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Clinical Trials/NCT05497128
NCT05497128UnknownNot Applicable

Standard Cut Rate 27-Gauge System Versus Ultrahigh-Speed 27-Gauge System in Macular Surgery : A Randomized Controlled Trial

Seoul National University Bundang Hospital1 site in 1 country66 target enrollmentStarted: September 1, 2022Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
66
Locations
1
Primary Endpoint
Efficiency of core vitrectomy

Study Overview

Brief Summary

The purpose of this study is to compare the efficiency and safety of ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)).

Detailed Description

During the last few decades, there have been dramatic changes in vitreoretinal surgery field with improvements in the performance of surgical retina equipment. As the innovation trend has been moving toward the smaller instrument calibers, the 27-gauge vitrectomy system has been developed. However, the vitrectomy system with the smaller calibers have limitations such as reduced instrument rigidity, limited availability of instrumentation, and decreased flow rate. To overcome these limitations, active developments have been ongoing to increase vitreous cutting speed, enlargement of the cutting port size, and enlargement of inner shaft to enable higher flow rates. Especially, the ultrahigh-speed cutter with improved cutting speed has the advantage of enabling safer vitrectomy because the faster cutting speed reduces retinal movement and minimizes the risk of iatrogenic retinal breaks. However, ultrahigh-speed cutting has a limitation in that it can reduce the flow rate through the vitreous cutter as it affects the duty cycle (percentage of time the cutter port is open relative to the complete cutting cycle). Therefore, the duty cycle of ultrahigh-speed cutter has also been improved so as not to delay the time for vitrectomy.

The investigators would like to evaluate the efficiency and safety of vitrectomy using a recently released ultra high-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) and a standard cut rate 27-gauge system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA)) by comparing the duration of vitrectomy and the rate of complications.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
19 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •All consecutive eyes requiring macular surgery (i.e. epiretinal membrane, vitreomacular traction etc.) that underwent 27-gauge vitrectomy at Seoul National University Bundang Hospital (SNUBH) from September 2022 to August
  • •Patients will be randomized to receive 27-gauge vitrectomy with 20,000 cpm probes (20K group) or 27-gauge vitrectomy with 10,000 cpm probes (standard group).

Exclusion Criteria

  • •Previously vitrectomized eye
  • •Trauma cases
  • •Proliferative diabetic retinopathy with fibrovascular membranes
  • •Retinal detachment with proliferative vitreoretinopathy
  • •Macular hole
  • •Endophthalmitis
  • •Inability to consent for procedure

Arms & Interventions

Ultrahigh-speed cut rate 27-gauge system

Experimental

Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 20,000 cpm probes.

Intervention: Ultrahigh-speed cut rate 27-gauge system (Device)

Standard cut rate 27-gauge system

Active Comparator

Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 10,000 cpm probes.

Intervention: Standard cut rate 27-gauge system (Device)

Outcomes

Primary Outcomes

Efficiency of core vitrectomy

Time Frame: During the vitrectomy

Time to completion of core vitrectomy

Secondary Outcomes

  • Efficiency of peripheral vitrectomy(During the vitrectomy)
  • Intraoperative complications(During the vitrectomy)
  • Efficiency of surgery(During the surgery)
  • Postoperative complications(Postoperative period within 4 months after the vitrectomy)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kyu Hyung Park

Professor

Seoul National University Bundang Hospital

Study Sites (1)

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