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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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CP19-01 PAS F/u of PMA Cohort


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General
Study Status Study Pending
Application Number P030016 S035/ PAS001
Date Current Protocol Accepted  
Study Name CP19-01 PAS F/u of PMA Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post-approval study is to evaluate the continued safety and effectiveness of the EVO/EVO+ Visian® Implantable Collamer® Lens (ICL) in the original PMA P030016/S035 cohort.
The study design is a continued follow-up of premarket cohorts of the original PMA P030016/S035 study which enrolled and implanted 327 subjects (327 primary eyes and an additional 302 fellow eyes) at 14 clinical sites in the US. Post approval follow-up of the PMA cohort will continue through the Year 3 visit (Postoperative Visit 8, Day 1050 – 1170).
Study Population Description The study population includes all subjects enrolled and who completed Postoperative Visit 5 under the original study protocol for Study CP19-01 (approved under IDE G190184).
Sample Size In order to detect an AE with a true probability of occurrence among eyes of 1% with 95% probability, based on the binomial distribution, a sample of at least 300 eyes is required.
Data Collection Co-Primary Endpoints
Co-primary endpoints will be evaluated in all eyes (primary and fellow eyes) using descriptive statistics with comparisons to PMA data for the approved and currently marketed MICL and TMICL devices, where appropriate. The co-primary endpoints have no prespecified performance targets.
Distribution of percent endothelial cell density (ECD) losses and the percent of eyes that have ECD <1500 and ECD <1000 through Postoperative Visit 8 (Day 1050 – 1170).
Incidence of adverse events (AEs) through Postoperative Visit 8 (Day 1050 – 1170).
Follow-up Visits and Length of Follow-up Subjects will be seen for 3 study visits in this PAS at the following timepoints after the original date of surgery: Year 1 (Days 330-420), Year 2 (Days 690-810) and Year 3 (Days 1050-1170).


CP19-01 PAS F/u of PMA Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
1 year report 08/22/2022    
2 year report 08/22/2023    
3 year report 08/22/2024    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

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