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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 Progress Adequate
Application Number P040020 S049/ PAS001
Date Current Protocol Accepted  
Study Name AcrySof IQ ReSTOR +3.0 Toric PAS
General Study Protocol Parameters
Study Design Retrospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own 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 Phase A: Subjects must be 22 years of age or older and have planned implantation in at least one eye with an ACRYSOF IQ RESTOR +3.0

D Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models

SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling. The subject must not have ocular or intraocular

infection or inflammation at the screening visit or on the day of surgery, nor any history of intraocular inflammation within the past

12 months.

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 Phase A: The study will enroll and implant 3300 eyes from 30 sites across the U.S. to ensure 3,000 eyes evaluable for up to postoperative 180 days.

Phase B: The number of cataract surgeries reported in Medicare LDS was approximately 60,000 per year in 1994-1999. Therefore, it is anticipated

that there will be approximately 180,000 surgeries available to estimate the background rate from 2011 through 2013.
Data Collection Phase A: 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 IOLs.

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.

All reported cases will be reviewed by an independent Clinical Adjudication Committee to determine relatedness of the events to the

ACRYSOF IQ RESTOR Toric IOL.

Phase B: The primary endpoint was the rate of post-surgical intraocular inflammation based on the associated coding of endophthalmitis, uveitis, or other codes related to postsurgical intraocular inflammation (with and without the nonspecific code for other complications) within 180 days following cataract surgery.

Endophthalmitis identified by the following ICD-9 diagnosis codes: 360.00 (purulent), 360.01 (acute), 360.02 (panophthalmitis), 360.03

(chronic), 360.04 (vitreous abscess), 360.12 (Panuveitis), 360.19 (other) Uveitis or other events related to post-surgical inflammation identified by

the following ICD-9 diagnosis codes: 364.00 (acute and subacute iridocyclitis, unspecified), 364.01 (primary iridocyclitis), 364.02 (recurrent iridocyclitis), 364.03 (secondary iridocyclitis, infectious), 364.04 (secondary iridocyclitis, noninfectious), 364.05 (hypopyon), 364.23 (lens-induced iridocyclitis), 364.3 (unspecified iridocyclitis), 379.8 (other specified disorders of eye and adnexa).

Other complications be identified by the following ICD-9 diagnosis code: 997.99 (Complications affecting other specified body systems, not elsewhere

classified). This claim should be from an eye care professional (to avoid non ophthalmic complications).
Follow-up Visits and Length of Follow-up Phase A: Within postoperative 180 days.

Phase B: Within 180 days of cataract surgery.


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    
two year report 06/22/2020    
Phase A final report 04/21/2021    


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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