Post Market Clinical Follow-up (PMCF) Pilot Study for the Clareon UVA IOLs Using Retrospective Data Collection From the WaveTec AnalyzOR Database
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,090
- 试验地点
- 1
- 主要终点
- Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit
研究概览
简要总结
The purpose of this study is to provide real world evidence (RWE) on the performance of the Clareon ultraviolet absorbing (UVA) intraocular lenses (IOLs) to support the overall body of evidence on the Clareon IOL family.
详细描述
In this retrospective postmarket study, the WaveTec AnalyzOR Database will be reviewed. All available data that meet the data selection criteria as of the data cutoff will be analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Monocular Best Corrected Distance Visual Acuity (BCDVA) at Postoperative Visit
时间窗: Month 1 postoperative
The database will be reviewed for assessments of monocular (by-eye) best corrected distance visual acuity at the first postoperative visit. The first postoperative visit will be defined as the visit which occurred approximately 28 days or later from the operative visit during which time the IOL remained implanted in the eye and an eye exam was performed.
次要结局
未报告次要终点