Dr. Dalel Tartak announced that her LASIK Center, HyperSpeed LASIK, installed the newest and most advanced FDA-approved LASIK platform in the United States. The ALLEGRETTO WAVE® Eye-Q ("Eye-Q System"), manufactured by WaveLight AG (FWB:WLT), is also the fastest LASIK platform available in the country today. HyperSpeed LASIK was second only to Massachusetts Eye and Ear Infirmary (MEEI), a teaching affiliate of Harvard Medical School, and was the first private LASIK Center to install the Eye-Q system in the United States.
"Our LASIK Center has always been devoted to providing patients with the safest and most advanced cutting-edge technology available for LASIK," said Dr. Tartak. "With the Eye-Q, I can achieve the most precise outcomes possible while ensuring the highest level of safety and comfort for my patients. In addition, the speed differential between other LASIK platforms and the Eye-Q is so extraordinary and is truly HyperSpeed-like, it is like comparing a Volkswagen Beetle to a Porsche 911 GT3, respectively."
The Eye-Q system has a frequency of 400 pulses per second. Therefore, the average treatment time for correcting four to five diopters of nearsightedness or farsightedness is just eight to ten seconds, about the time it takes to pour a cup of coffee. Shorter LASIK treatments have been shown to reduce healing time while decreasing the risk of post-operative infections, over-corrections and under-corrections.
The Eye-Q features WaveLight's proprietary Wavefront Optimized technology, which has been shown to preserve the natural shape of the cornea and prevent the induction of optical errors that could lead to night vision problems or loss of contrast sensitivity (the ability to see the images crisply). The system has the potential to provide a majority of patients with better than 20/20 vision, which has been coined "eagle vision," according to Dr Tartak. "Eagles have the innate ability to see better than 20/20, both day and night," she added.
This new LASIK platform also features WaveLight's proprietary PerfectPulse Technology that ensures maximum safety at high speed. PerfectPulse Technology was specifically developed to monitor and control each laser pulse that is delivered to the cornea during the LASIK procedure. Another component of this technology is a high speed, active eye-tracking device which monitors eye movement 400 times per second and adjusts the laser beam accordingly in less than six milliseconds.
"The Eye-Q has been one of the most highly sought-after LASIK platforms in the world and we are now pleased to offer this advanced new platform to physicians in the US," said Wolfgang Tolle, CEO of WaveLight, Inc. "Given Dr. Tartak's reputation as a national expert in refractive surgery, HyperSpeed LASIK is an ideal location for the Eye-Q laser."
Dr. Tartak is a board certified ophthalmologist and has performed more than 60,000 refractive surgical procedures. She is one of three top doctors in the United States specializing in Near Vision CK, and was the inventor of the procedure "CK post-Intacs," which restores vision in patients with keratoconus without the need for a corneal transplant. Dr. Tartak has also been a featured speaker at the American Society of Cataract and Refractive Surgeons and the American Academy of Ophthalmology since 1992. She has been named one of America's top Ophthalmologists by the Consumer Research Council of America for several consecutive years.
"Superior vision with LASIK is dependant not only on the surgeon's skill and experience but also on the technology used to deliver the treatment," Dr. Tartak added. "I am truly excited to introduce the most advanced technology in laser vision correction to our patients nationwide. I believe our patients will truly benefit from the highest level of safety and precision possible, while achieving spectacular visual outcomes."
About Dalel Tartak MD, Incorporated
Dalel Tartak, MD, born in Madrid, Spain is President and CEO of Dalel Tartak MD, Incorporated. Dr. Tartak is dedicated to serving the Hispanic community in the United States and worldwide, providing access to the most advanced technology available in refractive surgery and vision correction treatments at reasonable prices. Refractive surgical treatments include HyperSpeed LASIK, "No-Cut" LASIK (LASEK), Custom WaveFront LASIK, Near Vision CK, Intacs for Keratoconus, Cataract with multi-focal lens featuring ReZoom and ReSTOR® lens, "No-Cut" Pterygium with amniotic membrane graft and Intraocular Lens implant featuring Verisyse and Visian ICL lens. Dr. Tartak's LASIK Center, HyperSpeed LASIK, has also been awarded the prestigious designation as the "Center of Excellence" for Intacs. Dr. Tartak has been featured numerous times on CNN, Telemundo and Univision.
About WaveLight AG (ISIN DE 000 512 5603)
WaveLight AG has been listed on Deutsch Börse AG's Prime Standard segment since January 2003: The company, which develops, manufactures and markets a full range of high-quality products for ophthalmology, specializes in vision optics. The market success of WaveLight is based on a dense sales network comprised of WaveLight's own sales channels as well as the sales channels of strategic partners.
Further information on WaveLight is available at: www.wavelight.com/eyes
All information is given and all assessments are made on the basis of extremely conscientious research. However, no guarantee is given with regard to the information or assessments published. No liability whatsoever is accepted. The above statements do not represent an invitation to buy or sell securities. All rights reserved.
Disclaimer for Myopia:
a. Approval of the premarket approval application is for the WaveLight 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 ‰¤ 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® 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."
Disclaimer for Hyperopia:
a. Approval of the premarket approval application is for the WaveLight 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 ‰¤ 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%); 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® Eye-Q Excimer Laser System for laser assisted in situ keratomileusis (LASIK) treatments of hyperopic refractive errors up to +6.0 diopters (D) of with and without astigmatic refractive errors up to 5.0 D with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D."