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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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General
Study Status Completed
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.

Interim or Final Data Summary
Actual Number of Patients Enrolled 118 (101 patients implanted)
Actual Number of Sites Enrolled 44
Patient Follow-up Rate Overall follow-up rate among those enrolled: 104% (429/396)

The follow-up rate among those implanted was 95.8% at 1-month, 93.8% at 6-month, and 91.3% at 1-

year
Final Safety Findings The rate of severe visual distortion was 0% and 1.4% for the Toric and control groups, respectively;

None in the Toric group, and two subjects in the control group reported severe visual distortion

under overall circumstances for the 5 items of interest in the questionnaire at 6-months.

The percentage of subjects who completed the 6-month questionnaire and reported severe visual

distortions at the 6-month visit was 5.9% (11/187) in the Toric group and 5.0% (7/141) in the control

group. The 11 Toric subjects reported 14 severe visual distortions while the 7 control subjects

reported 22 severe visual distortions.

There were no unexpected medical findings. Lens findings of misalignment were the most common

finding reported by the investigator.

A total of 33 subjects experienced 42 ocular serious/device-related adverse events (SAE/ADEs) in 38

eyes as determined by the investigators. Forty events were categorized as serious by medical

monitor(s) based on the definition of SAE per the protocol. These included 12 reports (a rate of

5.6%, 12/214) of IOL misalignment that required secondary surgical intervention to reposition the

lens all resolved without sequelae.
Final Effect Findings No effectiveness study endpoints were included in the approved protocol.
Study Strengths & Weaknesses Strength: More than 80% follow-up rate, there is a comparator group.

Weaknesses: No randomization, lack of representativeness (92% were White).
Recommendations for Labeling Changes The PAS study design, methods and results must be included in the labeling.

Additionally, it should be included in the following: protocol deviations results and sensitivity analysis


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 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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