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.
The objective of this study is to collect post-approval data relative to the
incidence of endophthalmitis
(within 30 days) for cataract surgery patients treated with the ReSure Sealant when used by a broad group of physicians under commercial use conditions.
This study is designed as a retrospective, multicenter, observational, single- arm post-approval registry study that will include up to 100 US centers and will enroll at least 4857 patients treated with ReSure Sealant.
Study Population Description
The study population is defined as all patients who receive at least one application of
the ReSure Sealant on the operative eye in 2014 or 2015 (up to October 2015).
A sample of 4857 patients provides approximately 82% power (alpha = 0.05) to detect a
difference (P1 – P0) of -0.0020, using a one-sided binomial test, where P0 is the proportion of endophthalmitis within 30 days under the null hypothesis (0.0040) and P1 is the proportion of endophthalmitis within 30 days under the alternative hypothesis (0.0020).
The results assume that the population proportion under the null hypothesis is 0.0040.
The primary endpoint will be the occurrence of endophthalmitis (based on
the ‘specific’ definition) within 30
days (±10 days) of the cataract procedure.
Endophthalmitis is defined (i.e., sensitive definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed belowhas been reported.
Endophthalmitis is defined (i.e., specific definition) to have occurred if at least one of the ICD-9-CM or ICD-10-CM codes listed below has been reported and at least one of the CPT-4/HCPCS procedure codes listed below has been reported.
360.0 – purulent endophthalmitis
360.00 – unspecified purulent endophthalmitis
360.01 – acute endophthalmitis
360.02 – panophthalmitis
360.03 – chronic endophthalmitis
360.04 – vitreous abscess
364.03 – secondary iridocycitis, infectious
CPT-4 / HCPCS Procedure Codes:
CPT-4: 66030 – injection of medication in anterior chamber
CPT-4: 67005/67010 – anterior vitrectomy
CPT-4: 67028 – intravitreal injection of pharmacologic agent
CPT-4: 67036 – pars plana vitrectomy
Followup Visits and Length of Followup
As a retrospective study, there is technically no follow-up. The study is designed primarily to
ascertain if Medicare patients treated with ReSure Sealant were diagnosed with endophthalmitis within 30 days of cataract surgery. Patients from the Clinical PAS will be pooled into this study with the outcome reported through site/investigator record review.