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

Macular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05497128
• Other study ID #: B-2112-728-001
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 2022
• Est. completion date: August 2023

Study information

• Verified date: August 2022
• Source: Seoul National University Bundang Hospital
• Contact: Kyu Hyung Park, M.D., Ph.D.
• Phone: 82-31-787-7373
• Email: jiani4[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 66
• Est. completion date: August 2023
• Est. primary completion date: August 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Macular Disease

Intervention

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))
• 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))

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyunggi-do

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital	Alcon Research

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficiency of core vitrectomy	Time to completion of core vitrectomy	During the vitrectomy
Secondary	Intraoperative complications	i.e. iatrogenic retinal breaks, intraocular bleeding, retinal detachment, etc.	During the vitrectomy
Secondary	Postoperative complications	i.e. intraocular bleeding, retinal detachment, etc.	Postoperative period within 4 months after the vitrectomy
Secondary	Efficiency of peripheral vitrectomy	Time to completion of peripheral vitrectomy	During the vitrectomy
Secondary	Efficiency of surgery	Time to completion of the surgery	During the surgery