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.
This is a prospective Registry with patients reporting outcomes
Study Population Description
The device is indicated for adults 21-45 years of age:to correct myopia ranging from -3.0
diopters to < - 15.0 diopters with less, than or equal to 2.5 diopters of astigmatism at the spectacle, plane; * to reduce myopia ranging from greater than -15.0 diopters to - 20.0, diopters with less than or equal to 2.5 diopters of astigmatism at tile spectacle plane; and, with an anterior chamber depth (ACD) 3.00 mm or greater, and a stable refractive history within 0.5 diopter for 1 year prior to implantation. The Study includes subjects who are 21-45 years of age with myopia of -3.0 diopters to -20 diopters.
3,000 eyes will be enrolled
2,000 treated eyes needed with 5-year data
Corneal edema, cataract, chronic uveitis, glaucoma, retinal detachment, second surgery, and other complications assessed by
Followup Visits and Length of Followup
6, 12, 18, 24, 36,48, and 60 months after implantation