Transcript Visian ICL User Guidance

Financial Disclosure: Staar Surgical has paid travelling costs to this meeting
INTRODUCTION
Since 2010 Visian ICL (Staar Surgical) can correct mixed astigmatism and
hyperopic astigmatism
This is the first phakic IOL than can correct such
refractive defects through small incision (2.7 mm)
This poster presents the first cases implanted in
the world with > 6 months follow up.
PATIENTS AND METHODS
-Seeking for refractive surgery
INCLUSION CRITERIA
Personal nomogram combining:
-Hyperopia and astigmatism
- Sulcus to sulcus (UBM)
-No general or ocular illness
- ACD (Scheimpflug)
-No familiar hystory of glaucoma
-HWTW (Scheimpflug)
ICL SIZING
-ACD (endoth.-lens): > 2.8 mm ( Scheimpflug image)
-Corneal marks: Slit lamp
SURGERY
-Topical anesthesia (5% lydocaine)
-Subj/Obj cyclo refraction
PREOP STUDY
-Total aberrometry (COAS, Wavefront Sci)
-2.75 mm temporal limbar incision
-Healon™, Acetil coline;
-Scheimpflug tomography (Sirius, CSO; Galilei, Ziemer)
-Corneal Hysteresis (ORA, Reichert)
-Ocular biometry (Lenstar, Haag Streit)
-UBM (Vumax II ,Sonomed)
-YAG iridotomy (x2)
-ICL sph and cy calcs by STAAR
-6 months
FOLLOW UP
-Vault measurent: OCT (RTVue, OptoVue)
RESULTS
AGE
SPH
CYL
AXIS
SPH
CYCLO Sph Eq BCVA
P.
J.
27
OD
4
-3
10
5.5
4
1
P.
J.
27
OS
6.25
-3.75
155
7.5
5.62
1
S.
A.
42
OD
5
-2.5
20
7
5.75
0.45
L.
A.
29
OD
6.75
-4.75
15
7.75
5.37
0.9
L.
A.
29
OS
8.5
-5.75
173
9.5
6.62
0.55
MEDIAN
6.25
-3.75
7.50
5.63
0.90
STD DEV
1.72
1.32
1.44
0.95
0.26
ICL ICL ICL
SURGERY ICL SIZE SPH CYL AXIS
UCVA
BCVA VAULT
SPH
Sph
AXIS Eq
CYL
17/06/2010
12.6
2
4
97
1
1
640
0
0
0
10/06/2010
12.6
4.5
5.5
67
1
1
620
0
0
0
07/06/2010
12.6
5.5
3.5
118
0.45
0.45
600
0.5
-0.5
20 0.25
07/06/2010
12.1
5.5
6
82
0.95
0.95
200
0.5
-0.5
20 0.25
31/05/2010
12.6
3
6
103
0.45
0.50
350
0.5
-1.25 170 -0.12
MEDIAN
4.50 5.50
0.95
0.95
600
0.50 -0.50
0.00
STD DEV
1.56 1.17
0.29
0.28
197
0.27
0.17
0.51
RESULTS
VECTOR ANALYSIS (Alpins method)
CYL AXIS SPH
CYL AXIS
PREOP PREOP PREOP POSTOP POSTOP POSTOP
SPH
TIA
TIA
AXIS
SIA
SIA
AXIS
DV
DV
AXIS
ERROR
MAGNITUDE
ANGLE OF CORRECTIO ADJUSTM.
ERROR
N ANGLE
COEFF.
INDEX
OF
SUCCES
4
-3
10
0
0.01
3
10
2.99
10
0.01
180
-0.01
0
60
1.00
0.00
6.25
-3.75
155
0
0.01
3.75
155
3.74
155
0.01
180
-0.01
0
60
1.00
0.00
5
-2.5
20
0.5
-0.5
20
2.5
20
2.00
20
0.5
20
-0.50
0
80
1.25
0.20
6.75
-4.75
15
0.5
-0.5
20 4.75
15
4.26
14
0.5
20
-0.49
-1
80
1.12
0.11
8.5
-5.75
173
0.5
-1.25
165 5.75
173
4.56
175
1.25
165
-1.19
2
45
1.26
0.22
͊͊
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MEDIAN
3.75
3.74
0.50
-0.49
1.12
0.11
STD DEV
1.32
1.03
0.51
0.48
0.13
0.10
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PREOP / POSTOP
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SIA
SUBJECTIVE VISUAL QUALITY
7
6
0=Very bad
5
1=Bad
4
2=Regular
PREOP
3
POSTOP
All eyes were scored 4
3=Godd
4=Very good
2
1
0
SPH
1
CYCLO
CYL
2
Eq Sph
3
CYCLO
Surgical Incidences: No incidence was reported. Lens manipulation was
undistinguishable from other models (ICH, ICM or TICM)
Postop Incidences: Eye nº 5 had a postop Rx = +1 sph -2.75 cyl x 165º since first
postop day. Misalignment was surgically corrected on Oct 5th
Safety index: (BCVA postop / BCVA preop): 1.00
Efficacy index: (UCVA postop / BCVA preop): 0.99
DISCUSSION
First cases implanted with the new hyperopic toric ICL show an excellent
efficacy / safety balance in 6 months follow up.
Postoperative UCVA was very close to preop BCVA showing a very accurate
sphere and cylinder lens calculation.
There was no difference between BCVA pre and postop. No patient lost VA
lines and all of them were subjectively satisfied with visual quality. No haloes
or other optic secondary effects were reported.
Cartridge loading, intraocular injection, unfolding and sulcus placement
maneouvres were similar to other ICL models
DISCUSSION
The new hyperopic toric (VTICH) ICL corrects
such errors through small incision (2.75 mm)
There are some design differences respect
the old ICH (hyperopic) or TICM (toric myopic) models:
-4 penetrating holes
-2 longer alignment marks
-Stored in BSS:
The available dioptric range is: 0 to +10 (sph) and 0.5 to 6 (cyl)
Optical zone is 5.73 mm for all hyperopic toric ICLs.
CONCLUSSIONS
First experience with the new hyperopic toric (VTICH) ICL is very promising
Refractive correction efficacy is high: Both in terms of Sph. Equivalent and
astigmatism
Safety is very good with no VA impairment or optical side effects
Thank You
[email protected]