Is Smile Surgery FDA-Approved?

Small incision lenticule extraction (SMILE) is a comparatively recent refractive treatment that treats many refractive defects, including myopia, hyperopia, presbyopia, and astigmatism. With the FDA’s certification of SMILE in 2016, doctors now have a wider choice of viable solutions to give patients who require refractive surgery to minimise their need for glasses. The FDA formally recognised the VisuMax Femtosecond Laser for the tiny incision lenticule extraction (SMILE) technique to lessen or eradicate nearsightedness in eligible patients aged 22 and up. Doctors should carefully consider the patient labelling and explore their objectives with their eye care practitioner because only some are suitable for SMILE.


What does FDA do?

The FDA, a division of the United States Department of Health and Human Services, safeguards public health by guaranteeing the purity, efficiency, and integrity of human and animal pharmaceuticals, vaccinations, other genetic substances intended for human use, and medical devices. The organisation is also responsible for the health and safety of our country’s food supply, pharmaceuticals, nutritional supplements, devices that emit electromagnetic radiation, and tobacco product regulation.


What is VisuMax Femtosecond Laser?

The VisuMax is the sole femtosecond laser that can carry out SMILE LASIK surgery, which treats nearsightedness in a comfortable, bladeless, flapless laser operation. The FDA has authorised SMILE to cure clear nearsightedness and astigmatism down to 3D. You could be aware of the femtosecond laser, which has been used in LASIK procedures to treat nearsightedness, farsightedness, and astigmatism since 2001. The same laser procedure may provide better, more precise and effective solutions in cataract corrective surgery.

The VisuMax Femtosecond Laser effectively reshapes the cornea by removing several ocular tissues. A femtosecond (extremely fast, brief) laser produces incisions inside the cornea, forming a disc-shaped tissue fragment the doctor finds through some tiny incisions in the cornea’s exterior. The elimination of tissue alters the form of the cornea, which rectifies nearsightedness. An assessment of the device’s security and efficacy in correcting nearsightedness discovered that the operation produced permanent vision correction after six months. At six months, all except one of the 328 individuals had untreated (without eyeglasses or lenses) eyesight of 20/40 or higher, and 90 per cent achieved corrected eyesight of 20/20 or greater.


A brief overview and background of SMILE

Beginning in 2007, an intrastromal lenticule procedure known as Femtosecond Lenticule Extraction (FLEx) was offered as an alternative to LASIK for patients with high myopia. Advances in scanning modalities and power settings resulted in faster visual recovery periods and corrective results comparable to LASIK. After the deployment of FLEx, a treatment known as tiny aperture lenticule extraction (SMILE) was created, which involved making a small 2-3 mm incision and extracting the entire corneal lenticule without the necessity of a flap.

This technique was formed in several areas, such as Europe, China, and India and started in September 2011. The FDA granted permission for spherical myopic corrections in the United States in 2016; clearance for compounded myopia astigmatism came in October 2018.

SMILE is also less expensive than LASIK since it merely needs a single laser station as opposed to more than the requirement by LASIK.


Benefits of SMILE

Because the surgery is minimum and less intrusive, the incision is only 3 mm long, less than any other surgery. Also, the recovery process following surgery is relatively short, and people can return to their regular lives very quickly. Because the incision is small, few corneal nerves are affected, and the cornea’s stability is preserved effectively.

In the initial few days after surgery, the patient is encouraged to conduct just a few particular tasks cautiously and rest most of the time. There is a low risk of problems following the SMILE procedure. Still, the patient must consult with the doctor about any potential hazards. These are a few important precautions to take before surgery. Even if there are a few issues, they are just under or overcompensated vision. Some issues are treatable with additional treatments or by wearing glasses.

Infection and inflammatory diseases are other common consequences. It also offers this operation an excellent choice for people who lead busy lives and work. Because generating a corneal flap is unneeded in SMILE surgery, all future issues are prevented. Each of these factors contributes to the effectiveness of SMILE treatment.

SMILE surgery also reduces the likelihood of dry eye, ectasia, and corneal loss. Problems such as Presbyopia, Myopia, Astigmatism, and Hypermetropia can be treated fast with this operation. Because the SMILE Surgery is flapless, the user does not have to be concerned about nerve injury, a fragile cornea, problems, or dry eye.

The SMILE Surgery’s Success

This operation is also successful because patients may resume their daily lives and activities instead of many other treatments. After all, only minimal scars are required. Patients can cure and speed up recovery compared to other procedures because biological tissue recovers quickly since no flap or cut is created. Therefore, healing occurs the following day.

In the first week after surgery, the patient can resume outdoor sports, swimming, etc. Nonetheless, some strenuous activities are normally discouraged during the initial 20 days after surgery, after which the patient may continue them.

The technique that has these various advantages is also quite safe. The fundamental idea underlying SMILE surgery would have been to make existing LASIK much safer and more reliable for patients in the long term.

According to studies, no SMILE surgery patient has ever required retreatment, implying that SMILE surgical procedure has had a high success rate in the twenty months it has been conducted on people. The likelihood of a patient undergoing LASIK surgery for just any reoperation is 0.5% to 0.10%, and this operation has indeed been conducted on individuals for a complete adult.

Patients also reported no infections associated with their eyes following the SMILE procedure. Also, following the SMILE operation, patients do not have difficulties like dry eyes or poor night vision. Many prefer SMILE surgery over other operations since the procedure is quite comfortable. The surgery’s ease is primary because it utilises the femtosecond laser, which has a minimal suction impact on the patient’s eyes, as opposed to those other surgeries that generate flaps.

SMILE is known for producing similar results as LASIK with a few potential advantages, like speedier post-op dry eye recovery, the enervation of ocular neurons, and a possible biomechanical benefit.


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