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FDA-Approved Clinical Results

FDA-Approved Clinical Results

Product catalog summary

Statement of Intended Use
This document provides a summary of FDA-approved data on the effectiveness and safety of treatments for Myopia and Hyperopia using the WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser. It distinguishes between the clinical outcomes of Wavefront Optimized® and Wavefront-Guided treatments.

Myopia Treatment Outcomes
Both treatment types significantly improved Best Spectacle Corrected Visual Acuity (BSCVA) and Uncorrected Visual Acuity (UCVA). Over 97% of patients maintained or gained lines of BSCVA, with 93% achieving 20/20 UCVA or better post-treatment. Aberrations were reduced effectively without symptomatic increases.

Hyperopia Treatment Outcomes
Wavefront Optimized® procedures resulted in over 67% of patients achieving 20/20 vision or better without glasses. The treatment improved symptoms such as glare and light sensitivity, with 95% achieving 20/40 or better post-treatment.

Clinical Data and Indications
The WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser System is indicated for LASIK treatments in patients with stable refractive errors. Clinical trials showed high effectiveness, with 98% achieving 20/40 vision or better and 84.4% achieving 20/20 or better without corrective lenses. The system is recommended for use by trained professionals, with alternatives including eyeglasses and other surgeries.

Conclusion
The WaveLight® ALLEGRETTO WAVE® Eye-Q Excimer Laser provides effective, personalized treatments for myopia and hyperopia, with high patient satisfaction and recommendation rates.

Clinical Data for Myopia
Clinical trials for myopia with and without astigmatism showed visual fluctuations increased from 12.8% at baseline to 28.6% at 3 months. Long-term risks beyond 12 months have not been studied.

Clinical Data for Hyperopia
In trials with 290 eyes, 95.3% achieved 20/40 vision or better at 6 months, and 67.5% achieved 20/20 vision. Adverse events included glare, night driving glare, light sensitivity, visual fluctuations, and halos. Long-term risks beyond 12 months remain unstudied.

Clinical Data for Mixed Astigmatism
Trials with 162 eyes showed 95.8% achieved 20/40 vision or better at 3 months, and 67.6% achieved 20/20 vision. Adverse events included increased sensitivity to light, visual fluctuations, and halos. Long-term risks beyond 6 months have not been studied.

Wavefront-guided Treatment of Myopia
In a study with 374 eyes, 99.4% achieved 20/40 vision or better, and over 92% achieved 20/20 vision at 6 months. Adverse events included light sensitivity and visual fluctuations. Long-term risks beyond 6 months have not been studied.

Contraindications
LASIK is contraindicated for pregnant or nursing women, patients with certain diseases, and those taking specific medications like isotretinoin and amiodarone hydrochloride.

Warnings
LASIK is not recommended for patients with systemic diseases affecting wound healing, history of Herpes keratitis, significant dry eye, severe allergies, or unreliable preoperative wavefront examination.

Precautions
Safety and effectiveness have not been established for patients with progressive refractive errors, ocular diseases, previous surgeries, or certain corneal conditions. Specific limitations on pupil size, age, and refractive error apply.

Adverse Events and Complications
For myopia, adverse events included lost or misaligned flaps and corneal epithelial defects. For hyperopia, a retinal detachment was reported. For mixed astigmatism, no protocol-defined adverse events occurred. For wavefront-guided myopia, complications included corneal epithelial defects and foreign body sensation.

Attention
The safety and effectiveness of LASIK have been established only with specific optical and ablation zone sizes.

Catalog excerpts

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 Spectacle...

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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 Wavefront...

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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 tter...

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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 the...

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