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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) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Extended F/u of IDE Cohort Study


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General
Application Number P080030 / PAS001
Current Plan Approved 03/05/2013
Study Name OSB Lead-Extended F/u of IDE Cohort Study
General Study Protocol Parameters
Study Design Randomized Clinical Trial
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Extended follow-up of subjects previously enrolled in Glaukos Study

GC-003; Follow-up through 5 years postoperative

Study Population Description ¿ Inclusion Criteria: Subjects previously enrolled in Glaukos Study GC-003 who are able and willing to participate in this extended follow-up study;

¿ Exclusion Criteria:

o Subjects previously enrolled in Glaukos Study GC-003 who are not able or willing to participate in this extended follow- up study

o Patients not previously enrolled in Glaukos Study GC-003

Device subjects received the Glaukos iStent in conjunction with

cataract surgery and controls subjects received cataract surgery alone.

Sample Size Of 290 subjects enrolled in Study GC-003, extended follow-up is

planned on subjects eligible to participate in this extended follow-up study.

Data Collection The safety measurement listed in the outline section as:

¿ Postoperative ocular adverse events

¿ Findings from OR medication use, BSCVA, VF

measurements and pachymetry

¿ Findings from slit-lamp, fundus and gonioscopic measurements

Follow-up Visits and Length of Follow-up 5 years postoperative. 2 years from completion of the IDE study

Annual

Final Study Results
Number of Patients 108
Number of Sites 25
Follow-up Rate Only 42.35% (108/255) enrolled at the beginning of the IDE cohort continuation study. Of those 108 subjects enrolled, 100% of subjects were followed through the fifth year post procedure.
Safety Findings Kaplan-Meier (K-M) analyses for the sight-threatening adverse event rate at 5 years are provided by randomized groups: all eyes with cataract surgery and iStent versus randomized cataract surgery only. The cumulative Kaplan-Meier probability that a patient experienced a sight-threatening adverse event is 26.0% (95% CI 15.6%, 36.3%) in the randomized cataract surgery with stent group (stent group) and 42.8% (95% CI 27.9%, 57.8%) in the cataract surgery only group (control group). These results indicate that the stent group is non-inferior to the control group (p=0.009). Based on the upper 1-sided 90% confidence limit (CL), the stent group has a lower incidence of sight-threatening adverse events than the control group. Analyses presented for the comparison of all eyes with cataract surgery and iStent versus randomized cataract surgery only provide cumulative Kaplan-Meier probability that a patient experienced a sight-threatening adverse event is 28.5.0% (95% CI 19.6%, 37.4%) in the Overall Cataract Surgery with iStent (stent group) and 42.8% (95% CI 27.9%, 57.8%) in the Randomized Cataract Surgery Only (control group). These results indicate that the stent group is non-inferior to the control group (p=0.015). Based on the upper 1-sided 90% confidence limit (CL),the stent group has a lower incidence of sight-threatening adverse events than the control group.
Effect Findings This study does not include any effectiveness endpoints
Strengths & Weaknesses Strength: The continued IDE study is an observational study with a clinical trial design with longer term follow-up of safety data.

Weakness: The enrollment rate from the premarket cohort for the eligible subjects is only 42%. The low enrollment rate could introduce bias to the study.

Label Changes As a result, upon completion of the post approval studies with significant clinical findings, labeling changes is

recommended to update the labeling with long-term device performance results regarding safety



OSB Lead-Extended F/u of IDE Cohort Study Schedule

Report Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
six month report 12/24/2012 12/26/2012 Overdue/Received
one year report 06/25/2013 06/25/2013 On Time
18 month report 12/24/2013 01/27/2014 Overdue/Received
two year report-Final Report 06/25/2014 05/01/2014 On Time
response to R11 RDEF (final report) 09/29/2014 09/29/2014 On Time


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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