Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

Clinical Investigation of AcrySof® IQ PanOptix™ IOL Model TFNT00

The purpose of this clinical study is to compare the visual outcomes of the AcrySof IQ PanOptix Multifocal Intraocular Lens (IOL) Model TFNT00 against that of a monofocal lens, the AcrySof Monofocal IOL Model SN60AT, in order to demonstrate comparable distance vision and superior near and intermediate vision.

Both eyes of a subject must require cataract surgery to qualify for enrollment into this study. Subjects participating in the trial will attend a total of 10 study visits over a 7-month period. Of these 10 visits, 1 is preoperative, 2 are operative, and the remaining 7 are postoperative visits. Primary endpoint data will be collected at the Month 6 (Day 120-180) post second eye implantation visit.

Inclusion Criteria:

• Diagnosed with 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.
• Preoperative keratometric astigmatism of less than 1.0 diopter (D) in both operative eyes.

Exclusion Criteria:

• Clinically significant corneal abnormalities including corneal dystrophy, irregularity, inflammation or edema
• Previous refractive surgery or refractive surgery procedures (including, but not limited to LASIK, astigmatic keratotomy, and limbal relaxing incisions)
• Glaucoma (uncontrolled or controlled with medication)
• Degenerative eye disorders (e.g. macular degeneration or other retinal disorders)
• Pregnant or lactating
• Expected to require a second surgical intervention or retinal laser treatment.