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.
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.
Study Type
OBSERVATIONAL
Enrollment
529
Unilateral implantation of the KAMRA inlay in the corneal stroma.
Monocular Near Visual Acuity
Percentage of implanted eyes with monocular near visual acuity of 20/40 or better is greater than or equal to 75% of implanted eyes.
Time frame: Five years
Best-corrected distance visual acuity
Percentage of implanted eyes with a persistent loss of two or more lines of best-corrected distance visual acuity from baseline at the subject's last study visit is less than 5%.
Time frame: Five years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.