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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Vitrectomy; Retinal Detachment; Macular Hole; Vitreous Hemorrhage; Epiretinal Membrane

Treatments: Device: 25 gauge 20,000 cpm Hypervit Dual Blade; Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter

Study type: Interventional

Funder types: Other

Identifiers

NCT05710458

20K

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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72 participants in 2 patient groups

25 gauge 20,000 cpm Hypervit Dual Blade

Experimental group

Description:

New vitrectomy blade with higher cutting rate

Treatment:

Device: 25 gauge 20,000 cpm Hypervit Dual Blade

25 gauge 10,000 Ultravit vitrectomy cutter

Active Comparator group

Description:

Existing vitrectomy blade with cutting rate 10,000 cut/min

Treatment:

Device: 25 gauge 10,000 cpm Ultravit Vitrectomy Cutter