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 purpose of this post-approval study is to evaluate the rates of visual distortions for
the TECNIS Toric IOLs with >2.0 D of cylinder correction at the corneal plane (Models ZCT300 and ZCT400) in a larger population in clinical practice compared to a non-toric control IOL and to ensure the continued safety of the approved devices.
Bilateral cataracts with corneal astigmatism of approximately 2.00 D to
3.62 D based on the combination
of preoperative keratometric cylinder and the expected effect of (Surgeon-estimated) surgically induced astigmatism (SIA).
Up to 435 subjects will be enrolled to achieve bilateral implantation in
approximately 385 subjects: 220
TECNIS Toric ZCT300 and ZCT400 subjects (including a minimum of approximately 30%, or 70, ZCT400 subjects) and 165 control subjects (assumes a 10% drop-out rate for a minimum of 200 toric and 150 control subjects available for evaluation at
6 months). Subjects will choose to be implanted with the same lens in
both eyes, either the toric IOLs or the non-toric control IOL.
¿ Rates of severe visual distortions (with glasses or contact lenses, if correction is
needed) at 6 months for each of the following questions:
o things appearing distorted o objects appearing tilted
o floors or flat surfaces appearing curved o queasiness related to vision
¿ Rates of IOL repositioning procedures (secondary surgical intervention)
due to IOL misalignment
¿ Rates of other adverse events
Followup Visits and Length of Followup
6 months to 1 year
All subjects are intended to have bilateral cataract surgery with the
surgery occurring within approximately 1 month of the first- eye surgery (≤60 days). Two postoperative study visits will be conducted; at 1 month (30-60 days after the second-eye surgery) and at 6 months (120-180 days after the second-eye surgery) for both eyes together. However, subjects who underwent an IOL repositioning procedure due
to IOL misalignment or who reported a severe visual distortion at 6 months will return for a final visit at 1 year (330-420 days after the second-eye surgery) postoperatively.