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 the study is to assess the safety of the intraocular telescope as measured
by the cumulative incidence of patients who within 5 years after implantation experience persistent vision-impairing corneal edema (corneal edema leading to persistent loss of best corrected distance visual acuity >2 lines from pre-surgery baseline level). Interventional, prospective, multicenter, open label, single group assignment, safety study.
Study Population Description
The intraocular telescope is indicated for monocular implantation to improve vision in patients greater than
or equal to 65 years of age with stable severe (distance BCVA of 20/160 or poorer) to profound (distance BCVA of 20/800 or better) vision impairment caused by bilateral central scotomas associated with end-stage age-related macular degeneration.
Patients must: - have retinal findings of geographic atrophy or disciform scar with foveal involvement, as determined by fluorescein angiography - have evidence of visually significant cataract (>Grade 2) - agree to undergo preoperative training in the use of a trial external telescope to verify: - at least a five-letter improvement on the ETDRS chart with a trial external telescope - adequate peripheral vision in the eye not scheduled for surgery - agree to participate in a postoperative visual training rehabilitation.
The sample size of 770 Subjects was calculated under the following assumptions: Two-sided type I
error = 0.05. Power of 95%. Over a five year period from implantation, the true percentage of patients experiencing the primary outcome is 12%. The proportion of the population that is -lost- (i.e., dies, does not return for a visit, or is lost to follow-up) is 15% each year. Kaplan- Meier curves will be calculated to describe the time course of persistent vision -impairing corneal edema. The Greenwood formula will be used to calculate the variance of the five-year event rate. The minimum and maximum numbers of sites participating in IMT- PAS-01 are 20 and 50 .
The clinical parameters to be evaluated in both eyes at study visits are: 1. Best spectacle-corrected