f Post-Approval Studies (PAS) Database
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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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PAS, Adult and Pediatric


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General
Study Status Delayed
Application Number /
Requirement Number		 P170039 / PAS001
Date Original Protocol Accepted 09/23/2019
Date Current Protocol Accepted  
Study Name PAS, Adult and Pediatric
Device Name CustomFlex Artificial Iris
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Child: 2-12 yrs, Transit. Adolescent B (as adults) : 18-21 yrs, Adult: >21
Detailed Study Protocol Parameters
Study Objectives Prospective, nonrandomized, multi-center, safety study. This is an extended follow-up post-approval study (PAS). The study population is limited to adult and pediatric subjects who participated in the previous 12-month AI-001 IDE clinical trial and are implanted with the CUSTOMFLEX®ARTIFICIALIRIS for less than 36 months (adults) or 60 months (pediatrics).
Study Population The study includes the implanted subjects. There is no control arm. The postoperative outcomes are compared to their preoperative baseline.
Sample Size Up to 527 adult and pediatric eyes implanted with the CUSTOMFLEX®ARTIFICIALIRIS in the AI-001 IDE clinical trial. The sample size is based on demonstrating the cumulative device related adverse event rate was less than 5% for all adverse events in the study and, no individual adverse event should exceed a rate of 1%. The proposed sample size (527 adult and pediatric eyes) is sufficient to achieve >90% power of detecting an individual device related adverse rate with an incidence of at least 2.0%.
Key Study Endpoints The primary study outcome is to evaluate device related adverse events (AEs) postoperatively at the Month 36 (adults) or Month 60 (pediatrics).
The secondary study outcome is to evaluate the cumulative rate of intraocular lens (IOL)-related AEs at the Month 36 (adults) or Month 60 (pediatrics).
Other outcomes:
Secondary surgical interventions, implant position, device or surgery related complications, and device malfunctions or defects. Outcomes that will be evaluated include, but are not limited to:
Cumulative AEs
Endothelial cell density (ECD) changes
Device malfunction or defects
Device related complications
Follow-up Visits and Length of Follow-up 36 months postoperatively for adults and 60 months post-operatively for pediatric subjects.


PAS, Adult and Pediatric Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 11/28/2018 12/27/2018 Overdue/Received
1 year report 05/30/2019 05/30/2019 On Time
18 month report 11/28/2019 01/30/2020 Overdue/Received
2 year report 05/29/2020 05/28/2020 On Time
3 year report 05/29/2021 06/01/2021 Overdue/Received
4 year report 05/29/2022 06/02/2022 Overdue/Received
5 year report 05/29/2023 06/01/2023 Overdue/Received
6 year report 05/29/2024    


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

Additional Resources

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