Next Generation Cataract Surgery Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 8
- 主要终点
- Percent of 'Yes' Responses to the Binary Question: "Did UNITY VCS Anterior Segment 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 user preference data.
详细描述
Subjects will attend a screening visit (Day -60 to Day 0), a surgery visit (Day 0), and 3 post-surgical visits (Day 1, Week 1, Month 1) for an overall individual duration of up to 3 months. One eye (study eye) will be treated. This study will be conducted in the United States.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to understand and sign an IRB/IEC approved Informed Consent form.
- •Willing and able to attend all scheduled visits as required by the protocol.
- •Clinically documented diagnosis of age-related noncomplicated cataract.
- •Eligible to undergo primary hydrophobic acrylic intraocular lens implantation into the capsular bag.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Women of childbearing potential as defined in the protocol.
- •Planned postoperative procedures during the course of the study in the operative eye.
- •Previous intraocular or corneal surgery in the operative eye.
- •Diagnosis of glaucoma or ocular hypertension (IOP > 21 mmHg) in the operative eye.
- •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 Anterior Segment 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 management of fluid as well as removal, cutting, and coagulation of ocular materials. One eye (study eye) contributed data to the analysis. No hypothesis testing was pre-specified for this endpoint.
次要结局
- Time From Incision Entry to Incision Closure(Day 0 surgery)