A Prospective, Single-arm, Non-comparative, Open-label, Monocular, Post Approval Study to Assess Safety and Device Performance of the Vista Vitrectomy Probe During Vitrectomy Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 8
- 主要终点
- Incidence of visually significant vitreous hemorrhage
研究概览
简要总结
This is a prospective, single-arm, non-comparative, open-label, monocular, post approval study to assess safety and device performance of the Vista Vitrectomy Probe during vitrectomy surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female participant with age ≥ 18 years at the time of screening.
- •Subject must have a clinical indication for anterior vitrectomy.
- •Subjects must be able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
- •Subjects must be willing and able to comply with all treatment and follow-up study procedures.
排除标准
- •Subjects who have experienced any significant trauma in the operative eye within the past month.
- •Subjects with any active ocular infection or history of any herpetic infection that has cleared less than one month prior to the pre-operative visit.
- •Subjects with prior history of uncontrolled glaucoma or uveitis refractory to treatment or ocular hypertension (IOP>30mm Hg) in study eye.
- •Subjects with any medical condition (e.g., uncontrolled diabetes) that, based on the Investigator's medical judgment, poses a concern for the subjects' safety.
- •Female subjects of child bearing potential with positive urine pregnancy test
- •Subjects who have participated in any drug or device clinical investigation within 30 days prior to entry into or during this study.
结局指标
主要结局
Incidence of visually significant vitreous hemorrhage
时间窗: Month 1
Calculate the incidence of post-operative visually significant vitreous hemorrhage (visual acuity defined by counting fingers or worse)
Incidence of choroidal detachment
时间窗: Month 1
Calculate the incidence of post-operative choroidal detachment
Incidence of post-operative rates of retinal tears
时间窗: Month 1
Calculate the incidence of post-operative rates of retinal tears
Incidence of retinal detachment
时间窗: Month 1
Calculate the incidence of post-operative retinal detachment
Incidence of ocular hypotony
时间窗: Month 1
Calculate the incidence of post-operative ocular hypotony
Incidence of endophthalmitis
时间窗: Month 1
Calculate the incidence of post-operative endophthalmitis
Incidence of sclerotomy complications like leakage
时间窗: Month 1
Calculate the incidence of post-operative sclerotomy complications like leakage
次要结局
- Percentage of eyes with clinical evidence of incomplete vitrectomy, such as vitreous strands or pupil peaking(Days1, 7, 30 & 90)
- Surgeon- will assess device adequacy for removal of vitreous(Day 0 (Operative Visit))