Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery

A Prospective, Randomized Study of Cataract Surgery With the Assistance of the OptiMedica Femtosecond Laser System Compared to Standard Surgical Procedure of Continuous Curvilinear Capsulorhexis and Ultrasonic Phacoemulsification

The purpose of this study is to evaluate the safety and efficacy of the OptiMedica Femtosecond Laser System to perform surgical maneuvers used in the treatment of subjects with cataracts. The safety and efficacy will be compared to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Inclusion Criteria:

• Able and willing to comply with the treatment/follow-up schedule and requirements
• Able to understand and provide written Informed Consent
• ETDRS (Early Treatment of Diabetic Retinopathy Study) visual acuity equal to or worse than 20/32 (best corrected)
• Age between 50 and 80 years old
• Pupil dilates to at least 7 mm
• Subject able to fixate
• Grade 1-4 nuclear sclerotic cataract (Lens Opacities Classification System - LOCS III)
• Axial length between 22 and 26 mm

Exclusion Criteria:

• Pregnant, intending to become pregnant during course of the study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
• Participation in a study of another device or drug within 3 months prior to study enrollment or during this study, and as per the Investigator's careful discretion, as long as not contradictory to any of the above criteria
• Any condition which, in the Investigator's opinion, would make it unsafe (for the subject or for the study personnel) to treat the subject as part of this research study or for which cataract surgery is contraindicated
• Anterior chamber depth (anterior corneal surface to anterior capsule margin) less than 2.5 mm via IOL Master (Zeiss).
• History of prior ocular surgery
• History of ocular trauma
• Co-existing ocular disease affecting vision
• History or current use of alpha-1 antagonist medication (e.g., Flomax)
• Known sensitivity to planned concomitant medications