In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
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.
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.
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
Followup Visits and Length of Followup
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).