Post-Approval Studies (PAS) Database

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

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
Clinical Trial Number(s)	NCT01860612
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	06/07/2024	Overdue/Received
7 year report	05/29/2025

Contact Us

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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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• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Program Background