• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

  • Print
  • Share
  • E-mail

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...


OSB Lead-New Enrollment PAS

Suggest Enhancement / Report Issue | export reports to excelExport to Excel
Study Status Completed
Application Number P930014 S045/ PAS001
Date Current Protocol Accepted 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 greater than or equal to 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 IOL

- 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).

Interim or Final Data Summary
Actual Number of Patients Enrolled 409
Actual Number of Sites Enrolled 85
Patient Follow-up Rate 95.6% (391/409)
Final Safety Findings The “severe” visual distortion is reported low, 0% in Toric and 0.6% (1 subject) in non-Toric study arms at 6 months follow-ups. The superiority of AcrySof IQ Toric IOL to AcrySof IQ IOL was not established in this study because the low incidence rate of severe visual distortions reported in both groups. The incidence of “moderate” distortions also does not appear to be clinically significantly different between study arms.

For subjects with > 10 degrees of lens axis misalignment, there were not severe visual distortions or documented reports of visual impairment, and no interventions were performed to reposition the IOL for those subjects at any time during the study.

Non-Serious Ocular Adverse Events

There were no important differences between the Toric (‘Overall’ column) and the non-Toric groups regarding in terms of the rate of ocular AEs that occurr ed at the rate of 1% or greater. In the first eye implanted there were 11 cases of dry eye (4.8%), 11 (4.8%) posterior capsule opacification, nine (3.9%) intraocular pressure increased, four (1.7%) allergic conjunctivitis, four (1.7%) visual impairment, three (1.3%) vision blurred, three (1.3%) vitreous detachment, three (1.3%) corneal abrasion, two (0.9%) eye allergy, one (0.4%) eye irritation, one (0.4%) blepharitis, and one (0.4%) iritis.

In the second eye implanted, there were 12 cases of dry eye (5.3%), 10 (4.4%) posterior capsule opacification, six (2.7%) intraocular pressure increased, six (2.7%) vitreous detachment, five (2.2%) vision blurred, four (1.8%) allergic conjunctivitis, three (1.3%) eye irritation, three (1.3%) eye irritation,

three (1.3%) eye pruritus, three (1.3%) punctate keratitis, three (1.3%) visual impairment, three3 (1.3%) intraocular lens reposition, one (0.4%) blepharitis, one (0.4%) iritis, and one (0.4%) lacrimation increased.

Monocular UCDVA and BCDVA

A greater proportion of subjects in the Toric group had a 20/40 or better Uncorrected Distance Visual Acuity (UCDVA) in both eyes compared to the non-Toric group. The majority of subjects in both groups had 20/40 or better Best Corrected Distance Visual Acuity (BCDVA). However, the proportion of eyes with BCDVA of 20/20 or better was considerably lower in the non-Toric group.

A higher proportion of subjects in the Toric group had BCDVA of 20/25 or better compared to the proportion of subjects in the non-Toric group. A comprehensive review of the subject level demographics, manifest refraction, SLE findings, DFE findings, and AEs did not reveal any systemic differences between the groups which may explain the observed difference.

One eye (C11020.1838.4403) in the Toric group had a BCDVA worse than 20/63 at Visit 2.

Overall analysis of the PAS supportive safety endpoints, do not raise concerns regarding the safety of the

Toric IOL models when compared to the Non-Toric.

Final Effect Findings No effectiveness endpoints were included in the study.
Study Strengths & Weaknesses Strengths:

A concomitant comparator group treated with a non-Toric device is included

A high follow-up rate was achieved


¿ Sample size was not large enough to be able to evaluate t he primary endpoint because an unexpected low incidence rate of severe visual distortions was found.

¿ No randomization of treatments was conducted (Toric vs. non-Toric)

¿ No masking procedures were included

Recommendations for Labeling Changes The results of the post-approval study, MDR analyses and literature review during post-market did not show any data that may be different than that obtained in pre-market and already included in the labeling.

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

Related Links