Transcript Document

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
• 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
CK Presbyopia FDA Clinical Trial
Protocol 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)
CK Presbyopia FDA Clinical Trial
Protocol RCS-011-PRS
24 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
CK Presbyopia FDA Clinical Trial
Protocol RCS-011-PRS
24 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
CK Presbyopia FDA Clinical Trial
Protocol RCS-011-PRS
24 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
CK Presbyopia FDA Clinical Trial
Protocol RCS-011-PRS
24 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)
CK Presbyopia FDA Clinical Trial
Protocol RCS-011-PRS
24 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
MRSE over time
Average K over time
Monocular UCVA-D and N
Binocular UCVA-D and N
What can you see without glasses?
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24 Months
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0
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