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FDA-Approved Clinical Results - 6 Pages

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FDA-Approved Clinical Results

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FDA-Approved Clinical Results

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Statement of Intended Use The following document summarizes the FDA-approved eectiveness and safety data from: • The Myopia Wavefront Optimized® and Wavefront-Guided Treatment Study • The Hyperopia Wavefront Optimized® Treatment Trial The intended use of this document is to communicate the results of these studies and dierentiate the clinical outcomes of Wavefront Optimized® and Wavefront-Guided treatments. The WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser

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A Broad Spectrum of Myopic Vision Correction 99% 100% 93% 93% 100% The WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser in conjunction with the ALLEGRO Analyzer® 76% 80% aberrometer provides eective, customized treatments for patients with higher order aberrations and 64% complex vision correction needs. 25% All eyes naturally have higher order spherical aberrations. In eyes with relatively normal levels of higher 22% order spherical aberrations, a Wavefront Optimized® treatment has been shown to be eective in producing 0% WaveLight® Wavefront-Guided WaveLight® Wavefront Optimized® Best...

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Myopic Clinical Outcomes Summary for Wavefront Optimized® and Wavefront-Guided Treatment Study Groups1 For eective treatment of myopia, Wavefront Optimized® and Wavefront-Guided procedures enable the development of precise, personalized vision correction. • Wavefront-Guided LASIK is proven to reduce aberrations, specically trefoil and spherical aberrations (patients up to -4.0 D or more than 0.3 μm RMSh) • Wavefront Optimized® LASIK also reduced aberrations in patients with pre-op RMSh < 0.4 μm • No symptomatic increase in aberrations observed after More than 97% of both patient groups...

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WaveLight Wavefront-Guided FDA-Approved Clinical Results Uncorrected Visual Acuity (UCVA) Eectiveness – Hyperopia ® Wavefront-Guided Wavefront Optimized 95% FDA clinical trial results for Wavefront Optimized® 20% WaveLight WaveLight WAVE® Eye-Q Excimer Laser continues to maintain its Wavefront-Guided Wavefront Optimized® ® Gain > 2 83% Gain = 2 Gain 67% =1 Unchanged Loss = 1 Loss = 2 34% Loss > 2 After 80% Wavefront Optimized® LASIK, >/- 20/16 or better glare40% bright lights, light from 6 months; 6 The percent of N=260 subjects reporting months; N=212 0% WaveLight® vefront Optimized® etter...

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Health Care Professional Information Sheet-All WaveLight® Allegretto Wave® System Indications The WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System Caution: Federal (USA) law restricts this device to sale by, or on the order of, a physician. Statements regarding the potential benets of wavefront-guided and Wavefront Optimized® laser-assisted in-situ keratomileusis (LASIK) are based upon the results of clinical trials. These results are indicative of not only the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System treatment but also the care of...

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