Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting Intraocular Lens (IOL) Model TFNT00



Status:Active, not recruiting
Conditions:Ocular
Therapuetic Areas:Ophthalmology
Healthy:No
Age Range:22 - Any
Updated:4/14/2017
Start Date:September 7, 2015
End Date:June 30, 2017

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Investigation of AcrySof® IQ PanOptix™ Presbyopia-Correcting IOL Model TFNT00

The purpose of this study is to investigate visual outcomes and assess safety at 12 months
(330-420 days) post bilateral implantation of the AcrySof® IQ PanOptix™
Presbyopia-Correcting IOL.

This study will be conducted in regions where the test article is approved at the time of
study start.

Inclusion Criteria:

- Diagnosis of bilateral cataracts with planned cataract removal by phacoemulsification
with a clear cornea incision;

- Able to comprehend and willing to sign informed consent and complete all required
postoperative follow-up procedures;

- Clear intraocular media other than cataract in both eyes;

- Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

- Clinically significant corneal abnormalities including corneal dystrophy,
inflammation or edema;

- Ocular trauma, corneal transplant, retinal conditions, degenerative eye disorders, or
color vision deficiencies;

- Glaucoma (uncontrolled or controlled with medication) or ocular hypertension;

- Pregnant or lactating;

- Expected to require ocular surgical or retinal laser treatment;

- Other protocol-specified exclusion criteria may apply.
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