Change in Patient-Reported Outcomes and Visual Acuity After Bilateral Implantation of Apodized Diffractive +3.0 IOLs

Stephen Lane, MD

Consultant, Alcon Laboratories, Inc.Alcon sponsored the study and provided statistical and presentation support.

ASCRS 2010

Methods

Purpose To assess changes in patient-reported outcomes (PRO),

satisfaction, and visual acuity (VA) after bilateral implantation of the AcrySof® IQ ReSTOR® +3.0 D IOL in cataract patients

Prospective, multi-center, 6-month trial Twelve U.S. study centers Subjects ≥21 years of age in need of bilateral cataract

surgery Bilateral implantation of IQ ReSTOR® +3.0 D IOL Cataract TyPE at baseline and 6 months post-operatively Results reported for 147 subjects

ASCRS 2010

Assessments Binocular Uncorrected Visual Acuities

100% contrast Early Treatment Diabetic Retinopathy Study (ETDRS) chart under photopic lighting Uncorrected Near VA (UCNVA) at 40 cm Uncorrected Intermediate VA (UCIVA) at 60 cm Uncorrected Distance VA (UCDVA) at 4 m

Cataract TyPE questionnaire Limitations in distance vision function Limitations in near vision function Limitations in social activities Satisfaction with vision Self rating of vision quality

ASCRS 2010

Uncorrected Near Visual AcuityHorizontal line across the center of each diamond = group mean. Vertical span

of each diamond = 95% confidence intervals around the group mean

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

LogM

AR

Visit 0 UCNVA Visit 6M UCNVA

Label

log

MA

R

Preop 6 months

p<.0001

20/40

20/20

Statistically significant improvement in Near VA from preop baseline.

20/25

20/32

20/50

20/80

20/60

ASCRS 2010

Uncorrected Intermediate Visual Acuity

p<.0001

log

MA

R

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

Log

MA

R A

djus

ted

Visit 0 UCIVA Visit 6M UCIVA

Label

Statistically significant improvement in Intermediate VA from preop baseline.

6 months

p<.0001

log

MA

R

Preop

20/20

20/25

20/40

20/32

20/50

20/80

20/60

ASCRS 2010

Uncorrected Distance Visual Acuity

-0.1

0

0.1

0.2

0.3

0.4

0.5

0.6

0.7

0.8

0.9

LogM

AR

Visit 0 UCDVA Visit 6M UCDVA

Label

log

MA

R

Preop 6 months

p<.0001

20/40

20/20

20/25

20/32

20/50Statistically significant improvement in Distance VA from preop baseline.

20/60

ASCRS 2010

Limitations in Distance Vision

Assessed limitations associated with: usual daily activities, recognizing people or objects across the street, daytime & nighttime driving, reading street or freeway signs, watching television, walking up or down stairs.

0

1

2

3

4

PreopWithout Glasses

PreopWith Glasses

PostopWithout Glasses

Lim

itatio

n S

cale

(0-

4)

Statistically significant less limitations in distance vision activities.

p<.0001

None

Extreme

PreopWithout Glasses

PreopWith Glasses

6 monthsWithout Glasses

Lim

itat

ion

Sca

le (

0-4)

ASCRS 2010

Limitations in Near Vision Function

Assessed limitations associated with activities such as: reading a magazine, doing crafts or hobbies (sewing, painting), reading labels or prices, depth perception (pouring coffee, hitting a golf ball, or parking a car), and shaving or putting on makeup.

0

1

2

3

4

DAT

A

LNV V0 WOG LNV V0 WG LNV V6M WOG

LABELPreop

Without GlassesPreop

With Glasses6 months

Without Glasses

Lim

itat

ion

Sca

le (

0-4)

p<.0001

None

Extreme

Statistically significant less limitations in near vision activities.

ASCRS 2010

Limitations in Social Function

Assessed limitations in social activities such as: going out to dinner, going to the movies, visiting with friends or relatives, going to party or dance, going to sporting events or church.

0

1

2

3

4

DAT

A

LSA V0 WOG LSA V0 WG LSA V6M WOG

LABEL

Lim

itat

ion

Sca

le (

0-4)

PreopWithout Glasses

PreopWith Glasses

6 monthsWithout Glasses

None

Extreme

Statistically significant less patient reported limitations in social activities.

p<.0001

ASCRS 2010

Overall Satisfaction with Vision

0

1

2

3

4S

AT

ISF

AC

TIO

N

SC

AL

E

VIS

IT 0

OV

ER

AL

L W

OG

VIS

IT 0

OV

ER

AL

L W

G

VIS

IT 6

M

OV

ER

AL

L W

OG

CLASS

PreopWithout Glasses

PreopWith Glasses

6 monthsWithout Glasses

Sa

tis

fac

tio

n S

cale

(0

-4)

p<.0001

Statistically significant improvement in overall satisfaction from preop baseline.

Not Satisfied

Completely Satisfied

ASCRS 2010

Self-rating of vision quality

0

1

2

3

4

5

6

7

8

9

10

SE

LF

-RA

TIN

G

OF

VIS

ION

VIS

IT 0

SR

V W

OG

VIS

IT 0

SR

V W

G

VIS

IT 6

M

SR

V W

OG

Class

PreopWithout Glasses

PreopWith Glasses

6 monthsWithout Glasses

Se

lf-R

atin

g o

f V

isio

n

(0-1

0)

p<.0001Best

Worst

Statistically significant higher self-rating of uncorrected vision quality compared with preop baseline.

ASCRS 2010

Conclusions

Statistically significant improvements observed for patients with bilateral AcrySof IQ ReSTOR +3.0 D Add IOL at 6 months compared with preoperative visit:

improved near, intermediate, and distance VA less limitations in distance vision activities less limitations in near vision activities less limitations in social activities greater overall satisfaction with vision higher self-rating of vision