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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 Study

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Application Number P030002 S027/ PAS001
Current Plan Approved 02/09/2016
Study Name OSB Lead-New Enrollment Study
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The objective of this post approval safety study is to evaluate the incidence of

IOL vaulting (ie, position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) of the Trulign Toric IOL following cataract surgery at up to three years post implantation.

This is a prospective, multicenter, open-label, single arm, post approval study at a minimum of 30 and up to 50 clinical sites in the US.

Study Population Description All subjects who meet eligibility criteria will be consecutively offered enrollment

into the trial until a site meets the maximum number, or the study has fulfilled all enrollment requirements. If both eyes of a subject are eligible for enrollment, the first treated eye should be chosen at the discretion of the surgeon after consultation with the subject. All eyes will be treated in accordance with the Trulign Toric IOL labeled indications for use and the Physician Labeling Directions for Use (DFU).

Sample Size The study will enroll up to approximately 686 eyes:

A final sample size of 500 eyes is required. Given losses of 10% per year, after three years the remaining proportion would then be 0.93 or 0.729. Given these losses, if 500/0.729 = 686 eyes are enrolled then approximately 500 eyes will be available after three years.

Data Collection The study endpoint is the incidence of clinically significant IOL vaulting (ie,

position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) up to three years post implant.

Follow-up Visits and Length of Follow-up Study participants will be followed for 3 years postoperatively.

OSB Lead-New Enrollment Study Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 11/18/2013 01/28/2014 Overdue/Received
one year report 05/20/2014 06/25/2014 Overdue/Received
18 month report 11/18/2014 11/24/2014 Overdue/Received
two year report 05/20/2015 05/20/2015 On Time
three year report 06/18/2016 06/17/2016 On Time
four year report 05/19/2017    
five year report 05/19/2018    

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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