Standard Cut Rate 27-Gauge System Versus Ultrahigh-Speed 27-Gauge System in Macular Surgery

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

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)).

Study Overview

• Status: Not yet recruiting
• Conditions: Macular Disease
• Intervention / Treatment: Device: Ultrahigh-speed cut rate 27-gauge system; Device: Standard cut rate 27-gauge system

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 Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kyu Hyung Park, M.D., Ph.D.; Phone Number: 82-31-787-7373; Email: jiani4@snu.ac.kr
• Study Contact Backup: Name: Se Joon Woo, M.D.; Phone Number: 82-31-787-7379; Email: sejoon1@snu.ac.kr

Study Locations

• Korea, Republic of
  • Gyunggi-do
    • Seongnam, Gyunggi-do, Korea, Republic of, 13620
      • Seoul National University Bundang Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 2023. 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:

1. Previously vitrectomized eye
2. Trauma cases
3. Proliferative diabetic retinopathy with fibrovascular membranes
4. Retinal detachment with proliferative vitreoretinopathy
5. Macular hole
6. Endophthalmitis
7. Inability to consent for procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Ultrahigh-speed cut rate 27-gauge system; Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 20,000 cpm probes.	Device: Ultrahigh-speed cut rate 27-gauge system; The ultrahigh-speed cut rate 27-gauge system (27+®GA HYPERVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))
ACTIVE_COMPARATOR: Standard cut rate 27-gauge system; Patients will receive the pars plana vitrectomy in the macular disease with the 27-gauge vitrectomy systems with 10,000 cpm probes.	Device: Standard cut rate 27-gauge system; The current standard cut rate 27-gauge vitrectomy system (27+®GA Advanced ULTRAVIT® Vitrectomy Probe (Alcon Laboratories, Fort Worth, TX, USA))

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficiency of core vitrectomy	Time to completion of core vitrectomy	During the vitrectomy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative complications	i.e. iatrogenic retinal breaks, intraocular bleeding, retinal detachment, etc.	During the vitrectomy
Postoperative complications	i.e. intraocular bleeding, retinal detachment, etc.	Postoperative period within 4 months after the vitrectomy
Efficiency of peripheral vitrectomy	Time to completion of peripheral vitrectomy	During the vitrectomy
Efficiency of surgery	Time to completion of the surgery	During the surgery

Collaborators and Investigators

• Sponsor: Seoul National University Bundang Hospital
• Collaborators: Alcon Research
• Investigators: Principal Investigator: Kyu Hyung Park, M.D., Ph.D., Seoul National University Bundang Hospital, Seongnam, Gyunggi-do, South Korea

Publications and helpful links

General Publications

• Reibaldi M, Rizzo S, Avitabile T, Longo A, Toro MD, Viti F, Saitta A, Giovannini A, Mariotti C. Iatrogenic retinal breaks in 25-gauge vitrectomy under air compared with the standard 25-gauge system for macular diseases. Retina. 2014 Aug;34(8):1617-22. doi: 10.1097/IAE.0000000000000112.
• Dugel PU, Abulon DJ, Dimalanta R. Comparison of attraction capabilities associated with high-speed, dual-pneumatic vitrectomy probes. Retina. 2015 May;35(5):915-20. doi: 10.1097/IAE.0000000000000411.
• Mariotti C, Nicolai M, Saitta A, Orsini E, Viti F, Skrami E, Gesuita R, Reibaldi M, Giovannini A. STANDARD CUT RATE 25-GAUGE VITRECTOMY VERSUS ULTRAHIGH-SPEED 25-GAUGE SYSTEM IN CORE VITRECTOMY: A Randomized Clinical Trial. Retina. 2016 Jul;36(7):1271-4. doi: 10.1097/IAE.0000000000000924.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2022
• Primary Completion (ANTICIPATED): August 1, 2023
• Study Completion (ANTICIPATED): August 1, 2023

Study Registration Dates

• First Submitted: August 7, 2022
• First Submitted That Met QC Criteria: August 9, 2022
• First Posted (ACTUAL): August 11, 2022

Study Record Updates

• Last Update Posted (ACTUAL): August 15, 2022
• Last Update Submitted That Met QC Criteria: August 11, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Vitrectomy; Macular disease
• Other Study ID Numbers: B-2112-728-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No