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HYDROPHOBIC & HYDROPHILIC IOLs

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CONTENTS

HYDROPHOBIC IOLs

Features of RUMEX Hydrophobic IOLs

UV&blue light blocking

Contrast sensitivity

Color vision

Natural chromophore

Negative pherical berration

Low glass transition temperature

Low chromatic aberration

Double square-edge

HYDROPHILIC IOLs

Features of RUMEX Hydrophilic IOLs

Co-aspheric optic design

Best- orrected isual cuity

UV&blue light blocking

Double square-edge

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HYDROPHOBIC IOLs

RUMEX HYDROPHOBIC IOLs

RUMEX offers you and highest quality standards with AquaFree IOLs. The soft hydrophobic material of AquaFree Yellow IOLs possess the most important . During the manufacturing process, the lens material is tray-polymerized and then eliminating the occurrence of glistenings.

An excellent sharp edge in optic and haptics on both sides of the lens, high-quality material with less than 0,5% water content,

are the features that make RUMEX IOLs unique.

Natural yellow material with natural chromophore

Advanced ptical ngineeringSpecial surface polishing

Low transition temperatureExtreme double square edge around entire optic periphery 360° barrier helps to prevent PCO caused by cellular migrationMethod of Sterilization: Ethylene Oxide (ETO)

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in RUMEX AquaFree Yellow IOLs the patient and diseases that can be caused by chronic exposure to blue light:

• Macular Degeneration• Eye Fatigue• Myopia• Red Eye Syndrome• Sleeping Quality

• Presbyopia

Macular Degeneration

HYDROPHOBIC IOLs

100-380nm 380-500nm

500-700nm

FEATURES OF RUMEX HYDROPHOBIC IOLs

UV&blue light blocking

RUMEX AquaFree Yellow Hydrophobic IOL provides (blue light filtering) similar to a young natural crystalline lens. It filters out harmful violet rays protecting the retina without blocking essential blue light range (from 465 nm to 495 nm) .

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HYDROPHOBIC IOLs

Contrast sensitivity

has been studied n patients with blue-filtering RUMEX AquaFree Yellow implanted to assess the patients image quality.

Data reported for a total of 382 patients in nine different studies confirmed that there was

Color vision

was evaluated to confirm that the yellow from the blue light filtering chromophore

A total of 430 patients were evaluated. No significant difference was observed in test results for the patients with the blue-filtering IOL implanted, as compared to eyes implanted with the control UV-absorbing IOL.

Natural chromophore

possesses Chromophore

concentration of AquaFree Yellow is 0.02% which doesn't affect negatively the color perception of the patient. Natural chromophore and its lower concentration provide a

under low light condition.

In the chart you can find the visible transmission spectrum of AquaFree Yellow +20D IOL.

RUMEX Hydrophobic IOL AquaFree Yellow provides better protection of Macula.

SPECTRAL TRANSMITTANCE CURVE OF RUMEX AQUAFREE IOL

The cutoff wavelength of 10% transmission for UV light is 392 nm

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Yellow 4 years old 53 years oldWAVELENGTH (nm)

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Negative pherical berration (SA)Intraocular l

n the human eye is a combination of the positive spherical

RUMEX offers the aspheric intraocular lens with negative spherical aberration so that it offsets all or part of positive SA of the average cornea. This ensures good contrast sensitivity and visual acuity, which is especially crucial in low-contrast environments and dim light conditions.

Figure 1. A: a lens without spherical aberration B: a lens with spherical aberration

In the young eye, the natural lens typically has negative SA and offsets the positive spherical aberration of cornea. An old patient can still have but might have difficulties in the lower contrast conditions (fog, dust). RUMEX aspheric IOL is calculated so that the residual spherical aberration in the eye is adjusted for the

Low glass transition temperature (Tg)

Glass transition temperature is a very important characteristic of the IOL material.

RUMEX IOL material offers the RUMEX IOL acrylic . Because of the very low transition temperature,the RUMEX IOL is soft and easy to inject at room temperature.

Many surgeons prefer RUMEX IOL because of its excellent material behavior. The haptic of the IOL is designed not to transmit any forces to the optic part of the lens. The optic part is free from any stress which contributes to high stability in the capsule bag.

A B

0°C-50°C-100°C 100°C50°C

Silicone Tg < -100°C PMMA Tg > 100°C11°C

RUMEX hydrophobic

acrylic IOL

HYDROPHOBIC IOLs

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RUMEX IOL has a high , compared to some other competitors on the market (fig.2).

Higher Abbe number Lower Abbe number

Figure 2. Abbe number comparison of the IOLs manufactured by different companies on the market

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55

AMOAcrylic

50

RUMEXAquaFree

47

Crystallinelens

42

HoyaAcrylic

42

AMOSilicone

37

AlconAcrylic

Abbe number

Low chromatic aberration

is the failure of a lens to focus all colors to the same point.

Chromatic aberration of IOL material is a significant parameter for image quality and contrast sensitivity.

The is an important parameter for the material quality. A high Abbe number is associated with less chromatic aberration (chromatic dispersion) and better optical performance.

HYDROPHOBIC IOLs

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Cells Lens capsule

PCO

Best- orrected isual cuity (BCVA)

Eight studies were conducted to check the best-corrected visual acuity (fig.3) of the patients with the RUMEX AquaFree IOL implanted.

The data reported demonstrate that all the 344 patients had a BCVA of 20/40 or better, which is a better result compared to the historical control rate of 92.5%, as reported in ISO 11979-7.

Figure 3.

HYDROPHOBIC IOLs

Square edge of RUMEX IOL Square edge of a competitor’s IOL

prevent PCO caused by cellular migration.

Double square- dge

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AQUAFREE YELLOW PRELOADED

Efficient minimal invasive surgery

• RUMEX Hydrophobic IOLs are suitable forincisions as small as 2.2 mm

• The preloaded system represents injection• Now the lens fits more accurately inside the lens box in the cartridge, and it's easier

for the surgeon • injector ensures forceless one-hand injection without capsule

stretching• The and integrated cartridge of the fully single-use system ensure

simple and predictable IOL

1. Add viscoelastic under the plate and into the biggest part of the tip

2. Close the flap and lock in position

3. Inject the lens with one continuous motion until the lens is out.

*RUMEX is an official distributor of Swiss company Medicel in all countries with the exception of theUnited Kingdom, Italy, Ireland and Brazil

HYDROPHOBIC IOLs

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HYDROPHOBIC IOLs

AQUAFREE YELLOW / AQUAFREE YELLOW PRELOADED

Foldable aspheric monofocal one-piece IOLs

AquaFree Yellow Aspheric*

AquaFree Yellow Aspheric Preloaded*

Min. incision size 2.2 mm

Overall diameter 13.0 mm

Optic diameter 6.0 mm

Power rangeD to +9D (1D steps)

+10D to +30D (0.5D steps)

Self-unfolding Yes

Water content <0.5%

Angulation 0°

Material Natural Yellow Hydrophobic Acrylic

Optic design Biconvex, square edgeRefractive index 1.5

Abbe number 50

Nominal A-constant 118.7

Optimized optical constants

Haigis: a0=1.32, a1=0.40, a2=0.10

HofferQ: pACD=5.51

Holl.1: sf=1.75

SRK/T: 118.9

SRK II: 119.2

n: 190

Ref. : [304],[332]

Transition temp. of material 11°CFiltration UV and blue light (400-475 nm)AC-depth 5.51Shelf life 5 years

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• Material (copolymer of hydrophilic and hydrophobic monomers) – high level ofbiocompatibility with a strong matrix, which exhibits excellent folding and unfoldingcharacteristics

• 5° angulation eliminates wrinkles and reduces PCO• Double square edge around entire optic periphery 360° barrier helps to prevent

PCO caused by cellular migration• Co- spheric optic design minimizes glare and unwanted images• IOL’s center thickness is 0.51 mm for 10.0 power

0.80 mm for 20.0 power1.10 mm for 30.0 power

The periphery thickness is 0.25 mm for all powers• Not tacky – a lens does not stick to itself or instruments• No vacuoles or glistening due to the fact that the lenses are lathe cut and not molded.

Molded lenses trap air which will produce vacuoles and glistenings• Finite Element Analysis (FEA) geometry designed to minimize capsular bag stretching• Method of Sterilization: Steam Sterilization at 121 °C

Co-aspheric optic design

Every human cornea has some level of asphericity, some positive and some negative. Some IOLs are intended to correct one or the other with either positive or negative asphericity on one side of the lens. However, this "one size fits all" approach in many cases leaves too little correction or even overcorrection which leaves the eye in a worse condition than before.

Standard non-aspheric IOLs introduce additional sphericalaberrations into the eye. Co-aspheric lenses like RUMEX have

. In this way, the eye is neither over - nor undercorrected but is left in the natural state without any additional aberrations introduced by the lens itself.

RUMEX Hydrophilic IOLs add no spherical aberration

Image with an aspheriс IOL implanted

Image with a non-aspheric IOL implanted

HYDROPHILIC IOLs

RUMEX HYDROPHILIC IOLS

Highly biocompatible hydrophilic material of RUMEX Hydrophilic IOLs with a exhibits . During the

manufacturing process, the lens material is tray-polymerized and then eliminating the occurrence of vacuoles or glistenings. The lathe cutting forms a genuine

a result not possible with injection molding. Bi convex aspheric optic design, extreme square-edge, and high-quality material are the features of the RUMEX Hydrophilic IOLs.

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Best- orrected isual cuity

A study was conducted to check the best-corrected visual acuity (fig. ) of the patients with the RUMEX Hydrophilic IOL implanted.

The data reported for study demonstrate that almost 98% of the 266 patients had a BCVA of 20/40 or better, which is a better result compared to the historical control rate of 92.5%, as reported in ISO 11979-7.

Figure 4.

Better or = 20/40

Worse than 20/40

Totals

RUMEX Hydro-Sense

25997.37%

72.63%

266

Historical controls

389392.47%

3177.53%

4210

Totals 4152 324 4476

UV&blue light blocking

All RUMEX Hydrophilic IOLs contain a filter to block harmful ultra-violet (UV) light.

RUMEX Hydro-Sense Yellow also without blocking essential blue light , providing complete natural protection without losing contrast sensitivity or color perception. This helps to and prevent a common cause of visual loss among older people: age-related macular degeneration.

In charts below you can find the visible transmission spectrum of RUMEX Hydrophilic IOLs +20D.

HYDROPHILIC IOLs

SPECTRAL TRANSMITTANCE CURVE OF RUMEX HYDRO-SENSE IOL

The cutoff wavelength of 10% transmission for UV light is 380 nm.

SPECTRAL TRANSMITTANCE CURVE OF RUMEX HYDRO-SENSE YELLOW IOL

The cutoff wavelength of 10% transmission for UV light is 410 nm.

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HYDRO-4 ASPHERIC, HYDRO-SENSE ASPHERIC, HYDRO-SENSE ASPHERIC YELLOW

Foldable aspheric monofocal one-piece IOLs

Hydro-4 Aspheric*Hydro-Sense

Aspheric*Hydro-Sense

Aspheric Yellow*

Min. incision size 1.8 mm suitable for MICS

2.2 mm

Overall diameter 11 mm 12.5 mm

Optic diameter 6.0 mm

Power range-5D to +9D (1D steps)

+14D to +25D (0.5D steps)+25D to +38D (1D steps)

Self-unfolding Yes

Water content 23.5 – 27.5 %

Angulation 5°

Material Hydrophilic AcrylicNatural Yellow

Hydrophilic Acrylic

Optic design Biconvex, square edgeRefractive index 1.46

Abbe number 55

Nominal A-constant 118.0

Optimized Optical constants

HofferQ: pACD=5.08

Holl.1: sf=1.31

SRK/T: 118.2

SRK II: 118.5

n: 213

Ref. :[341]

Filtration UV UV and blue light

HYDROPHILIC IOLs

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RUMEX International Company14240 Carlson Circle, Building K, Suite 8, Tampa, FL 33626,USA