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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04859556
• Other study ID #: 10K
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2021
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: June 1, 2020
• Est. primary completion date: January 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Device:
• Alcon 25Gauge, 10,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system
• Alcon 25Gauge, 5,000 cuts per minute Ultravit cutter
a proprietary Vitrector from Alcon for the use on the Constellation system

Locations

Country	Name	City	State
Hong Kong	University of Hong Kong	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Alcon Research

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vitrectomy time	The time needed to remove all vitreous	1 day
Secondary	Safety and complications	Associated Intraoperative and post operative complications	up to 6 months
Secondary	Number of instruments used	The total number of additional instruments used (scissors, forceps, etc)	1 Day