FIRST FDA-APPROVED LASIK SYSTEM DESIGNED TO REDUCE NIGHTTIME GLARE COMES TO TUCSON
— PIMA EYE INSTITUTE, first TUCSON LASIK center to acquire technology clinically proven to reduce number-one post-LASIK complaint —
TUCSON, AZ, JULY of 2009 – LASIK surgery, to correct nearsightedness and farsightedness, continues to be the most popular elective surgery in the United States. However, until recently, freedom from glasses and contact lenses often came with a price: the potential for LASIK-induced night vision problems — such as glare and halos — that can affect an individual’s ability to drive at night. According to a recent report from the American Academy of Ophthalmology, poor night vision is the number one post-LASIK complication. Pima EyeInstitute is the first TUCSON eye care center to offer the ALLEGRETTO WAVE® with PerfectPulse Technology™, an FDA-approved LASIK technology specifically built to address certain optical distortions that are the chief cause of nighttime vision and glare.
The ALLEGRETTO WAVE’s PerfectPulse Technology automatically determines each individual's unique pre-operative corneal curvature and provides a treatment that not only corrects nearsightedness and farsightedness, but also maintains the cornea's natural shape following treatment. Unlike other conventional lasers that can provide an incomplete treatment to the periphery of the cornea, PerfectPulse Technology applies additional treatment to the outer edges of the cornea to reduce the likelihood of induced optical imperfections.
As a result, clinical studies submitted to the U.S. Food and Drug Administration (FDA) in 2003 demonstrated that nearly 90 percent of patients had no increase in glare, halos and light sensitivity, and almost 20 percent of patients actually reported improved night-vision following treatment with this laser system.
"No other conventional LASIK treatment takes into account the unique curve and slope of each individual's cornea," said Dr. Ajay Sanan, Medical Director Pima Eye Institute. “Since we acquired the ALLEGRETTO WAVE, patients are more satisfied than ever with their post-LASIK vision, and glare and halo issues have been virtually eliminated."
“I considered LASIK surgery for several years, but I heard from friends and colleagues that I might be trading glasses and contact lenses for night vision problems,” said Michael, a patient at Pima Eye Institute. “Then, I heard about a new treatment that could give me the best of both worlds – clear day and night vision. I went to see Dr. Sanan because he is the only ophthalmologist in my area with the ALLEGRETTO WAVE. Today, my vision is 20/16 and I can see better than ever before during the day and night.”
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.
For more information about the ALLEGRETTO WAVE with PerfectPulse Technology, please contact Pima Eye Institute at www.pimaeye.com or 520.229.1554.
ABOUT Pima Eye Institute PC
ABOUT THE ALLEGRETTO WAVE®
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 approved 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.allegrettowave.com.
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Sources:
Steinert RF, Koch DD, Lane SS, Stulting RD. LASIK surgery screening guidelines for patients. Eye Surgery Education Council. Posted on February 11, 2002 at http://www.furlongvision.com/feb-11-2002.html.
The Comprehensive Report on the Refractive Market. Market Scope, LLC. October 2004.
Disclaimer for Myopia:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE® 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.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, 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).
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:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE® 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.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, 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:
a. Approval of the premarket approval application is for the WaveLight ALLEGRETTO WAVE® 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.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, 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:
a. Approval of the premarket approval application is for the 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.
b. LASIK is an elective procedure with the alternatives including but not limited to eyeglasses, 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 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.”
