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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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ODE Lead Post-Approval Study


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General
Study Status Progress Inadequate
Application Number P150034 / PAS001
Date Current Protocol Accepted 12/27/2016
Study Name ODE Lead Post-Approval 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 study is to evaluate the long-term safety of the Raindrop Near Vision Inlay implanted in an emmetropic population.

This study is a continuation of a single-arm, prospective, multicenter study to evaluate the long-term safety of the Raindrop® Near Vision Inlay implanted in an emmetropic population (continued follow-up of premarket cohort). All subjects who meet the inclusion criteria will be followed over a 60-month period or 24 months post inlay removal, whichever is longer, at the clinical sites that participated in Investigation Device Exemption (IDE) study G090149 (Protocol P09-0003).
Study Population Description Presbyopic Subjects from G090149 whether currently enrolled or not, who have not passed the 60 month post-operative inlay implantation window or the 24-month post-removal window, whichever is longer after initial implantation, will be recruited.
Sample Size Subjects from G090149 who have provided informed consent for long-term (up to 5 years after implantation or 2 years after removal, whichever is longer) follow-up.
Data Collection Rate of persistent BCDVA loss of 2 lines or more at the last available visit.

Rate of secondary surgical interventions over 60 months postoperatively.
Follow-up Visits and Length of Follow-up 60-months postoperative initial inlay implantation, or 24 months after removal, whichever is longer. Subjects are assessed at the following time points: 48 Months, and 60 Months, for those subjects without inlay removal; annually after removal.


ODE Lead Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/28/2016 01/23/2017 Overdue/Received
one year report 06/29/2017 06/28/2017 On Time
18 month report 12/28/2017    
two year report 06/29/2018    
three year report 06/29/2019    
four year report 06/28/2020    
five year report 06/28/2021    


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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