One Year Results of the FDA Clinical Trial of a New Personalized Hyperopia Treatment Stephen G Slade, MD The Laser Center of Houston Houston, Texas Consultant for B&L, Alcon, Technolas, AMO, Revision Optics
Zyoptix- personalized wavefront guided platform Technolas 217-Z excimer laser Hartmann-Shack aberometer (Zywave) Topography data (Orbscan II-z) Zywave data is combined with the Orbscan data to generate the custom treatment plans.
Zyoptix Hyperopia FDA Trial Six sites in U.S. Limits of treatment range: +4.0 D sphere and +4.0 D cylinder (OZ 6-7 mm surgeon decision) Study eyes: 159 (80 patients) Postop follow up - 1year Without Rotational Eye Tracker Without Advanced Nomogram for hyperopia
Mean MRSE Mean Preop Sphere= 1.81 ± 1.09D (range 0-4 D) Cylinder=0.83 ± 0.67 (range 0-4)
Uncorrected Visual Acuity
Uncorrected Visual Acuity at 1 Year (n=147)
Change in BCVA Preop to 1 Year (n=155)
Refractive Error
Comparison to Other Systems Achieved 20/20 or Better at 6 Months
Conclusion Tecnolas 217 with Zyoptix Personalized Treatment for Hyperopia provides: Excellent uncorrected visual acuity Stable MRSE Highly predictable outcomes