mics platform - eyetube.net · trifocal optic design, that provides patients with true...
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Carl Zeiss Meditec AGGoeschwitzer Str. 51–5207745 JenaGermany www.meditec.zeiss.com/lisa-triwww.meditec.zeiss.com/contacts
Carl Zeiss Meditec SASAvenue Paul Langevin, BP517053 La Rochelle Cedex 9Francewww.meditec.zeiss.com/iolwww.meditec.zeiss.com/contacts
0297 AT LISA tri 839MP 0459 BLUEMIXS 180 injector
Your local contact:
ArgentinaCarl Zeiss Argentina S.A.Calle Nahuel Huapi 4015 / 25C1430 BCO Buenos AiresArgentinaPhone: +54 11 45 45 66 [email protected]
AustraliaCarl Zeiss Pty LtdTenancy Office 4, Level 1 40-52 Talavera RoadNorth Ryde NSW 2113 AustraliaPhone: +61 2 9020 [email protected]
AustriaCarl Zeiss GmbHLaxenburger Str. 21100 ViennaAustriaPhone: +43 1 79 51 [email protected]
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BrazilCarl Zeiss do Brasil Ltda.Av. Naçoes Unidas, 21711CEP04795-100 São PauloBrazilPhone: +55 11 5693 [email protected]
CanadaCarl Zeiss Canada Ltd.45 Valleybrook DriveToronto, ON M3B 2S6CanadaPhone: +1 800 387 [email protected]
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Czech RepublicCarl Zeiss spol. s.r.o.Radlická 14/3201150 00 Prague 5Czech RepublicPhone: +420 233 101 [email protected]
FranceCarl Zeiss Meditec France SAS60, route de Sartrouville78230 Le PecqFrancePhone: +33 1 34 80 21 [email protected]
GermanyCarl Zeiss Meditec VG mbHCarl-Zeiss-Strasse 2273446 OberkochenGermanyPhone: +49 7364 20 [email protected] Ophthalmology:Phone: +49 800 470 50 [email protected]
Hong KongCarl Zeiss Far East Co. Ltd.Units 11-12. 25/FTower 2, Ever Gain PlazaNo. 88 Container Port RoadKwai ChungHong KongPhone: +852 2332 [email protected]
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NetherlandsCarl Zeiss B.V.Trapezium 300Postbus 3103364 DL SliedrechtNetherlandsPhone: +31 184 43 34 [email protected]
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PolandCarl Zeiss sp. Z o.o.ul. Lopuszanska 3202-220 WarsawPolandPhone: +48 22 858 [email protected]
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United KingdomCarl Zeiss Ltd.509 Coldhams LaneCambridgeCambridgeshire, CB1 3JSUnited KingdomPhone: +44 1223 401 [email protected]
AT LISA tri 839MPClinical Leaflet
MICS Platform
“AT LISA tri offers far better intermediate vision performance to my patients, even in low light conditions, without compromising performance in near and far vision.” 1
The very good refractive outcomes are reflected
in the results of the patient satisfaction evaluation
in study B. The level of satisfaction that patients
reported regarding their vision was rated very good
and good in 92 % of patients for distance vision,
88 % for near vision and 84 % for intermediate
vision.
A high level of patient satisfaction was also
reported in study C. 26 patients were asked to
rate their vision in certain situations. 100 % of the
patients are satisfied or very satisfied with their
vision when watching TV and reading newspapers
and 92 % of the patients with computer distances. Figure 5: Patient satisfaction for distance, intermediate and near vision
(study C), one month post-operative
These preliminary clinical results highlight the advantages of this next generation
trifocal optic design, that provides patients with true multifocality, delivering
excellent intermediate vision without compromising near and distance vision. It is
ideal for patients who are looking for a high level of spectacle independence,
and comfortable vision during computer work.
Conclusion
0%
20%
40%
60%
80%
100%
Computer(intermediate)
Newspaper(near)
TV(distance)
very satisfied or satisfied
acceptable92%
8%
100%100%
Vision
Patient Satisfaction Evaluation
Patient Satisfaction
1 Dominique Piétrini, MD (Paris, France)
Study UDVA CDVA UIVA CIVA UNVA CNVA
A 0.05 ± 0.08 0.01 ± 0.04 0.18 ± 0.16 0.15 ± 0.17 0.16 ± 0.19 0.09 ± 0.09
B 0.12 ± 0.15 0.09 ± 0.12 0.20 ± 0.19 0.20 ± 0.19 0.27 ± 0.16 0.17 ± 0.21
C -0.03 ± 0.08 -0.05 ± 0.07 0.08 ± 0.11 0.07 ± 0.10 0.22 ± 0.12 0.20 ± 0.11
In study C a binocular defocus curve was measured.
The visual acuity is maintained above 0.10 logMAR
(0.80 decimal) within a defocus diopter range of
+1.0 D to -2.5 D. The defocus diopters from -1.0 D
to -2.0 D illustrate the very good intermediate
visual acuity. The defocus curve shows a very clear
transition for patients from near to distance
vision over the complete defocus diopter range,
in contrast to bifocal IOLs.
Figure 2: Binocular best distance uncorrected and corrected visual acuity (mean values)
at distance, intermediate and near (study B).
Contrast SensitivityIn study C, monocular photopic contrast sensitivity
of 60 eyes was measured with best distance
correction after six months. The clinical results
demonstrate that good contrast sensitivity is
maintained within the normal range.
This is achieved due to the higher light energy
transmittance and optimization of the diffractive
ring design.
Figure 4: Contrast sensitivity of AT LISA tri 839MP under photopic
conditions (study C)
AT LISA tri 839MP preloaded
Optic Design Trifocal, diffractive, aspheric (aberration correcting)
Material Hydrophilic acrylic (25 %) with hydrophobic surface
Optic Diameter 6.0 mm
Total Diameter 11.0 mm
Haptic Angulation 0°
Lens Design Single-piece, MICS
Near Addition +3.33 D at the IOL plane
Intermediate Addition +1.66 D at the IOL plane
Incision Size 1.8 mm
Company Labeled A-Constant1
118.6
Diopter Range From 0.0 to +32.0 D, 0.5 D increments
ACD 5.32
Implantation in Bag
Injector BLUEMIXS® 180
1 Please refer to our web pages for optimized A-Constants.
Technical Data
Table 3: Monocular visual acuities for distance, intermediate and near vision in logMAR
* Data on file
logC
S
Spatial Frequency (cpd)
Normal range of healthy phakic patients
Photopic Contrast Sensitivity (n = 60)
Figure 3: Defocus curve (study C)
Defocus Curve (n = 30)
Defocus (D)
Visu
al A
cuity
(log
MA
R)
0.50
0.30
0.20
0.00
0.40
0.10
-0.10
-0.20
1.0 0.5 0.0 -0.5 -1.0 -1.5 -2.0 -2.5 -3.0
Binocular Visual Acuity
Monocular Visual Acuity
Visu
al A
cuity
(log
MA
R)
Visu
al A
cuity
(dec
imal
)
0.00
0.10
0.20
0.30
0.40
0.50
1.00
0.80
0.63
0.50
0.40
0.32uncorrected (n=26) best distance corrected (n=21)
Intermediate NearDistance
0.003 6 12 18
0.50
1.00
1.50
2.00
2.50
Visual Acuity First clinical results for one month post-operative
visual acuity show that the AT LISA tri 839MP
provides very good intermediate visual acuity in
addition to very good far and near vision. The
monocular uncorrected and best distance corrected
near and intermediate visual acuity were measured
at 33 to 40 cm and 66 to 80 cm respectively.
Study A: 60 eyes / 36 patients, German multicentric clinical data collection*
Study B: 86 eyes / 43 patients, European prospective clinical trial*
Study C: 60 eyes / 30 patients, prospective case series, Dr. Peter Mojzis, Czech Republic*
Results from study B show significant improvement
in patients’ visual acuity with binocular
implantation of AT LISA tri 839MP when compared
with the monocular visual acuity results.
Visual acuity was assessed at far, intermediate
and near vision for 25 patients after one month.
The best distance corrected and uncorrected
visual acuity results for near vision at 40 cm were
reported at 0.08 ± 0.20 and 0.18 ± 0.16, and
intermediate visual acuity 0.09 ± 0.16 and 0.09
± 0.16 D respectively (logMAR).
Table 2: Three studies were conducted throughout 2011 and 2012.
AT LISA® tri represents the next generation of ZEISS
multifocal IOLs and is the first trifocal preloaded
true-MICS IOL for real intermediate vision. This new
member of the AT LISA family, based on the proven
AT LISA platform, offers superior intermediate
vision* without compromising distance and near
vision due to an optimized optic design with an
additional dedicated focal point. The near and
intermediate additions of the AT LISA tri 839MP
are +3.33 D and +1.66 D, offering a reading and
intermediate distance of approximately 40 and
80 cm respectively.
Throughout 2011 and 2012, three observational clinical studies (Table 2) were conducted in four European
countries. The interim results comparing one month post-operative data are reviewed in this report.
Introduction
Clinical studies
Study Eyes SE ± SD (D) Sphere ± SD (D) Cylinder ± SD (D)
A 51 +0.10 ± 0.29 +0.22 ± 0.35 -0.24 ± 0.24
B 47 -0.03 ± 0.36 +0.21 ± 0.34 -0.45 ± 0.47
C 60 -0.26 ± 0.42 -0.12 ± 0.40 -0.28 ± 0.28
Refraction Clinical results show that the AT LISA tri 839MP
provides very good post-operative refractive
results (Table 1).
The predictability of the refractive results of the
AT LISA tri 839MP is excellent. In all patients
(100 %) participating in study A, a post-operative
spherical equivalent (SE) of less than 1 D was
measured. In this study, results after one month
reported 88 % of eyes with a SE ± 0.5 D, and
72 % achieved a SE ± 0.25 D.
Table 1: Mean post-operative refraction after 1 month *Data on file.
Figure 1: Percentages of Residual Spherical Equivalents from
51 eyes after 1 month post-operatively (study A)
Post-operative Spherical Equivalents
± 0.75 D
± 0.50 D
± 0.25 D
100 %
88 %
72 %