Presentation by Detlev Breyer (MD), Eye Surgeon, at the ASCRS 2017 in Los Angeles dealing with innovative Treatments of Cataracts and Presbyopia. Title: Refractive versus Diffractive Optics for Enhanced Depth of Focus Intraocular Lenses (EDOF IOL): Comparison of Visual Outcomes and Photopsia

1. Refractive vs Diffractive Optics for Enhanced Depth of Focus
Intraocular Lenses (EDOF IOL).
Comparison of Visual Outcome and Photopsia.
E. Taylor, D. Breyer, H. Kaymak, K. Klabe, P. Hagen, 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. Monofocal IOL (mon, cc)
Comfort MF15 (mon, cc, n=63)
Symfony (mon, cc, n=36)
Reference Curve VA=1,0 (mon, sc)
0.00
0.25
0.50
0.75
1.00
1.25
-3.0
-2.5
-2.0
-1.5
-1.0
-0.5
0.0
DecimalVA
Defocus [D]
n = number of eyes
mon = monocular
bin = binocular
sc = uncorrected
cc = distance corrected
EV = emmetropic vision
BV = blended vision
% = MIOL capacity
(area under curve)
Motivation: Defocus Curves Comfort & Symfony
72%
43%
75%
100%
No significant (p<0.05) differences between visual acuity values from 0.0 to -2.5D
 Almost identical curves
Question: How do both IOL
perform in other categories?

4. LENTIS Comfort MF15 (Oculentis)
• Purely refractive optics
 No diffractive ring structures
 High light transmission
• Rotationally asymmetric:
Anterior: Sector-shaped segment with
+1.5D addition
for improved intermediate vision
• Bifocal optic

5. TECNIS Symfony (AMO)
• Posterior: Diffractive optic with specific ring design
(Echelette structure)
• Reduced chromatic aberration:
 Improved contrast sensitivity
• Continuous focus (EDOF)

6. 0.00
0.10
0.20
0.30
0.40
0.50
0.60
-0.5 0 0.5 1 1.5 2 2.5 3 3.5
MTF
Defocus [D]
MTF-Focus-Through Curve
Comfort Symfony
Ex Vivo: MTF Curves
Device: PMTF (Lambda-X)
Eye model: ISO11979-2 (no aberrations)
Wave length: 546nm (green)
Aperture diameter: 3mm
Spatial frequency: 50cycles/mm
Effective addition: 1.5D 1.78D
• MTF curves display similar characteristics
• Symfony better in intermediate range
• Transfer of measured optical bench values to clinical
outcomes difficult

7. Materials and Methods: Preoperative Patient Data
Mean ± Standard deviation Comfort Symfony
Number of eyes 1281 53
M:F [%] 45:55 53:47
Age [years] 67 ± 10 70 ± 9
Spherical Equivalent (SE) [D] -0.9 ± 4.3 -0.1 ± 2.7
Cylinder [D] -0.9 ± 0.8 -0.6 ± 0.6
IOL power [D] 19.6 ± 5.0 22.4 ± 3.1
Target refraction [D] -0.4 ± 0.5 -0.5 ± 0.6
Retrospective data analysis for different implantation variants
Distance [cm] 33 40 50 67 100 200 oo
Defocus [D] -3 -2,5 -2 -1,5 -1 -0,5 0
Emmetropic vision
Blended vision

8. Materials and Methods: Postoperative Examinations
Follow-up measurements
(up to 3 months postop.)
• Manifest Refraction
(Phoropter)
• Visual Acuity
(ETDRS reading chart)
• Defocus curves
• Subjective photopsia
(Halo&Glare Simulator, CZM)
• Patient questionnaire
(Quality of Vision)

9. 0%
25%
50%
75%
100%
loss3
ormore
loss2
loss1
unchanged
gain1
gain2
gain3
ormore
Percentageofeyes[%]
∆CDVA [Snellen Lines]
Safety: CDVA(post) - CDVA(pre)
Comfort MF15 (n=627)
Symfony (n=52)
Results: Safety
• No eye with loss of 2 lines or more
• High gains in Snellen Lines mainly due to cataract patients
• No significant (p<0.05) difference between mean ∆CDVA
• Good results for both Comfort and Symfony with respect to safety

10. 0%
25%
50%
75%
100%
(-oo, -1) [-1, -0.5) [-0.5, 0.5] (0.5, 1] (1, oo)
Percentageofeyes[%]
∆SE [D]
Predictability: SE(post) - SE(target)
Comfort MF15 (n=643)
Symfony (n=53)
Results: Predictability
• Small deviation from target refraction
• No significant (p<0.05) difference between mean ∆SE
• Addition can make precise measurement of manifest refraction harder in daily routine

11. Monofocal IOL (mon, cc)
Comfort EV (bin, sc, n=36)
Symfony EV (bin, sc, n=14)
Comfort BV (bin, sc, n=56)
Symfony BV (bin, sc, n=20)
Reference Curve VA=1,0 (mon, sc)
0.00
0.25
0.50
0.75
1.00
1.25
-3.0
-2.5
-2.0
-1.5
-1.0
-0.5
0.0
DecimalVA
Defocus [D]
n = number of eyes
mon = monocular
bin = binocular
sc = uncorrected
cc = distance corrected
EV = emmetropic vision
BV = blended vision
% = MIOL capacity
(area under curve)
• High MIOL capacities
• Symfony slightly better at intermediate distance
• Comfort BV with better distance VA than Symfony BV
Results: Binocular Defocus Curves
95%
43%
100%
85%
93%
100%

12. Halo & Glare
• Dominant reason for MIOL explantation:
Photopsia:
 Halo & Glare
 Aberrations
 …
• Physical reason: Defocus
 Image of point-like source
appears as an extended area
• Inevitable in case of MIOL due to
addition
Example:
Comfort MF15

13. Halo & Glare Simulator
Simulation software from CZM:
• Subjective matching of patients photopsia via a graphic user interface
• Binocular and uncorrected
• 4 categories:
„mild“„none“
„moderate“ „severe“

14. 0%
25%
50%
75%
100%
"none" "mild" "moderate" "severe"
PercentageofEyes[%]
Strength of Halo&Glare
Halo & Glare Simulator
Phakic Eyes (n=126)
Comfort EV (n=30)
Comfort BV (n=36)
Symfony EV (n=16)
Symfony BV (n=18)
n = number of eyes
EV = emmetropic vision
BV = blended vision
Results: Halo & Glare Simulator
• Comfort EV and BV comparable to phakic eyes
• Diffractive Symfony with higher values than refractive Comfort

15. Summary
Implantation
variant
Uncorrected VA [logMAR]
MIOL
capacity
[%]
Halo & Glare
UDVA UIVA UNVA
Simulator:
Strength
[%]
QoV: „How bothersome are
Halo&Glare?“ 1=„Not at all“, 2=„A
little“, 3=„Quite“, 4=„Very“
Comfort EV 0.00 ± 0.09 0.05 ± 0.15 0.17 ± 0.22 85 30 ± 21 1.7 ± 1.0
Comfort BV -0.03 ± 0.07 -0.01 ± 0.09 0.09 ± 0.14 95 30 ± 16 1.7 ± 0.9
Symfony EV -0.01 ± 0.05 -0.03 ± 0.04 0.11 ± 0.15 93 46 ± 24 1.3 ± 0.6
Symfony BV 0.06 ± 0.11 -0.03 ± 0.06 0.03 ± 0.09 100 54 ± 19 3.3 ± 0.8
• Similar results with respect to safety and predictablity
• Knowledge of defocus curves and MIOL capacities is key for meeting patients
visual needs
• Less Halo&Glare for refractive Comfort BV compared to diffractive Symfony BV
• Comfort BV has better distance visual acuity than Symfony BV
• Our favorites: Comfort BV and Symfony EV

16. Thank you very much for your attention!