NCT03173664

Post-Approval Study With the KAMRA Inlay

Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 529 (estimated)
• Sponsor: AcuFocus, Inc. · Industry
• Sex: All
• Age: 45 Years – 60 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed 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) 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.

Conditions

• Presbyopia

Interventions

Type	Name	Description
DEVICE	KAMRA Inlay	Unilateral implantation of the KAMRA inlay in the corneal stroma.

Timeline

• Start date: 2018-07-31
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2017-06-02
• Last updated: 2018-05-18

Regulatory

• FDA-regulated device study