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CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS

Conductive Keratoplasty for the Treatment of Presbyopic Emmetropes and Hyperopes to Improve Near Vision FDA Clinical Trial Protocol RCS-0110PRS 24 Month Data. CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS.

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CK Presbyopia FDA Clinical Trial Protocol RCS-011-PRS

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  1. Conductive Keratoplasty for the Treatment of Presbyopic Emmetropes and Hyperopes to Improve Near VisionFDA Clinical TrialProtocol RCS-0110PRS24 Month Data

  2. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS • A Prospective Multicenter Clinical Trial to Evaluate the Safety and Effectiveness of the ViewPoint CK System for the improvement in near vision in Presbyopic Emmetropes and Hyperopes utilizing the Conductive Keratoplasty (CK) Procedure

  3. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS 188 eyes of 150 subjects 61% female 39% male Mean age: 52.9 years old Age range: (43.7, 70.8) years old Mean Target: -1.47 Target range: (-1.00, -2.25)

  4. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS24 Month Data • Treatment range (+1.00 to +2.25D) • 16 and 24 spot patterns • Conventional Pressure • Myopic target (-1.00 to -2.00D) • non-dominant eye for monovision

  5. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS24 Month Data • Safety • Preservation of BSCVA • No eyes (0%) report loss of > 2 lines of BSCVA at 24 months • Induced Cylinder • 97% have no clinically significant IC at 24 months • Adverse Events • No Device or Procedure related Ocular AEs reported at 24M • Complications • No Complications reported at 24M

  6. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS24 Month Data • Efficacy (Emmetropic Presbyopes) • Accuracy to Target @ 24 Months • + 0.50D = 53% • + 1.00D = 91% • UCVA-N • 75% of eyes treated are J3 or better at 24 months • 51% of eyes treated are J2 or better at 24 months

  7. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS24 Month Data • Subjective Response • Quality of Vision: • 87% (Moderate, Marked or Extreme Improvement at 24 months) • Patient Satisfaction • 79% (Satisfied or Very Satisfied at 24 months) • Quality of Depth Perception • Pre-op: 94% (Good, Very Good or Excellent) • 24 months: 90% (G, VG, E)

  8. CK Presbyopia FDA Clinical TrialProtocol RCS-011-PRS24 Month Data • Key issue is STABILITY • MRSE over time • Average Keratometry over time • In the Eye treated for Near: • UCVA-Near over time • UCVA-Distance over time • Binocular UCVA-Distance and Near • Patient’s Subjective Perception over time

  9. MRSE over time

  10. Average K over time

  11. Monocular UCVA-D and N

  12. Binocular UCVA-D and N

  13. What can you see without glasses?

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