Evaluation of Efficacy and Long-term Safety for the InFo - Instant Focus © Lens / PMCF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 主要终点
- Near best corrected visual acuity
研究概览
简要总结
This is a monocentric, longitudinal, prospective, observational post-market follow-up study.
30 patients with a cataract will receive an InFo - Instant Focus © lens implant. After the cataract procedure, data collection will take place during visits planned by the physician as part of normal follow-up.
Patients with cataract will be recruited from the clinic by the investigator based on the inclusion and exclusion criteria.
The patient will be followed up after one day, one week, one month, six months, one year and three years post-op. An interim analysis will be performed with one-year clinical results.
The main objective of the study is to evaluate is to evaluate efficacy and long-term safety for the InFo - Instant Focus © lens.
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
- 18 Years 至 —（Adult, Older Adult）
- 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
Near best corrected visual acuity
时间窗: Year 1
Intermediate (80cm) best corrected visual acuity
时间窗: Year 1
Far best corrected visual acuity
时间窗: Year 1
Near uncorrected visual acuity
时间窗: Year 1
Intermediate (80cm) uncorrected visual acuity
时间窗: Year 1
Far uncorrected visual acuity
时间窗: Year 1
次要结局
- Contrast sensitivity(Year 1)
- Tilting sensitivity(Year 1)
- Decentration sensitivity(Year 1)
- Patient satisfaction(Year 1)
- Adverse events(Year 1)