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

Study Overview
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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.

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.

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

Conditions
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Vitrectomy, Epiretinal Membrane, Macular Hole, Vitreous Hemorrhage, Retinal Detachment

Intervention / Treatment
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* Device: 25 gauge 20,000 cpm Hypervit Dual Blade
* Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25 gauge 20,000 cpm Hypervit Dual Blade<br>New vitrectomy blade with higher cutting rate | Device: 25 gauge 20,000 cpm Hypervit Dual Blade<br>* Vitrectomy blade with increased cutting rate to 20,000 cut/min<br>* Other names: 20K;|
| Active Comparator: 25 gauge 10,000 Ultravit vitrectomy cutter<br>Existing vitrectomy blade with cutting rate 10,000 cut/min | Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter<br>* Existing Vitrectomy blade with cutting rate 10,000 cut/min<br>* Other names: 10K;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Core vitrectomy | Measurement of core vitrectomy duration by Constellation Vision System | intraoperative (From the moment probe enter into the eye till performing the air/fluid exchange to complete the vitrectomy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-inferiority of intraoperative and postoperative complication | Safety and Efficacy | 3 months |