Next Generation Cataract and Vitreoretinal Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 10
- 主要终点
- Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"
研究概览
简要总结
The purpose of this study is to obtain device-specific safety and performance clinical data to support marketability in Europe and to collect formal user feedback.
详细描述
Subjects will attend a screening visit (Day -30 to Day 0), a surgery visit (Day 0), and 4 post-surgical visits (Day 1, Week 1, Month 1, Month 3) for an overall individual duration of approximately 4 months. One eye (study eye) will be treated. This study will be conducted in Australia.
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
- •Requires posterior segment surgery in the operating room with or without simultaneous cataract surgery;
- •Clear media except for cataract and vitreous hemorrhage;
- •In simultaneous cataract and vitreoretinal surgery, eligible to undergo primary hydrophobic acrylic intraocular lens (IOL) implantation into the capsular bag;
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Previous vitrectomy in the operative eye aside from those requiring silicone oil removal;
- •Neovascular or uncontrolled glaucoma;
- •Planned glaucoma or postoperative surgeries during study aside from silicone oil removal;
- •Inadequate pupil dilation (less than 6 millimeters);
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Using Vitreoretinal or Combined Surgical Functionality Perform Per the Intended Use as Defined in Protocol Section 5.1?"
时间窗: Day 0
As recorded by the surgeon on a user questionnaire based on Day 0 surgery experience. From Protocol Section 5.1, the intended use for UNITY VCS is to facilitate the management of fluid and gases, as well as removal, grasping, cutting, illumination, and coagulation of ocular materials during ocular surgery. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
次要结局
- Mean Total Time in Eye(Day 0 operative, up to surgery completion)
- Percent of 'Yes' Responses to the Binary Question, "Was Anatomical Success Achieved for Intended Treatment?"(Month 3 Postoperative)
- Mean Change in Monocular Best Corrected Distance Visual Acuity (BCDVA) From Preoperative to Month 3(Preoperative (Day -30 to 0), Month 3 Postoperative)