1. The new Akreos MI 60 lens Joel Pynson, MD - Director Design Engineering Bausch & Lomb, Toulouse - France London, September 9th 2006

2. Akreos material • Hydrophilic acrylic • Made of MMA and HEMA • Hydration rate : 26% • First human implantation : July 1998 • Excellent biocompatibility • Superior optic quality (machining versus molding) • Over 1.5 millions lenses implanted

3. Akreos AO • To improve the PCO rate with a full 360° barrier • To improve the visual results with an aspheric optic • To reduce the incision size from 3.2 mm to 2.8 mm

5. Spherical Aberration Typical Spherical IOL S.A. < 0 “Undercorrected” Proposed Aspherical IOL S.A. = 0 Proposed Aspherical IOL S.A. > 0 “Overcorrected”

6. Advantages • Better optic quality whatever is the pupil diameter • Optic quality not modified by lens decentration • Suitable for any cornea, even cornea with negative spherical aberration

7. Next generation : Akreos MI 60 • Goals : develop a sub 2mm (MICS) IOL without jeopardising the stability of the implant inside the capsular bag. • Design new haptics that are both slender and ensure excellent stability of the implant. • Check the behaviour of the implant experimentally, by using a computer-generated finite element model • Check the behaviour of the implant experimentally, by using the Miyake technique

8. Akreos MI60 haptic design • 4 haptics angled at about 10° • A rigid part near the 360° barrier and forming, together with the lens, a rigid central area • A thinner, external flexible part • A curved terminal part.

9. Akreos MI60 – ANSYS model

10. Akreos MI60 – Carrara model

11. Miyake Test

12. Pilot Clinical Study on Akreos Micro-incision Lens • Single centre, one surgeon, 20 patients • Primary outcome: corneal incision size • Secondary outcomes: • Visual quality: UCVA, BCVA (Logmar chart), • Intracapsular stability: centration vs pupil, anterior-posterior displacement, PCO • Follow up: 12 months

13. Injection technique 1: “cartridge in” • Standard injection technique, 10 patients • Mean incision size: • 2.11mm before implantation (min 2, max 2.3) • 2.22 mm after implantation • Stretch : 0,11 mm • Minimal incision size • Min 2.2 mm

14. 1.25 mm Injection technique 2:“cartridge out” • Wound-assisted technique, 10 patients • ICD = incision diameter, no extra pressure during lens injection => Isobaric injection • Mean incision size • 1,77 mm before injection (min 1,7, max 1,9 ) • 1,86 mm after injection • Stretch : 0,09 mm • Minimal incision size • Min 1,8 mm • Isobaric injection achieved with the Medicel Viscoglide 1.8 system Short learning curve

15. Stability of refraction over time logMAR Visual Acuity • Gain of 6 lines of UCVA (left side) • Good predictability of refractive outcome • Good early post-op BCVA, • Stability of VA at 1 year

16. Lens Stability versus Pupil Left to right: patient 10 at 15 days, 1 month, 3 month , 6 month and 1 year • At 1, 3, 6 month and 1 year, minimal movements were observed. • Y1 : 0.11mm (SD=0.088) • Lens very stable in bag.

17. Posterior Capsule Opacification (n=18) • Retro-illumination pictures were analysed with EPCO 2000 software analysis of 6mm and 3mm central area • EPCO scores at 1-Year in line with what we are used to see with standard lenses.

18. Conclusions • Akreos Micro-incision Lens has demonstrated to be safe and effective after 1-Year follow up • It allows insertion through a 1.8mm incision • Isobaric injection reduces incision trauma • Innovative design provides excellent intracapsular stability at 1 year • Visual acuity is excellent and stable • At 1 year , PCO rates are very low