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 Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Vitreous Hemorrhage, Macula Hole, Epiretinal Membrane, Retinal Detachment

Intervention / Treatment
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* Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
* Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter


Participation Criteria
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Eligibility Criteria
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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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 10k 25G cutter<br>New cutter, with a 10,000 cut per minute blade | Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter<br>* a proprietary Vitrector from Alcon for the use on the Constellation system<br>|
| Active Comparator: 5k 25G cutter<br>Traditional cutter, with a 5,000 cut per minute blade | Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter<br>* a proprietary Vitrector from Alcon for the use on the Constellation system<br>|

What is the study measuring?
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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 |