Presentation by Detlev Breyer (MD) at the ASCRS 2017 in Los Angeles. Title: Long-term Results of Refractive Lenticule Extraction ReLEx SMILE compared to Femto-LASIK.

1. Long-term Results of Refractive Lenticule Extraction
ReLEx SMILE compared to Femto-LASIK
P. Hagen, D. Breyer, H. Kaymak, K. Klabe, F. Kretz, G. Auffarth

2. Financial Disclosure
Breyer, Kaymak & Klabe Eye Surgery and Premium Eyes are Consulting, Study Center & MAB for:
Abott, Alcon, AlimeraSciences, Allergan, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron, Geuder, iOptics, LensAR,
Novartis, Oculentis, Oertli, Revision Optics, Santen, Staar Surgical, Thea, Topcon, Visufarma, Ziemer

3. Theoretical Background:
ReLEx SMILE & Femto-LASIK
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 3
CZM Mel 80
• Excimer laser
• Femto-LASIK:
 Flap creation using
VisuMax®
 Tissue ablation through
laser vaporization of corneal
stroma
CZM VisuMax
• Femtosecond laser
• Low laser pulse energies
• Corneal suction
• ReLEx SMILE:
 Intracorneal lenticule is
created by a pattern of laser
induced cavitation bubbles
 Mechanical removal of
lenticule through small
peripheral incision
Pictures are used with the kind permission of CZM
Idea: Retrospectively compare long-term results
of both groups:
1. Femto-LASIK (flap thickness 100-120µm)
2. ReLEx SMILE (cap thickness 120-150µm)
Target refraction: emmetropia

4. Materials and Methods: Preoperative Patient Data
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Treatment
Femto-LASIK
targ. refr.: emmetropia
ReLEx SMILE
targ. refr.: emmetropia
Number of eyes 366 653
Age [years] 36 ± 9 34 ± 8
Central thickness [µm] 550 ± 29 545 ± 31
Sphere [D] -2.32 ± 2.11 -3.87 ± 1.88
Cylinder [D] -0.87 ± 0.88 -0.70 ± 0.70
Spherical Equivalent [D] -2.76 ± 2.02 -4.22 ± 1.89

5. Materials and Methods: Postoperative Examinations
Examinations
(up to 3 year postop.):
• Manifest refraction
(Phoropter)
• Visual acuity measurement at far
(ETDRS-chart)
• Wave front analysis
(KR-1W Topcon)
• Patient questionnaire
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 5

6. -1
-0.75
-0.5
-0.25
0
0.25
0.5
0.75
1
Sphere Cylinder SE
RefractivePower[D]
Manifest Refraction
Smile 6M (n=138)
Smile 1Y (n=129)
Smile 2Y (n=43)
Smile 3Y (n=17)
-1
-0.75
-0.5
-0.25
0
0.25
0.5
0.75
1
Sphere Cylinder SE
RefractivePower[D]
Manifest Refraction
Lasik 6M (n=44)
Lasik 1Y (n=41)
Lasik 2Y (n=23)
Lasik 3Y (n=27)
Results: Manifest Refraction
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 6
Differences in manifest refraction:
• 1 year after surgery: Mean values for sphere and SE significantly (p<0.05) better in
SMILE group
• Tendentially slightly narrower standard deviations for sphere in case of SMILE

7. 0%
25%
50%
75%
100%
loss3
ormore
loss2
loss1
unchanged
gain1
gain2
gain3
ormore
Percentageofeyes[%]
∆CDVA [Snellen Lines]
Safety: Change in CDVA (post. - pre.)
Lasik 6M (n=44)
Lasik 1Y (n=39)
Lasik 2Y (n=22)
Lasik 3Y (n=26)
Smile 6M (n=140)
Smile 1Y (n=129)
Smile 2Y (n=86)
Smile 3Y (n=34)
Results: Safety
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 7
Significant (p<0.05) differences:
• At 6 months and 1 year: SMILE with slightly better results.
 Slight advantages for ReLEx SMILE in terms of safety

8. Results: Predictability 1 Year after Surgery
• 1 year after surgery:
No significant differences
for predictability of SE
outcome in Femto-LASIK
and ReLEx SMILE group
• Slight undercorrection of
roughly 10%
 Compensate for in
planning phase of OP
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 8

9. Results: Predictability 2 Years after Surgery
• 2 years after surgery:
No significant differences
for predictability of SE
outcome in Femto-LASIK
and ReLEx SMILE group
• Slight undercorrection of
roughly 10%
 Compensate for in
planning phase of OP
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 9

10. Results: Predictability 3 Years after Surgery
• 3 years after surgery:
No significant differences
for predictability of SE
outcome in Femto-LASIK
and ReLEx SMILE group
• Slight undercorrection of
roughly 10%
 Compensate for in
planning phase of OP
• More data needed for
ReLEx SMILE group
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 10

11. -0.4
-0.2
0
0.2
0.4
0.6
0.8
1
1.2
1.4
1.6
pre 3M 6M 1Y 2Y
UDVA[logMAR]
Visual recovery
Lasik
Smile
Results: Visual Recovery
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 11
n = number of eyes preop. 3M 6M 1Y 2Y
LASIK 348 43 47 34 9
SMILE 614 149 128 128 37
Differences in UDVA:
• Preop.: LASIK has significantly better UDVA than SMILE (eyes are less myopic)
• Postop.: In total, slightly better mean values for SMILE, however, differences not significant
3-year data needed

12. -2.0
-1.5
-1.0
-0.5
0.0
0.5
1.0
1.5
Astigmatism (RMS) Total HOA (RMS) Coma (RMS) Spherical
Aberration
OcularAberrations[µm]
Ocular Aberrations (6mm)
Lasik preop. (n=255)
Lasik post (n=157)
Smile preop. (n=631)
Smile post (n=524)
Results: Wave Front Analysis
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 12
Significant (p<0.05) differences:
• Astigmatism is reduced by Femto-LASIK and ReLEx SMILE
• Higher order aberrations slightly increased by both treatments
No significant differences between both groups
post: 3M to 2Y

13. Conclusion and Outlook
© by Premium Eyes Laser Eye Surgery · premiumeyes.de · · Slide17-06-04 13
Comparison of long-term results (up to 3 years):
• Safety:
- Slight advantages for ReLEx SMILE compared to Femto-LASIK
• Predictability:
- No significant differences between SMILE and LASIK
- Compensation of undercorrection of roughly 10% has to be considered in planning phase
of the surgery
- More 3-year data for ReLEx SMILE needed
• Visual recovery:
- Tendentially slightly better UDVA-values for ReLEx SMILE compared to Femto-LASIK (not significant)
• Wave front analysis:
- No significant differences between both groups
• Patient questionnaire:
- Less dry eyes, less pain sensation and better patient comfort were observed in ReLEx SMILE groups
 ReLEx SMILE is the treatment of choice

14. Thank you very much for your attention!