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临床试验/NCT05497128
NCT05497128Unknown不适用

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

Seoul National University Bundang Hospital2 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2022年9月最近更新:
适应症

试验速览

阶段
不适用
入组人数
66
试验地点
2
主要终点
Efficiency of core vitrectomy

研究概览

简要总结

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)).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

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

结局指标

主要结局

Efficiency of core vitrectomy

时间窗: During the vitrectomy

Time to completion of core vitrectomy

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Kyu Hyung Park

Professor

Seoul National University Bundang Hospital

研究点 (2)

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