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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment Study


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General
Study Status Progress Adequate
Application Number P120023 / PAS002
Date Current Protocol Accepted 05/16/2017
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description 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.

Study Population Description 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.

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.



Data Collection 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





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).



OSB Lead-New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
18 month report 10/15/2016 09/26/2016 On Time
two year report 04/16/2017 04/13/2017 On Time
final report (phase 1) 07/28/2017 07/20/2017 On Time
three year report 04/16/2018    
four year report 04/16/2019    
five year report 04/15/2020    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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