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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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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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AcrySof IQ ReSTOR +3.0 Toric PAS


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General
Study Status Study Pending
Application Number P040020 S049/ PAS001
Date Current Protocol Accepted 08/28/2020
Study Name AcrySof IQ ReSTOR +3.0 Toric PAS
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 Design Description Phase A: This is a prospective, multicenter, post-approval active surveillance study to report the rate of post-surgical intraocular inflammation

(based upon a specified case definition) reported within a 180-day post-surgical period following implantation of an ACRYSOF IQ

RESTOR Toric IOL in the US.

Phase B: This is a retrospective epidemiological study to estimate the historical background rate of post-surgical intraocular inflammation following

implantation of an intraocular lens (IOL) in the United States. All cataract surgeries reported in 2011 through 2013 in the Medicare Limited Data Set

(LDS) files will be reviewed to look at the frequency of post-surgical intraocular inflammation within 180 days of cataract surgery.
Study Population Description Cohort 1: Adult subjects, 22 years of age or older, implanted from November 2018 through July 2020 with an ACRYSOF® IQ RESTOR® Multifocal Toric IOL (+3.0 D or +2.5 D). The study enrollment is complete for Cohort 1.

Cohort 2: Adult subjects, 22 years of age or older, implanted after July 2020 with an ACRYSOF® IQ RESTOR® +3.0 D Multifocal Toric IOL or ACRYSOF® IQ RESTOR® +2.5 D Multifocal IOL.

Phase B:

Data from the Part B (Physician/Supplier) files from all beneficiaries with one or more claims for cataract surgery in 2011 to 2013 were considered.

The Part B file encompasses service by the ophthalmologist in both inpatient and outpatient settings.
Sample Size Cohort 1: 478 subjects were enrolled, 706 eyes were implanted, and 703 eyes completed the postoperative follow-up evaluation up to 180 days.

Cohort 2: 3600 eyes will enroll to implant 3300 from 30 sites across the U.S. to ensure 3,000 eyes evaluable for up to postoperative 180 days.
Data Collection There are no performance endpoints in this study.

Safety Endpoints:

The primary safety endpoint is the rate (per 1,000 IOL implants) of post-surgical intraocular inflammation (based upon the specified case definition) reported within a 180-day post-surgical period following attempted implantation of ACRYSOF® IQ RESTOR® Toric +3.0 D Multifocal IOL or ACRYSOF® IQ ReSTOR® +2.5 D Multifocal IOL (Cohort 2).

The secondary safety endpoints are the rates (per 1,000) of Toxic Anterior Segment Syndrome (TASS), acute postoperative endophthalmitis, chronic postoperative endophthalmitis, and uncategorized cases of post-surgical intraocular inflammation (based upon the specified case definition), respectively, reported within a 180-day post-surgical period following implantation of ACRYSOF® IQ RESTOR® Toric IOLs or ACRYSOF® IQ ReSTOR® IOL (Cohort 2).
Follow-up Visits and Length of Follow-up Within postoperative 180 days.



AcrySof IQ ReSTOR +3.0 Toric PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 06/22/2017 07/12/2017 Overdue/Received
one year report 12/22/2017 12/13/2017 On Time
Phase B final report 06/22/2018 06/19/2018 On Time
six month report-Phase A 12/22/2018 12/18/2018 On Time
one year report-Phase A 06/22/2019 08/06/2019 Overdue/Received
18 month report-Phase A 12/22/2019 12/20/2019 On Time
two year report 06/22/2020 07/09/2020 Overdue/Received
three year report 06/22/2021    


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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