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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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COMPASS XXT Post-Approval Study


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General
Study Status Study Pending
Application Number P150037 / PAS003
Date Current Protocol Accepted  
Study Name COMPASS XXT Post-Approval Study
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 Continued follow-up PAS (COMPASS XXT; protocol GLD122-P004) 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 (COMPASS trial; G080209; TMI-09-01).
Study Population Description Subjects who completed the COMPASS trial, 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 374 eyes of 374 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 Safety outcome:

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

Rate of occurrence of ocular AEs

Central and peripheral (nasal) endothelial cell density (ECD) measurements

Analyses of rate of loss and rate of low ECD (i.e., less than or equal to 1000 cells/mm2)

Assessment of stabilization of endothelial cell loss (ECL)

Corneal sequelae associated with ECL

Association between peripheral and central ECD count and number of observed rings

Secondary surgical interventions (SSIs) to modify the device position (e.g., repositioning, trimming, explanation)

Effects of SSIs on central and peripheral ECD

CyPass® Micro-Stent movement and/or malposition

Corneal AEs (e.g., corneal decompensation, tube corneal touch, corneal edema, etc.) caused by CyPass® Micro-Stent

Losses in Best Corrected Visual Acuity (BCVA) greater than or equal to 10 letters

Change in visual field mean deviation (MD)

Change in central corneal thickness

Effectiveness outcomes:

Mean intraocular pressure (IOP)

Proportion of subjects with a 20% or better reduction in IOP from COMPASS washed out baseline and on zero medication

Proportion of subjects with mean IOP less than or equal to 18 mmHg

Number of ocular hypotensive medications
Follow-up Visits and Length of Follow-up 10 years after CyPass stent implantation


COMPASS XXT Post-Approval Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 10/09/2020    
one year report 04/09/2021    


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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