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

Phase 3

Completed

Brief Summary: 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.

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 (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

Arm && Interventions

Group	Intervention	Description
FS Laser Surgery	FS Laser Surgery	For femtosecond laser-assisted cataract surgery group (FS Laser Surgery), subjects will receive capsulotomy, lens segmentation and, at investigator discretion, lens softening using the femtosecond laser device. If necessary, ultrasound (U/S) phacoemulsification will also be applied to facilitate removal of the crystalline lens during cataract surgery.
CCC Surgery	CCC Surgery	For the continuous curvilinear capsulorhexis (CCC) group (CCC Surgery), subjects will receive the standard of care for CCC and U/S phacoemulsification surgery to facilitate removal of the crystalline lens during cataract surgery.

Primary Outcome Measures

Name	Time	Method
Deviation From Intended Capsulotomy Diameter	Day of Surgery	Capsulotomy diameter 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. CDE is a unit used for the Alcon Infinity System (the U/S phacoemulsification used in this study). It is not expressed in standard units such as watts or Joules. CDE, which accounts for the power and time of two ultrasound delivery modes (longitudinal and torsional), is calculated as follows: CDE = (Phaco time x average phaco power) + (torsional time x average torsional aptitude x 0.4) 0.4 is a factor representing the approximate reduction of heat dissipated at the incision as compared to conventional phacoemulsification.