toric artiflex j.l.güelli.m.o. instituto de microcirugía ocular de barcelona universidad autónoma...
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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
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