Post-Approval Study With the KAMRA Inlay

Not yet recruiting

• Conditions: Presbyopia

• Registration Number: NCT03173664
• Lead Sponsor: AcuFocus, Inc.

Brief 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.

Study Timeline

• Study First Submitted: 2017-05-25
• Study First Submitted QC: 2017-05-30
• Study First Posted: 2017-06-02
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-17
• Last Update Posted: 2018-05-18
• Study Start: 2018-07-31
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 529

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Monocular Near Visual Acuity	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.

Secondary Outcome Measures

Name	Time	Method
Best-corrected distance visual acuity	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%.