FASTER, MORE COMFORABLE LASIK TREATMENTS NOW AVAILABLE AT Pima Eye Institute PC Studies Show Shorter Procedures Reduce Risk of Over-Correction Pima Eye Institute is the only eye center in Tucson to offer a the ALLEGRETTO WAVE laser technology. Delivering 200 laser pulses per second, the ALLEGRETTO WAVE with PerfectPulse Technology reduces the fixation time of the patient under the laser and results in less dehydration of the cornea which may positively impact post operative recovery and account for more precise outcomes. "Although LASIK has earned an excellent safety profile, many patients are concerned about the length of the procedure," said Dr. Ajay Sanan, Physician and Surgeon of Pima Eye institute. When we can tell patients the average treatment time is less than twelve seconds per eye rather than 30 or even 60 seconds with competing technologies they are instantly more comfortable with the procedure. Faster treatments are also safer for the patient because the procedure can be completed before the cornea becomes dehydrated. Several published studies demonstrate that decreasing the length of the LASIK procedure and the amount of heat applied to the cornea during treatment can reduce corneal dehydration, thereby improving visual outcomes and reducing complications. Dr. Sanan's patients are reporting significant visual improvements since acquiring the ALLEGRETTO WAVE 5 months ago. Nearly 98 percent of his patients are attaining 20/20 vision or better. No/ post-operative night vision problems have been reported and less than 1 percent of patients have required LASIK re-treatment, versus 5 percent with laser systems that Dr. Sanan has used in the past. The ALLEGRETTO WAVE s proprietary PerfectPulse Technology incorporates several proprietary safety features that help to further protect a patient s vision: - Smart Energy Control: Each laser pulse is checked three times before it is delivered to the cornea. If laser pulse energy is not at the desired level when it reaches these checkpoints, the system will automatically adjust before delivering the next pulse. 1 / 6
- Fast Eye-tracking: Three independent infrared sources follow the eye's movements 200 times per second once for every laser pulse administered. The system reacts in just four to six milliseconds (ms) if the eye shifts even a fraction of a millimeter. This virtually eliminates the chance of errant laser pulses that could impact the cornea. - Wavefront-Optimization: Automatically determines each individual's unique pre-operative corneal shape and provides a treatment that not only corrects nearsightedness and farsightedness, but also maintains the cornea's natural curve following treatment. As a result, studies have found the ALLEGRETTO WAVE to be one of the first lasers in which patients reported a reduction in postoperative glare compared to their pre-operative vision. - Non-Overlapping Pulses: The laser's internal computer monitors the location of each pulse applied to the eye and makes sure that if a location needs additional pulses, it is treated no more than once every fifth laser pulse. This reduces the chances of any kind of heating effects occurring in the eye. The ALLEGRETTO WAVE has been successfully used since the late 90s in Europe, where it has been the leader in international sales for the past three years. In the U.S., it was the first new laser platform to be cleared by the Food and Drug Administration (FDA) in nearly five years, and that clearance was for the highest-ever ranges of nearsightedness and farsightedness. For more information about the ALLEGRETTO WAVE with PerfectPulse Technology, please contact Pima Eye institute PC at www.pimaeye.com or 520.229.1554. ABOUT Dr. Ajay Sanan, M.D. at Pima Eye Institute PC ABOUT THE ALLEGRETTO WAVE 2 / 6
The ALLEGRETTO WAVE, manufactured by WaveLight AG, was the first refractive laser to receive concurrent approvals for the treatment of myopia up to 12 diopters with astigmatism of up to 6 diopters and hyperopia up to +6 diopters with astigmatism of up to +5 diopters, not exceeding a mean spherical equivalent of +6 diopters. The laser is also approve to treat mixed astigmatism of up to 6 diopters at the spectacle plane. For more information about the benefits and risks associated with this product, please visit http://www.fda.gov or http://www.allegretto wave.com. Sources: Iseli HP, Mrochen M, Hafezi, F, Seiler T. Clinical Photoablation With a 500-Hz Scanning Spot Excimer Laser. Journal of Refractive Surgery 2004; 29 Dougherty PJ, Wellish KL, Maloney RK. Excimer Laser Ablation Rate and Corneal Hydration. American Journal of Ophthalmology 1994; 118:169-176 Joo CK, Kim TG. Corneal perforation during laser in situ keratomileusis. 1999 ASCRS and ESCRS. Published by Esevier Science Inc. Disclaimer for Myopia: Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of myopic refractive errors up to 12.0 diopters (D) of sphere with and without astigmatic refractive errors up to -6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. c. Approval of the application is based on clinical trials in the United States with 901 eyes treated, of which 813 of 866 eligible eyes were followed for 12 months. Accountability at 3 months was 93.8%, at 6 months was 91.9%, and at 12 months was 93.9%. d. The studies found that of the 844 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 98.0% were corrected to 20/40 or better, and 84.4 % were corrected to 20/20 or better without spectacles or contact lenses. e. The clinical trials showed that the following subjective patient adverse events were reported as moderate to severe at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: visual fluctuations (12.8% at baseline versus 28.6% at 3 months). 3 / 6
f. Long term risks of LASIK for myopia with and without astigmatism beyond 12 months have not been studied. g. Note that the complete name for this ophthalmic laser is WaveLight ALLEGRETTO WAVE Excimer Laser System for laser assisted insitu keratomileusis (LASIK) treatments of myopic refractive errors up to 12.0 diopters (D) of sphere with and without astigmatic refractive errors up to 6.0 D at the spectacle plane. Disclaimer for Hyperopia: Excimer Laser System to perform LASIK treatments in patients 18 years of age or older for the reduction or elimination of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D; and in patients with documented evidence of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia. contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. c. Approval of the application is based on clinical trials in the United States with 290 eyes treated, of which 100 of 290 eligible eyes were followed for 12 months. Accountability at 3 months was 95.2%, at 6 months was 93.9%, and at 12 months was 69.9%. d. The studies found that of the 212 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 95.3% were corrected to 20/40 or better, and 67.5 % were corrected to 20/20 or better without spectacles or contact lenses. e. The study showed that the following subjective patient adverse events were reported as much worse by at least 1% of the subjects (in order of increasing frequency) at 6 months post final treatment: glare from bright lights (3.0%); night driving glare (4.2%) light Sensitivity (4.9%); visual fluctuations (6.1%); and halos (6.4%). f. Long term risks of LASIK for hyperopia with and without astigmatism beyond 12 months have not been studied. g. Note that the complete name for this ophthalmic laser is WaveLight ALLEGRETTO WAVE Excimer Laser System for laser assisted insitu keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of sphere with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D. Disclaimer for Mixed Astigmatism: Excimer Laser System to perform LASIK treatments in patients 21 years of age or older for the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane; and in patients with documentation of a stable manifest refraction defined as less than or equal to 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. 4 / 6
contact lenses, photorefractive keratectomy (PRK), and other refractive surgeries. c. Approval of the application is based on clinical trials in the United States with 162 eyes treated, of which 111 were eligible to be followed at 6 months. Accountability at 1 month was 99.4%, at 3 months was 96.0%, and at 6 months was 100.0%. d. The studies found that of the 142 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 3-month stability time point, 95.8% achieved acuity of 20/40 or better, and 67.6% achieved acuity of 20/20 or better without spectacles or contact lenses. e. The clinical trials showed that the following subjective patient adverse events were reports as moderate to sever at a level at least 1% higher than baseline of the subjects at 3 months post-treatment: sensitivity to light (43.3% at baseline versus 52.9% at 3 months); visual fluctuations (32.1% at baseline versus 43.0% at 3 months); and halos (37.0% at baseline versus 42.3% at 3 months). f. Long term risks of LASIK for mixed astigmatism beyond 6 months have not been studied. g. The safety and effectiveness of LASIK surgery has ONLY been established with an optical zone of 6.0 7.0 mm and an ablation zone of 9.0 mm. h. Note that the complete name for this ophthalmic laser is WaveLight ALLEGRETTO WAVE Excimer Laser System for laser assisted in-situ keratomileusis (LASIK) treatments of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane. Disclaimer for wavefront-guided treatment of Myopia: Excimer Laser System used in conjunction with the WaveLight ALLEGRO Analyzer. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as? 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. contact lenses, photorefractive keratectomy (PRK), traditional LASIK and other refractive surgeries. c. Approval of the application is based on a randomized clinical trial in the United States with 374 eyes treated; 188 with wavefront-guided LASIK (Study Cohort) and 186 with Wavefront-Optimized LASIK (Control Cohort). 178 of the Study Cohort and 180 of the Control Cohort were eligible to be followed at 6 months. In the Study Cohort, accountability at 1 month was 96.8%, at 3 months was 96.8%, and at 6 months was 93.3%. In the Control Cohort, accountability at 1 month was 94.6%, at 3 months was 94.6%, and at 6 months was 92.2%. d. The studies found that of the 180 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point in the Study Cohort, 100% were corrected to 20/40 or better, and 93.4% were corrected to 20/20 or better without spectacles or contact lenses. In the Control Cohort, of the 176 eyes eligible for the uncorrected visual acuity (UCVA) analysis of effectiveness at the 6-month stability time point, 100% were corrected to 5 / 6
20/40 or better, and 92.8% were corrected to 20/20 or better without spectacles or contact lenses. e. The clinical trials showed that the following subjective patient adverse events were reported as "moderate to severe" at a level at least 1% higher than baseline of the subjects at 3 months post-treatment in the Study Cohort: light sensitivity (37.2% at baseline versus 47.8% at 3 months) and visual fluctuations (13.8% at baseline versus 20.0% at 3 months). In the Control Cohort, halos (36.6% at baseline versus 45.4% at 3 months) and visual fluctuations (18.0% at baseline versus 21.9% at 3 months). f. Long term risks of wavefront-guided LASIK for myopia with and without astigmatism beyond 6 months have not been studied. g. Note that the complete name for this ophthalmic laser is "WaveLight ALLEGRETTO WAVE Excimer Laser System used in conjunction with the WaveLight ALLEGRO Analyzer. The device uses a 6.5 mm optical zone, a 9.0 mm ablation/treatment zone, and is indicated for wavefront-guided (WFG) laser assisted in situ keratomileusis (LASIK): 1) for the reduction or elimination of up to -7.00 diopters (D) of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane; 2) in patients who are 18 years of age or older; and 3) in patients with documentation of a stable manifest refraction defined as 0.50 D of preoperative spherical equivalent shift over one year prior to surgery. 6 / 6