Study of the Femtosecond Laser System as Compared to Continuous Curvilinear Capsulorhexis for Cataract Surgery
Condition: Cataract
MeSH terms: Cataract
Intervention: FS Laser Surgery; CCC Surgery
Intervention description: The Catalys System is an ophthalmic surgical laser system intended for use in cataract surgery to perform capsulotomy, lens segmentation, and lens softening, which are all part of cataract surgery when this femtosecond laser is used.; Subjects will receive the standard of care for CCC and U/S cataract surgery to facilitate removal of the crystalline lens. CCC is a procedure that is part of cataract surgery.
Intervention MeSH terms: Dipivefrin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 30.0
Sex: All
Minimum age: 50 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Cataract; Surgery, cataract extraction; Optical devices, laser

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.
    

Eligibility criteria:

        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