Clinical Outcomes of a Novel Non- Diffractive …...Starbursts Halos Glare) DFT015 (n=106) SN60WF...

$: Clinical Outcomes of a Novel Non- Diffractive …...Starbursts Halos Glare) DFT015 (n=106) SN60WF (n=80) In two large-scale, independent trials, the proportions of patients not at$
AcrySof®IQ Vivity™EXTENDED VISION IOL

1


1TOPIC | MM/DD/YY | FOR INTERNAL BUSINESS USE ONLY

CATHLEEN MCCABE, MD

FINANCIAL DISCLOSURES: CONSULTANT AND INVESTIGATOR FOR ALCON

Clinical Outcomes of a Novel Non-

Diffractive Extended Vision IOL

Holly Garrett


22

EDF IOLS ARE DESIGNED TO PROVIDE CONTINUOUS VISION FROM DISTANCE TO INTERMEDIATE

Functional near

Distance

Intermediate

Continuous vision2

EDF IOL1

EDF, extended depth of focus; IOL, intraocular lens


33| 09/04/19 | FOR INTERNAL BUSINESS USE ONLY

EDF IOLS ARE DESIGNED TO ADDRESS VISION QUALITY ISSUES ASSOCIATED WITH MULTIFOCAL IOLS

Multifocal IOLs are associated with:

Photic phenomena, such as glare and halo1,2

Glare Halo

Reduced contrast sensitivity*2

*Compared with monofocal IOLs



ANSI CRITERIA TO DEFINE EDF IOLS HAVE RECENTLY BEEN DEVELOPED1,2

≥0.5 D greater than monofocal controlDepth of focus

Superior to a monofocalDCIVA

Achieve 0.2 logMAR or better in 50% of eyesDCIVA

Non-inferior to a monofocalBCDVA

There are no criteria regarding visual disturbances for EDF IOLs

ANSI, American National Standards Institute;BCDVA, best-corrected distance visual acuity;DCIVA, distance-corrected intermediate visual acuity




Vivity design intends to provide:

ACRYSOF IQ VIVITY EXTENDED VISION IOL HAS BEEN DESIGNED TO EXCEED THE CRITERIA FOR EDF IOL’S

Preserved mesopic contrast sensitivity

Monofocal visual disturbance profile

An extended range of vision (>1.5 D)

Superior intermediate and near vision, and comparable distance vision to AcrySof® IQ Monofocal IOL

Monofocal visual disturbance profile



THE SURFACE PROFILE OF VIVITY IS RELATIVELY FLAT AND SMOOTH, SIMILAR TO THAT OF A MONOFOCAL IOL

VivityAcrySof® IQ Monofocal VivityAcrySof® IQ Monofocal



Diffractive EDF IOL

VIVITY UTILIZES A NON-DIFFRACTIVE WAVEFRONT-SHAPING TECHNOLOGY TO STRETCH AND SHIFT THE WAVEFRONT

Acrysof IQ (SN60WF) IOLBase Power

AcrySof® IQ Vivity (DFT015) Wavefront-Shaping Technology

Non-Diffractive Wavefront-Shaping

(2.2 mm)

Surface transition 1Slightly elevated smooth plateau (~1 µm) stretches the wavefront resulting in an extended focal range

Surface transition 2Small curvature change shifts the wavefront creating an extended negative focal range

Elevation is 2.5×greater

Diffractive elevated rings contribute to halos



PINHOLE HALO SIMULATIONS



SAFETY AND EFFECTIVENESS OF VIVITY HAS BEEN ASSESSED IN TWO CLINICAL STUDIES

1:1AcrySof® IQ

Monofocal IOL (n=113)

AcrySof® IQ Vivity IOL(n=107)*

Bilateral implantation Follow-upRandomization

US study1

(N=221)

OUS study2

6 months§5:4

AcrySof® IQ Vivity IOL(n=156)†

AcrySof® IQ Monofocal IOL (n=120)‡

(N=282)

6 months

*Vivity was only implanted in first eye of one patient; †Vivity was only implant in first eye of two patients; ‡monofocal was only implanted in first eye of one patient; §an interim analysis was conducted at 3 monthsOUS, Outside United States



ANSI CRITERIA TO DEFINE EDF IOLS HAVE RECENTLY BEEN DEVELOPED 1,2

≥0.5 D greater than monofocal controlDepth of focus

Superior to a monofocalDCIVA

Achieve 0.2 logMAR or better in 50% of eyesDCIVA

Non-inferior to a monofocalBCDVA


ANSI, American National Standards Institute;BCDVA, best-corrected distance visual acuity;DCIVA, distance-corrected intermediate visual acuity

All 4 criteria plus a monofocal visual disturbance profiledemonstrated in 2 large, pivotal trials


11

-0.2

0

0.2

0.4

0.6

0.8

1-2.5-2-1.5-1-0.500.511.5

SN60WF (n=111)

DFT015 (n=106)

Defocus (D)

LogM

AR

01.5 1.0 0.5 -0.5 -1.0 -1.5 -2.01

0.8

0.6

0.4

0.2

0

-0.2

-2.50.0

Defocus (D)

SN60WF (n=106)

DFT015 (n=145) LogM

AR

1.0

0.63

1.6

0.4

0.25

0.16

0.1De

cim

al

1.0

0.63

1.6

0.4

0.25

0.16

0.1

Deci

mal

Bars represent 95% confidence interval *All-implanted analysis set; †best-case analysis set. OUS, outside the US

Data from two large clinical trials showed that DFT015 had a greater negative range of binocular defocus compared with SN60WF at 6 months

US trial* OUS trial†

BINOCULAR DEFOCUS CURVES AT 6 MONTHS DEMONSTRATE CONTINUOUS VISION FROM DISTANCE TO FUNCTIONAL NEAR



VIVITY HAS IMPROVED DISTANCE-CORRECTED AND UNCORRECTED INTERMEDIATE AND NEAR VISUAL ACUITY

US Trial

-0.03

0.05

0.25

-0.07

0.20

0.39

-0.2-0.1

00.10.20.30.40.50.6

Bin

ocu

lar

dis

tan

ce-c

orr

ecte

d

visu

al a

cuit

y (l

og

MA

R)

SN60WF (n=113)

DFT015 (n=106)

BCDVA (4m)

DCIVA (66cm)

DCNVA (40cm)

Vivity provides improved distance-corrected intermediate andnear visual acuity, while maintaining monofocal distance vision

BCDVA, best corrected distance VA, DCIVA, distance corrected intermediate VA, DCNVA, distance corrected near visual acuityUCDVA, uncorrected distance visual acuity; UCIVA, uncorrected intermediate visual acuity; UCNVA, uncorrected near visual acuity

0.04 0.06

0.21

-0.02

0.14

0.34

-0.2

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6UCDVA

(4 m)UCIVA(66 cm)

UCNVA(40 cm)

Bin

ocu

lar

un

corr

ecte

d

visu

al a

cuit

y (l

og

MA

R)

6mo Mean MRSE DFT015 .049 D

SN60WF .081 D


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*Safety-analysis set; †assessed using the QUVID questionnaire; ‡negative dysphotopsia; §percent difference between DFT015 minus SN60WFQUVID, Questionnaire for Visual Disturbance

US trial*†

66.073.6 77.1

88.6 95.3 89.6 90.6

61.8

82.773.0

86.597.3

85.6 80.2

0102030405060708090

100

Starbursts Halos Glare Hazyvision

Doublevision

Dark area Blurredvision

DFT015 (N=106) SN60WF (N=113)

‡

A higher proportion of DFT015 recipients

reported not experiencing blurred

vision compared with SN60WF

recipients (10.4% difference; 95% CI 0.6, 20.1)§

The proportions of DFT015 recipients free of each visual disturbance at 6 months were comparable to those of SN60WF recipients

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No visual disturbance

reported

PATIENTS REPORTING NO VISUAL DISTURBANCES† AT 6 MONTHSPr

opor

tion

of p

atie

nts %


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*Safety-analysis set; †assessed using the QUVID; ‡assessed using the QoVquestionnaire1 OUS, outside the US; QoV, Quality of Vision; QUVID, Questionnaire for Visual Disturbance McAlinden C et al. Invest Ophthalmol Vis Sci 2010;51:5537

OUS trial*‡US trial*†

73.683.0 78.1

71.8

89.175.7

0

20

40

60

80

100

Starbursts Halos Glare

Prop

ortio

n of

pat

ient

s (%

)

DFT015 (n=106) SN60WF (n=113)

72.6 75.5 73.663.8

77.5

57.5

0

20

40

60

80

100

Starbursts Halos GlarePr

opor

tion

of p

atie

nts (

%)

DFT015 (n=106) SN60WF (n=80)

In two large-scale, independent trials, the proportions of patients not at all bothered by starburst, halo, and glare were comparable between the DFT015 and SN60WF groups at 6 months

No bother reported

PATIENTS NOT AT ALL BOTHERED BY STARBURSTS, HALOS, OR GLARE AT 6 MONTHS



MONOCULAR MESOPIC CONTRAST SENSITIVITY COMPARABLE TO MONOFOCAL

OUS Trial

No clinically relevant differences were observed for monocular mesopic contrast sensitivity

*Per ISO 11979-7cpd, cycles per degree

Lo

g c

on

tras

t 1.6

2.0

1.8

1.4

1.2

0.6

0.8

1.0

1.5 3.0 6.0 12.0Spatial frequency (cpd)

Without glare

1.4

2.0

1.8

1.6

1.2

Lo

g c

on

tras

t

0.6

0.8

1.0

1.5 3.0 6.0 12.0Spatial frequency (cpd)

With glare

SN60WF (n=118)DFT015 (n=152)

Clinically meaningful drop in contrast sensitivity*

Clinically meaningful drop in contrast sensitivity*



VIVITY ALLOWS PATIENTS REDUCED SPECTACLE DEPENDENCE AT NEAR AND INTERMEDIATE

US Trial

Patients experienced less spectacle dependence at near and intermediate distances in bright and dim conditions with Vivity

Pat

ient

s “n

ever

/rar

ely”

w

eari

ng s

pect

acle

s (%

)

SN60WF (n=113)DFT015 (n=107)

Data based off results from IOLSAT questionnaire response

46

8794

39

8493

16

58

92

11

53

89

0

20

40

60

80

100

Up close Arm's length Far away Up close Arm's length Far away

Bright light Dim light



PATIENTS REPORTING GOOD/VERY GOOD VISION IN BRIGHT AND DIM LIGHT

US Trial

Vivity maintained enhanced vision quality without spectacles in bright and dim lighting conditions

Pati

en

ts w

ith

“g

oo

d/v

ery

g

oo

d”

vis

ion

wit

ho

ut

sp

ecta

cle

s (

%)

SN60WF (n=113)DFT015 (n=107)

Data based off results from IOLSAT questionnaire response

52

92 94

38

83 88

25

63

92

8

51

78

0

20

40

60

80

100

Up close Arm's length Far away Up close Arm's length Far away

Bright light Dim light



VIVITY ENABLES FLUENT READING AT A RANGE OF FONT SIZES

OUS Trial

0

20

40

60

80

100

120

140

2.5 M 2.0 M 1.6 M 1.25 M 1.0 M

Dis

tanc

e-co

rrec

ted

read

ing

spee

d (w

ords

/min

)

20 pt 16 pt 14 pt 11 pt 8 pt

Font size

With Vivity, patients maintain a fluent reading speed across a wide range of font sizes at intermediate (66 cm)

Fluent reading speed

SN60WF (n=117)

DFT015 (n=151)



CLINICAL DATA SHOW THAT ACRYSOF® IQ VIVITY IS AN EFFECTIVE EDF IOL

Safety and effectiveness of Vivity have been assessed in two randomized, controlled, multicenter clinical studies

Compared to an apheric monofocal, Vivity provides continuous vision, with non-inferior distance, and superior intermediate and near vision*

*Compared with AcrySof® IQ monofocal

Vivity maintains a visual disturbance profile comparable to an aspheric monofocal*

Clinical Outcomes of a Novel Non- Diffractive …...Starbursts Halos Glare) DFT015 (n=106) SN60WF...

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Transcript of Clinical Outcomes of a Novel Non- Diffractive …...Starbursts Halos Glare) DFT015 (n=106) SN60WF...