Post-approval Follow-up Study of the IC-8 Apthera IOL
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 196
- 试验地点
- 20
- 主要终点
- Rates of ocular adverse events
研究概览
简要总结
The purpose of this study is to evaluate the long-term safety of the IC-8 Apthera intraocular lens (IOL).
详细描述
A prospective, multi-center, open-label, single-group, post-approval follow-up study of IC-8 Apthera intraocular lens (IOL) subjects previously implanted with the IC-8 Apthera IOL in the Investigational Device Exemption (IDE) clinical study (G180075). All subjects will undergo one scheduled study visit, which is the 3-year post IC-8 Apthera IOL implantation visit. There is one study group: subjects enrolled in the US IDE study (G180075) and implanted with the IC-8 Apthera IOL.
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
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Enrolled in Investigational Device Exemption (IDE) G180075 study and implanted with the IC-8 Apthera intraocular lens (IOL)
- •Able to comprehend and have signed a statement of informed consent
- •Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
排除标准
- •There are no exclusion criteria for this study
结局指标
主要结局
Rates of ocular adverse events
时间窗: 3 years post IC-8 Apthera IOL implantation
Rates of ocular adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
Rates of other serious adverse events
时间窗: 3 years post IC-8 Apthera IOL implantation
Rates of other serious adverse events in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
Rates of subjective visual disturbances
时间窗: 3 years post IC-8 Apthera IOL implantation
Rates of subjective visual disturbances will be assessed using responses to patient Reported Outcomes (PRO) and responses to non-directed question(s)
Rates of secondary surgical interventions (SSIs)
时间窗: 3 years post IC-8 Apthera IOL implantation
Rates of secondary surgical interventions in the IC-8 Apthera intraocular lens (IOL) eyes will be assessed from the time the patient exited United States Investigational Device Exemption (IDE) G180075 through the Study visit
次要结局
未报告次要终点