Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
| Registry | NCT03173664 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 529 (Estimated) |
| Sponsor | AcuFocus, Inc. (Industry) |
| Conditions | Presbyopia |
| Interventions | KAMRA Inlay (Device) |
| Dates | start 2018-07-31 (estimated), primary completion 2026-01-01 (estimated), completion 2026-01-01 (estimated), first posted 2017-06-02, last updated 2018-05-18 |
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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.
Sex: All, ages: 45 Years to 60 Years, accepts healthy volunteers
Inclusion Criteria: 1. Meet the indications for use for this device; 2. Do not have any of the conditions described in the contraindications in the labeling of the device; 3. Are willing and able to provide informed consent; 4. Are not participating in any other clinical studies during the course of the study. Exclusion Criteria: 1. Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or 2. Subject is not a fluent speaker of U.S. English.