Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| KAMRA Inlay | Device | Unilateral implantation of the KAMRA inlay in the corneal stroma. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Five years |
| Measure | Description | Time Frame |
|---|---|---|
| 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%. | Five years |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Phakic, presbyopic patients between the ages of 45 and 60 years old who have cycloplegic refractive spherical equivalent of +0.50 diopters to -0.75 diopters with less than or equal to 0.75 diopters of refractive cylinder, who do not require glasses or contact lenses for clear distance vision, and who require near correction of +1.00 to +2.50 diopters of reading add.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Srividhya Vilupuru, O.D., Ph.D | Contact | 949/585-9511 | 182 | svilupuru@acufocus.com |
| Nicholas Tarantino, O.D. | Contact | 949/585-9511 | 106 | ntarantino@acufocus.com |
| Name | Affiliation | Role |
|---|---|---|
| TBD TBD, M.D. | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D011305 | Presbyopia |
| ID | Term |
|---|---|
| D012030 | Refractive Errors |
| D005128 | Eye Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided