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Published byAlexia Hancock Modified over 5 years ago
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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
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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.
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Zyoptix Hyperopia FDA Trial
Six sites in U.S. Limits of treatment range: +4.0 D sphere and 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
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Mean MRSE Mean Preop Sphere= 1.81 ± 1.09D (range 0-4 D) Cylinder=0.83 ± 0.67 (range 0-4)
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Uncorrected Visual Acuity
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Uncorrected Visual Acuity at 1 Year (n=147)
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Change in BCVA Preop to 1 Year (n=155)
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Refractive Error
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Comparison to Other Systems
Achieved 20/20 or Better at 6 Months
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Conclusion Tecnolas 217 with Zyoptix Personalized Treatment for Hyperopia provides: Excellent uncorrected visual acuity Stable MRSE Highly predictable outcomes
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