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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

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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 %