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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-COMPASS Extenstion Study


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General
Study Status Progress Adequate
Application Number P150037 / PAS001
Date Current Protocol Accepted 11/03/2016
Study Name ODE Lead-COMPASS Extenstion Study
General Study Protocol Parameters
Study Design Prospective & Retrospective Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Continued follow-up PAS (COMPASS trial; protocol TMI-09-01-E) is a long-term safety, multicenter, observational study with no planned interventions. The aim of the study is to evaluate the long-term safety of CyPass® Micro-Stent glaucoma implant in subjects who have completed participation of the IDE clinical trial (TMI-09-01).
Study Population Description Subjects who completed the protocol TMI-09-01, are able to understand the study requirements and willing to follow study instructions and are willing to return for required study follow-up visits.
Sample Size 480 eyes of 480 subjects. This is based on the number of subjects implanted with the CyPass Micro-Stent, completed 24 month follow-up in study Protocol TMI-09-01 and will meet the study eligibility criteria
Data Collection • Primary safety outcome:

o Rate of occurrence of sight-threatening adverse events (AEs)

• Secondary outcomes- Safety:

o Best Corrected Visual Acuity (BCVA)

o Rate of occurrence of ocular AEs

o Slit lamp, goniscopy and fundus findings

o Visual field mean deviation (MD)

o Central corneal thickness

o Central corneal endothelial cell density (ECD)

o Rate of occurrence of CyPass movement, defined as a change by at least 1 in the number of CyPass rings visible (e.g., from 0 rings to 1 rings or from 3 rings to 2 rings) that does not result in clinical sequelae (e.g., secondary surgical intervention to modify device position, corneal endothelial touch by device, corneal edema leading to loss of BCVA > 2 lines at the last postoperative visit in comparison with preoperative BCVA, progressive endothelial cell loss (ECL), erosion of device through sclera, or device obstruction requiring secondary surgical intervention), and that is not attributable to:

- variations in gonioscopic viewing angle or illumination,

- changes in angle anatomy due to concomitant findings such as resolution of hyphema,

- changes in anterior chamber depth, or

- development of focal peripheral anterior synechiae

• Secondary outcomes- Effectiveness:

o Mean change in intraocular pressure (IOP)

o Proportion of subjects who are not using ocular hypotensive medication with = 20% reduction in IOP from baseline in the COMPASS Trial

o Proportion of subjects who are not using ocular hypotensive medication with IOP = 6 mmHg and = 18 mmHg
Follow-up Visits and Length of Follow-up 5 years after the post-randomization from the COMPASS trial.


ODE Lead-COMPASS Extenstion Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 01/27/2017 01/25/2017 On Time
one year report 07/29/2017 07/26/2017 On Time
18 month report 01/27/2018    
two year report 07/29/2018    
three year report 07/29/2019    
four year report 07/28/2020    
five year report 07/28/2021    


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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