Safety and Efficacy of a Violet Visible Light Blocking Intraocular Lens (IOL)

• Best Corrected Distance Visual Acuity [ Time Frame: One year ] [ Designated as safety issue: No ]
  Snellen Equivalent visual acuity of 20/40 or better
  
  
• Uncorrected Distance Visual Acuity [ Time Frame: One Year ] [ Designated as safety issue: No ]
  Snellen Equivalent of 20/40 or better at one year
  
  

• Contrast Sensitivity [ Time Frame: 4-6 months ] [ Designated as safety issue: No ]
  Contrast sensitivity is the measurement of how faded an image may become before it can clearly be seen. Contrast sensitivity was measured in photopic and mesopic conditions at the following spatial frequencies: 3.0, 6.0, 12.0, and 18 cpd (cycles per degree). Contrast sensitivity is measured in log units. A higher value for the logarithmic units translates to better contrast sensitivity.
  
  
• Subject Satisfaction - Subjects Satisfied With Overall Eyesight Rated as "Good" or "Excellent". [ Time Frame: One Year ] [ Designated as safety issue: No ]
  Subjects indicating a subjective response to a multiple choice question, "At the present time, would you say your eyesight using both eyes (with glasses or contact lenses, if you wear them) is excellent, good, fair, poor, or very poor or are you completely blind?", on a multi-item questionnaire administered by interviewer to determine subject satisfaction with their overall visual outcome at the one year visit.
  
  

The investigational IOL will be found to be safe and effective with respect to visual acuity, color vision, contrast sensitivity and complications and will be similar to results for the ZA9003 control eyes. Complication rates and adverse event rates will be within the FDA grid for posterior chamber IOLs.