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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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New Enrollment of Post Approval Study

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Study Status Progress Adequate
Application Number P980040 S039/ PAS001
Date Current Protocol Accepted 04/23/2018
Study Name New Enrollment of Post Approval Study
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 purpose of this post-approval study is to evaluate the rates of visual distortions for the TECNIS Toric IOLs with >2.0 D of cylinder correction at the corneal plane (Models ZCT300 and ZCT400) in a larger population in clinical practice compared to a non-toric control IOL.

The design is a prospective, multi-center, bilateral, non- randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA.

Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference.

Study Population Description Patients with bilateral cataracts with corneal astigmatism of approximately 2.00 D to 3.62 D based on the combination of preoperative keratometric cylinder and the expected effect of surgically induced astigmatism.

Sample Size A sample size of a minimum of 396 enrolled subjects to achieve bilateral implantation of approximately 294 subjects: 169 TECNIS Toric ZCT300 and ZCT400 and 125 control subjects will be enrolled.

A two-group large-sample normal approximately test of proportions with a one- sided 0.05 signficance level using only 37 evaluable toric subjects and 27 evaluable control subjects will have a greater than 90% power to detect a rate of severe visual distortions for toric subjects as being 10 percentage points or greater than that for control subjects. This assumes severe visual distortion rates of 1% for both the toric and control subjects. Therefore, the sample size proposed for a minimum of 396 enrolled subjects, assuming a 10% drop out rate for a minimum of 152 toric and 112 control subjects available for evaluation at 6 months, is sufficient to demonstrate a non-inferiority in the rate of severe visual distortions (the primary endpoint of this study) between the two study groups in a larger population in clinical practice, and thereby demonstrate the continued safety of the toric IOLs.

Data Collection Primary Endpoint

Rate of severe visual distortions; defined as the percentage of subjects who report a severe visual distortion under overall circumstances at 6 months postoperative for any of

the following 5 visual distortion items of interest:

-lines that slant, tilt, split or separate o flat surfaces appearing curved

-objects appearing further away or closer than they actually are

-objects appearing to have a different size or shape o physical discomfort related to vision.

Other Endpoints

Ratings of individual items included on the visual distortion questionnaire

Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment

Rates of other adverse events

Follow-up Visits and Length of Follow-up Six months; any subjects that undergo a lens repositioning

procedure due to IOL misalignment or that report a severe visual distortion at six months, will be followed through 1 year postoperatively.

New Enrollment of Post Approval Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 10/14/2013 11/20/2013 Overdue/Received
one year report 04/15/2014 04/15/2014 On Time
18 month report 10/14/2014 10/23/2014 Overdue/Received
Validation phase report 02/06/2015 02/06/2015 On Time
two year report 04/15/2015 04/15/2015 On Time
three year report 04/14/2016 04/13/2016 On Time
four year report 04/14/2017 04/20/2017 Overdue/Received
five year report 04/14/2018 04/13/2018 On Time
Final Report 09/30/2019 10/01/2019 Overdue/Received

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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