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

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

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

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

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

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

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.

Akreos MI60 – ANSYS model

Akreos MI60 – Carrara model

Miyake Test

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

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 P=0,001 (Man Whitney test) IN OUT Before injection 2,11 mm (0,08) 1,77 mm (0,07) After IOL implantation 2,22 mm (0,04) 1,86 mm (0,07) Stretch stretch=0,11 (0,06) stretch=0,09 (0,06) Wilcoxon test p=0,008 p=0,007

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 1.25 mm Short learning curve

Stability of refraction over time logMAR Visual Acuity Stability of refraction over time REF preOp D15 M1 M3 M6 M12 mean -1,09 -0,61 -0,5 -0,45 -0,4 SD 2,37 0,59 0,6 0,54 0,56 0,62 N 20 19 18 min -7,5 -2 -1,75 max 2,75 0,5 0,75 Gain of 6 lines of UCVA (left side) Good predictability of refractive outcome Good early post-op BCVA, Stability of VA at 1 year

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.

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.

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