Treat more patients, better.
The custom treatment your patients want…
The custom treatment options you need.
No two patients are alike, so why would you treat them the same? Some LASIK systems say they offer “true” custom LASIK, but LASIK can’t be truly custom unless it offers you, the surgeon, the flexible treatment options to treat more patients, how you see fit.
Offering the widest range of wavefront-based LASIK, OptiLASIK™ Laser Vision Correction – powered by WaveLight® Allegretto Wave® Lasers– provides multiple custom treatment options, so you can choose the unique procedure that’s right for your patients:
> Wavefront Optimized® LASIK was developed to consider the unique curvature of the eye, preserving the natural, aspheric shape of the cornea, for less induced spherical aberration.1
> Wavefront-Guided LASIK is designed to provide personalized treatment, with a reduction of higher order aberrations.2,3
Laser vision correction isn’t one-size-fits-all. When it comes to LASIK, you need options. You need OptiLASIK™ Vision Correction.
The Allegretto Wave® Eye-Q Laser:
The performance behind the procedure.
Studies show that surgical issues can be reduced with faster, more accurate procedures.4 OptiLASIK™ Laser Vision Correction is powered by the advanced Allegretto Wave® Eye-Q Laser, specially designed to enhance safety at high speeds:
- 400 Hz Excimer Laser combines small spot size and high-speed ablation, for precise correction of fine imperfections, with the benefits of reduced environmental exposure.4
- PerfectPulse Technology® maintains consistent pulse energy and placement, for precise corneal sculpting.5,6
- High-Speed 400 Hz Eye Tracking actively tracks the fastest eye movement and verifies location before releasing pulses.7
- Thermal Optimized Shot Distribution helps minimize the potential for thermal buildup.8
Together, these innovations allow the Allegretto Wave® Eye-Q Laser to provide improved patient comfort and excellent clinical results, with a low potential for complications or retreatment.2
Where Surgeons Stand:
77% of surgeons want custom LASIK that does more.
22% of surgeons are fine with less from “true” custom LASIK.
Make your choice – text “LESS” or “MORE” to “46957-92397”
References:
- Waring GO, Durrie DS. Emerging trends for procedure selection in contemporary refractive surgery: consecutive review of 200 cases from a single center. J Refract Surg. 2008;24:S419-S423.
- US Food and Drug Administration. Summary of safety and effectiveness data for a supplemental premarket approval application. http://www.fda.gov/cdrh/pdf2/P020050S004b.pdf. Accessed February 12, 2009.
- Padmanadham P, Mrochen M, Basuthkar S, et al. Wavefront-guided versus wavefront-optimized laser in situ keratomileusis: contralateral comparative study. J Cataract Refract Surg. 2008;34:389-397.
- Alio JL, Hamid IM. Intraoperative complications of LASIK. In: Albert D, Miller J, Azar D, Cocks ACF, Blodi B, eds. Albert & Jakobiec’s Principles and Practice of Ophthalmology. 3rd ed. Philadelphia, PA: Saunders W B Co; 2008:1051-1059.
- Seiler T, Koller T. Excimer laser instrumentation. In: Albert D, Miller J, Azar D, Cocks ACF, Blodi B, eds. Albert & Jakobiec’s Principles and Practice of Ophthalmology. 3rd ed. Philadelphia, PA: Saunders W B Co; 2008:981-985.
- Huang D, Arif M. Spot size and quality of scanning laser correction of higher order wavefront aberrations. J Cataract Refract Surg. 2002;28:407-416.
- Chalita MR, Krueger RR. Wavefront-guided excimer laser surgery. In: Albert D, Miller J, Azar D, Cocks ACF, Blodi B, eds. Albert & Jakobiec’s Principles and Practice of Ophthalmology. 3rd ed. Philadelphia, PA: Saunders W B Co; 2008:1041-1049.
- Mrochen M, Schelling U, Wuellner C, et al. Influence of spatial and temporal spot distribution on the ocular surface quality and maximum ablation depth after photoablation with 1050 Hz excimer laser system. J Cataract Refract Surg. 2009;35:363-373.
Myopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q 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 posttreatment: 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® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ 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.”
Hyperopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q 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® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System for laser assisted in-situ 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.”
Mixed Astigmatism:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q 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 reported as “moderate to severe” 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® / ALLEGRETTO WAVE® Eye-Q 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.”
Wavefront-Guided Treatment of Myopia:
a. Approval of the premarket approval application is for the WaveLight® ALLEGRETTO WAVE® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® ALLEGRO Analyzer® device. 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, 99.4% 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, 99.4% 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 (18.3% 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® / ALLEGRETTO WAVE® Eye-Q Excimer Laser System used in conjunction with the WaveLight® ALLEGRO Analyzer® device. 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.”