Contoura Vision versus SMILE Laser Eye Surgery - US FDA Results
Contoura Vision versus SMILE
Small incision lenticule extraction (SMILE) was introduced in 2011 and has been acclaimed as the new option for patients seeking better vision without glasses. In this, the corneal flap is replaced by removing the corneal stroma lenticule (some tissue from the substance of the cornea) from a very small incision to reduce the complications of corneal flap and dry eye. Recent studies have indicated that there is less more corneal nerves are preserved when treated with SMILE compared with LASIK, which can reduce the incidence of dry eye. However, it is critical to remember that there is no wavefront-guided individual treatment to reduce the production of aberrations in SMILE.
Contoura vision is the latest entrant into the refractive surgery paradigm, and is known to have revolutionized the patient experience following laser vision correction. In this technique, 22000 data points on each of the corneas is recorded, and treated accordingly in order to minimize aberrations, and to provide perfect vision postoperatively. Since the technology uses the specific corneal curvature of the individual patient to provide a customized laser ablation of the cornea, the individual defects in the corneal optical system of the eye, are addressed, which results in a sharper and brighter vision after surgery.
Direct comparison of SMILE and Contoura Vision LASIK: Which is better?
The Journal of Refractive Surgery, one of the most respected peer reviewed journals in the world, published a head to head comparison between SMILE and Contoura vision LASIK by Kanellopoulos et al.
This prospective, randomized contralateral eye study included 44 eyes of 22 patients with bilateral myopia or myopic astigmatism.
Treated eyes were divided into two groups: 22 eyes were treated with Contoura Vision LASIK and the other eye of each patient was treated with SMILE.
They reported that the results of Contoura Vision LASIK at 3 months were far superior to that of SMILE, putting the Contoura Versus SMILE argument to rest.
86.4% of the LASIK group and 68.2% of the SMILE group had a vision of 20/20 and 59.1% and 31.8%, respectively, had vision of 20/16 (super vision).
Especially in case of astigmatism, which is critical to evaluating any refractive surgery, residual refraction cylinder (≤ 0.25 D) was 81.8% for the Contoura Vision group and 50% for the SMILE group establishing its superiority for both myopia, and astigmatism.
In fact, the authors concluded that Topography-guided or Contoura Vision LASIK was superior in all visual performance parameters studied, both subjective and objective, including visual aberrations. This difference could be because of the superior technology of Contoura Vision: the eye tracking, cyclorotation compensation, and active centration control.
This article definitely proves what the FDA results of the two techniques tell us, which mainly focus on the independent evaluation of the two technologies used for providing the patient better vision without glasses.
SMILE US FDA trial results:
The SMILE procedure has been approved by the US FDA to reduce or eliminate nearsightedness in certain patients 22 years of age or older.
FDA adds that not all patients are candidates for SMILE, and individuals should carefully review the patient labeling and discuss their expectations with their eye care professional.
The implications of the studies conducted by the US FDA to grant approval for the surgical technique are as below:
The procedure is safe and effective and has resulted in stable vision correction for the duration of follow up. Of the 328 patients enrolled at five investigational sites, 88% of patients had uncorrected visual acuity of 20/20 or better, and all but one had uncorrected visual acuity of 20/40 or better. Clinical studies have shown that SMILE can reduce corneal denervation and postop dry eye compared with flap-related refractive procedures such as LASIK, and may enhance biomechanical stability
Contoura Vision US FDA trial results
The results of the clinical trial by the US FDA for granting approval to the Contoura Vision technique are also now available.
The results indicate that:
More than 92% of patients treated with Contoura achieved 20/20 or 6/6 vision, while more than 64% achieved 20/16 vision or better, and 34% achieved 20/12.5.
Remember that 20/20 or 6/6 vision is considered normal for human beings, 20/16 means better vision than normal by almost two lines. 20/12.5 was not even recorded with SMILE.
Almost one third of the patients had better unaided vision following surgery, than they had ever had with their glasses/contact lenses, that is the vision correction was superior to that with glasses.
Interestingly, these patients also reported a significant improvement in their “quality of vision” also, with decrease in visual disturbances like glare, haloes and difficulty in night time driving etc.
In fact, studies on Contoura vision patients post-operatively reported an improvement of symptoms associated with traditional LASIK, including : 6 % decrease in light sensitivity, 4 % decrease in difficulty driving at night, 4 % decrease in reading difficulty, 4 % decrease in glare.
Most Important Consideration:
Astigmatism
FDA has approved SMILE for correction of only 0.5 Diopter of astigmatism. Contoura has been approved for six times as much, that is, up to 3 Diopters of astigmatism.This means that Contoura is far more effective than SMILE.
WOW Factor:
Vision recovery after SMILE takes a minimum of three days, while that after Contoura Vision is instantaneous. You step out of the hospital smiling and happy, with perfect vision after Contoura, while the recovery takes time with SMILE.
Verdict
Most importantly, it is matching the patient to the procedure that is the most essential part of ensuring patient delight at the end of the surgery. A comprehensive eye evaluation, together with a detailed conversation about the patients’ needs and expectations is essential before one can be chosen over the other. There is no doubt that Contoura Vision is superior to SMILE in almost all patients.Whether you’re a candidate for Contoura Vision LASIK, standard wavefront-optimized LASIK, SMILE or an implantable collamer lens can only be determined during your consultation and eye evaluation. Make sure you discuss all of the vision correction options, LASIK and otherwise, that may be available, before arriving at a decision.
Comments