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

Sponsor

The University of Hong Kong (Other)

Overall Status

Completed

CT.gov ID

NCT04859556

Collaborator

Alcon Research (Industry)

Enrollment

Location

Arms

Actual Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Vitreous Hemorrhage Macula Hole Epiretinal Membrane Retinal Detachment	Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Care Provider)

Masking Description:

Patients and Care provider are not able to differentiate the two different cutters since the port size are the exact same for both.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 1, 2018

Actual Primary Completion Date :

Jan 1, 2019

Actual Study Completion Date :

Jun 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 10k 25G cutter New cutter, with a 10,000 cut per minute blade	Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter a proprietary Vitrector from Alcon for the use on the Constellation system
Active Comparator: 5k 25G cutter Traditional cutter, with a 5,000 cut per minute blade	Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter a proprietary Vitrector from Alcon for the use on the Constellation system

Arm

Intervention/Treatment

Experimental: 10k 25G cutter

New cutter, with a 10,000 cut per minute blade

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

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

Active Comparator: 5k 25G cutter

Traditional cutter, with a 5,000 cut per minute blade

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

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

Outcome Measures

Primary Outcome Measures

Vitrectomy time [1 day]
The time needed to remove all vitreous

Secondary Outcome Measures

Safety and complications [up to 6 months]
Associated Intraoperative and post operative complications
Number of instruments used [1 Day]
The total number of additional instruments used (scissors, forceps, etc)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Hong Kong	Hong Kong		Hong Kong

Sponsors and Collaborators

The University of Hong Kong
Alcon Research

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

The University of Hong Kong

ClinicalTrials.gov Identifier:

NCT04859556

Other Study ID Numbers:

First Posted:

Apr 26, 2021

Last Update Posted:

Apr 26, 2021

Last Verified:

Apr 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 26, 2021