Post-Approval Study With the KAMRA Inlay

Presbyopia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03173664
• Other study ID #: KAMR-203-PASQ
• Status: Not yet recruiting
• Start date: July 31, 2018
• Est. completion date: January 2026

Study information

• Verified date: May 2018
• Source: AcuFocus, Inc.
• Contact: Srividhya Vilupuru, O.D., Ph.D
• Phone: 949/585-9511
• Email: svilupuru[@]acufocus.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 529
• Est. completion date: January 2026
• Est. primary completion date: January 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Presbyopia

Intervention

Device:
• KAMRA Inlay
Unilateral implantation of the KAMRA inlay in the corneal stroma.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
AcuFocus, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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