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We Compared
Contoura Vision, SMILE & LASIK
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US - FDA Study Results (From US-FDA Website)
Wavelight Topo Guided PMA P020050/S12 : FDA Summary of safety and data effectiveness
Zeiss VisuMax PMA 150040 : FDA Summary of Safety and Data Effectiveness
Contoura Vision
Time - 12 Months
N - 249
%20/20 (6/6) - 93%
%20/12 (6/4) - 34%
%20/10 (6/3) - 16%
Loss of Lines - Nil
SMILE
Time - 12 Months
N - 310
%20/20 (6/6) - 88%
%20/12 (6/4) - Not Recorded
%20/10 (6/3) - Not Recorded
Loss of Lines - 2.6%
Inference of US-FDA Study
The US-FDA study conclusively shows the following:
1. The range of correction was higher with CONTOURA VISION than with SMILE.
2. 93% patients achieved 20/20 (6/6) or better vision with CONTOURA VISION whereas in SMILE only 88% could achieve 20/20 (6/6) or better with SMILE (5% less compared to CONTOURA VISION).
3. Vision better than 20/20 ie 20/12 was achieved in 34% with CONTOURA VISION but was not recorded with SMILE
4. There was no loss of vision as recorded on the vision chart in CONTOURA VISION whereas 2.6% of the patients lost one line on the vision chart.
US-FDA Comparison
Contoura Vision & SMILE
Comparison Study
Right Eye - Contoura Vision
Left Eye - SMILE
J Refract Surg. 2017 May 1;33(5):306-312. doi: 10.3928/1081597X-20170221-01. Kanellopoulos AJ.
PURPOSE
Contoura Vision Versus Small Incision Lenticule Extraction (SMILE) for Myopia and Myopic Astigmatism: A Randomized, Prospective, Contralateral Eye Study, One Eye Operated on Contoura Vision Platform and Other Eye Operated on SMILE Platform.
CONCLUSIONS
CONTOURA VISION WAS FOUND SUPERIOR TO SMILE IN ALL VISUAL PERFORMANCE PARAMETERS STUDIED, BOTH SUBJECTIVE AND OBJECTIVE. The main difference between the two techniques likely derives from the eye tracking, cyclorotation compensation, and active centration control in the CONTOURA Lasik technology studied in contrast to the current technology available with SMILE procedures. This difference appears to affect refractive and visual aberration performance outcomes.
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