Toric Artiflex J.L.GüellI.M.O. Instituto de Microcirugía Ocular de Barcelona Universidad Autónoma...
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Transcript of Toric Artiflex J.L.GüellI.M.O. Instituto de Microcirugía Ocular de Barcelona Universidad Autónoma...
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