The ReLEx SMILE Laser: State of the Art Laser Eye Surgery
When Did ReLEx SMILE Become Available In The U.S.?
SMILE is an acronym that is short for Small Incision Lenticular Extraction. SMILE is a minimally invasive approach using a femtosecond laser to correct vision with removal of a tiny piece of tissue from within the cornea. It is safe, effective, patients enjoy a quick recovery, and gives the benefits of LASIK without the flap. This newly approved FDA procedure is only possible with the Zeiss VisuMax femtosecond laser. Why is this fact important? Dr. Dishler was instrumental in the development and approval of ReLEx SMILE in the U.S.A and the first surgeon in North America to use the Zeiss VisuMax Femtosecond laser.
In 2012, Dr. Dishler became the medical monitor for the FDA clinical trial for ReLEx SMILE for myopia, or nearsightedness, and since then he has helped guide this innovative procedure to FDA approval on September 13, 2016. He is a true pioneer in his field and has a strong commitment to his patients. This makes Dr. Dishler the first and most experienced surgeon in the U.S.A. (Jan. 2007) and all of North America to acquire and help develop Zeiss VisuMax technology!
Dr. Dishler is a World Renown Laser Refractive Surgeon in Denver, Colorado and brings not only excellent surgical skills but is truly vested in bringing new technologies to the field of refractive surgery.
Dr. Dishler “First in LASIK” – Zeiss Career Highlights:
First surgeon in the U.S.A. to perform SMILE post- FDA approval March 3, 2017.
Official physician trainer for Zeiss VisuMax and M.E.L. 80 laser technology (2013)
First surgeon (2012) in North America to perform the ReLEx SMILE procedure.
Dishler Laser Institute is named a Zeiss Center for Clinical Excellence (2008).
First surgeon in North America to use the Zeiss MEL 80 Excimer and the VisuMax Femtosecond lasers (2007).
Jon G. Dishler M.D., First Surgeon in North America to perform the Innovative SMILE procedure from Zeiss, Introduces ReLEx SMILE- A New Flapless Laser Treatment.
Please read our press release celebrating the announcement of the next medical breakthrough in LASIK. The FDA clinical trial for SMILE, has been FDA approved. For the past 3 years, Dr. Dishler and our staff have been involved in enrolling patients for this clinical trial. Our hard work in gathering data for this approval has been validated. We will be the first LASIK clinic in Colorado and to offer this new refractive procedure!
What Is ReLEx SMILE?
“Small Incision Lenticule Extraction” or SMILE for short, is a minimally invasive treatment to correct nearsightedness. It is also called Refractive Lenticule Extraction or ReLEx. It is a breakthrough procedure available to the American market. Until now, laser vision correction for nearsightedness, or myopia, involved using one laser to create a corneal flap, lifting this flap and then using another laser to reshape the cornea.
ReLEx SMILE is different; no flap is made, only one laser is used, and it produces excellent results, all in one single fast procedure. The VisuMax laser creates a lenticle, a disc shaped piece of tissue, inside the intact cornea. Which is then removed through a small tunnel like incision. This unique procedure is exclusively available with use of the Carl Zeiss VisuMax® femtosecond laser.
Watch the video SMILE with the Zeiss VisuMax Femtosecond laser
How Is ReLEx SMILE Done?
The best thing about the flapless technique is that the ReLEx SMILE procedure is less invasive. Because it is an all Femto procedure, it is a rapid treatment time of about 35 seconds to precisely create the lenticule. There is no need to move the patient to another laser which minimizes stress and increases convenience. The laser is noiseless and odorless which helps ensure patient comfort. Anesthetic eye drops are given to numb the eyes entirely. There are no injections during the procedure. Then the state-of-the art VisuMax femtosecond technology makes a bubble like pattern within the cornea to create the lenticule with the utmost precision and predictability. Next, the patient will follow the directions of the surgeon and focus on a light. The refractive lenticule is removed via one small incision. The actual procedure takes about 10 minutes per eye and the patient is very comfortable during the procedure. The removal of the refractive lenticule changes the way light bends into the eye, allowing you to see clearly once again. The micro incision heals itself.
Who Is A Good Candidate For ReLEx SMILE?
Those patients who qualify for LASIK typically will qualify for ReLEx SMILE:
Age 22 years or older
Myopia from -1.50D to -10.00D with no more than -0.50D of astigmatism
No changes in your glasses prescription in the last 12 months
Normal topography and corneal thickness similar to what is required for LASIK surgery
No previous eye surgery
You are in good general health and no past history of eye diseases
What Are The Benefits Of ReLEx SMILE?
The Main Benefit of ReLEx Smile: It Works. Effectively.
Flapless: Because there is no flap, there are also no flap-related complications. There is no chance of the flap dislodging, moving, or wrinkling.
All Femto: ReLex is based entirely on femtosecond technology. The VisuMax creates the lenticule with precision and predictability. The procedure is not dependent upon complex nomograms or complicated laser testing (fluence tests). Intraoperative ambient conditions or individual corneal characteristics have virtually no influence on the reproducibility of the femtosecond lenticule.
Single step: With Zeiss ReLEx SMILE, the entire correction is performed as a single-step: on one laser, with one treatment plan and one laser process. In a way, it could be called a “one-stop” refractive surgery.
Less invasive: This refractive procedure is less obtrusive. The anatomically curved contact glass is more comfortable and without a flap, both factors allow for a more gentle surgery with greater ease for the patient. Patients have also reported less discomfort in the initial healing phase due to the small corneal incision.
Less incidence of dry eye: Requiring only a small incision rather than a flap, the upper layers of the cornea remain largely intact, therefore, fewer corneal nerves are disrupted. This technique may result in a lower occurrence of dry-eye syndrome, a common side effect of other laser refractive procedures.
Predictability: Our studies have shown consistent results with outstanding predictability very close to target refraction. This predictable outcome has been seen across the entire range of correction, from low to high level of myopia. 100% of all patients achieved target refraction within the typical “satisfaction zone” (± 1 D). 97% of all patients achieved target refraction within 0.5 D.
Healing: Similar to LASIK, ReLEx heals quickly. But because there is no flap created this can further reduce the incidence of infection, epithelial ingrowth or flap complications.
Other benefits: See the FAQ’s for other potential benefits to SMILE.
Frequently Asked Questions
Q: Who is the best candidate for SMILE?
A: Most everyone who is a candidate for LASIK would also be a candidate for SMILE within the approved range of correction
Q: What are the potential additional benefits of SMILE?
A: Although not proven in the US FDA study, there are less nerve endings severed in SMILE vs LASIK and this can translate into less dry eye symptoms and more rapid recovery
Q: What are the benefits of not having a “flap”?
A: The structure of the eye is more maintained so it is likely stronger against traumatic injury, of particular interest to some occupations and sports interests. The risks in LASIK of flap dislocation are eliminated as well. There is some evidence that the cornea remains stronger and this could mitigate against risks such as ectasia but this is yet to be proven conclusively.
Q: What is the long term results with SMILE?
A: The US FDA study only followed patients for 1 year, but the results were extremely stable over this time period. International results have demonstrated stability for longer periods of time. It is reasonable to assume the stability over time would be at least as good as LASIK.
Q: How is the eye shaped in SMILE compared with LASIK?
A: Both procedures are based on the same mathematical model to change the corneal shape known as Munnerlyn’s Formula. The difference is that LASIK becomes slightly less accurate at higher amounts of corrections whereas SMILE has consistent high accuracy of treatment.
Q: Do SMILE patients sometimes achieve better than 20/20 vision?
A: Yes, quite a number of the study subjects had uncorrected vision less than 20/20 but a few had slightly worse vision than 20/20. Overall the results were comparable or better than LASIK studies.
Q: Is the recovery period shorter than LASIK?
A: Yes, there is no need for goggles at night during the healing after SMILE, and typically there is less limitation on activities as compared to LASIK
Q: SMILE is new to the US, how often has it been performed worldwide.
A: There are over 100 sites internationally, including Canada where SMILE is approved and close to half a million procedures have been performed worldwide. It has gained tremendous acceptance in many locations.
Q: What is the future improvements planned for SMILE?
A: Currently SMILE is only approved for nearsightedness, and it is best for patients who wear soft non astigmatism correcting contact lenses or glasses with minimal astigmatic correction. There is an ongoing study to also be able to correct astigmatism and hopefully this will also be approved within the next year.
Q: I have other questions, what should I do?
A: You should start with having an examination to find out if you are a candidate for SMILE, and get your questions answered by an expert. There were five study sites throughout the United States and these would be your best option to get your questions answered. We expect that within a year there will be approximately 100 sites in the US offering SMILE, so stay tuned!