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

Primary Purpose

Vitreous Hemorrhage, Macula Hole, Epiretinal Membrane

Status
Completed
Phase
Not Applicable
Locations
Hong Kong
Study Type
Interventional
Intervention
Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vitreous Hemorrhage

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

10k 25G cutter

5k 25G cutter

Arm Description

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

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

Outcomes

Primary Outcome Measures

Vitrectomy time
The time needed to remove all vitreous

Secondary Outcome Measures

Safety and complications
Associated Intraoperative and post operative complications
Number of instruments used
The total number of additional instruments used (scissors, forceps, etc)

Full Information

First Posted
April 20, 2021
Last Updated
April 21, 2021
Sponsor
The University of Hong Kong
Collaborators
Alcon Research
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1. Study Identification

Unique Protocol Identification Number
NCT04859556
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
January 1, 2019 (Actual)
Study Completion Date
June 1, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong
Collaborators
Alcon Research

4. Oversight

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
Data Monitoring Committee
Yes

5. 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vitreous Hemorrhage, Macula Hole, Epiretinal Membrane, Retinal Detachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare 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.
Allocation
Randomized
Enrollment
52 (Actual)

8. Arms, Groups, and Interventions

Arm Title
10k 25G cutter
Arm Type
Experimental
Arm Description
New cutter, with a 10,000 cut per minute blade
Arm Title
5k 25G cutter
Arm Type
Active Comparator
Arm Description
Traditional cutter, with a 5,000 cut per minute blade
Intervention Type
Device
Intervention Name(s)
Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
Intervention Description
a proprietary Vitrector from Alcon for the use on the Constellation system
Intervention Type
Device
Intervention Name(s)
Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter
Intervention Description
a proprietary Vitrector from Alcon for the use on the Constellation system
Primary Outcome Measure Information:
Title
Vitrectomy time
Description
The time needed to remove all vitreous
Time Frame
1 day
Secondary Outcome Measure Information:
Title
Safety and complications
Description
Associated Intraoperative and post operative complications
Time Frame
up to 6 months
Title
Number of instruments used
Description
The total number of additional instruments used (scissors, forceps, etc)
Time Frame
1 Day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Hong Kong
City
Hong Kong
Country
Hong Kong

12. IPD Sharing Statement

Plan to Share IPD
No

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

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