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.

Learn more...

CP19-01 PAS F/u of PMA Cohort

General
Study Status	Ongoing
Application Number / Requirement Number	P030016 S035/ PAS001
Date Original Protocol Accepted	05/04/2022
Date Current Protocol Accepted
Study Name	CP19-01 PAS F/u of PMA Cohort
Device Name	EVO/EVO+VISIAN Implantable Collamer Lens
Clinical Trial Number(s)	NCT04283149
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 Objectives	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	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.
Key Study Endpoints	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 Reporting Schedule

Reporting Schedule	Report Date Due	FDA Receipt Date	Applicant's Reporting Status
1 year report	08/22/2022	10/04/2022	Overdue/Received
2 year report	08/22/2023	08/14/2023	On Time
final report	08/22/2024	04/02/2024	On Time

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

---

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