A Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting Intraocular Lenses (IOLs)

A Randomized, Subject-Masked Comparison of Visual Function After Bilateral Implantation of Presbyopia-Correcting IOLs

The purpose of this study is to evaluate visual and refractive parameters in a series of subjects bilaterally implanted with presbyopia-correcting intraocular lenses (IOLs) during cataract surgery.

Each subject completed a preoperative examination of both eyes, implantation of IOL at the operative visit for each eye, and up to 4 postoperative visits (each eye examined at Day 1-2, with binocular visits at Month 1 and Month 3 after the second implantation). The second implantation occurred within 30 days of the first.

Inclusion Criteria:

• Sign informed consent;
• Able to attend postoperative examinations per protocol schedule;
• Diagnosed with bilateral cataracts;
• Planned cataract removal by phacoemulsification with implantation of an intraocular lens (IOL);
• Preoperative astigmatism ≤ 2.5 diopter;
• Good ocular health, with the exception of cataracts;
• Free of disease(s)/condition(s) listed in the "Caution" section of the AcrySof IQ and Acri.LISA package inserts;
• Able to undergo second eye surgery within one month of the first eye surgery;
• Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

• Previous corneal surgery;
• Planned multiple procedures during cataract/IOL implantation surgery;
• Any ocular disease and/or condition that may compromise study results;
• Pregnant or planning pregnancy during course of study;
• History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, etc.)
• Diabetic retinopathy;
• Macular degeneration;
• History of retinal detachment;
• Other protocol-defined exclusion criteria may apply.