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Refractive Cataract Toolset® Prospective Clinical Study

• 4 Investigational sites
• No device-related surgical complications were observed
• LRI Arm (n = 53)
  At 6 weeks, 85% of eyes
  achieved residual manifest
  cylinder ≤ 0.5D 		• Capsulorhexis Arm (n = 22)
  100% of eyes achieved
  goal of 6mm or less
  capsulorhexis diameter

Pre-Op Corneal Cylinder (n=53)
6 week Post-Op Manifest Cylinder (n=53)
Each ring = 0.5 D step

  Pre-Op
Centroid (D) 0.133
Mean Cylinder (D) 1.090
Standard Deviation (D) 0.430
% Eyes ≤ 0.50 D 4%

Source: Abstract Packer, AAO/ISRS 2010
  Post-Op
Centroid (D) 0.051
Mean Cylinder (D) 0.368
Standard Deviation (D) 0.356
% Eyes ≤ 0.50 D 85%

Retrospective Analysis of 3D HD Visualization vs. Conventional Oculars During Routine Cataract Surgery

• Methods:

   • Analyzed consecutive cases from adjacent OR for a single surgeon
   • Routine cataract cases using two methods of visualization

Visualization Method # of Eyes Unplanned Vitrectomy
TrueVision® 3D 293 0.35% (1)
Traditional Oculars 461 1.09% (5)

• Results:

   • Unplanned vitrectomy rate was lower in TrueVision® 3D cases
   • Comparable mean surgical times (8:06 for TVS, 7:53 for oculars)

Source: Abstract Weinstock, ASCRS 2010
  
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