Toric Artiflex

J.L.Güell

I.M.O.Instituto de Microcirugía Ocular de Barcelona

Universidad Autónoma de BarcelonaUniversidad de Lugano

ESCRS Vienna 2011

3.5mm 4.9mm

2.8mm

4.8mm

main advantages of the Artisan-Artiflex concept:

A

C

B

D

E

ARTIFLEX® Toric PIOL

Clinical results of the European

Multicenter Study

February 2010

Lens specifications

ARTIFLEX® Toric

Overall Ø 8.5 mm

Body Ø 6.0 mm

Optical zone Ø 5.5 mm

Body material Polysiloxane

Haptic width 3.0 mm

Haptic material PMMA

Adhesive Loctite®

Power range (D)

Cylinder Sphere

-1.0 -1.0 to -13.5

-1.5 -1.0 to -13.0

-2.0 -1.0 to -12.5

-2.5 -1.0 to -12.0

-3.0 -1.0 to -11.5

-3.5 -1.0 to -11.0

-4.0 -1.0 to -10.5

-4.5 -1.0 to -10.0

-5.0 -1.0 to -9.5

Cylinders available at 0° and 90°

Study design

•125 eyes•7 investigators

- Camille Budo - Michiel Luger

- Antonio Marinho - Ben Christiaans

- Burkhard Dick - Jose Güell

- Rudy Nuijts•6 months follow-up

Primary study objective:Study the performance of the ARTIFLEX toric PIOL and establish the mechanical properties of the lens in the anterior chamber.

Efficacy

Pre-op BSCVA ≥ 1.0 : 67.5%6 months post-op UCVA ≥ 1.0: 63.6%

Pre-op BSCVA vs. post-op UCVA

0%

10%

20%

30%

40%

50%

60%

0.2 0.4 0.5 0.63 0.8 1 1.2 1.6

Snellen Visual Acuity (decimals)

Ey

es

(%

)

BSCVA Pre-op (n=120)

UCVA Day 1 (n=117)

UCVA Week 1 (n=118)

UCVA Month 1 (n=110)

UCVA Month 3 (n=103)

UCVA Month 6 (n=107)

Deviation from emmetropia

£ 0.5 D: 93.2%

£ 1.0 D: 100%

0%

10%

20%

30%

40%

50%

60%

0 =0.5 =1.0 =2.0 >2.0

Deviation of SE from emmetropia (D)

Ey

es

(%

)

Month 1 (n=110)

Month 3 (n=102)

Month 6 (n=104)

Intended vs. achieved refraction

6 months follow-up, n=104

£ 0.5 D: 81.7%£ 1.0 D: 99.0%

y = 0.0052x2 + 1.11x + 0.6071

-15

-12

-9

-6

-3

0

-15 -12 -9 -6 -3 0

Intended Spherical Equivalent (D)

Ac

hie

ve

d S

ph

eri

ca

l Eq

uiv

ale

nt

(D)

Absolute cylinder reduction

6 months follow-up, n=104

0.36

2.24

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

Pre-op 6 months

Ab

so

lute

cy

lind

er

(D)

Induced astigmatism – vector analysis

5.0

4.0

3.0

2.0

1.0

0.0

1.0

2.0

3.0

4.0

5.0

5.0 4.0 3.0 2.0 1.0 0.0 1.0 2.0 3.0 4.0 5.0

Preoperative (n=120)

6 Months postoperative (n=104)

Preoperative (mean)

Postoperative (mean)

Stability

Spherical equivalent over time

Manifest subjective refraction

-0.06-0.10-0.13-0.16-0.01

-7.58

-12

-8

-4

0

4

Pre-op(n=120)

1 day(n=29)

1 week(n=115)

1 month(n=110)

3 months(n=102)

6 months(n=104)

Re

fra

cti

on

SE

(D

)

Efficacy and safety index

1m 3m 6m

Efficacy indexUCVA post / BCVA pre

0.99 1.02 1.03

1m 3m 6m

Safety indexBCVA post / BCVA pre

1.11 1.14 1.13

Complications

1d 1w 1m 3m 6m

n 120 120 120 119 114

Glare 1.7% 6.7% 14.2% 5.0% 9.6%

Halos 0.8% 8.3% 11.7% 10.1% 4.4%

Pigment 0.8% 5.8% 12.5% 12.6% 15.8%

Non-pigment 1.7% 4.2% 10.0% 12.6% 12.3%

Synechia 0% 0% 1.7% 2.5% 4.4%

Oval pupil 0.8% 0.8% 0% 0.8% 2.6%

Raised IOP 0% 4.2% 1.7% 0% 0%

SSI 0% 0% 0.8% 0% 0%

Other 2.5% 3.3% 1.7% 6.1% 1.8%

IOP

17.115.315.0 16.415.2 14.5

0

5

10

15

20

25

Pre-op(n=120)

1 day(n=112)

1 week(n=116)

1 month(n=109)

3 months(n=102)

6 months(n=104)

IOP

(m

mH

g)

Pre-op vs. post-op IOP

Endothelial Cell Count

Pre-op 3 months 6 months

1500

2000

2500

3000

3500

4000

En

do

thel

ial c

ell c

ou

nt

(cel

ls/m

m2)

n=92 n=85n=120

Comparison and outliers ECC

Pre-op vs. post-op

Contrast sensitivity

1,041,12

1,69

1,90

1,52

1,881,73

1,57

0,40

0,60

0,80

1,00

1,20

1,40

1,60

1,80

2,00

2,20

A (3cpd) B (6cpd) C (12cpd) D (18cpd)

Ph

oto

pic

co

ntr

ast

sen

siti

vity

(lo

g)

Population norm 20-55 y

Population norm 20-55 y

Pre-op (n=45)

3 months post-op (n=29)

Spatial Frequency (cycles/degree)

Preoperative and 3 months postoperative CS

forme frustre KC, high myopic astigmatism

postkeratoplasty hyperopic astigmatism