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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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OSB Lead-TECNIS Symfony Toric New Enrollment Study


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General
Study Status Study Pending
Application Number P980040 S065/ PAS001
Date Current Protocol Accepted  
Study Name OSB Lead-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
devices.
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


OSB Lead-TECNIS Symfony Toric New Enrollment Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
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 07/15/2019    
four year report 07/14/2020    
five year report 07/14/2021    
Final Report 07/14/2022    


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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