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

Not Applicable

Completed

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

• Registration Number: NCT04859556
• Lead Sponsor: The University of Hong Kong

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

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-05-01
• Primary Completion: 2019-01-01
• Study Completion: 2020-06-01
• Status Verified: 2021-04
• Study First Submitted: 2021-04-20
• Study First Submitted QC: 2021-04-21
• Last Update Submitted: 2021-04-21
• Study First Posted: 2021-04-26
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
10k 25G cutter	Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter	New cutter, with a 10,000 cut per minute blade
5k 25G cutter	Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter	Traditional cutter, with a 5,000 cut per minute blade

Primary Outcome Measures

Name	Time	Method
Vitrectomy time	1 day	The time needed to remove all vitreous

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Hong Kong; 🇭🇰 Hong Kong, Hong Kong