Post-Approval Study With the KAMRA Inlay
Post-Approval Study of Clinical Outcomes and Visual Symptoms With the KAMRA Inlay
1 other identifier
observational
529
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2018
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 25, 2017
CompletedFirst Posted
Study publicly available on registry
June 2, 2017
CompletedStudy Start
First participant enrolled
July 31, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2026
CompletedMay 18, 2018
May 1, 2018
7.4 years
May 25, 2017
May 17, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Best-corrected distance visual acuity
Five years
Interventions
Unilateral implantation of the KAMRA inlay in the corneal stroma.
Eligibility Criteria
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.
You may qualify if:
- Meet the indications for use for this device;
- Do not have any of the conditions described in the contraindications in the labeling of the device;
- Are willing and able to provide informed consent;
- Are not participating in any other clinical studies during the course of the study.
You may not qualify if:
- Subject has insufficient ability to read or write that would prevent them from completing a questionnaire without help; or
- Subject is not a fluent speaker of U.S. English.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AcuFocus, Inc.lead
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
TBD TBD, M.D.
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 25, 2017
First Posted
June 2, 2017
Study Start
July 31, 2018
Primary Completion
January 1, 2026
Study Completion
January 1, 2026
Last Updated
May 18, 2018
Record last verified: 2018-05
Data Sharing
- IPD Sharing
- Will not share