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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Macula Hole; Retinal Detachment; Vitreous Hemorrhage; Epiretinal Membrane

Treatments: Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter; Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04859556

10K

Details and patient eligibility

About

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

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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52 participants in 2 patient groups

10k 25G cutter

Experimental group

Description:

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

Treatment:

Device: Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter

5k 25G cutter

Active Comparator group

Description:

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

Treatment:

Device: Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter