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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-New Enrollment PAS

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Application Number P930014 S045/ PAS001
Current Plan Approved 09/18/2015
Study Name OSB Lead-New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objective of this study is to demonstrate superiority of the AcrySof® IQ Toric High Cylinder Power study group (IOL Models SN6AT6-SN6AT9) to the AcrySof® IQ Aspheric NATURAL IOL Model SN60WF concurrent control group with spectacle correction, for the rate of severe visual distortions at 6 months post bilateral implantation in subjects with pre-operative corneal astigmatism ≥ 2.57 D.

This is a prospective, non-randomized, unmasked study, with data collection through electronic case report forms (eCRF).

Study Population Description Adult subjects in need of bilateral cataract surgery with pre- operative corneal astigmatism in the targeted range
Sample Size Total Sample size: 400

-AcrySof® IQ Toric IOL Model SN6AT6-SN6AT9: 230

-AcrySof® IQ Aspheric NATURAL IOL Model SN60WF:170

Data Collection The primary safety endpoint for this study is the rates of severe visual distortions as measured by the Assessment of Photic Phenomenon & Lens EffectS (APPLES) ¿ Visual

Distortion Questionnaire.

Subjects in both groups will be categorized as experiencing a severe visual distortion if they indicate ¿severe¿ as a response to any one of the three visual distortion related questions on the APPLES ¿ Visual Distortion Questionnaire.

In this study the following supportive safety variables will be evaluated:

¿ Adverse events

o Lens dislocation o Pupillary block

o Cumulative rate of any ocular SSIs at 6 months

- Cumulative rate of IOL repositioning at 6 months

- Cumulative rate of IOL explantation at 6 months

- Cumulative rate of ocular SSIs related to visual distortions at 6 months

¿ Any other vision-threatening adverse event related to the


¿ Uncorrected Distance Visual Acuity (UCDVA)

¿ Best Corrected Distance Visual Acuity (BCDVA)

¿ Lens axis misalignment

For serious adverse events, the following change of definition is made in protocol version 3.0

Serious Adverse Event (SAE) - adverse event that led to any of the following:

¿ Death.

¿ A serious deterioration in health that either resulted in:

a) A life-threatening illness or injury.

NOTE: Life-threatening means that the individual was at immediate risk of death from the event as it occurred, i.e., it does not include an event which hypothetically might have caused death had it occurred in a more severe form.

b) Any potentially sight-threatening event or permanent impairment to a body structure or a body function

c) In-patient hospitalization or prolonged hospitalization.

NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigation plan, without serious deterioration in health, is not considered a serious adverse event. In general, hospitalization signifies that the individual remained at the hospital or emergency ward for observation and/or treatment (usually involving an overnight stay) that would not have been appropriate in the physician's office or an out-patient setting. Complications that occur during hospitalization are adverse events. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether ¿hospitalization¿ occurred, the event should be considered serious.

d) A medical intervention to prevent a) or b), or any surgical intervention (excluding posterior capsulotomy)

e) Any indirect harm as a consequence of incorrect

diagnostic test results when used within manufacturer's instructions for use.

¿Fetal distress, fetal death, or a congenital abnormality or birth defect.

Follow-up Visits and Length of Follow-up Six months, except those with Secondary Surgical

Intervention (360-420 days).

OSB Lead-New Enrollment PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 11/01/2011 11/30/2011 Overdue/Received
interim report 02/09/2012 02/09/2012 On Time
one year report 05/02/2012 05/03/2012 Overdue/Received
18 month report 10/31/2012 11/01/2012 Overdue/Received
two year report 05/02/2013 04/29/2013 On Time
three year report 05/02/2014 05/22/2014 Overdue/Received
wrong report 05/19/2014 05/19/2014 On Time
four year report 05/02/2015 06/10/2015 Overdue/Received
Final Report/5 yr report 05/01/2016 04/13/2016 On Time

Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD

Phone: (301) 796-6134
Fax: (301) 847-8140

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