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. The design is a prospective, multi-center, bilateral, non- randomized, open-label, comparative clinical study conducted at up to 80 sites in the USA. Subjects will choose to be bilaterally implanted with either 1) the TECNIS 1-Piece Toric IOLs, Model ZCT300 and/or ZCT400, or 2) the TECNIS Monofocal Model ZCB00 non-toric control IOL, according to subject preference.
Study Population Description
Patients with 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 surgically induced astigmatism.
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). With 200 toric subjects and 150 control subjects, this study has over 90% power to evaluate the rate of severe visual distortions for toric subjects as being no more than 10 percent higher than control subjects. This assumes use of one side of a two-sided 90% confidence interval and severe visual distortion rates of 0.02 for toric and control subjects.
Primary Endpoint Rate of severe visual distortions; defined as the percentage of subjects who report a
severe visual distortion under overall circumstances at 6 months postoperative for any of the following 5 visual distortion items of interest: -lines that slant, tilt, split or separate o flat surfaces appearing curved -objects appearing further away or closer than they actually are -objects appearing to have a different size or shape o physical discomfort related to vision. Other Endpoints Ratings of individual items included on the visual distortion questionnaire Rates of IOL repositioning procedures (secondary surgical intervention) due to IOL misalignment Rates of other adverse events
Followup Visits and Length of Followup
Six months; any subjects that undergo a lens repositioning procedure due to IOL misalignment or that
report a severe visual distortion at six months, will be followed through 1 year postoperatively.