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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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Modified Hydrus New Enrollment PAS


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General
Study Status Protocol Overdue
Application Number P170034 / PAS002
Study Name Modified Hydrus New Enrollment PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Device Subjects Serve as Own Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description The primary objectives are to evaluate device-related safety endpoints (e.g., malposition, obstruction, development of chronic inflammatory adhesions [peripheral anterior synechiae], repositioning, and other downstream clinical sequelae) to support the safety and effectiveness of the device.



The new enrollment study is a prospective, non-randomized, multicenter, single arm, post approval study of the Hydrus Microstent. This is a new enrollment study, in which the subject enrollment phase to qualify and treat 330 eyes of 330 subjects at 20 to 30 sites is expected to last up to 60 months including enrollment and 8 study visits. Based on an estimated screen failure rate of 35%, up to 545 subjects who agree to participate in the study and are able to complete clinical follow-up will be enrolled and screened.

Study Population Description The new enrollment study to estimate the rate of occurrence of clinically significant device malposition, 300 eyes/subjects are needed based on the premarket rate of 1.6% with a precision of 1.4%. The study will enroll up to 545 adult patients with mild to moderate primary open angle glaucoma (POAG) undergoing cataract surgery from 20 to 30 sites across different US geographies. Assuming no more than 35% screen failures and 10% drop-out rate at 60 months, approximately 330 subjects are to be treated to ensure 300 subjects evaluable at 60 months of follow up.
Sample Size The new enrollment study to estimate the rate of occurrence of clinically significant device malposition, 300 eyes/subjects are needed based on the premarket rate of 1.6% with a precision of 1.4%. The study will enroll up to 545 adult patients with mild to moderate primary open angle glaucoma (POAG) undergoing cataract surgery from 20 to 30 sites across different US geographies. Assuming no more than 35% screen failures and 10% drop-out rate at 60 months, approximately 330 subjects are to be treated to ensure 300 subjects evaluable at 60 months of follow up.



Follow-up Visits and Length of Follow-up The length of follow-up will be 1 years for the new enrollment study


Modified Hydrus New Enrollment PAS Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 02/08/2019 03/21/2019 Overdue/Received
one year report 08/10/2019   Overdue
18 month report 02/08/2020    
two year report 08/09/2020    
three year report 08/09/2021    


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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