Evaluation of Long-term Safety and Performance of AcrySof IQ Vivity Extended Vision and AcrySof IQ Vivity Toric Extended Vision Intraocular Lenses
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Incidence of adverse events
研究概览
简要总结
The purpose of this post-market study is to describe the long-term safety and performance of AcrySof IQ Vivity and AcrySof IQ Vivity Toric intraocular lens (IOL) models in a real-world setting through routine clinical practice.
详细描述
This study includes a retrospective chart review to obtain preoperative, operative, and post-operative data, and one prospective visit to collect key long-term safety and performance endpoints in a sample of subjects commercially implanted with the specified IOLs for 3 to 5 years in the real world.
This study will be conducted in the US and in Spain.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •22 years old or older at Visit
- •Able to understand and sign an approved informed consent form.
- •Implantation of AcrySof IQ Vivity and/or Vivity Toric IOL models in both eyes for 3 to 5 years prior to enrollment.
- •Documented medical history and required pre-operative baseline information available for retrospective data collection.
- •Other protocol-specified inclusion criteria may apply.
排除标准
- •Corneal refractive surgery after AcrySof Vivity or AcrySof Vivity Toric IOL implantation.
- •Pregnant or nursing at the time of enrollment.
- •Childbirth after IOL implantation.
- •Other protocol-specified exclusion criteria may apply.
结局指标
主要结局
Incidence of adverse events
时间窗: Up to Year 3-5 postoperative
An adverse event (AE) is defined as any untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects, users, or other persons, whether or not related to the study device. Adverse events reported or observed since the time of initial exposure to the study model IOL will be recorded.
Mean Binocular Best Corrected Distance Visual Acuity (BCDVA) at Visit 1
时间窗: Visit 1, Year 3-5 postoperative
Visual acuity (VA) will be assessed binocularly (both eyes together) with correction in place using letter charts at a distance of 4 meters. BCVA will be recorded in logarithm Minimum Angle of Resolution (logMAR) LogMAR values typically range from -0.3 (20/10 vision on the Snellen chart) to 1 (20/200 vision). A logMAR acuity of 0.0 corresponds to 20/20 Snellen acuity (normal distance visual acuity), with a negative value denoting better than 20/20 visual acuity. No hypothesis testing is prespecified for this endpoint.
Incidence of device deficiencies
时间窗: Up to Year 3-5 postoperative
A device deficiency is defined as an inadequacy of a medical device with respect to its identity, quality, durability, reliability, safety, or performance. Device deficiencies reported or observed since the time of initial exposure to the study model IOL will be recorded.
次要结局
未报告次要终点