Post-Approval Study With the KAMRA Inlay
Last updated on July 2021Recruitment
- Recruitment Status
- Not yet recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Presbyopia
- Type
- Observational
- Design
- Observational Model: CohortTime Perspective: Prospective
Participation Requirements
- Age
- Between 45 years and 60 years
- Gender
- Both males and females
Description
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)...
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.
Tracking Information
- NCT #
- NCT03173664
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: TBD TBD, M.D.
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