Ref : Med 2010-ppt-01 Why a new Iol ? To integrate latest surgeons' requirements in terms of : Asphericity Protection against maculopathies Perfect and

Ref : Med 2010-ppt-01

Why a new Iol ?

To integrate latest surgeons' requirements in terms of :

• Asphericity • Protection against maculopathies

• Perfect and stable axial positioning

• Low PCO rate

• Ease of handling and injection through small incision


In more details...

Bi-Flex has been developed taking into considerations that it should offer :

• An improved vision quality whilst retaining an excellent depth of field

• The potential to opt for the natural yellow filter and thus respect the natural evolution of the crystalline lens

• An adequate design to guarantee an implant centred with stable axial positioning immediately after surgery

• An easy handling and injection whatever the surgical programme used (including operations where small-size incisions are used)

• A pertinent material for total biocompatibility with the ocular tissues and with greatly reduced post-operative inflammation rates.


What are the results?

An intra-ocular lens with all the necessary qualities

With : For :

• Aspheric lenses• Limiting optical aberrations (spherical, coma, chromatic) and improvement of the visual comfort of patients

• Access to a “natural” yellow filter which reduces the transmission of wavelengths of less than 500nm

• Prevention against the toxicity of blue light without alteration of colour vision

• Optimised design• optimal stability and better refractive predictability

• Combination of hydrophobic and hydrophilic monomers

• A high biocompatibility, a low PCO rate and a perfect pseudoplasticity enabling injections through small incision


The

Bi-FLEX 677 AB Bi-FLEX 677 ABY


4 major assets for

1. Adapted design for optimised mechanical behaviour and optical quality

2. A material recognised throughout the profession

3. A “natural” yellow filter for better protection of the macula

against the blue light

4. Aspheric implants to limit optical aberrations and improve the visual

comfort of patients


Asset N°1 Adapted design for optimised mechanical behaviour and optical quality

With: • A design suitable to standard surgical techniques

(co-axial, bi-axial, micro-axial, etc.) enabling insertion through incisions of less than 2.2 mm, with no risk of tearing.

• Excellent haptic compressibility to ensure a perfect adaptability to the size of the bag

• An aspheric optical design for implants immune to the usual defects in positioning such as decentration or tilting.




Zoom on design

The designs guaranteed by the Medicontur expertise and by its 20 years of experience : the design combines all the qualities of monobloc implants with those of 3-piece implants for:

• Excellent stability

• Optimised symphysis

• Very limited capsular retraction

• Complete ease-of-use


Zoom on the design

In detail:

• A square edge over 360° for effective control of the development of PCO.

• A real 6 mm optic size

• Flat implant but with a posterior vaulting

• Perfect contact zone with the capsulefor a stable implant in the plane and excellent refractive results.


Zoom on the Bi-Flex design

In detail: (continuation)

• Discontinuities on the optical diameter for Bi-Flex, positioned at 90°to each other to stabilise the optic, fix the implant against the capsule and have better control of post-operative rotation.

• An optimised elbow-shaped bend for Bi-Flex, with a wide loop connection and a wider space (Dolphin zone) for increased stability, optimal flexion without overlap of the end of the loop on the optic and perfect symphysis with reduced risk of capsular retraction.

• Blunt loop ends for Bi-Flex for trauma-free insertion of the implant.


Zoom on design history

• Comparison with the ACR6DSE

• Comparison with IDEA


Note the approx. 60°contact angle and the decentralised IOL in the lower right.

ACR6D-SE Corneal design in a flexible ring

Near the tip of the loop there is an area of no contact.


63° contact angle with simulation of rigid capsular sac of 9.0 mm diameter.

Note that only the central part of the loops rests on the capsular equator.

ACR6D-SE Corneal design in a rigid ring


74°contact angle with simulation of rigid capsular sac of 9.0 mm diameter.

Note the good contact (homogeneous) of the loops with the capsular equator for their entire length.

Xcelens IDEA design in a rigid ring


Bi-FLEX

Bi-Flex design in a rigid ring

91°contact angle with simulation of rigid capsular sac of 9.0 mm diameter.

Note the good contact (homogeneous) of the loops with the capsular equator for their entire length.

In total Bi-Flex has more than 180°contact angle with the capsular

bag.


Bi-FLEX

Bi-FLEX IDEA

versus IDEA: in a flexible capsular bag simulation


The square-edges of the Flex range are

perfectly sharp thanks to a new

technology : the polish free method.

Square edges ACR6D-SE

versus ACR6D-SE: comparison SE


Ultimate stability

Perfect and stable axial

positioning



The Bi-Flex range is compatible with the MedJet injection system for

incision sizes 2.2 mm and sub 2.0 mm


Asset n°2

A material recognised throughout the profession :

the 25% Hydrophobic/Hydrophilic material


Asset N°2 A material recognised throughout the profession : the 25% Hydrophobic/Hydrophilic material

To note:

• Copolymer material (25%) combining hydrophobic and hydrophilic monomers for additional properties.

• Excellent pseudo-elasticity for the implants, due to the hydrophobic monomers.

• Post-operative inflammation rate greatly reduced due to the hydrophilic monomers.

• Implants totally compatible with the ocular tissues.


What is the winning combination?

• 2-HEMA : 2-hydroxyethyl methalycrate

A hydrophilic monomer

• EOEMA : 2-ethoxyethyl methalycrate

A hydrophobic monomer

To form a copolymer with: • Lower water content• Higher refractive index• Improved mechanical properties.

For improved mechanical properties : • superior pre-insertion folding capacities• post-insertion unfolding and optical properties perfect recovery.


Medicontur foldable raw material : a combination of two monomers

- HEMA, highly hydrophilic monomer

Pure HEMA = 38% water content

• BIOCOMPATIBILITY

- EOEMA, hydrophobic monomer

Approximately 2% water content

•ELASTICAL PROPERTIES

•SOFTNESS

Ratio EOEMA - HEMA

EOEMA

36%

HEMA

64%

25% water content after combination of the two monomers, to form an highly biocompatible polymer

Mixing hydrophily and hydrophoby


MMAMethylmetacrylate

RAYNERB&L

CORNEAL

HEMAHydroxyethylmetacrylate

Rare IOLs in pure HEMAPALMLENS (CORNEAL) EOEMA

Etoxyethylmetacrylate

Flex range lens

The Flex range raw material specificity : the longest chain

Comparison with other polymers : focus on the molecular scale


Apart from design, chain length has a proven effect against cell adhesion :

Hydrogel MMA 26% Bi-Flex, Q-Flex, Z-Flex material

Anti-PCO behaviour

A long chain acts as a « molecular eyelash »to prevent cell adhesion and protein deposit

Our raw material : low adhesion for a low PCO rate


A long chain of medium hydrophily :an essential specification for mini & micro cataract surgery

pHEMA Hydrogel MMA 26% Bi-Flex material

• Lower risk of tears with the Flex range than with HEMA thanks to a reduced hydrophily and the tensile strength of hydrophobic monomers

• Much softer elasticity properties of the Flex range, 3 times better than MMA26% material

Bi-Flex, Z-Flex & Q-Flex ’lens raw material : perfect for any kind of incision

Soft and re-arrangeable innovative matrix


What are the properties of the IOLs conferred by this material?

Folding and Unfolding Good to Excellent

Memory Excellent

Biocompatibility Excellent

Average visual acuity Good to excellent, with no inflammation

Dislocation None (no cases reported)

Opacification None (no cases reported)

Incidence of PCO Very Low

Yag laser compatibility Excellent


Asset n°3

A “natural” yellow filter for better protection

of the macula against the blue light


Asset N°3 A “natural” yellow filter for better protection of the macula against blue light

For:

• Increasing the protection of the macula

the defence mechanisms of which change with age

• Compensating the disappearance of the yellow pigment

which has developed in the lens over the years, and which reinforces the protection

of the retina against photo-toxic short waves.

• Totally preserving colour vision and excellent contrast perception

because the filtration does not interfere with the chromatic sensitivity of the retina.


Zoom on the compensation of the disappearance of the yellow pigment

1. The natural crystalline lens is replaced>> The “natural” yellow filter barrier disappears

2. The macula does not benefit anymore from the “natural” yellow filter barrier.Macula’s defense mechanisms are also altered with age.>> It is dangerously exposed to blue light.

That is why Bi-FLEX 677 ABY, Q-FLEX 640 ABY, Z-FLEX 690 ABY

include a protective filter adapted to these wave lengths.


Nature’s own solutions are the best…

Why our Medicontur yellow filter is said to be “natural”?

Because our material integrates the same UV-A blocking and violet light

filtering chromophore that is in the human crystalline lens

Why is Medicontur natural yellow filter superior?

Because it protects the retina without blocking the required blue light.

Medicontur natural yellow filter provides complete natural protection without

making the retina losing its contrast sensitivity or colour perception.


Conclusion on Yellow natural filter

The Medicontur’s approach aiming at protecting the retina from UV-A and

violet light is based upon nature’s own solutions.

Medicontur IOL material thus integrates the same UV-A blocking and violet

light filtering chromophore that is in the human crystalline lens.

The Medicontur natural Yellow filter is superior to any other yellow IOL

material because it protects the retina without blocking the required blue

light. It provided complete natural protection without making the retina

loosing its contrast sensitivity or colour perception.


Asset n°4

Aspheric implants to limit optical aberrations and

improve the visual comfort of patients


Asset N°4 Aspheric implants to limit optical aberrations and improve the visual comfort of patients

With:

• A neutral asphericity approach, which constitutes the best choice in case of unknown individual corneal aberration

• The retention of the natural physiological aberrations of the cornea, mainly sphericity, to provide the patient with good quality vision and depth of field.

• The recognition of the physiological ocular asymmetries (kappa angle) in the design of FLEX lenses to minimise the astigmatism and coma aberrations.


What is an aberration?

An aberration is an optical limitation that reduces image quality.

It usually results in a local or global blur.It can also produce distortion or color trouble.

There are 3 main aberration types:

• Chromatic aberration

• Coma aberration

• Spherical aberration


The image of a point is a circular spot with annular separated colors :yellow, red and blue

Chromatic aberration


Coma aberration

The image of a point is a comet-like spot :the image is blurry, particularly at the comet tail.The more tilted the lens is, the more aberrated


Spherical aberration

The image of a point is a circular spot : the image is blurry.The more the power is or the bigger the pupil is, the more aberrated.


+-No SA

or slighly +

This compensation effect of the crystalline lens has been fully described in literature [9]

++ SA ++ Increased spherical aberrations

PHAKIC EYE : COMPENSATION EFFECT

PSEUDOPHAKIC EYE with SPHERICAL IOL :


NEUTRAL CORRECTING

PROSGood depth of field

Not sensitive to tilt and decentration

Sharp image

CONS Less precise image qualityNo depth of field

Sensitive to tilt and decentration

OUR APPROACH

No spherical aberration Spherical aberration

CORRECTING IOLNEUTRAL IOL

+

0

+

-

+

CURRENT ASPHERIC IOLS : 2 major approaches


Why to chose a neutral asphericity?

Because :

1. The human eyes are naturally asymmetrical >> there is a benefit to have a lens not sensitive to tilt and decentration

2. Bi-Flex specific designs are optimized >> to minimize coma and astigmatism aberrations

3. While preserving natural and physiological spherical aberrations of the cornea >> to improve depth of field.


The optical result in the eye

With

the image on the retina is the sharpest possible created by a single lens – not contributing to any pre-existing spherical aberration in the eye.

• Flex IOLs

• Spherical

• Flex IOLs

• Spherical


THE MEDICONTUR FUTURE

Documents

Ref : Med 2010-ppt-01 Why a new Iol ? To integrate latest surgeons' requirements in terms of : Asphericity Protection against maculopathies Perfect and