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

Retinal Detachment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05710458
• Other study ID #: 20K
• Status: Completed
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2023
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: November 30, 2022
• Est. primary completion date: October 12, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Epiretinal Membrane
• Hemorrhage
• Macular Hole
• Retinal Detachment
• Retinal Perforations
• Vitrectomy
• Vitreous Hemorrhage

Intervention

Device:
• 25 gauge 20,000 cpm Hypervit Dual Blade
Vitrectomy blade with increased cutting rate to 20,000 cut/min
• 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter
Existing Vitrectomy blade with cutting rate 10,000 cut/min

Locations

Country	Name	City	State
Hong Kong	Grantham Hospital	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

References & Publications (2)

O'Malley C, Heintz RM Sr. Vitrectomy with an alternative instrument system. Ann Ophthalmol. 1975 Apr;7(4):585-8, 591-4. — View Citation

Rizzo S, Genovesi-Ebert F, Belting C. Comparative study between a standard 25-gauge vitrectomy system and a new ultrahigh-speed 25-gauge system with duty cycle control in the treatment of various vitreoretinal diseases. Retina. 2011 Nov;31(10):2007-13. doi: 10.1097/IAE.0b013e318213623a. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Non-inferiority of intraoperative and postoperative complication	Safety and Efficacy	3 months