of instruments used

    Time frame: 1 Day

    The total number of additional instruments used (scissors, forceps, etc)

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Alcon Research

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Apr 26, 2021
Registry last updated
Apr 26, 2021

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.

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