Long-term Evaluation of Safety and Performance of Clareon Presbyopia-Correcting Intraocular Lenses (IOLs)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 470
- 试验地点
- 14
- 主要终点
- Rate of Device Deficiencies
研究概览
简要总结
The purpose of this Post-Market Clinical Follow-up study is to describe the long-term safety and performance of the Clareon Vivity and Vivity Toric and Clareon PanOptix and PanOptix Toric IOLs.
详细描述
Subjects will be recruited from a population that has already undergone lens implantation. Retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. Prospective data will be collected from time of study enrollment through the Year 1 follow-up visit.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Subject or legally authorized representative must be able to understand and sign an approved Informed Consent Form.
- •Subject must have had bilateral implantation of Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOLs between 3-6 months prior to enrollment.
- •Subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection.
- •Other protocol-defined inclusion criteria may apply.
排除标准
- •Subject is currently participating in another investigational drug or device study.
- •Subject has had corneal refractive surgery after Clareon Vivity, Clareon Vivity Toric, Clareon PanOptix, or Clareon PanOptix Toric IOL implantation.
- •Subject is pregnant at the time of enrollment.
- •Other protocol-defined exclusion criteria may apply.
研究组 & 干预措施
Clareon Vivity IOL - Toric
Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon Vivity IOL.
干预措施: Clareon Vivity IOL - Toric (Device)
Clareon PanOptix IOL - Non Toric
Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon PanOptix IOL.
干预措施: Clareon PanOptix Trifocal IOL - Non Toric (Device)
Clareon PanOptix IOL - Toric
Implantation with Clareon PanOptix IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a toric Clareon PanOptix IOL.
干预措施: Clareon PanOptix Trifocal IOL - Toric (Device)
Clareon Vivity IOL - Non Toric
Implantation with Clareon Vivity IOLs in both eyes 3-6 months prior to enrollment, with at least one of the eyes implanted with a non-toric Clareon Vivity IOL.
干预措施: Clareon Vivity IOL - Non Toric (Device)
结局指标
主要结局
Rate of Device Deficiencies
时间窗: Up to Year 3
Device deficiencies will be assessed at each prospective visit. Examples include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance
Rate of Adverse Events
时间窗: Up to Year 3
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary Block * Retinal Detachment * Secondary Surgical Interventions (Explantation/exchange/repositioning)
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at each prospective visit
时间窗: Up to Year 3
BCDVA will be assessed at a distance of 4 meters using letter charts and recorded in logarithm Minimum Angle of Resolution (logMAR).
Number of Adverse Events
时间窗: Up to Year 3
Protocol-specified ocular adverse events will be assessed at each prospective visit and include the following: * Cystoid Macular Edema (CME) * Hypopyon * Endophthalmitis * Lens dislocation * Pupillary Block * Retinal Detachment * Secondary Surgical Interventions (Explantation/exchange/repositioning)
Number of Device Deficiencies
时间窗: Up to Year 3
Device deficiencies will be assessed at each prospective visit. Examples include the following: * Failure to meet product specifications (e.g., incorrect IOL power) * IOL defect * Broken IOL optic * Broken IOL haptic * Scratched IOL optic * Unsealed device packaging * Suspected product contamination * Lack of performance
次要结局
未报告次要终点