Performance Comparison of the 25 Gauge 20,000cpm HYPERVIT Dual Blade vs. 10,000cpm ULTRAVIT Vitrectomy Cutter

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-01

Study Completion Date

2022-11-30

Brief Summary

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This prospective randomised controlled trial will be conducted to investigate that increasing the vitrectomy cutting rate from 10,000 cut/min to 20,000 cut/min will result more efficiency and shorter core vitrectomy time, and it is equally safe as compared to the current 10,000 cut/min. We plan to target the patients undergoing for vitrectomy for common vitreoretinal pathology. Our plan is to conduct a randomised study with 2 arms, one with the higher cutting rate (20,000 cut/min) versus a second arm using the existing system 10,000 cuts/min.

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Detailed Description

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In addition, we will measure the core vitrectomy duration by Constellation Vision System stopwatch. We will count the duration when the vitrectomy probe enter into the eye to the moment the performing the air/fluid exchange by shaving the peripheral vitreous to complete the vitrectomy. For our second outcome measure to prove the no-inferiority of intraoperative and postoperative complications patients will have 3 months follow up visits.

Conditions

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Vitrectomy Epiretinal Membrane Macular Hole Vitreous Hemorrhage Retinal Detachment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Patients are randomised and masked from the treatment

Study Groups

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25 gauge 20,000 cpm Hypervit Dual Blade

New vitrectomy blade with higher cutting rate

Group Type EXPERIMENTAL

25 gauge 20,000 cpm Hypervit Dual Blade

Intervention Type DEVICE

Vitrectomy blade with increased cutting rate to 20,000 cut/min

25 gauge 10,000 Ultravit vitrectomy cutter

Existing vitrectomy blade with cutting rate 10,000 cut/min

Group Type ACTIVE_COMPARATOR

25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

Intervention Type DEVICE

Existing Vitrectomy blade with cutting rate 10,000 cut/min

Interventions

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25 gauge 20,000 cpm Hypervit Dual Blade

Vitrectomy blade with increased cutting rate to 20,000 cut/min

Intervention Type DEVICE

25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

Existing Vitrectomy blade with cutting rate 10,000 cut/min

Intervention Type DEVICE

Other Intervention Names

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20K 10K

Eligibility Criteria

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Inclusion Criteria

* Patient over 18 years of age who are undergoing vitrectomy for the following conditions:

* Macular hole
* Epimacular membrane
* Vitreous hemorrhage
* Primary retinal detachment

Exclusion Criteria

* Patient who is

* unable to give proper consent
* previous vitrectomy or scleral buckle surgery
* cases requiring silicone oil tamponed
* undergoing repeated retinal detachment surgery
* undergoing surgery for tractional diabetic retinopathy

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No