AcrySof® IQ ReSTOR® +2.5 D Multifocal Intraocular Lens (IOL) Model SN6AD2 [SV25T0] in Japan

Clinical Investigation of AcrySof® IQ ReSTOR® Multifocal Intraocular Lens Model SN6AD2

The purpose of this study is to evaluate safety and effectiveness of AcrySof® IQ ReSTOR® +2.5 D Multifocal IOL Model SN6AD2 [SV25T0] in Japanese cataract patients.

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 8 postoperative visits (each eye examined at Day 1-2, Day 7-14, and Day 30-60, with binocular visits at Day 120-180 and Day 330-420 after the second implantation). The second implantation occurred within 30 days of the first.

Inclusion Criteria:

• Sign informed consent;
• Diagnosed with bilateral cataracts;
• Planned cataract removal by phacoemulsification;
• Potential postoperative visual acuity of 0.5 decimal or better in both eyes;
• Preoperative astigmatism ≤ 1.5 diopter;
• Clear intraocular media other than cataract in study eyes;
• Calculated lens power within the available range;
• Able to undergo second eye surgery within 30 days of the first eye surgery;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Significant irregular corneal aberration as demonstrated by corneal topography;
• Any inflammation or edema (swelling) of the cornea;
• Diagnosed degenerative visual disorders predicted to cause future acuity losses to a level worse than 0.5 decimal;
• Diabetic retinopathy;
• Previous refractive surgery, retinal detachment, corneal transplant;
• Glaucoma;
• Pregnancy;
• Currently participating in another investigational drug or device study;
• Exclusion criteria during surgery;
• Other protocol-defined exclusion criteria may apply.