Is ReLEx SMILE Surgery Safe?

Posted by  On 10-04-2024

Refractive surgeries like ReLEx SMILE have gained popularity for their effectiveness in vision correction, but safety remains a top concern for many considering the procedure.

With more than 3.5 million procedures performed worldwide and a network of over 2,000 surgeons across 70 countries, SMILE has garnered widespread recognition for its efficacy and safety. Still, how does this cutting-edge procedure work its magic?

Let’s delve into the intricacies of this revolutionary procedure to uncover the truth behind its safety.

An Overview of ReLEx SMILE Surgery

The essence of laser surgical procedures lies in reshaping or refining the cornea, which is the eye’s primary lens responsible for light entry. This reshaping corrects the focal point of light onto the retina, eliminating the necessity for glasses or contact lenses.

ReLEx SMILE is the most recent advancement in corneal diopter reduction procedures, utilizing a single femtosecond laser that ensures upper-level reproducibility and predictability, even with high corrections.

How ReLEx SMILE Surgery Works

The procedure unfolds in a series of precise steps, each contributing to the attainment of optical clarity:

Step 1: Lenticule Creation

A delicate lenticule and a small incision are meticulously fashioned within the intact cornea, laying the groundwork for subsequent corrective measures.

Step 2: Lenticule Removal

With finesse and minimal disruption to corneal biomechanics, the crafted lenticule is delicately excised through the incision, setting the stage for refractive correction.

Step 3: Impairment Correction

The lenticule removal precipitates a transformative shift in corneal shape, culminating in the desired refractive correction and ushering in a newfound visual acuity.

Clinical Data Supporting ReLEx SMILE Eye Surgery’s Safety, Effectiveness, Predictability, and Stability

Let’s now examine two comprehensive studies that shed light on the safety and efficacy of ReLEx SMILE surgery.

One-Year Insights Into ReLEx SMILE Surgery

In a 2021 study, researchers delved into the one-year outcomes following ReLEx SMILE surgery in patients with myopia and myopic astigmatism. The study involved a total of 25 myopic eyes and 67 myopic astigmatic eyes.

The mean refractive spherical equivalent (MRSE) exhibited substantial reduction, indicating a successful correction of vision abnormalities. Uncorrected distance visual acuity (UDVA) improved postoperatively, with a significant percentage of patients achieving a UDVA of 0.5 or better.

Both groups experienced notable decreases in keratometric values after surgery, signaling consistent and reliable correction. A significant proportion of eyes (80% for myopic eyes, and 88% for myopic astigmatic eyes) maintained refractive outcomes within ±0.5D at 6 and 12 months. These findings confirmed ReLEx SMILE surgery’s safety and efficacy, making it a viable choice for precise vision correction.

Long-Term ReLEx SMILE Performance

Another study, conducted over five years, found promising results for ReLEx SMILE. Before the procedure, participants had a mean refractive error of -7.29 diopters. Five years later, the procedure showed an efficacy index of 1.09 and a safety index of 1.19, indicating high success rates.

The efficacy index measures the surgery’s success in achieving clear vision without corrective lenses. A score over 1.0 indicates improved vision beyond pre-surgery levels achievable with lenses.

The safety index compares postoperative vision to preoperative vision. A score above 1.0 signifies improved vision post-surgery, indicating a positive safety outcome.

Moreover, the study found no significant changes in ocular anatomy over the five-year period, indicating the stability of the procedure. Participants reported high satisfaction levels, with significantly improved quality of life compared to those who didn’t undergo ReLEx SMILE.

Safety Factors in ReLEx SMILE Surgery

ReLEx SMILE surgery earns its reputation for safety through a combination of meticulous technique, advanced technology, and extensive research validating its efficacy.

Now, let’s look into each of these factors to understand their contribution to the safety profile of ReLEx SMILE surgery:

Precise Preoperative Evaluation

Ophthalmic specialists meticulously assess corneal parameters to tailor the surgery, thus minimizing risks and ensuring optimal outcomes.

Precise Laser Technology

ReLEx SMILE utilizes state-of-the-art femtosecond laser technology to perform the entire procedure with high precision. The laser creates a thin lenticule within the cornea and a small incision for its removal, ensuring accurate and predictable outcomes.

Flap-Free Procedure

SMILE doesn’t involve creating corneal flaps, reducing risks associated with flap-related complications like dislocation or epithelial ingrowth. This flapless approach streamlines surgery and minimizes postoperative issues.

Biomechanical Integrity Preservation

Preserving corneal biomechanics is crucial for long-term safety. ReLEx SMILE’s minimally invasive technique curtails disruption, reducing the risk of complications like ectasia.

Strong Clinical Evidence

Extensive research supports ReLEx SMILE’s safety and efficacy, with studies consistently showing low complication rates and high patient satisfaction. This empirical evidence informs best practices, ensuring quality care.

Surgeon Skill and Training

Board-certified ophthalmic surgeons undergo rigorous training in refractive surgery, ensuring proficiency in ReLEx SMILE procedures. Continued education and adherence to best practices further enhance safety and efficacy.

Other Benefits of ReLEx SMILE

The benefits of ReLEx SMILE that extend beyond its high levels of safety and effectiveness include the following:

Reduced Risk of Corneal Abrasion

ReLEx SMILE has been shown to induce fewer higher-order aberrations (visual distortions), leading to a better quality of vision, especially in low-light conditions.

Reduced Risk of Infection

The small incision made during the procedure reduces the risk of contamination and infection compared to other procedures, like LASIK, which involve creating a flap in the cornea.

Rapid Visual Recovery

Patients experience rapid visual recovery, often within a day or two after surgery, allowing for a quicker return to daily activities compared to traditional methods.

Broad Applicability

ReLEx SMILE is versatile, addressing various refractive errors with precision and compatibility with advanced diagnostic technologies.

Broader Eligibility

ReLEx SMILE expands the pool of eligible candidates for refractive surgery. Thanks to its minimally invasive nature and preservation of corneal tissue, patients with thinner corneas or higher degrees of myopia who may not be suitable candidates for LASIK can often undergo ReLEx SMILE safely.

Side Effects and Risks of SMILE Laser Vision Correction

While ReLEx SMILE surgery has shown promising results, it is essential to consider the potential risks associated with any surgical procedure:

  • Correction issues: While the majority of patients achieve their desired level of vision correction following ReLEx SMILE surgery, there is a possibility of undercorrection or overcorrection, requiring further enhancement procedures.
  • Infection and inflammation: Though rare, there’s a risk of infection or inflammation, typical of any surgical procedure, albeit extremely low with ReLEx SMILE.
  • Corneal haze: There is an occasional development of a temporary cloudy layer on the cornea post-surgery. Typically, it resolves spontaneously, but may require additional treatment in rare cases.
  • Visual disturbances: Some patients may experience glare, halos, or night vision difficulties post-surgery, particularly during initial healing, which usually improves over time as the eyes adapt.

ReLEx SMILE Surgery With Clearview Vision Institute

If you’re tired of glasses or fed up with contact lenses, laser eye surgery offers an alternative worth considering. ReLEx SMILE surgery is one option we offer our patients to create excellent vision and eliminate the need for glasses and contact lenses.

To book a free, no-obligation consultation with Clearview Vision Institute, please call us at 647-493-6371 or contact us here.

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