Post-Approval Study With the KAMRA Inlay

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Presbyopia
• Intervention / Treatment: Device: KAMRA Inlay

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 Type: Observational
• Enrollment (Anticipated): 529

Contacts and Locations

• Study Contact: Name: Srividhya Vilupuru, O.D., Ph.D; Phone Number: 182 949/585-9511; Email: svilupuru@acufocus.com
• Study Contact Backup: Name: Nicholas Tarantino, O.D.; Phone Number: 106 949/585-9511; Email: ntarantino@acufocus.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: AcuFocus, Inc.
• Investigators: Principal Investigator: TBD TBD, M.D.

Study record dates

Study Major Dates

• Study Start (Anticipated): July 31, 2018
• Primary Completion (Anticipated): January 1, 2026
• Study Completion (Anticipated): January 1, 2026

Study Registration Dates

• First Submitted: May 25, 2017
• First Submitted That Met QC Criteria: May 30, 2017
• First Posted (Actual): June 2, 2017

Study Record Updates

• Last Update Posted (Actual): May 18, 2018
• Last Update Submitted That Met QC Criteria: May 17, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Refractive Errors; Presbyopia
• Other Study ID Numbers: KAMR-203-PASQ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes