NCT04859556

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: The University of Hong Kong · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vitreous Hemorrhage
• Macula Hole
• Epiretinal Membrane
• Retinal Detachment

Interventions

Type	Name	Description
DEVICE	Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter	a proprietary Vitrector from Alcon for the use on the Constellation system
DEVICE	Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter	a proprietary Vitrector from Alcon for the use on the Constellation system

Timeline

• Start date: 2018-05-01
• Primary completion: 2019-01-01
• Completion: 2020-06-01
• First posted: 2021-04-26
• Last updated: 2021-04-26

Locations

1 site across 1 country: Hong Kong