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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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Continuation Study - SAIL-101-PAS


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General
Study Status Study Pending
Application Number /
Requirement Number
P210005 / PAS001
Date Original Protocol Accepted 09/20/2022
Date Current Protocol Accepted  
Study Name Continuation Study - SAIL-101-PAS
Device Name IC-8 Apthera Intraocular Lens (IOL)
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives Objective: To evaluate the long-term safety of the IC-8 Apthera IOL.
Design:
Structure: Prospective, multi-center, open-label, single-group, post-approval follow-up study of subjects previously implanted with the IC-8 Apthera IOL in the IC-8 Apthera IOL IDE study (G180075).
Sites: 21 U.S. clinical sites that participated in the IC-8 Apthera IOL IDE study.
Duration: Approximately 18 months to allow for 12 months of enrollment and 6 months to conduct the 3-year post IC-8 Apthera IOL implantation visit.
Administration: There is no active treatment in this study.
Visit Schedule: All subjects will undergo one scheduled visit: the 3-year post IC-8 Apthera IOL implantation visit.
Study Population The study population will include patients previously implanted with the IC-8 Apthera IOL in the IC-8 Apthera IOL IDE study (G180075).
There are no Exclusion criteria for this study. All subjects that participated in the US IDE (G180075) are intended to be reconsented to participate in this study.
Subjects are eligible for the study if they meet the following Inclusion criteria:
Inclusion Criteria:
1. Enrolled in IDE G180075 study and implanted with the IC-8 Apthera IOL;
2. Able to comprehend and have signed a statement of informed consent;
3. Availability, willingness, ability and sufficient cognitive awareness to comply with examination procedures and study visit(s)
Sample Size No. of subjects: All 343 IC-8 Apthera IOL subjects are intended to be re-consented.
Sample size is based on the number of subjects who participated in the pivotal study G180075.
No. of sites: 21
Sites location: US
Key Study Endpoints Co-Primary Safety Endpoints:
• Rates of secondary surgical interventions (pars plana vitrectomy, explant, laser treatment, etc.)
• Rates of other serious adverse events (as described in ISO 11979-7 historical grid)
• Rates of ocular adverse events, including but not limited to the adverse events described in the ISO 11979-7 historical grid
• Rates of subjective visual disturbances
Additional Safety Endpoints:
Other parameters that will be collected and evaluated for safety in the study include but are not limited to the following:
• Monocular best-corrected distance visual acuity (BCDVA)
• Rate of IOL removals
Follow-up Visits and Length of Follow-up 1 visit at year 3.
Total length of follow-up: 3 years


Continuation Study - SAIL-101-PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 01/20/2023    
1 year report 07/22/2023    
18 month report 01/20/2024    
2 year report 07/21/2024    
3 year report 07/21/2025    


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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