2. 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

3. 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. 3

4. 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

5. The
Bi-FLEX 677 AB
Bi-FLEX 677 ABY

6. 4 major assets for
Adapted design for optimised mechanical behaviour and optical quality
A material recognised throughout the profession
A “natural” yellow filter for better protection of the macula against the blue light
Aspheric implants to limit optical aberrations and improve the visual comfort of patients 6

7. 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. 7

10. 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 10

11. 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 capsule for a stable implant in the plane and excellent refractive results. 11

12. 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. 12

13. Zoom on design history Comparison with the ACR6DSE
Comparison with IDEA 13

14. ACR6D-SE Corneal design in a flexible ring
Note the approx. 60°contact angle and the decentralised IOL in the lower right.
Near the tip of the loop there is an area of no contact.

15. ACR6D-SE Corneal design in a rigid ring
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.

16. Xcelens IDEA 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.

17. 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.

18. versus IDEA: in a flexible capsular bag simulation
Bi-FLEX
versus IDEA: in a flexible capsular bag simulation
Bi-FLEX
IDEA

19. versus ACR6D-SE: comparison SE
The square-edges of the Flex range are perfectly sharp thanks to a new technology : the polish free method.
Square edges ACR6D-SE

20. Ultimate stability
Perfect and stable axial
positioning

22. The Bi-Flex range is compatible with the MedJet injection system for
incision sizes 2.2 mm and sub 2.0 mm

23. Asset n°2
A material recognised throughout the profession : the 25% Hydrophobic/Hydrophilic material

24. 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. 24

25. 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. 25

26. Mixing hydrophily and hydrophoby
25% water content after combination of the two monomers, to form an highly biocompatible polymer
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
EOEMA
36%
HEMA
64%

27. Hydroxyethylmetacrylate Etoxyethylmetacrylate
Comparison with other polymers : focus on the molecular scale
MMA
Methylmetacrylate
RAYNER
B&L
CORNEAL
HEMA
Hydroxyethylmetacrylate
Rare IOLs in pure HEMA
PALMLENS (CORNEAL)
EOEMA
Etoxyethylmetacrylate
Flex range lens
The Flex range raw material specificity : the longest chain

28. 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
Apart from design, chain length has a proven effect against cell adhesion :
Hydrogel MMA 26%
Bi-Flex, Q-Flex, Z-Flex material

29. Soft and re-arrangeable innovative matrix
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

30. What are the properties of the IOLs conferred by this material?
Folding and Unfolding
Good to Excellent
Memory
Excellent
Biocompatibility
Average visual acuity
Good to excellent, with no inflammation
Dislocation
None (no cases reported)
Opacification
Incidence of PCO
Very Low
Yag laser compatibility 30

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

32. Asset N°3 A “natural” yellow filter for better protection of the macula against blue light
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. 32

33. 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. 33

34. 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. 34

35. 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.

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

37. 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. 37

38. There are 3 main aberration types:
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 38

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

40. 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

41. 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.

42. - + + PHAKIC EYE : COMPENSATION EFFECT No SA or slighly +
This compensation effect of the crystalline lens has been fully described in literature [9]
PSEUDOPHAKIC EYE with SPHERICAL IOL :
++ SA +
Increased spherical aberrations

43. + - CURRENT ASPHERIC IOLS : 2 major approaches CORRECTING IOL
NEUTRAL IOL + -
Spherical aberration
No spherical aberration
NEUTRAL
CORRECTING
PROS
Good depth of field
Not sensitive to tilt and decentration
Sharp image
CONS
Less precise image quality
No depth of field
Sensitive to tilt and decentration
OUR APPROACH

44. 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. 44

45. • Flex IOLs • Spherical • Flex IOLs • Spherical
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 45

46. THE MEDICONTUR FUTURE 46