Efficacy, precision, accuracy, and safety of the SMILE procedure

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1 Efficacy, precision, accuracy, and safety of the SMILE procedure Jesper Hjortdal Clinical professor Head of Corneal & Refractive Surgery Department of Ophthalmology Aarhus University Hospital Denmark Small incision lenticule extraction SMILE 1

2 Potential advantages of ReLEx Compared with the excimer laser, femtosecond laser cutting is independent of Stromal hydration Laser fluence Environment Better efficacy, precision, accuracy, safety optics The lenticule may be extracted through a small peripheral pocket avoiding a flap Sensitivity Stable corneal mechanics Small-incision lenticule extraction for moderate to high myopia: Predictability, safety, and patient satisfaction. Vestergaard A, Ivarsen AR, Asp S, Hjortdal JØ. Cataract Refract Surg Nov;38(11): Regression 0.18 D 2

3 PREDICTORS Predictors for the Outcome of Small-incision Lenticule Extraction for Myopia Jesper Hjortdal, Anders Vestergaard, Anders Ivarsen, Suganiah Ragunathan, Sven Asp J Refract Surg Dec;28(12): Refraction: ± 0.50 D 3

4 Results after SMILE Mean outcome independent of attempted correction Minor undercorrection with increasing age (0.1D / 10 y) Minor undercorrection in steep corneas (0.04 D / D) Data from Aarhus through 15 years LASIK (2000-4) SMILE ( ) LASIK (2004-9) 4

5 ACCURACY Accuracy after SMILE D error Safety and Complications of More Than 1500 Small-Incision Lenticule Extraction Procedures Anders Ivarsen, Sven Asp & Jesper Hjortdal. Ophthalmology. 121(4):

6 PRECISION Precision after SMILE Std. Dev. = 0.50 D 77% within ± 0.50 D 95% within ± 1.00 D Safety and Complications of More Than 1500 Small-Incision Lenticule Extraction Procedures Anders Ivarsen, Sven Asp & Jesper Hjortdal. Ophthalmology. 121(4):

7 EFFICACY Efficacy after SMILE Cumulative percentage of eyes Postoperative UDVA Preoperative CDVA 3 months: 82% UCVA % UCVA / /16 20/20 20/25 20/30 20/40 20/50 20/60 Snellen visual acuity 7

8 ASTIGMATISM Correction of Myopic Astigmatism with Small Incision Lenticule Extraction Anders Ivarsen and Jesper Hjortdal J Refract Surg. 2014; 30: Cylinder < 2.5 D 669 eyes Cylinder 2.5 D 106 eyes eq. eq. 8

9 Results after SMILE for Astigmatism A 6 B 3 Cylinder < 2.50 D Achieved astigmatic correction (D) 4 2 AKP error (D) 2 Error: 0.17 ± 0.42 D 1 Cylinder 2.50 D 0 Error: 0.59 ± 0.65 D Intended astigmatic correction (D) Intended astigmatic correction (D) SAFETY 9

10 Safety After 3 months 1.5% lost 2 or more Snellen lines 24 eyes invited for late follow-up (6-28 months) All had improved to within 1 Snellen line of pre-op CDVA Safety and Complications of More Than 1500 Small-Incision Lenticule Extraction Procedures Anders Ivarsen, Sven Asp & Jesper Hjortdal. Ophthalmology. 121(4): Safety Cap Perforation Haze after epithelial defect 10

11 Patients Satisfaction ReLEx - 2 prospective studies from Aarhus: patients (SMILE), 3 months follow-up - 34 patients (FLEX and SMILE), 6 months follow-up How satisfied are you with your laser surgery for nearsightedness? Mean score from 9.1 to 9.3 (range from 4.5 to 10) 97 % were satisfied or very satisfied Related to spectacle independence Questionnaire and verbal responses were identical (no examiner bias) 94 % to 100 % would recommend surgery to others. Vestergaard et al, JCRS 2012, SMILE Vestergaard et al, JCRS 2013, FLEX and SMILE 21 Refractive results in summary Very good spherical equivalent refractive outcome - independent on the attempted correction 13-16% undercorrection of high cylinders More than 90% may drive a car without glasses Very little refractive regression High patients satisfaction 11

12 Re-treatments Avoid new SMILE procedure in vicinity of previous cut irregular slices may result Comparison of four different VisuMax circle patterns for flap creation after small incision lenticule extraction. Riau AK, Ang HP, Lwin NC, Chaurasia SS, Tan DT, Mehta JS. J Refract Surg Apr;29(4): PRK (LASIK) Cap Opening (+excimer) SMILE above or deeper Safe distance Summary ReLEx SMILE is efficient, precise, accurate, and safe for treatment of moderate and high myopia, and for myopic-astigmatism Most surgeons prefer to do the enhancement by excimer laser ablation either on the surface, in the stromal bed after creation of a flap or opening the cap. 12

13 Three surgeons: Sven Asp, Anders Ivarsen, Jesper Hjortdal Four optometrists: Nicolaj, Henrik, Christina & Christian PhD: Anders Vestergaard; MS: Iben & Sashia 13

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