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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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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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TECNIS Symfony Toric New Enrollment Study

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Study Status Progress Adequate
Application Number P980040 S065/ PAS001
Date Current Protocol Accepted 06/16/2021
Study Name TECNIS Symfony Toric New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Design: Prospective, multicenter, non-randomized, open-label, bilateral comparative clinical study (Protocol TIOL-205-STPA).

Objective: To evaluate the rates of bothersome visual symptoms in a larger population in clinical practice for the TECNIS Symfony Toric IOLs with approximately 2.0 D or more of cylinder correction at the corneal plane (Models ZXT300 and ZXT375, higher-cylinder group), compared to the Symfony Toric IOL with approximately 1.0 D of cylinder correction at the corneal plane (Model ZXT150, lower-cylinder group), and to ensure the continued safety of the approved
Study Population Description All study subjects (Minimum 22 years of age) will be enrolled from the normal surgical cataract population at up to 50 sites in the U.S.A. This study will include only subjects intended to undergo bilateral primary phacoemulsification cataract extraction and IOL implantation who have either approximately 2.00 D to 3.00 D (higher-cylinder group) or approximately 1.00 D to JOHNSON & JOHNSON SURGICAL VISION, INC. CONFIDENTIAL Version 4.0 12 PR/TIOL-205-STPA 1.50 D (lower-
cylinder control group) of corneal astigmatism requiring correction in at least one eye.
Sample Size Up to 634 subjects will be enrolled to achieve bilateral implantation in approximately 506 subjects, resulting in approximately 240 evaluable subjects in the higher-cylinder group and 240 evaluable subjects in the lower-cylinder group at 6 months (assumes a 20% screen-fail rate and a 5% lost-to-follow up rate).
Data Collection Primary Endpoint: The primary co-endpoints are the rate of bothersome visual symptoms and the rate of difficulty with an activity due to the symptoms at 6 months postoperative. The rate of bothersome visual symptoms is defined as the percentage of subjects who reported a visual symptom that “very” or “extremely bothered” them. The rate of difficulty with an activity due to the symptoms is determined by the percentage of subjects who respond “Yes” to the question “Is there anything you have a lot of difficulty with, or do not do, because of (visual symptom) at 6 months postoperative. For these endpoints, the visual symptoms include:
o halos
o glare
o starbursts
The frequency and proportion of subjects reporting one or more of these items as very or extremely bothersome and impacting daily life via PRVSQ questionnaire will be used to determine the primary endpoint. This rate will be calculated for the higher-cylinder
(ZXT300 and ZXT375) and lower-cylinder (ZXT150) groups.

Other Endpoints:
Other questionnaire responses, such as rates of degree of bother
Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment
Rate of explants related to visual symptoms
Rates of other adverse events
Monocular uncorrected distance visual acuity
Monocular best corrected distance visual acuity
Mean percent reduction in absolute cylinder
Mean refractive cylinder and mean refractive cylinder compared to preoperatively-predicted cylinder
Mean spherical equivalent and mean spherical equivalent compared to preoperatively- predicted spherical equivalent
Percent of eyes with absolute cylinder within 0.50 D and within 1.00 D of preoperatively- predicted cylinder
Percent of eyes with spherical equivalent within 0.50 D and within 1.00 D of preoperatively- predicted spherical equivalent
Rates of medical and/or lens findings
Follow-up Visits and Length of Follow-up 6 months or 1-year if required

TECNIS Symfony Toric New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 01/13/2017 01/18/2017 Overdue/Received
one year report 07/15/2017 07/14/2017 On Time
18 month report 01/13/2018 01/17/2018 Overdue/Received
two year report 07/15/2018 07/16/2018 Overdue/Received
three year report 08/31/2019 08/30/2019 On Time
four year report 08/13/2020 08/13/2020 On Time
5 year report 09/13/2021 09/13/2021 On Time
final report 12/01/2022    

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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