Femtosecond Laser for Cataract Surgery

Phase 3

Terminated

Brief Summary: The objective of this study is to evaluate the safety and efficacy the OptiMedica Femtosecond Laser System, also known as the Catalys™ Precision Laser System, to perform two surgical maneuvers used in the treatment of subjects with cataracts. Efficacy will be evaluated by comparisons to the standard surgical procedure of continuous curvilinear capsulorhexis (CCC) and ultrasonic phacoemulsification.

Recruitment & Eligibility

Inclusion Criteria

Able and willing to comply with the treatment/follow-up schedule and requirements
Able to understand and provide written Informed Consent
ETDRS visual acuity equal to or worse than 20/32 (best corrected)
Age between 50 and 80 years old
Pupil dilates to at least 6 mm
Subject able to fixate
Grade 1-4 nuclear sclerotic cataract (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

Arm && Interventions

Group	Intervention	Description
U/S Surgery and CCC	U/S Surgery and CCC	Ultrasound (U/S) cataract surgery and continuous curvilinear capsulorhexis (CCC).
FS Laser Surgery	FS Laser Surgery	For femtosecond laser-assisted cataract surgery (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device.

Primary Outcome Measures

Name	Time	Method
Capsulotomy Dimension	Day of Surgery	Capsulotomy size will be measured during surgery for both the experimental and control groups.

Secondary Outcome Measures

Name	Time	Method
Cumulative Dissipated Energy (CDE)	Day of Surgery	CDE (the amount of ultrasound energy delivered during phacoemulsification of the crystalline lens) used will be measured during surgery.