PerfectPulse Technology® Features
Gaussian Beam - Small Pulse Diameter
Surface Quality
The WaveLight® ALLEGRETTO WAVE® laser systems' Gaussian beam profile ensures a smooth ablation without grooves or ridges, while the tiny 0.95 mm spot size provides a precise ablation of corneal tissue and very small transition zones.
In addition, it was designed to improve control of the pulses' shape and also maximum uniformity of each emitted pulse due to the different energy density (more in the center and less in the periphery).
ALLEGRETTO WAVE® laser systems are the only excimer lasers in the market to adjust the beam profile and energy distribution with a special optical electronic beam analyzing system during preventive maintenance. This ensures best shape of the Gaussian beam profile and smooth surface qualities.
The beam path is completely sealed and flushed with nitrogen. This prevents the creation of ozone and leads to a stable and constant laser beam supply at the cornea.
Active, Fast-Track Eye-Tracking System
Centration
Using a fine laser beam at high speed, the Alcon ALLEGRETTO WAVE® laser systems rely on their synchronous, video-based, active eye-tracking system to follow even the fastest eye movements with a response time of less than 6 ms.
The pupil-based system tracks pupils between 1.8 and 8.0 mm.
The closed-loop tracking mode reconfirms the eye's location again before a pulse is placed on the cornea to ensure that every pulse goes into the desired location.
To monitor the patient's eye, the active eye-tracking system utilizes three infrared light sources to accurately detect the contrast between pupil and iris. Being infrared, the eye-tracking system is not distorted by the illumination in the operating field.
The illumination sources are independent, meaning that the tracking system will continue to work even if one of the pods is covered by the surgeon's hand or a sterile drape; and the gooseneck shape of the illumination pods prevents backscattering of laser energy.
In addition, the eye-tracking system offers the possibility to determine the center of ablation on an individual basis.
A dilation of the patient's eye is not required.
Pulse Optimization
Speed
The ALLEGRETTO WAVE® Eye-Q laser works with a pulse frequency of 400 Hz. This results in a correction time of only 2 seconds per diopter (with a fully corrected optical zone of 6.5 mm). Thus, the average myopia correction takes about as little time as pouring a cup of coffee.
The rapid repetition rate may result in more comfort for the patient and a minimization of external influences.
Another advantage of both faster treatments and fewer post-treatment requirements is an optimal patient flow.
Optimal Shot Distribution
Due to the high pulse frequency, there is a general theoretical risk of thermal effects. The ALLEGRETTO WAVE® laser systems help prevent this by the fact that only every fifth pulse overlaps a previous one, so that the affected spot has sufficient time to cool in-between pulse application.
This minimization of thermal effects may be a factor in speeding up the healing process.
Closed-loop Energy Control
The integrated closed-loop energy control allows a stable energy flow throughout the treatment. This ensures higher precision and safety, as well as a lower rate of enhancements.
As a part of the advanced PerfectPulse Technology®, the closed-loop energy control system manages the energy levels of every laser pulse during the treatment. At several points throughout the laser beam path, the pulse energy is determined and output energy is automatically regulated in order to ensure stability.
Also, an ablation depth micrometer is used once every surgery day, allowing energy calibration within a tolerance of less than ±1.5 µm by performing ablation on a PMMA target.
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.”