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 primary objective of this study is to demonstrate superiority of the AcrySof® IQ Toric
High Cylinder Power study group (IOL Models SN6AT6-SN6AT9) to the AcrySof® IQ Aspheric NATURAL IOL Model SN60WF concurrent control group with spectacle correction, for the rate of severe visual distortions at 6 months post bilateral implantation in subjects with pre-operative corneal astigmatism ≥ 2.57 D.
This is a prospective, non-randomized, unmasked study, with data collection through electronic case report forms (eCRF).
Study Population Description
Adult subjects in need of bilateral cataract surgery with pre- operative corneal astigmatism in the
Total Sample size: 400
-AcrySof® IQ Toric IOL Model SN6AT6-SN6AT9: 230
-AcrySof® IQ Aspheric NATURAL IOL Model
The primary safety endpoint for this study is the rates of severe visual distortions as
measured by the Assessment of Photic Phenomenon & Lens EffectS (APPLES) ¿ Visual
Subjects in both groups will be categorized as experiencing a severe visual distortion if they indicate ¿severe¿ as a response to any one of the three visual distortion related questions on the APPLES ¿ Visual Distortion Questionnaire.
In this study the following supportive safety variables will be evaluated:
¿ Adverse events
o Lens dislocation o Pupillary block
o Cumulative rate of any ocular SSIs at 6 months
- Cumulative rate of IOL repositioning at 6 months
- Cumulative rate of IOL explantation at 6 months
- Cumulative rate of ocular SSIs related to visual distortions at 6 months
¿ Any other vision-threatening adverse event related to the
¿ Uncorrected Distance Visual Acuity (UCDVA)
¿ Best Corrected Distance Visual Acuity (BCDVA)
¿ Lens axis misalignment
For serious adverse events, the following change of definition is made in protocol version 3.0
Serious Adverse Event (SAE) - adverse event that led to any of the following:
¿ A serious deterioration in health that either resulted in:
a) A life-threatening illness or injury.
NOTE: Life-threatening means that the individual was at immediate risk of death from the event as it occurred, i.e., it does not include an event which hypothetically might have caused death had it occurred in a more severe form.
b) Any potentially sight-threatening event or permanent impairment to a body structure or a body function
c) In-patient hospitalization or prolonged hospitalization.
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the clinical investigation plan, without serious deterioration in health, is not considered a serious adverse event. In general, hospitalization signifies that the individual remained at the hospital or emergency ward for observation and/or treatment (usually involving an overnight stay) that would not have been appropriate in the physician's office or an out-patient setting. Complications that occur during hospitalization are adverse events. If a complication prolongs hospitalization or fulfills any other serious criteria, the event is serious. When in doubt as to whether ¿hospitalization¿ occurred, the event should be considered serious.
d) A medical intervention to prevent a) or b), or any surgical intervention (excluding posterior capsulotomy)
e) Any indirect harm as a consequence of incorrect
diagnostic test results when used within manufacturer's instructions for use.
¿Fetal distress, fetal death, or a congenital abnormality or birth defect.