A Clinical Study of the ACRYSOF® IQ EDF Intraocular Lens (IOL)

A Prospective, Randomized, Controlled, Multi-Center Clinical Study of the ACRYSOF® IQ Extended Depth of Focus (EDF) IOL

The purpose of the study is to demonstrate the safety and performance of the ACRYSOF® IQ EDF IOL.

Both eyes will be implanted. The second eye implantation will occur a minimum of 7 calendar days and a maximum of 28 calendar days from the first eye implantation.

Inclusion Criteria:

• Able to understand and sign an Independent Ethics Committee (IEC)/ Institutional Review Board (IRB) approved Informed Consent Form;
• Diagnosed with cataract in both eyes;
• Planned cataract removal by routine small incision surgery;
• Calculated IOL power is within the clinical study supply range (18.0-25.0 diopter (D) in 0.5 D steps);
• Preoperative regular astigmatism of less than 1.0 D.

Exclusion Criteria:

• Pregnancy or lactation current or planned during the course of the study;
• History of anterior segment (corneal, anterior chamber, sulcus) or posterior segment (uveal, vitreo-retinal) pathology including retinal vascular occlusive disease, retinal detachment or peripheral retinal laser photocoagulation, age-related macular degeneration (ARMD), glaucoma (uncontrolled or controlled with medication) or ocular hypertension, diabetic retinopathy, retinitis pigmentosa and any optic nerve pathology.