With regard to safety and predictability ReLEx SMILE is slightly better than Femtosecond LASIK. No overall superiority of any method. More long-term data needed

1. Five-Year Results of Refractive Lenticule Extraction
ReLEx SMILE compared to Femto-LASIK
Detlev R.H. Breyer, H. Kaymak, K. Klabe, P. Hagen, T. Ax, L. Beckers, F. Kretz, G. Auffarth
Breyer, Kaymak & Klabe Eye Surgery and Premium Eyes are Consulting, Study Center & MAB for:
Abott, Alcon, AlimeraSciences, Allergan, Alkahest, AMO, Bayer, Carl Zeiss Meditec, Ellex, Fluoron,
Gesundheitsamt Rhein-Neuss-Kreis, Geuder, Glaukos, Hangzhou Classon Tec, HOYA, iOptics, KangHong
Biotec., LensAR, Medicem, Novartis, Oculentis, Oertli, OMNITM, Optos, PharmaStulln, PhysIOL, Revision
Optics, Santen, Staar Surgical, Sifi Medtech, Teleon Surgical Optics, Thea, Topcon, Visufarma, Ziemer

2. Reported Long-Term Results
Years of
follow up
(Femto-)LASIK vs. ReLEx SMILE
Retrospective
analysis of our 5-
year data:
consequtive cases
3
5
10
15

3. VisuMax Mel 80
Materials and Methods: Preoperative Eye Data
Treatment
Femto-LASIK
(topography-guided)
ReLEx SMILE
Laser platform CZM Mel 80 CZM VisuMax
Number of eyes 371 1190
M:F [%] 49:51 45:55
mean ± SD min median max mean ± SD min median max p
Age [years] 36 ± 9 18 37 70 34 ± 8 19 33 72 <0.001
Sphere [D] -2.63 ± 1.81 -9.25 -2.25 1.25 -3.94 ± 1. 90 -9.75 -3.75 0.75 <0.001
Cylinder [D] -0.88 ± 0.89 -4.75 -0.75 0.00 -0.69 ± 0.68 -3.50 -0.50 0.00 <0.001
Spherical Equivalent (SE) [D] -3.07 ± 1.74 -10.00 -2.75 4.00 -4.29 ± 1.90 -10.00 -4.25 -0.13 <0.001
CDVA [logMAR] -0.01 ± 0.07 -0.28 0.00 0.36 -0.02 ± 0.06 -0.20 0.00 0.30 <0.001
UDVA [logMAR] 0.87 ± 0.40 -0.18 0.98 1.30 1.10 ± 0.30 -0.02 1.30 1.30 <0.001
Central Corneal thickness [µm] 549 ± 29 442 550 632 549 ± 30 469 547 655 0.97
Flap/Cap thickness [µm] 116 ± 9 100 120 160 138 ± 13 110 140 150 <0.001
Ablation/Lenticule thickness [µm] 68 ± 24 14 64 151 92 ± 29 36 89 168 <0.001
Target refraction (Laser) [D] 0.02 ± 0.43 -1.50 0.00 1.00 0.38 ± 0.40 -2.00 0.50 1.25 <0.001
SMILE eyes
more myopic
„hyperopic“
target SE due
to internal
nomogram

4. Results: Safety
Significant differences (p<0.05):
• SMILE with slightly (1-2 letters) better results at
6M, 1Y and 2Y
• LASIK with slightly (1-2 letters) better results at 5Y
No eyes
with loss 2
or more
“gain (loss) n“:
≥5*n (≤-5*n)
letters difference
∆CDVA = CDVA(post) - CDVA(pre)
n = #Eyes Femto-
LASIK
ReLEx
SMILE
p
MW ± SD
6 M
54 174
<0.05
0.01 ± 0.06 -0.01 ± 0.07
1 Y
55 271
<0.05
0.00 ± 0.06 -0.05 ± 0.08
2 Y
29 89
<0.05
0.01 ± 0.06 -0.03 ± 0.07
3 Y
34 50
0.16
-0.03 ± 0.07 -0.01 ± 0.07
5 Y
32 26
0.14
-0.03 ± 0.07 -0.01 ± 0.05
Percentageofeyes[%]
loss3
ormore
loss2
loss1
unchanged
gain1
gain2
gain3
ormore

5. Results: Predictability
• Slight undercorrection of roughly 10%
 Lead to usage of nomogram during planning
phase of surgery:
Increase targeted SE correction for myopic eyes
by 10%
Targeted SE correction =
SE(laser-target) – SE(pre)
Achieved SE correction =
SE(post) – SE(pre)
Linear Fitgerade: y = m*x + b
n = #Eyes
Femto-
LASIK
ReLEx
SMILE( m | b )
R²
6 M
54 176
( 0.96 | -0.20 ) ( 0.88 | 0.06 )
0.98 0.95

6. Results: Predictability
Targeted SE correction =
SE(target) – SE(pre)
Achieved SE correction =
SE(post) – SE(pre)
5Y3Y
Targeted SE correction =
SE(target) – SE(pre)
Achieved SE correction =
SE(post) – SE(pre)

7. Results: Uncorrected Distance Visual Acuity
Significant (p<0,05 , Wilcoxon Rangsummentest) differences:
• SMILE with slightly better UDVA 1 and 2 years after surgery
Consider subgroup with:
SE(target) = 0.0 dpt ± 0.5 dpt
• More data needed
6M 1J 2J 3J 5J 6M 1J 2J 3J 5J
LASIK SMILE
UDVA[logMAR]
monocular UDVA(post) [logMAR]
Median
Femto-
LASIK
ReLEx
SMILE
p
MW ± SD
6 M
0.00 0.00 0.05
0.04 ± 0.12 0.01 ± 0.12
1 J
0.00 -0.06 <0.001
0.01 ± 0.10 -0.03 ± 0.1
2 J
0.04 -0.04 <0.01
0.08 ± 0.20 -0.03 ± 0.09
3 J
0.03 0.00 0.05
0.06 ± 0.15 0.01 ± 0.13
5 J
0.02 0.00 0.82
0.03 ± 0.10 0,03 ± 0.10

8. Conclusion
Comparison of long-term results (up to 5 years):
• Significant differences (p<0.05) :
o Safety: SMILE [LASIK] slightly (1-2 letters) better at 6M, 1Y and 2Y [5Y]
o Predictability:
 Compensation of undercorrection of roughly 10%
 SMILE slightly more precise than LASIK at 2Y
o Astigmatic correction: No differences
o Visual recovery: Slightly better UDVA-values for ReLEx SMILE at 1Y und 2Y
 No overall superiority of any method
 More long-term data needed
• Disadvantage of retrospective long-term analysis:
o Usual follow up visits: 1D, 1W, 1M, 3M
 Low percentage of eyes at 6M, 1Y, 2Y, 3Y, 5Y
 Later follow up visits might be dominated by patients with bad outcome?
• Patient questionnaire:
o Less dry eyes, less pain sensation and better patient comfort in ReLEx SMILE
group
 ReLEx SMILE is the treatment of choice
Femto-LASIK ReLEx SMILE