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
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

14. 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

15. 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

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