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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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Extended f/u Premarket Cohort


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General
Study Status Study Pending
Application Number P170043 / PAS001
Date Current Protocol Accepted  
Study Name Extended f/u Premarket Cohort
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Objective Performance Criterion
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To evaluate the long -term rate of clinically relevant complications associated with iStent inject® placement and stability in subjects who have completed participation of the IDE clinical trial (GC-008). This is a long-term safety, multicenter, observational study with no planned interventions.
Study Population Description Subjects who underwent implantation of GTS400 stent(s) using the G2-M-IS injector system in conjunction with cataract surgery and completed the protocol GC-008 who are able to understand the study requirements, willing to follow study instructions and are willing to return for required study follow-up visits.
Sample Size 366 eyes of 366 subjects. This is based on the number of subjects implanted with GTS400 stent(s) using the G2-M-IS injector system, completed 24 month follow-up in study Protocol GC-008 and will meet the study eligibility criteria
Data Collection Safety Endpoint:

The rate of clinically relevant complications associated with iStent inject placement and stability as determined at 60 months. Specific device-related complications include clinical sequelae resulting from device position including, but not limited to:

Secondary surgical intervention (SSI) to modify device position (e.g., repositioning or explantation)

Corneal endothelial touch by device

Corneal edema leading to BSCVA loss > 2 lines at the Month 60 visit, in comparison with preoperative BSCVA

Other Safety Outcomes:

Rate of occurrence of sight-threatening adverse events including:

Persistent (at time of study exit) BSCVA loss greater than or equal to 3 lines compared to best recorded BSCVA at any postoperative visit

Endophthalmitis

Corneal decompensation

Retinal detachment

Severe choroidal hemorrhage or detachment or aqueous misdirection

Rate of ocular secondary surgical interventions (SSI)

Rate of other adverse events including:

Increase from baseline IOP of greater than or equal to 10 mmHg at any time greater than or equal to 30 days postoperative

BSCVA loss greater than or equal to 2 lines at Month 60 compared to screening

BSCVA loss greater than or equal to 2 lines at Month 60 compared to best recorded BSCVA at any postoperative visit

Device movement, defined as a stent not visible in the original location, that does not result in clinically relevant complications as described above (e.g., SSI to modify device position, corneal endothelial touch by device, or corneal edema leading to BSCVA loss > 2 lines at the Month 60 visit compared to preoperative BSCVA), and that is not attributable to any one or more of the following:

variations in gonioscopic, OCT or UBM viewing

angle or illumination

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

changes in anterior chamber depth

development of focal peripheral anterior synechiae (PAS)

Follow-up Visits and Length of Follow-up 60 months post-randomization in the IDE trial


Extended f/u Premarket Cohort Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/20/2018 12/20/2018 On Time
one year report 06/21/2019 06/14/2019 On Time
18 month report 12/20/2019    
two year report 06/20/2020    
three year report 06/20/2021    


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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