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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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OSB Lead-Clinical PAS

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Study Status Completed
Application Number P130004 / PAS002
Date Current Protocol Accepted 10/02/2014
Study Name OSB Lead-Clinical PAS
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group No Control
Analysis Type Descriptive
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description To collect post-approval data relative to the incidence of pre-specified Adverse Ocular Events for cataract surgery patients treated with ReSure Sealant when used by a broad group of physicians under commercial use conditions.

Prospective multicenter observational post-approval study that will be conducted at a minimum of 20 centers and up to 40 centers in the United States with enrollment of at least 598 sequentially-enrolled patients treated with ReSure Sealant. An expected minimum of 10 patients and a maximum of

60 patients may be enrolled at any one site.

Study Population Description Adult patients undergoing cataract surgery using the surgeon¿s standard techniqu treated with ReSure Sealant.
Sample Size A sample size of 598 achieves an alpha of 0.05 and 80% power to detect a difference (P1-P0) of -0.025 using a one-sided binomial test, where P0 is the proportion of individual primary endpoint adverse ocular events in the postoperative follow-up period under the null hypothesis (0.075) and P1 is the proportion of individual primary endpoint adverse ocular events under the alternative hypothesis (0.050). These results assume that the population proportion under the null hypothesis is 0.075.
Data Collection The primary endpoints will be the following Adverse Ocular Events occurring in the postoperative follow-up period:

¿Anterior chamber cells greater than level 1+ persisting at Visit 2 (≥ Day 20)

¿Hypotony (≤ 5 mmHg)

¿Ocular discomfort (an OCI score greater than 51.7 or a within-person increase from baseline of greater than 37.8)

¿Surgical reintervention

Follow-up Visits and Length of Follow-up 4 weeks post-procedure

Subjects will be evaluated in the immediate postoperative period (Visit 1: Day 1 to Day 3) and again at approximately 4 weeks post-procedure (Visit 2: Day 20 to Day 40).
Interim or Final Data Summary
Actual Number of Patients Enrolled 626 subjects
Actual Number of Sites Enrolled 22 sites
Patient Follow-up Rate 98.9%
Final Safety Findings Event rates for each primary endpoint are as follows: anterior chamber cells greater than level 1+ persisting at visit 2 (greater than or equal to Day 20) 0.8%; hypotony 0%; ocular discomfort 0.6%; surgical reintervention 0.5%. For each of the individual primary endpoints, the upper confidence bound was well below the threshold of 7.5%. Therefore, the null hypothesis is rejected and it can be concluded that the true proportion for each individual primary endpoint is less than 7.5%.

Final Effect Findings Effectiveness was not evaluated in the PAS.
Study Strengths & Weaknesses Study strengths include this study being a large-scale prospective study of 626 patients from 22 U.S. sites. The large sample size from varied regions of the U.S. increases the generalizeability of the study results to patients at large undergoing cataract surgery in the U.S.
Recommendations for Labeling Changes No

OSB Lead-Clinical PAS Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 07/09/2014 07/28/2014 Overdue/Received
one year report 01/08/2015 01/08/2015 On Time
18 month report 07/09/2015 07/08/2015 On Time
two year report 01/08/2016 12/28/2015 On Time
Final Report 06/30/2016 06/30/2016 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

Phone: (301) 796-6134
Fax: (301) 847-8140

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