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Medicontur

Medical Engineering Ltd [email protected] www.medicontur.com

Head Office Herceghalmi Road 1. 2072 Zsámbék Hungary

International Office Chemin des Aulx 18 1228 Plan-les-Ouates Geneva/Switzerland

LESS STEPS – MORE VISION

”Exceptionally good platform and

an optic that generates more

patient satisfaction in terms of defocus

curves and perceived dysphotopsia

symptoms. I would not change a thing

about this IOL.“

J. Fernandez MD, PhD, Spain

WOC 2018, Barcelona

FOCUS

on the patients vision

since 1989

Medicontur stands

for consistent high quality,

proven by more than

6 million

intraocular lenses

implanted.

„Clinical e

vidence of pr

ospectiv

e

ran

domized study catapul

ted Liber

ty

into th

e high quality tr

ifocal gr

oup

of IOLs available on th

e market

.“

E. V

an Ack

er, MD

, Belgium

ESCRS 20

17, Lisabon

TRIFOCAL

Complete Spectacle

Independence

7 RINGS TO

PERFECTION

Superior Contrast

Sensitivity

MC_LIBR_DBR_EN v001

(2)

THE MOST

BALANCED

TRIFOCAL

IOL

liberty-lens.com

References

A. AF, Dunai et al. (Hungary) Comparison of two multifocal IOL Types (50 Bi-Flex M &50 Acrysof IQ) – long term visual outcome. ESCRS 2016, 2017. B. E. Van Acker, MD, (Belgium) Comparison of clinical outcomes and patient satisfaction after implantation of two different types of diffractive apodized IOLs: 40 Bi-Flex M (based on PAD technology) 40 Finevision (Micro F) trifocal diffractive IOL. Prospective, randomized, observational study. ESCRS 2017. C. J. Györy (Hungary) Long term funcional and morphological outcomes and patient satisfaction after cataract surgery with 100 BiFlex M implantation with/without posterior central circular capsulorhexis (PCCC). ESCRS 2016, 2017. D. J. Fernandez MD, PhD, (Spain) Visual performance of patients implanted with progressive PAD Bi-Flex M analyzed by the Qvision iPAD Multifocal LensAnalyzer. ESCRS 2017. E. E. Law et al. (UK) Randomised clinical trial of the Bi-Flex M multifocal intraocular lens. ESCRS 2017. F. A Dexl. (Austria) Visual Outcome, Patient Satisfaction and Spectacle Independency after Implantation of 50 eyes ith  Progressive Bi-Flex M. Final Result of a Multicentric Trial with 50 Conscecutive Patients. ESCRS 2015. G. C. Naval. (Philippines) Evolution of multifocal practice. ESCRS 2014. H. N. Meijide (Argentina) Visual Outcomes After Bilateral Implantation of a New Progressive Apodized Diffractive Trifocal IOL. Clinical outcome ASCRS 2018 ID 42517. I.  J. García-Bella et al. (Spain) Visual outcomes after progressive apodized diffractive intraocular lens implantation. Eur J Ophthalmol. 2017 Sep. J. M. Assouline MD, PhD, (France) Comparative Outcome of Four Multifocal Intraocular Lens. ESCRS 2015.

(3)

ENHANCED QUALITY

OF VISION

IOL manufacturers eagerly compete for

superior intermediate performance or compress

the addition towards the intermediate to create

some „comfort“. While doing this they disregard

the main key of success for multifocal IOLs –

SPECTACLE INDEPENDENCE.

Medicontur chooses not to compromise

IOL performance.

Liberty equates to spectacle independence

without the compromise of reduced image

quality or visual acuity at near and far distances.

LIBERTY

FOR YOUR PATIENTS

(4)

THE MOST BALANCED

TRIFOCAL IOL

Less Diffractive Steps – More Vision

Light is scattered within an IOL by every diffractive step. Considerable additional light

scattering is caused by the manufactured imperfections of these steps on multiple points.

Therefore not only the quality but also the quantity of the manufactured steps has

a great impact on light scattering and loss of light energy.

The below symbolic figures demonstrate the difference in light scattering and energy loss

on two separate diffractive IOL profiles.

Quantity of Scattered Light

What does LESS STEPS mean for your patients?

Less light scattering improves vision by

Higher Contrast Sensitivity

Less Halos & Glare

N I F

N I F

Figure 1a: LIBERTY optic with 7 diffractive steps Moderate light scattering

Figure 1b:

Diffractive optic with 2× more diffractive steps creates minimum 3× more light scattering

(5)

Out-Of-Focus Light Intensity

Distribution by Visualization of

Light Propagation along the Optical Axis

Which Lens Would You Prefer For Driving At Night?

* Simulated by Zemax extension for calculation of light propagation after custom defined diffractive surfaces.

Light Energy Intensity at 4.5 mm Aperture* Halos in FAR focal plane

Log of relative intensity (-)

Log of relative intensity (-)

Log of relative intensity (-)

Defocus (D) Distance from optical axis (μm)

Distance from optical axis (μm)

Distance from optical axis (μm)

5.0 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 +0.5 -1.0

Distance from optical axis (μm)

150

100

50

0

-50

-100

-150

80 60 40 20 0

0

-20 20

-40 40

-60 60

-80 80

0

-20 20

-40 40

-60 60

-80 80

0

-20 20

-40 40

-60 60

-80 80

-20 -40 -60 -80

80 60 40 20 0 -20 -40 -60 -80

80 60 40 20 0 -20 -40 -60 -80 0 -1 -2 -3 -4 -5 -6 -7 -8

0 -1 -2 -3 -4 -5 -6 -7 -8

0 -1 -2 -3 -4 -5 -6 -7 -8

0 -1 -2 -3 -4 -5 -6 -7 -8

0 -1 -2 -3 -4 -5 -6 -7 -8

0 -1 -2 -3 -4 -5 -6 -7 -8

Medicontur Liberty

OUT-OF-FOCUS INTENSITY

OUT-OF-FOCUS INTENSITY

OUT-OF-FOCUS INTENSITY NEAR

NEAR

NEAR

FAR

FAR

FAR Defocus (D)

5.0 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 +0.5 -1.0

Distance from optical axis (μm)

150

100

50

0

-50

-100

-150

Competitor 1 - quadrifocal

Defocus (D)

5.0 4.5 4.0 3.5 3.0 2.5 2.0 1.5 1.0 0.5 0.0 +0.5 -1.0

Distance from optical axis (μm)

150

100

50

0

-50

-100

-150

Competitor 2 – trifocal apodized

(6)

Figure 2:  MTF through focus curves with central diffractive phase shifts at a destructive and a constructive interference level resulting in a 3rd focal point for intermediate vision.

Figure 1:  Radial profile with central diffractive phase shift elevated from a destructive level to a constructive interference level.

λPhase Shift

(

)

Radial distance from the optical axis (mm)

Bifocal = Destructive interference phase level

Trifocal = Elevated Phase Shift* Constructive interference

* patent pending 0.7

0.6 0.5 0.4 0.3 0.2 0.1

0.00.0 0.2 0.4 0.6 0.8 1.0 1.2 1.4

-0.8 -0.5 -0.3 0.0 0.3 0.5 0.8 1.0 1.5 1.5 1.8 2.0 2.3 2.5 2.8 3.0 3.3 3.5 3.8 4.0

MTF @ 50 lp/mm

Defocus in ISO eye model (D)

Bifocal = Destructive interference level Trifocal = EPS * Constructive interference

* patent pending

0.40 0.35 0.30 0.25 0.20 0.15 0.10 0.05 0.00

A TRIFOCAL DESIGN:

Elevated Phase Shift * (EPS) technology

Medicontur‘s proprietary, patented approach to trifocality uses EPS in the central part

of the optic to generate constructive interference between the 0th (far) and 1st (near)

diffractive order. This revolutionary optical design generates the 3rd focal point for

intermediate vision in a very unique way:

THE MOST BALANCED

TRIFOCAL IOL

EPS* technology uses only 7 rings within a 3 mm diameter for complete spectacle

independence, improved image quality and excellent performance at near and far.

(7)

7 steps to Trifocal perfection

LIBERTY IOLs achieve trifocal performance with

7 steps in a precise diffractive array within a

3 mm diameter leaving a

75% refractive lens surface.

LIBERTY IOLs are strongly pupil dependent using the NEAR TRIAD which implies miosis

under accommodation. We believe that too much light distribution into the near focus

above 3 mm aperture does not match normal ocular physiology.

The 4 charts below show the Useful Light Distribution in % of LIBERTY and 3 competitors

depending on the aperture [mm] *. LIBERTY provides the highest light distribution in the

near focus under accommodation and the highest for far vision under scotopic conditions.

100 %

50 %

0 %

2.0 2.5 3.0 3.5 4.0 4.5 5.0

Liberty

Aperture (mm) 100 %

50 %

0 %

2.0 2.5 3.0 3.5 4.0 4.5 5.0

Competitor 1 quadrifocal

Aperture (mm) 100 %

50 %

0 %

2.0 2.5 3.0 3.5 4.0 4.5 5.0

Competitor 2 trifocal apodized

Aperture (mm) 100 %

50 %

0 %

2.0 2.5 3.0 3.5 4.0 4.5 5.0

Competitor 3 trifocal non-apodized

Aperture (mm)

* Based on Strehl ratio calculated from Zemax simulated MTF values

Far Near Inter

(8)

1. TRIFOCAL PERFORMANCE *

2. COMPLETE SPECTACLE INDEPENDENCE *

3. EXCELLENT FAR – NEAR & GOOD INTERMEDIATE VISION *

4. REFRACTIVE PREDICTABILITY & LONG TERM STABILITY *

5. OUTSTANDING CONTRAST SENSITIVITY *

6. EXCELLENT READING SPEED *

7. MINIMAL REPORTS OF DYSPHOTOPSIA *

” The most balanced

trifocal IOL on the market.“

M. Assouline, MD, PhD

France

APAO 2018,

Hong Kong

10 CLINICAL

STUDIES

IN 12

COUNTRIES

MORE THAN

900 EYES

100

80

60

40

20

0

Percentage of patients (%) 96 92

4

96 4 44

Very Satisfied Satisfied Rather satisfied

95% of patients

HIGHLY

SATISFIED

at all distances

(study C)

* Confirmed by studies; see references.

(9)

THE MOST BALANCED

TRIFOCAL IOL

TRIFOCAL performance

and Spectacle Independence

Clinical evidence shows excellent far & near, good intermediate vision.

Outstanding Visual Performance for Liberty 677MY

(Study C)

Equivalent Clinical Visual Acuity compared to FineVision (PhysIOL)

(Study B)

1.6 1.4 1.2 1.0 0.8 0.6 0.4 0.2

0 1.00

0.70 0.40 0.20 0.10 0.00 -0.10 -0.15 -0.20

2.0 1.5 1.0 0.5 0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 -3.5 -4.0

Visual Acuity (decimal) Visual Acuity (logMAR)

Diopters

Binocular Defocus curve (24-month follow-up)

1.2 1.0 0.8 0.6 0.4 0.2 0.0

67 cm

+4.0 +3.5 +3.0 +2.5 +2.0 +1.5 +1.0 0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0 -3.5

Visual Acuity (decimal)

Liberty 677MY

Diopters FineVision (PhysIOL)

1.00 0.70 0.40 0.20 0.10 0.00 -0.10 Visual Acuity (logMAR)

(10)

THE MOST BALANCED

TRIFOCAL IOL

High Image QUALITY

Superior Contrast Sensitivity compared to FineVision (PhysIOL)

in different light conditions.

(Study B, C)

0.0 0.5 1.0 1.5 2.0 2.5

Spatial frequency Spatial frequency

3 6 12 18

PHOTOPIC

CYC/DEG CYC/DEG CYC/DEG

MESOPIC SCOTOPIC

Log Contrast Sensitivity

Liberty 677MY (Medicontur) FineVision (PhysIOL)

3 6 12 18

Spatial frequency

3 6 12 18

Equivalent Contrast Sensitivity

to Bi-Flex

Monofocal IOL

(Study E)

Equivalent Reading Speed

to Bi-Flex

Monofocal IOL

(Study E)

„After over 100 implantations trifocal performance is evident. Less halos & glare, better contrast sensitivity. All

my patients implanted with Liberty are spectacle independent.“ J. Győry, MD, Hungary     ESCRS 2017, Lisabon

1.7

1.6

1.5

1.4

ontrLog Cast Sensitivity 1.3

Liberty 677MY Pelli-Robson Contrast Sensitivity

Bi-Flex 677AB

Log Contrast Sensitivity

Liberty 677MY Bi-Flex 677AB CSV-1000

0.4 0.6

0.20 3 6 9 12 15 18

0.8 1.0 1.2 1.4 1.6 1.8 2.0

CYC/DEG

Liberty 677MY Bi-Flex 677AB 100

120 140 160 180 200 220

Words per minute

(11)

ACCURACY & PREDICTABILITY

Accuracy of refractive outcome of Liberty overshadow distinctively

literature average = ±0.5 D: 75.1%.

Excellent Long Term Refractive Stability and Visual Outcomes.

(Study C)

Mean spherical equivalent residual error of -0.15D (± 0.33D)

(Based on studies A, C, D)

Cooke DL, Cooke TL. J Cataract Refract Surg. 2016;42(8):1157-1164

UCVA vs BCVA

Uncorrected Corrected Cumulative Snell Visual Acuity (20/40 or better)

DISTANCE

TIME

INTERMEDIATE NEAR

2 3 1 4

0 0 0 0

2 3 1 2

1 2 16 29

67

19 44 56

85 89 97 93 99 100

100 100 100 100 100 100 100 100

100 100 100100

97 93 73 59 37 90 95 100

96100

20 44

63

37 57

80 98 95 93 90

95 77 47 26 0 0

100 100 100 100 100 100 100 100

20/12.5 20/16 20/20 20/25 20/32 20/40

20/12.5 20/16 20/20 20/25 20/32 20/40

20/12.5 20/16 20/20 20/25 20/32 20/40

20/12.5 20/16 20/20 20/25 20/32 20/40

20/12.5 20/16 20/20 20/25 20/32 20/40

20/12.5 20/16 20/20 20/25 20/32 20/40 100

80 60 40 20 0

100 80 60 40 20 0 3 Months Postop Cumulative percent of eyes (%)12 Months Postop Cumulative percent of eyes (%)

88% of Eyes

≤ ± 0.50D

Refractive Stability and Predictability

MC_LIBR_DBR_EN v001

(12)

Single use injection system for Liberty 677PMY preloaded IOLs

* Other powers upon request

** Patent pending

*** It is recommended that surgeons personalize the constants they use. Type Single-piece hydrophilic intraocular lens

for implantation into the capsular bag

Material 25% water content with UV absorber + blue light filter; Refractive Index 1.46; ABBE number 58 Optic design Biconvex, aspheric, diffractive-refractive, apodized Powers available* +8.00 D +35.00 D (increment: 0.50 D)

Diffractive zone EPS technology**, anterior surface, Ø 3.0 mm Addition +3.50 D (near); +1.75 D (intermediate)

A-constant*** 118.9 (SRK/T)

Dimensions Overall length 13.0 mm; optic Ø 6.0 mm PCO protection 360° Special Square Edge (patented)

Haptic angulation 0° – asymmetrical design with posterior vaulting Sterilization Steam (shelf life 5 years after sterilization) Storage conditions at +15 °C – +35 °C (15% – 50% humidity)

Liberty 677MY / 677PMY Technical Specification

1

st

CLICK LOADING

1. Put a drop of visco in the lens holder 2. Insert the injector into the

wet container

3

rd

CLICK READY

5. Push the red stopper forward to the end position

6. Fill visco

2

nd

CLICK CLOSING

3. Inject viscoelastic material into the cartridge nozzle

4. Fold up the cartridge nozzle

INJECTION

7. Push the plunger midway then pull back to the end and

continue pushing

(13)

A LEADING

HAPTIC DESIGN

FOR ROTATIONAL

STABILITY

PCO PROTECTION

360° posterior optic edge (≤ 10 um edge radius)

ROTATIONAL STABILITY

Ergonomic-adaptive fit with optimal balance

in haptic force – DOUBLE LOOP HAPTIC

180° contact angle between haptic

and the capsular bag equator at 9 mm Ø

PREMIUM MATERIAL &

ADVANCED

MANUFACTURING

TECHNOLOGY

SAFETY RECORDS

30 years experience in IOL design

and manufacturing

IMAGE QUALITY

Highest ABBE no. (58) for the lowest chromatic aberration

PCO protection

Low ionicity surface for less cell adhesion

RETINA PROTECTION

UV blocker

Violet light filtering

TRIFOCAL PERFORMANCE – SPECTACLE

INDEPENDENCE

HIGH QUALITY OF VISION

7 steps in a precise diffractive array with a

3 mm diameter leaving a

75% refractive lens surface

Minimal dysphotopic phenomena

Superior contrast sensitivity

Uncompromised near vision

PUPIL DEPENDENT using physiological NEAR TRIAD

Material. Design. Optics.

MC_LIBR_DBR_EN v001

(14)

* Other powers upon request

** Please note that at SEQ.: +8.0 D to +9.5 D, only cyl. +1.0 D to +4.5 D applies.

*** Patent pending

**** It is recommended that surgeons personalize the constants they use.

Type Single-piece hydrophilic trifocal toric intraocular lens for implantation into the capsular bag

Material 25% water content with UV absorber + blue light filter; Refractive Index 1.46; ABBE number 58

Optic design Biconvex, aspheric, diffractive-refractive, apodized, toric

Powers available* +8.00 D +35.00 D (increment: 0.50 D)

Cylinders

available** +1.00 D +4.50 D (increment: 0.50 D) +5.25 D; +6.00 D

Diffractive zone EPS technology***, anterior surface, Ø 3.0 mm

Addition +3.50 D (near); +1.75 D (intermediate)

A-constant**** 118.9 (SRK/T)

Dimensions Overall length 13.0 mm; optic Ø 6.0 mm

PCO protection 360° Special Square Edge (patented)

Haptic angulation 0° – asymmetrical design with posterior vaulting

Sterilization Steam (shelf life 5 years after sterilization)

Storage conditions at +15 °C – +35 °C (15% – 50% humidity)

Liberty 677MTY Technical Specification

(15)

THE MOST

BALANCED

TRIFOCAL

IOL

liberty-lens.com

References

A. AF, Dunai et al. (Hungary) Comparison of two multifocal IOL Types (50 Bi-Flex M &50 Acrysof IQ) – long term visual outcome. ESCRS 2016, 2017. B. E. Van Acker, MD, (Belgium) Comparison of clinical outcomes and patient satisfaction after implantation of two different types of diffractive apodized IOLs: 40 Bi-Flex M (based on PAD technology) 40 Finevision (Micro F) trifocal diffractive IOL. Prospective, randomized, observational study. ESCRS 2017. C. J. Györy (Hungary) Long term funcional and morphological outcomes and patient satisfaction after cataract surgery with 100 BiFlex M implantation with/without posterior central circular capsulorhexis (PCCC). ESCRS 2016, 2017. D. J. Fernandez MD, PhD, (Spain) Visual performance of patients implanted with progressive PAD Bi-Flex M analyzed by the Qvision iPAD Multifocal LensAnalyzer. ESCRS 2017. E. E. Law et al. (UK) Randomised clinical trial of the Bi-Flex M multifocal intraocular lens. ESCRS 2017. F. A Dexl. (Austria) Visual Outcome, Patient Satisfaction and Spectacle Independency after Implantation of 50 eyes ith  Progressive Bi-Flex M. Final Result of a Multicentric Trial with 50 Conscecutive Patients. ESCRS 2015. G. C. Naval. (Philippines) Evolution of multifocal practice. ESCRS 2014. H. N. Meijide (Argentina) Visual Outcomes After Bilateral Implantation of a New Progressive Apodized Diffractive Trifocal IOL. Clinical outcome ASCRS 2018 ID 42517. I.  J. García-Bella et al. (Spain) Visual outcomes after progressive apodized diffractive intraocular lens implantation. Eur J Ophthalmol. 2017 Sep. J. M. Assouline MD, PhD, (France) Comparative Outcome of Four Multifocal Intraocular Lens. ESCRS 2015.

(16)

Medicontur

Medical Engineering Ltd [email protected] www.medicontur.com

Head Office Herceghalmi Road 1. 2072 Zsámbék Hungary

International Office Chemin des Aulx 18 1228 Plan-les-Ouates Geneva/Switzerland

LESS STEPS – MORE VISION

”Exceptionally good platform and

an optic that generates more

patient satisfaction in terms of defocus

curves and perceived dysphotopsia

symptoms. I would not change a thing

about this IOL.“

J. Fernandez MD, PhD, Spain

WOC 2018, Barcelona

FOCUS

on the patients vision

since 1989

Medicontur stands

for consistent high quality,

proven by more than

6 million

intraocular lenses

implanted.

„Clinical e

vidence of pr

ospectiv

e

ran

domized study catapul

ted Liber

ty

into th

e high quality tr

ifocal gr

oup

of IOLs available on th

e market

.“

E. V

an Ack

er, MD

, Belgium

ESCRS 20

17, Lisabon

TRIFOCAL

Complete Spectacle

Independence

7 RINGS TO

PERFECTION

Superior Contrast

Sensitivity

MC_LIBR_DBR_EN v001

References

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