Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs

Launched by ALCON RESEARCH · Nov 6, 2018

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Preoperative cataract in the study eye(s)
• * Planned implantation in at least one eye with:
• • Cohort 1: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6) or an ACRYSOF IQ RESTOR +2.5 D Multifocal Toric IOLs (Models SV25T3, SV25T4, SV25T5, and SV25T6) in accordance with the product labeling from November 2018 to July 2020
• • Cohort 2: An ACRYSOF IQ RESTOR +3.0 D Multifocal Toric IOL (Models SND1T3, SND1T4, SND1T5 or SND1T6), or an ACRYSOF IQ RESTOR +2.5 D Multifocal IOL (Model SV25T0) in accordance with the product labeling after July 2020.
• • 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:
• • Eyes with clinically significant ocular, including adnexa, or intraocular infection or inflammation (at the screening visit prior to surgery or on the day of surgery)
• • History of any intraocular inflammation within the past 12 months (ex: uveitis, choroiditis)
• • Combined procedures introducing an additional medical device during cataract surgery (ex: cataract surgery with implant of glaucoma stent)
• • Other protocol-specified exclusion criteria may apply.