Post-Approval Study With the KAMRA Inlay
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|ClinicalTrials.gov Identifier: NCT03173664|
Recruitment Status : Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : May 18, 2018
|Condition or disease||Intervention/treatment|
|Presbyopia||Device: KAMRA Inlay|
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|
|Estimated Enrollment :||529 participants|
|Official Title:||Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay|
|Estimated Study Start Date :||July 31, 2018|
|Estimated Primary Completion Date :||January 2026|
|Estimated Study Completion Date :||January 2026|
- Device: KAMRA Inlay
Unilateral implantation of the KAMRA inlay in the corneal stroma.
- Monocular Near Visual Acuity [ Time Frame: 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.
- Best-corrected distance visual acuity [ Time Frame: Five years ]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%.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173664
|Contact: Srividhya Vilupuru, O.D., Ph.D||949/585-9511 ext firstname.lastname@example.org|
|Contact: Nicholas Tarantino, O.D.||949/585-9511 ext email@example.com|
|Principal Investigator:||TBD TBD, M.D.|