Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
This is a prospective, multicenter, post-approval active surveillance study. The purpose of this study is to report the rate of post-surgical intraocular inflammation (based upon a specified case definition) reported within a 180-day post-surgical period following attempted implantation of an ACRYSOF IQ RESTOR Toric or ACRYSOF IQ RESTOR IOL in the US.
If a second eye will participate in the study, subjects will receive the second eye cataract surgery within 20 days of the first eye surgery. Four postoperative follow-up visits are planned to occur at 1-2 days, 7-14 days, 30-60 days, and 90-180 days, for each enrolled eye. Subject participation in this study is expected to last up to 7 months, including a total of 6 study visits for subjects implanted in one eye and up to 11 visits for subjects implanted in both eyes. Upon completion of the 180 days follow-up visit, subjects will be exited from the study.
Inclusion Criteria:
Preoperative cataract in the study eye(s)
Planned implantation in at least one eye with:
Able to comprehend and sign a statement of informed consent
Willing and able to complete all required postoperative visits
Other protocol-specified inclusion criteria may apply.
Exclusion Criteria: