Postmarket Study of an Intraocular Lens Power Selection System

Postmarket Study of ORA With VerifEye+ and Barrett Toric Calculator Used for the Implantation of AcrySof Toric

The purpose of the study was to evaluate the visual acuity outcomes when using the Optiwave Refractive Analysis (ORA) with VerifEye+ and Barrett Toric Calculator for calculating intraocular lens (IOL) power and axis in subjects requiring cataract surgery and implanted with a toric IOL in both eyes.

Surgery was done on each eye on different days, 7 to 14 days apart. Subjects were seen for a total of 10 visits with a follow-up duration of 6 months.

Inclusion Criteria:

• Planned cataract surgery with IOL implantation
• Able to comprehend and sign the informed consent form
• Preoperative astigmatism of 0.75 to 3.00 Diopter
• Willing and able to complete all required postoperative visits
• Other protocol-defined inclusion criteria may apply

Exclusion Criteria:

• Unclear intraocular media other than cataract
• Pregnant or lactating
• Presence or history of any condition or finding that makes the subject unsuitable as a candidate for cataract surgery or study participation or may confound the outcome of the study, in the opinion of the Investigator.
• Other protocol-defined exclusion criteria may apply