Postmarket Study of an Intraocular Lens Power Selection System



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:12/19/2018
Start Date:August 16, 2018
End Date:April 2019

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Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric

The purpose of this study is to evaluate the visual acuity of eyes implanted with an Acrysof®
Toric intraocular lens (IOL) with lens power selected by the ORA System with VerifEye + and
Barrett Toric Calculator.

The study will be conducted at up to 10 sites in the US. Surgery will be done on each eye on
different days 7 to 14 days apart. Total follow-up duration is 6 months. There will be 10
visits in total.

Inclusion Criteria:

- Planned cataract surgery with IOL implantation

- Able to comprehend and sign the informed consent form

- Preoperative astigmatism of 0.75 to 3.00 Diopter

- Willing and able to complete all required postoperative visits

- Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

- Unclear intraocular media other than cataract

- Pregnant or lactating

- Presence or history of any condition or finding that makes the subject unsuitable as a
candidate for cataract surgery or study participation or may confound the outcome of
the study, in the opinion of the Investigator.

- Other protocol-defined exclusion criteria may apply
We found this trial at
9
sites
Mount Pleasant, South Carolina 29464
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Mount Pleasant, SC
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Florence, South Carolina 29501
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from
Florence, SC
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Kingston, Pennsylvania 18704
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from
Kingston, PA
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Mount Dora, Florida 32757
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mi
from
Mount Dora, FL
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Nacogdoches, Texas 75965
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from
Nacogdoches, TX
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Nashville, Tennessee 37232
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mi
from
Nashville, TN
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Panama City, Florida 32405
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mi
from
Panama City, FL
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Poughkeepsie, New York 12603
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mi
from
Poughkeepsie, NY
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Sioux Falls, South Dakota 57108
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mi
from
Sioux Falls, SD
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