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| General |
| Study Status |
Terminated |
Application Number /
Requirement Number |
P120023 / PAS002 |
| Date Original Protocol Accepted |
05/12/2016
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| Date Current Protocol Accepted |
05/16/2017
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| Study Name |
New Enrollment Study
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| Device Name |
KAMRA INLAY
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Device Subjects Serve as Own Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
The Post Approval Study (PAS) is comprised of 3 main elements:
1. Under KAMR-201-PRO1, the primary objective is to develop/adapt a patient reported outcomes (PRO) instrument that will assess KAMRA inlay-related visual symptoms and establish the content validity of that PRO instrument.
This part of the study is a non-interventional, qualitative
research, concept elicitation, cognitive debriefing interview study.
2. Under KAMR-202-PRO2, the primary objective is to assess the draft KAMRA Inlay Patient Questionnaire (KIPQ) for its ability to measure visual symptoms and its impact on subjects implanted with the KAMRA inlay.
This part of the study is a psychometric validation of the draft
KIPQ developed under the PRO1 study.
3. Under KAMR-203-PASQ the objectives are as follows:
a. Evaluate the long-term performance (effectiveness) and safety of the device
b. Evaluate the real-world performance of the device in subjects treated by refractive surgeons with a range of experience levels
c. Evaluate the performance of the device in racial/ethnic subgroups representative of the population for which the device is indicated.
This study is designed as an open-label, multicenter, prospective clinical study of at least 529 subjects from 20 to US sites implanted with the KAMRA inlay in the non-dominant eye.
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| Study Population |
Phakic, presbyopic patients between 45 and 60 years of age with 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.
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| Sample Size |
1. Under KAMR-201-PRO1, a total of 20-50 subjects implanted with the KAMRA inlay will be recruited from up to 5 sites for the study. Subjects will have a range of post-operative experience, satisfaction, visual symptoms, ages and educations. Non-Caucasian subjects will also be included.
2. Under KAMR-202-PRO2, a minimum of 105 subjects that have been enrolled under PASQ (new enrollment PAS) will be enrolled into this nested study, with approximately 15 subjects for each targeted population including Caucasian (Hispanic and Non- Hispanic), African American (Hispanic and Non-Hispanic), and Asian.
3. The second hypothesis (primary safety endpoint) would require 423 eyes. Considering a 20% dropout rate, a total of 529 eyes must be enrolled (from 30 to 50 US clinical sites).
This sample size will be adequate to test the first hypothesis (only requiring 142 eyes) and assess the other endpoints.
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| Key Study Endpoints |
The study endpoints are defined under KAMR -203-PASQ as follows:
1. Primary effectiveness endpoint: percentage of implanted eyes with monocular UCNVA of 20/40 or better at 5 years is ?75%.
2. Primary safety endpoint: fewer than 5% of eyes have persistent loss of two or more lines of BCDVA at 5 years after inlay implantation or 2 years after removal (whichever is longer).
3. Additional safety endpoints:
a.Less than 1% of eyes that had BCDVA of 20/20 preoperatively may have BCDVA worse than 20/40 at 5 years.
b.Cumulative incidence of ocular adverse events related to the device and associated with a functional vision loss of BCDVA worse than 20/40 at the time of adverse event should occur in no more than 10% of eyes; cumulative incidence of any single ocular adverse event related to the device and associated with a functional vision loss of BCDVA worse than 20/40 at the time of adverse event should occur in no more than 2.5% of eyes
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| Follow-up Visits and Length of Follow-up |
KAMR-201-PRO1: 1 single visit, one 90-minute interview.
KAMR-202-PRO2: follow-up is approximately 3.5 months, with total study duration of 9-12 months.
KAMR-203-PASQ: five years (or 2 years after removal, whichever is longer).
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