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

Use our guide to learn which trials are right for you!

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.

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.

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.
We found this trial at
7
sites
Cincinnati, Ohio 45242
?
mi
from
Cincinnati, OH
Click here to add this to my saved trials
Fresno, California 93720
?
mi
from
Fresno, CA
Click here to add this to my saved trials
Houston, Texas 77204
?
mi
from
Houston, TX
Click here to add this to my saved trials
Mount Dora, Florida 32757
?
mi
from
Mount Dora, FL
Click here to add this to my saved trials
Nashville, Tennessee 37232
?
mi
from
Nashville, TN
Click here to add this to my saved trials
New York, New York 10013
?
mi
from
New York, NY
Click here to add this to my saved trials
Poughkeepsie, New York 12603
?
mi
from
Poughkeepsie, NY
Click here to add this to my saved trials