Clinical trial NCT05497128: Standard Cut Rate 27-Gauge System Versus Ultrahigh-Speed 27-Gauge System in Macular Surgery
Official title: Standard Cut Rate 27-Gauge System Versus Ultrahigh-Speed 27-Gauge System in Macular Surgery : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Macular Disease
Keywords: Macular disease
Vitrectomy
Lead sponsor: Seoul National University Bundang Hospital
Sponsor class: OTHER
Collaborators: name: Alcon Research
First posted: 2022-08-11
Enrollment: 66
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Efficiency of core vitrectomy
timeFrame: During the vitrectomy
Secondary outcomes:
measure: Intraoperative complications
timeFrame: During the vitrectomy
measure: Postoperative complications
timeFrame: Postoperative period within 4 months after the vitrectomy
measure: Efficiency of peripheral vitrectomy
timeFrame: During the vitrectomy
measure: Efficiency of surgery
timeFrame: During the surgery
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyunggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital, Seongnam, Gyunggi-do, South Korea
name: Kyu Hyung Park, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.