LONG TERM LONG TERM OUTCOMES OF OUTCOMES OF

RESTOR IOL RESTOR IOL IMPLANTATIONIMPLANTATION

Lori Dao, Orkun Muftuoglu, V. Vinod Lori Dao, Orkun Muftuoglu, V. Vinod Mootha, Steven M. Verity, R. Wayne Mootha, Steven M. Verity, R. Wayne

Bowman, H. Dwight Cavanagh, James Bowman, H. Dwight Cavanagh, James P. McCulleyP. McCulley

University of Texas Southwestern Medical CenterDepartment of Ophthalmology

Dallas, Texas

Drs. Bowman, Verity, and McCulley receive consultant reimbursement from Alcon.Dr. Cavanagh receives research reimbursements from Ciba and Menion.None of the authors have financial interest in the subject matter of this poster.Supported in part by an unrestricted research grant from Research to Prevent Blindness, Inc., New York, New York.

INTRINTROODUCTIONDUCTION Multifocal IOLs were introduced to restore the distance and Multifocal IOLs were introduced to restore the distance and

near without any correction.near without any correction. Early models provided limited near correction and/or often Early models provided limited near correction and/or often

related with glare and halosrelated with glare and halos Recent models are reported to provide more powerful near Recent models are reported to provide more powerful near

correction with less unwanted visual phenomena. correction with less unwanted visual phenomena.

The AcrySof apodized diffractive IOL (Alcon Laboratories Inc., The AcrySof apodized diffractive IOL (Alcon Laboratories Inc., Fort Worth, Texas) Fort Worth, Texas) GGoodood biocompatability with high refractive index biocompatability with high refractive index, , FlexibilityFlexibility The diffractive steps gradually reduce in height and spacing The diffractive steps gradually reduce in height and spacing

from the lens center to the edge from the lens center to the edge Add power of +4.0 Diopters (D).Add power of +4.0 Diopters (D).

PURPOSEPURPOSE

To evaluate To evaluate the long-term the long-term visual visual and refractive outcomes of and refractive outcomes of

apodized diffractive apodized diffractive multifocal multifocal IOL (Restor) implantation.IOL (Restor) implantation.

METHODSMETHODS Retrospective Retrospective

IRB approval UT Southwestern Medical Center IRB approval UT Southwestern Medical Center Declaration of Helsinki guidelines for Declaration of Helsinki guidelines for HIPAA HIPAA Retrospective design, no consent form for the inclusion to the Retrospective design, no consent form for the inclusion to the

study.study.

322 eyes of 176 consecutive patients underwent 322 eyes of 176 consecutive patients underwent phacoemulsification surgeryphacoemulsification surgery with with AcrySof AcrySof RestorRestor IOL IOL implantationimplantation between between December 2005 and December 2005 and JuneJune 2008 at the 2008 at the University of Texas Southwestern Medical Center. University of Texas Southwestern Medical Center. 53 eyes of 34 patient who had refractive surgery prior to 53 eyes of 34 patient who had refractive surgery prior to

Restor IOL implantation wRestor IOL implantation wereere excluded excluded 269 eyes of 151 patients included in the study269 eyes of 151 patients included in the study 2 eyes of 1 patient with Restor explanted due to glare. 1 2 eyes of 1 patient with Restor explanted due to glare. 1

patient unhappy with Restor chose monofocal for fellow eye.patient unhappy with Restor chose monofocal for fellow eye. The preoperative and follow-ups 1, 6 months, and the last follow-The preoperative and follow-ups 1, 6 months, and the last follow-

up after Restor IOL implantation were evaluated for this studyup after Restor IOL implantation were evaluated for this study 14 eyes of 8 patients lost to follow-up 6 months after Restor IOL 14 eyes of 8 patients lost to follow-up 6 months after Restor IOL

impantation.impantation.

GroupsGroups

LRI, 35, 13%

LRI/LASIK, 22, 8%

LASIK, 61, 23%

Restor only, 151,

56%

Restor only LRI LRI/LASIK LASIK

Number of eyes

Number of patients

All 269 151

Restor only 151 94

LRI 35 23

LRI/LASIK 22 14

LASIK 61 45

UCNVA

0.00

0.02

0.04

0.06

0.08

0.10

0.12

0.14

0.16

0.18

1 month 6 month Last F/U

Time

Nea

r V

isu

al A

cuit

y (l

og

mar

)

All eyes Restor Only Restor+LRI Restor+LRI+LASIK Restor+LASIK

1 month: p = 0.716 month: p = 0.46Last f/u: p = 0.30, P = One-way ANOVA

UCVA

0.00

0.05

0.10

0.15

0.20

0.25

0.30

0.35

1 month 6 month Last F/U

Time

Vis

ua

l A

cu

ity

(lo

gm

ar)

All eyes Restor Only Restor+LRI Restor+LRI+LASIK Restor+LASIK

1 month: p = 0.006 month: p = 0.09Last f/u: p = 0.13 , P = One-way ANOVA

Spherical Equivalent and Spherical Equivalent and CylinderCylinder

Spherical Equivalent

-4.00

-3.50

-3.00

-2.50

-2.00

-1.50

-1.00

-0.50

0.00

0.50

Pre-op 1 Month 6 Months Last F/U

Time

Sphe

rıcal

Equiv

alent

All eyes Restor Only Restor+LRI Restor+LRI+LASIK Restor+LASIK

Cylinder

0.00

0.20

0.40

0.60

0.80

1.001.20

1.40

1.60

1.80

2.00

Pre-op 1 Month 6 Months Last F/U

Time

Cylin

der (D

)

All eyes Restor Only Restor+LRI Restor+LRI+LASIK Restor+LASIK

CONCURRENT UCVA / CONCURRENT UCVA / UCNVAUCNVA for Restor and for Restor and

Restor + LRIRestor + LRIPOSTOPERATIVE UNCORRECTED DISTANCE AND NEAR VISUAL ACUITY

3138

43 4554

6975 77

59

7580

90

63

7782

92

0

1020

3040

50

6070

8090

100

20/20 or better 20/25 or better 20/30 or better 20/40 or better

% o

f eye

s

J1+ or better J1 or better J3 or better J5 or better

Restor and Restor+LRI Restor and Restor+LRI GroupsGroups

UCVAUCVA

63

7782

9296

0

10

20

30

40

50

60

70

80

90

100

20/20 or better 20/25 or better 20/30 or better 20/40 or better 20/50 or better

% of

eyes

UCNVAUCNVA

48

70

8792

96 98

0

10

20

30

40

50

60

70

80

90

100

J1+ or better J1 or better J2 or better J3 or better J5 or better J7 or better

% of

eyes

Nd:YAGNd:YAGComparison of vision and refraction of eyes that underwent Nd:YAG capsulotomy and those that did not at last follow-up.

YAG (-) YAG (+) P*

VISUAL ACUITY (logmar)

UCVA 0.10 ± 0.12 0.15 ± 0.21 0.16

BSCVA 0.03 ± 0.07 0.08 ± 0.13 0.01

UCNVA 0.10 ± 0.12 0.13 ± 0.14 0.14

REFRACTION (D)

S -0.03 ± 0.50 -0.26 ± 0.67 0.05

C 0.65 ± 0.33 0.50 ± 0.23 0.02

SE 0.10 ± 0.36 -0.04 ± 0.54 0.07

*Student’s t-test

DiscussionDiscussion Although Although Restor alone Restor alone andand Restor+LRI Restor+LRI groups groups

significantly had better UCVA at 1 month, there significantly had better UCVA at 1 month, there was no significant difference in UCVA between was no significant difference in UCVA between groups at last follow-up.groups at last follow-up.

No statistically significant differenceNo statistically significant difference in in BCVA BCVA andand UCNVA between UCNVA between groups groups at 1 mos, 6 mos or at 1 mos, 6 mos or last f/u. last f/u.

UCNVA and UCVA were stable for the duration UCNVA and UCVA were stable for the duration of follow-upof follow-up in in Restor alone Restor alone andand Restor+LRI Restor+LRI groups. groups.

Spherical equivalent and cylinderSpherical equivalent and cylinder were were stable stable for all groupsfor all groups

69%69% of eyes in of eyes in Restor alone Restor alone andand Restor+LRI Restor+LRI groupsgroups had had concurrent concurrent 20/25 or better UCVA 20/25 or better UCVA and J1 or better UCNVAand J1 or better UCNVA at last follow-up at last follow-up