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

Study Overview

• Status: Completed
• Conditions: Vitreous Hemorrhage; Retinal Detachment; Epiretinal Membrane; Macula Hole
• Intervention / Treatment: Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter; Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter

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 Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • University of Hong Kong

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vitrectomy time	The time needed to remove all vitreous	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety and complications	Associated Intraoperative and post operative complications	up to 6 months
Number of instruments used	The total number of additional instruments used (scissors, forceps, etc)	1 Day

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Alcon Research

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2018
• Primary Completion (Actual): January 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: April 20, 2021
• First Submitted That Met QC Criteria: April 21, 2021
• First Posted (Actual): April 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 21, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Retinal Diseases; Eye Hemorrhage; Hemorrhage; Retinal Detachment; Epiretinal Membrane; Vitreous Hemorrhage; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Adrenergic Agonists; Dipivefrin
• Other Study ID Numbers: 10K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No