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]

BelgiumCarl Zeiss NV-SAIkaroslaan 491930 ZaventemBelgiumPhone: +32 2 719 39 [email protected]

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]

ChinaCarl Zeiss Shanghai Co. Ltd.1/f., Ke Yuan Building11 Ri Yin Nan RoadWaigaoqiao Free Trade Zone2005 Yang Gao Bei RoadShanghai 200131ChinaPhone: +86 21 5048 17 [email protected]

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]

IndiaCarl Zeiss India Pvt. Ltd.Plot No.3, Jigan Link RoadBommasandra Industrial AreaBangalore 560 099IndiaPhone: +91 80 4343 [email protected]

ItalyCarl Zeiss S.p.A.Viale delle Industrie 2020020 Arese (Milan)ItalyPhone: +39 02 93773 [email protected]

MalaysiaCarl Zeiss Sdn Bhd.Lot2, Jalan 243/51 A46100 Petaling JayaSelangor Darul EhsanMalaysiaPhone: +60 3 7877 50 [email protected]

MexicoCarl Zeiss de México S.A. de C.V.Avenida Miguel Angel de Quevedo 49604010 Mexico CityMexicoPhone: +52 55 59 99 [email protected]

NetherlandsCarl Zeiss B.V.Trapezium 300Postbus 3103364 DL SliedrechtNetherlandsPhone: +31 184 43 34 [email protected]

New ZealandCarl Zeiss NZ Ltd15B Paramount DriveP.O. Box 121 - 1001Henderson, Auckland 0650New ZealandPhone: +64 9 838 [email protected]

PolandCarl Zeiss sp. Z o.o.ul. Lopuszanska 3202-220 WarsawPolandPhone: +48 22 858 [email protected]

SingaporeCarl Zeiss Ptd. Ltd.50 Kaki Bukit PlaceSingapore 415926SingaporePhone: +65 6741 [email protected]

South AfricaCarl Zeiss (Pty.) Ltd.363 Oak AvenueFerndaleRandburg 2194South AfricaPhone: +27 11 886 [email protected]

South KoreaCarl Zeiss Co. Ltd.Seoul 121-828Mapo-gu141-1, Sangsu-dong2F, BR Elitel Bldg.South KoreaPhone: +82 2 3140 [email protected]

SpainCarl Zeiss Meditec Iberia S.A.Ronda de Poniente, 15Tres Cantos28760 MadridSpainPhone: +34 91 203 37 [email protected]

SwedenCarl Zeiss ABTegeluddsvaegen 7610254 StockholmSwedenPhone: +46 84 59 25 [email protected]

SwitzerlandCarl Zeiss AGFeldbachstrasse 818714 FeldbachSwitzerlandPhone: +41 55 254 [email protected]

ThailandCarl Zeiss Thailand90 CyberWorld Tower A, 36th Floor, Unit A 3601230 Ratchadapisek RoadHuaykwang, Bangkok 10310ThailandPhone: +66 2 248 [email protected]

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 %

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