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Post-Approval Study With the KAMRA Inlay

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ClinicalTrials.gov Identifier: NCT03173664
Recruitment Status : Not yet recruiting
First Posted : June 2, 2017
Last Update Posted : May 18, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Presbyopia 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.


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Study Type : Observational
Estimated Enrollment : 529 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
Estimated Study Start Date : July 31, 2018
Estimated Primary Completion Date : January 2026
Estimated Study Completion Date : January 2026

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


Primary Outcome Measures :
  1. Monocular Near Visual Acuity [ Time Frame: 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 :
  1. Best-corrected distance visual acuity [ Time Frame: 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%.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03173664


Contacts
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Contact: Srividhya Vilupuru, O.D., Ph.D 949/585-9511 ext 182 svilupuru@acufocus.com
Contact: Nicholas Tarantino, O.D. 949/585-9511 ext 106 ntarantino@acufocus.com

Sponsors and Collaborators
AcuFocus, Inc.
Investigators
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Principal Investigator: TBD TBD, M.D.

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Responsible Party: AcuFocus, Inc.
ClinicalTrials.gov Identifier: NCT03173664     History of Changes
Other Study ID Numbers: KAMR-203-PASQ
First Posted: June 2, 2017    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Presbyopia
Refractive Errors
Eye Diseases