Clinical Evaluation of the Akreos AO Microincision Lens in a European Multicenter study

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Clinical Evaluation of the Akreos AO
Microincision Lens in a European Multicenter study
San Francisco ASCRS 2009

• Pr. Beatrice Cochener Brest University France

Co-authors Prof T Kohnen, Dr R Bellucci, Dr A
Behndig, Prof J Alió
E Travel and expenses reimbursed by Bausch Lomb
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Study Design

• Multicenter clinical evaluation of the Akreos
  Micro Incision Lens
• Akreos MI60 IOL properties
• aspheric, aberration-free optic
• Implanted through a 1.8mm incision
• using the wound-assisted implantation technique
• 4-point fixation design
• Hydrophilic acrylic material
• 360 barrier and square edge, 10 haptic
  angulation
• 24-month prospective, EC FDA approved, clinical
  investigation
• 125 patients at 5 European sites (France,
  Germany, Italy, Spain,Sweden)
• Post operative evaluation
• Primary Outcomes visual acuity, stability, PCO,
  HOA
• Follow up V1 (Day 1), V2 (Days 7-14) V3 (Days
  30-60) V4 (Days120-180) V5
  (Days 330-420) and V6 (Days 630-780)

Akreos MI60 IOL(Bausch and Lomb)
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Demographic data
Methods and technique

• Topical anesthesia
• Biaxial microincision cataract surgery
• Clear corneal incision in 72 mean size 1.5
  0.29mm
• OVD Amvisc plus in 59, Coatel in 37
• Capsulorhexis from 4 to 6mm, on the optic in
  96 of cases
• Posterior capsule cleaning
• Injection wound assisted technique 1.7 0.2mm
• Implantation (ViscoJect Medicel system 1.8mm
  cartridge)
• Incision hydration
• No stitch in 94.4

• 125 subjects (surgeries between Aug 06 and Oct
  07)
• All the patients achieved the 6-Month follow-up
• Gender 40 male, 60 female
• Mean age 691 years (range 47 84)
• 62 OD, 38 OS
• Cataract graded slight to moderate in 67.2 and
  dense to very dense in 32.8

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Tilt and Decentration
Wavefront Analysis

• Pictures captured using the Scheimpflug system
• Follow-up V2 (Day 7-14) V3 (Days 30-60) V4
  (Days 120-180) and V5 (Days 330-420)
• 2 sites Pr Kohnen and Pr Cochener

• Exported from the Zywave aberrometer
• Measurements V3 (30 60 days) / V4 (120 - 180
  days)
• Calculations for 4 , 5 and 6 mm pupil diameter
• 2 sites Germany and Sweden

• Images at 180 and 90
• Fitting of curves to anterior corneal surface
  and IOL surfaces

• HOA are expressed as
• Zernicke coefficient spherical aberration
• RMS of Zernicke orders 3rd (coma and trefoil),
  4th (SA, secondary astigmatism, quadrafoil) and
  5th orders

L. Lundström and P. Unsbo, Transformation of
Zernike coefficients scaled, translated, and
rotated wavefronts with circular and elliptical
pupils, J. Opt. Soc. Am. A, 24, 569-577 (2007).

• Calculation of tilt and decentration of the IOL
  by the camera software

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Results Incision size

• Lens power implanted 21.2 2.5D (range 15.5 to
  30.0D)
• Wound stretch with implantation 0.10 0.2mm

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Results Manifest Refraction
SE preOp 1-2W 1-2M 4-6M 11-14M
mean -0.62 -0.06 -0.04 0.02 -0.09
SD 2.82 0.87 0.86 0.87
min -9.0 -3.75 -4.0 -4.13 -4.13
max 8.38 2.75 2.50 2.75 2.88
MRSE within 1D 1-2M 4-6M 11-14M
0.01 to 0.99 37 33 32
plano 16 10 10
-0.01 to -0.99 29 35 31
total 82 78 72
preliminary results
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Results UCVA
UCVA Day1 1-2W 1-2M 4-6M 11-14M
20/20 6 38 32 34 18
20/40- 20/21 30 45 42 47 45
Total 36 83 74 81 63
UCVA D1 1-2W 1-2M 4-6M 11-14M
mean 0.43 0.26 0.23 0.23 0.23
SD 0.29 0.25 0.19 0.24 0.24
min -0.2 -0.16 -0.18 -0.18 -0.18
max 1.0 1.0 0.9 1.0 1.0
N 114 104 106 107 88
preliminary results
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Results BCVA
BCVA Pre OP 1-2W 1-2M 4-6M 11-14M
20/20 1 41 59 51 49
20/40- 20/21 28 44 33 45 41
lt20/40 29 85 92 96 90
BCVA Pre OP 1-2W 1-2M 4-6M 11-14M
mean 0.46 0.11 0.04 0.02 0.05
SD 0.24 0.22 0.17 0.14 0.19
min -0.06 -0.2 -0.2 -0.2 -0.2
max 1.0 0,96 0,98 0.50 0.7
N 124 104 105 106 87
preliminary results

• FDA historical control rate at 6 months 92.5

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Results Tilt Decentration
Degrees 1-2W 1-2M 11-14M
N 28 23 31
Mean 1.01 1.20 1.20
SD 0.66 0.88 0.86
mm V2 V3 V5
N 16 14 20
Mean 0.29 0.25 0.31
SD 0.16 0.11 0.20
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Results Wavefront Analysis
No difference between visits
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Results EPCO scores
Full optic 1-2M n80 4-6M n103 11-14M n84
Mean 0.02 0.02 0.08
SD 0.08 0.06 0.16
min 0.0 0.0 0.0
max 0.55 0.41 0.76
3mm 1-2M n80 4-6M n104 11-14M n73
Mean 0.004 0.003 0.023
SD 0.02 0.01 0.08
min 0.0 0.0 0.0
max 0.19 0.10 0.52
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Conclusion

• Akreos MI60 is safe and easily implanted through
  a 1.8mm incision with the wound assisted
  technique
• Good lens stability improved performance
  compared with data published in the literature
• Excellent quality of vision comparable results
  to Akreos AO (Akreos MI60 uses the same
  aspheric, aberration-free optic)
• Less total HOA and SA aberrations compared with
  Akreos AO, indicating the less surgical induced
  corneal aberration due to microincision technique
• ref Johansson B, Sundelin S, Wikberg-Matsson
  A, Unsbo P, Behndig A. Visual and optical
  performance of the Akreos Adapt Advanced Optics
  and Tecnis Z9000 intraocular lenses J Cataract
  Refract Surg 2007331565-1572