Post Approval Study of the AcrySof® IQ ReSTOR® Toric IOLs
Status: | Recruiting |
---|---|
Conditions: | Ocular |
Therapuetic Areas: | Ophthalmology |
Healthy: | No |
Age Range: | 22 - Any |
Updated: | 4/4/2019 |
Start Date: | November 27, 2018 |
End Date: | January 2021 |
Contact: | Alcon Call Center |
Email: | alcon.medinfo@alcon.com |
Phone: | 1-888-451-3937 |
The purpose of this post-approval 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 Intraocular Lens
(IOL) in the US.
inflammation (based upon a specified case definition) reported within a 180-day post-surgical
period following attempted implantation of an ACRYSOF® IQ RESTOR® Toric Intraocular Lens
(IOL) in the US.
Qualified subjects will receive cataract surgery followed by implantation of the ACRYSOF IQ
RESTOR +3.0 D Toric IOL or an ACRYSOF IQ RESTOR +2.5 D Toric IOL at the surgery visit. If a
second eye will participate in the study, subjects will receive the second eye cataract
surgery within 60 days of the screening visit. 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.
RESTOR +3.0 D Toric IOL or an ACRYSOF IQ RESTOR +2.5 D Toric IOL at the surgery visit. If a
second eye will participate in the study, subjects will receive the second eye cataract
surgery within 60 days of the screening visit. 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 an ACRYSOF IQ RESTOR 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
- 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:
- 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 during cataract surgery (ex: cataract surgery with implant of
glaucoma stent)
- Other protocol-specified exclusion criteria may apply.
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