Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia

11/27/01


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Refractec ViewPoint™ CK System for the Treatment of Spherical Hyperopia

Questions for Panel Consideration

Question for Panel Consideration

Induced Increase in Cylinder Magnitude (% of eyes)

Induced Change in Vector Cylinder Magnitude (% of eyes)

Induced Absolute Axis Shift (% of all treated eyes)

Post-op Cylinder Magnitude (% of eyes) Note: all eyes had baseline cylinder magnitude 0.75D or less

Effect of Induced Cylinder on Uncorrected Visual Acuity (% of eyes at month 12)

Question for Panel Consideration

Question for Panel Consideration

Stability of MRSE 12-month consistent cohort (n=186)

Stability of MRSE cohort with 2 consecutive visits

Accuracy of MRSE

Question for Panel Consideration

Visual Symptoms with ?5% increase over baseline (% eyes with moderate to severe symptoms)

Question for Panel Consideration

Requested Indication for Use

Question for Panel Consideration

Questions for Panel Consideration

Question for Panel Consideration

Question for Panel Consideration

Question for Panel Consideration

Question for Panel Consideration

Question for Panel Consideration

Question for Panel Consideration

Author: JPG