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 post approval safety study is to evaluate the incidence of
(ie, position change such as clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) of the Trulign Toric IOL following cataract surgery at up to three years post implantation.
This is a prospective, multicenter, open-label, single arm, post approval study at a minimum of 30 and up to 50 clinical sites in the US.
Study Population Description
All subjects who meet eligibility criteria will be consecutively offered enrollment
into the trial until a
site meets the maximum number, or the study has fulfilled all enrollment requirements. If both eyes of a subject are eligible for enrollment, the first treated eye should be chosen at the discretion of the surgeon after consultation with the subject. All eyes will be treated in accordance with the Trulign Toric IOL labeled indications for use and the Physician Labeling Directions for Use (DFU).
The study will enroll up to approximately 686 eyes:
A final sample size of 500 eyes
is required. Given losses of 10% per year, after three years the remaining proportion would then be 0.93 or 0.729. Given these losses, if 500/0.729 = 686 eyes are enrolled then approximately 500 eyes will be available after three years.
The study endpoint is the incidence of clinically significant IOL vaulting (ie,
position change such as
clinically significant anterior vaulting, clinically significant tilt, and secondary surgical intervention related to such vaulting) up to three years post implant.
Followup Visits and Length of Followup
Study participants will be followed for 3 years postoperatively.