Surgical Procedure Efficiency Evaluation stuDy (SPEED): Combination Phaco-Vitrectomy Surgeries With UNITY VCS vs. Constellation in a Real-World Operating Room Setting
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)?
研究概览
简要总结
The purpose of this real-world evidence study is to compare surgical procedure times for UNITY® VCS and CONSTELLATION® Vision System.
详细描述
Eligible subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy). This single visit, time-and-motion study will be conducted in the United Kingdom. This study will be conducted by Alcon Vision LLC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Able to understand and sign an informed consent form (ICF) that has been approved by an ethics committee.
- •Planned combined phacovitrectomy procedure at one of the selected surgical sites.
- •Planned combined phacovitrectomy procedure with 25-gauge (G) vitrectomy tools.
排除标准
- •Unplanned/emergency phacovitrectomy.
- •Pregnant.
- •Past history of phacovitrectomy. cataract, vitrectomy in the planned operative eye.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
UNITY VCS
Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
干预措施: UNITY VCS (Device)
CONSTELLATION
Subjects will undergo routine scheduled combined anterior-posterior segments surgery (phacovitrectomy)
干预措施: CONSTELLATION (Device)
结局指标
主要结局
Proportion of surgeons replying "efficient" or "very efficient" to the question, "How would you rate overall OR (operating room) efficiency of the console for the combined phaco-vitrectomy surgery (including set-up/tear-down)?
时间窗: Up to Day 1 post completion of the surgery
Responses will be collected on a 5-point scale where 1=Very Inefficient, 2=Inefficient, 3=Neutral, 4=Efficient, and 5=Very Efficient.
次要结局
未报告次要终点