Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 529
- 主要终点
- Monocular Near Visual Acuity
研究概览
简要总结
KAMRA inlay, to be unilaterally implanted into the cornea of a subject's non-dominant eye. The inlay is to be inserted into a stromal pocket created with a surgical femtosecond laser.
详细描述
This is a post-approval study of the KAMRA inlay performance and potential device-related issues in a broader population over an extended period of time after pre-market establishment of reasonable safety and effectiveness.
Study objectives include:
- Evaluate the long-term performance (effectiveness) and safety of the device;
- Evaluate real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels;
- Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is intended.
In addition, the data from a subset of the first 105 subjects who have been enrolled in this study will be used to validate the KAMRA Inlay Patient Questionnaire (KIPQ) for the assessment of patients who have received the KAMRA inlay for the treatment of presbyopia.
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
- 45 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meet the indications for use for this device;
- •Do not have any of the conditions described in the contraindications in the labeling of the device;
- •Are willing and able to provide informed consent;
- •Are not participating in any other clinical studies during the course of the study.
排除标准
- •Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
- •Subject is not a fluent speaker of U.S. English.
结局指标
主要结局
Monocular Near Visual Acuity
时间窗: Five years
Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes.
次要结局
- Best-corrected distance visual acuity(Five years)