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

Not Applicable

• Conditions: Macular Disease
• Interventions: Device: Ultrahigh-speed cut rate 27-gauge system; Device: Standard cut rate 27-gauge system

• Registration Number: NCT05497128
• Lead Sponsor: Seoul National University Bundang Hospital

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 Timeline

• Status Verified: 2022-08
• Study First Submitted: 2022-08-07
• Study First Submitted QC: 2022-08-09
• Study First Posted: 2022-08-11
• Last Update Submitted: 2022-08-11
• Last Update Posted: 2022-08-15
• Study Start: 2022-09
• Primary Completion: 2023-08
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrahigh-speed cut rate 27-gauge system	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.
Standard cut rate 27-gauge system	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.

Primary Outcome Measures

Name	Time	Method
Efficiency of core vitrectomy	During the vitrectomy	Time to completion of core vitrectomy

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyunggi-do, Korea, Republic of