Long-Term Clinical Outcomes Of Subjects Enrolled In The RxSight Light Adjustable Lens (LAL) And Light Delivery Device (LDD) New Enrollment Study
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit
研究概览
简要总结
This is an observational, follow up study of subjects previously enrolled in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study". The primary objective of this study is to collect long-term safety and effectiveness data on RxSight LAL in subjects previously implanted in the "RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject and study eye with prior participation in the CSP-029 study and implanted with the LAL.
排除标准
- •Subjects with serious co-morbid conditions that in the judgment of the investigator makes inclusion in the study not in the best interest of the subject.
研究组 & 干预措施
Light adjustable lens (LAL) and Light Delivery Device (LDD)
Light adjustable lens (LAL) and Light Delivery Device (LDD)
干预措施: Light Adjustable lens (LAL) and Light Delivery Device (LDD) (Device)
结局指标
主要结局
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit
时间窗: Up to 55 months
Mean manifest cylinder at the Long-Term follow up visit
时间窗: Up to 55 months
Mean absolute manifest refraction spherical equivalent (|MRSE|) at the Long-Term follow up visit compared between the RxSight LAL and Control group
时间窗: Up to 55 months
Mean manifest cylinder at the Long-Term follow up visit compared between the RxSight LAL and Control group
时间窗: Up to 55 months
次要结局
未报告次要终点