High-speed Beveled Tip Versus Standard Tip Vitrectomy Probe: a Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Time to Completion of Core Vitrectomy and Shave of Vitreous Base
研究概览
简要总结
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm.
Study Design:
This is a randomized controlled trial comparing the efficiency of the Ultravit High-Speed Beveled Probe with the current Alcon vitrector probe in a cohort of patients undergoing routine vitrectomy surgery.
Hypothesis:
The Advanced Ultravit high-speed beveled probe will show non-inferiority to the standard, Alcon (non-beveled) Ultravit 7500 cpm with regards to time to completion of vitrectomy and surgical outcomes.
详细描述
High-speed beveled tip versus standard tip vitrectomy probe: a prospective randomized clinical trial
Background:
The Advanced Ultravit High-Speed Beveled Probe (Alcon) has a beveled-tip design that allows the cutting port to come closer to the retina compared to the previous vitrectr probe design. This allows the surgeon to maneuver in tight tissue planes and increases the functionality of the vitrector probe. This in combination with the increased cut rate of 10,000 independent cuts per minute reduces traction on the retina and increases efficiency of vitreous removal.
Purpose:
The purpose of this study is to compare the efficiency of the new Utravit High-Speed 10000 cpm Beveled Probe to the current standard vitrector probe- Alcon (non-beveled) Ultravit 7500 cpm.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Randomization and data storage will occur in RedCap. Patients will be randomized the day of surgery by a masked study coordinator. The randomization numbers will be generated using the following procedure to ensure that treatment assignment is unbiased and concealed from patients and investigator staff. A patient randomization list will be produced by the IRT provider using a validated system that automates the random assignment of patient numbers to randomization numbers. These randomization numbers are linked to the different treatment arms. The randomization scheme for patients will be reviewed and approved by a member of the Randomization Group.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The study population will be male and female patients 18 years old or older with the presence of pathology requiring routine vitreoretinal surgery (vitreous opacities, vitreous hemorrhage, vitreomacular traction, macular hole, epiretinal membrane) without previous history of vitreoretinal surgery. Ability to consent to procedure.
排除标准
- •Previous incisional intraocular surgery other than uncomplicated cataract surgery with intraocular lens placement
- •Inability to consent for procedure
结局指标
主要结局
Time to Completion of Core Vitrectomy and Shave of Vitreous Base
时间窗: Time to completion of core vitrectomy and shave of vitreous base (12 ± 3 minutes )
Intraoperative efficiency of vitrectomy surgery regarding time to completion of core vitrectomy and shave of vitreous base
次要结局
未报告次要终点
研究者
Shriji Patel
Assistant Professor
Vanderbilt University Medical Center