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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 of Post Approval Study


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General
Application Number P980040 S039/ PAS001
Current Plan Approved 08/25/2015
Study Name OSB Lead-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 Up to 435 subjects will be enrolled to achieve bilateral implantation in approximately 385 subjects: 220 TECNIS Toric ZCT300 and ZCT400 subjects (including a minimum of approximately 30%, or 70, ZCT400 subjects) and 165 control subjects (assumes a 10% drop-out rate for a minimum of 200 toric and 150 control subjects available for evaluation at 6 months).

With 200 toric subjects and 150 control subjects, this study has over 90% power to evaluate the rate of severe visual distortions for toric subjects as being no more than 10 percent higher than control subjects. This assumes use of one side of a two-sided 90% confidence interval and severe visual distortion rates of 0.02 for toric and control subjects.

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.



OSB Lead-New Enrollment of Post Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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    
five year report 04/14/2018    


Contact Us

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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