Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber IOL



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:Any
Updated:2/10/2017
Start Date:March 2015
End Date:December 2019

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A Prospective, Post Approval Study to Evaluate the Trulign™ Toric Posterior Chamber Intraocular Lens (IOL)

To evaluate the incidence of IOL vaulting (ie, position change) of the Trulign™ Toric IOL
following cataract surgery.

The objective of this post approval safety study is to evaluate the incidence of IOL
vaulting (ie, position change) of the Trulign™ Toric IOL following cataract surgery at up to
three years post implantation.

Inclusion Criteria:

- Subjects who are able and willing to comply with the follow-up schedule

- Subjects must have a clinically documented diagnosis of age-related cataract that is
considered amenable to treatment with standard phacoemulsification/extracapsular
cataract extraction

- Subjects must require a lens power from 4 to 33 D

- Subjects must have a Best Corrected Visual Acuity (BCVA) equal to or worse than
20/40, with or without a glare source

Exclusion Criteria:

- Subjects with any anterior segment pathology in the study eye likely to increase the
risk of complications from phacoemulsification cataract surgery

- Subjects with associated ocular conditions which could affect the stability of the
IOL

- Subjects with clinically significant irregular corneal astigmatism in the study eye
We found this trial at
1
site
Rochester, New York 14609
Phone: 714-760-7363
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mi
from
Rochester, NY
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