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.
Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v
Silver Spring, MD
20993-0002
Surgery consisting of implantation of one (1) GTS100
stent in conjunction with cataract surgery, or cataract surgery only
1:1 randomization plan (treatment group to control group)
Washout of ocular hypotensive medications at Month 23 (if on medications)
Follow-up through 5 years postoperative
Study Population Description
Males or Females, 22 years of age or older
Inclusion and exclusion criteria are consistent with
the IDE study except the subject age changed from 18 to 22 years and older.
Sample Size
With estimated rates of 0.03 (3%) for PT and Pc at 5 years, a Type
I error
rate of 5%, a Type II error rate of 20% (i.e., 80% power), a randomization ratio of 1:1, 1- sided testing, a two-group large-sample normal approximation test of proportions, and a 5 of 0.05 (i.e., a non-inferiority margin of 0.05 or 5%), the required sample size is 288 subjects (or 144 per group). Due to the age of the study population, it is estimated that the study will have a drop-out rate of 20%. With allowance for up to 20% losses to follow-up, the sample size for randomization is set at 360 subjects, of whom
180 will undergo stent implantation in conjunction with cataract surgery and 180 will undergo cataract surgery only.
360 eyes of 360 subjects randomized at a minimum of 20 sites and up to 45 sites; it is expected that about 1100 subjects or more will undergo screening and baseline exams and operative procedures in order to obtain 360 randomized eyes.
Data Collection
The primary endpoints will be the occurrence of sight-threatening adverse
events. The sight threatening adverse events
include BCVA loss 3 lines, endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection.
Other important ocular adverse events includes increase in IOP of >10 mmHg at any time postoperative, and loss of best spectacle corrected visual acuity of > 1 line (> 5 letters) at >3 months postoperative. Additional safety events of interest include findings from IOP, best spectacle corrected visual acuity, visual field, pachymetry, and specular microscopy measurements, and findings from slit-lamp, fundus and gonioscopic examinations.
Effectiveness Outcomes
The effectiveness outcomes, although not the primary endpoint of this safety study, are the outcomes of IOP reduction > 20% vs. baseline IOP without ocular hypotensive medication, and
IOP <18 mmHg without ocular hypotensive medication, at 24 months. The rate of these effectiveness outcomes will be compared between the
treatment and control groups
Followup Visits and Length of Followup
Frequency of Follow-up
Assessments the examination schedule is as follows:
