Kenneth Lipstock, MD

Lipstock LASIK and Cataract Center

Richmond, Virginia

www.lipstocklaser.com

Introduction

The MAST Study demonstrated that the

nanoFLEX (STAAR aspheric single piece

collamer iol) provided optimal vision at

intermediate and satisfactory at near Intermediate (80cm) binocular DCVA = 20/24

Near (40cm) binocular DCVA = 20/50

Present study designed to evaluate how best to

utilize the intrinsic properties of the nanoFLEX

to optimize visual outcomes

All LensesDistance-Corrected Bilateral Average Near &

Intermediate VA

0

10

20

30

40

50

60

Near Intermediate

Sn

ell

en

Acu

ity 2

0/-

NanoFLEX (n=63)

AMO Tecnis sililcone aspheric 3 piece iol (n=61)

20/50

20/24

20/28

20/52

p = 0.832

p = 0.072

Binocular VA at Near (40 cm): All Lenses

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20/40 or Better

20/50 or Better

20/63 or Better

20/80 or Better

32%

71%

95%100%

46%

72%

79%

93%

% o

f P

ati

en

ts

NanoFLEX (n=63)

AMO Tecnis sililcone aspheric 3 piece iol (n=61)

p = 0.006

p = 0.112

Binocular VA at Intermediate (80 cm): All

Lenses

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

20/20 or Better 20/25 or Better 20/32 or Better 20/40 or Better

35%

79%

100% 100%

34%

74%

82%

93%

% o

f P

ati

en

ts

NanoFLEX (n=63)

AMO Tecnis sililcone aspheric 3 piece iol (n=61)

p = <0.001

Purpose

To evaluate the visual outcomes of

patients undergoing routine cataract

surgery with phacoemulsification

followed by bilateral implantation of

aspheric (nanoFLEX) intraocular lenses

(IOLs) using blended vision.

Methods Prospective evaluation of patients who had undergone

bilateral phacoemulsification with implantation of nanoFLEX IOLs.

All patients with a DCVA 20/25 or better in each eye underwent ETDRS testing under controlled lighting utilizing the Functional Vision Analyzer (Stereo Optical) for binocular UCDVA and UCNVA and repeated for the dominant eye.

MN Reading Cards were used to measure binocular UCNVA and UCIVA and reading speed.

Patient satisfaction questionnaire administered

IRB approval obtained

Key Inclusion/Exclusion

Inclusion Criteria: DCVA of 20/25 or better in both eyes

Spherical equivalent in the dominant eye to be

± 0.50 or less and in the nondominant eye

between -0.88 and -1.87 and cyl ± 0.75 both eyes

Exclusion Criteria: No amblyopia or tropias or posterior capsular

opacification

All other ocular pathology allowed as long as DCVA ≤ 20/25 and no significant visual field loss

No LVC pre-op or post-op

Patient Baseline Characteristics 13 pts (ongoing study)

6 to 20 months post-op

69% male

Mean age 64 (52-73)

Pathology: dry eye, paracentral full thickness corneal scar, ABMD, AMD

Post Operative Refractions (means) Mean Spherical Equivalent

• Dominant = +0.02 D

• Non-dominant = -1.23 D Mean Cylinder

• Dom = 0.44 D

• Non-dom = 0.42

Mean Corrected Distance Vision (BCDVA)

• Dom= 20/16.8

• Non-dom = 20/18.6

Binocular UCVA

0%

20%

40%

60%

80%

100%

20/15 or Better 20/20 or Better 20/25 or Better 20/32 or Better 20/50 or Better

15%

38%

69%

85%

100%

61%

92%

100%

54%

100%

% o

f P

ati

en

ts

Near (40cm) Mean = 20/25Intermediate (80cm) Mean = 20/16Distance Mean = 20/19

Comparison of Reading Acuity at 40cm & 80cm

between nanoFLEX Blended Vision and Premium

IOLDistance Corrected Visual Acuities

nan

oF

LE

X B

V

ReS

TO

R D

1

¤

Syn

ch

ron

y

#

Cry

sta

Len

s

§

Tecn

is M

F ¥

nan

oF

LE

X B

V

ReS

TO

RD

1

*

Syn

ch

ron

y

#

Cry

sta

Len

s

§

Tecn

is M

F ¥

0

5

10

15

20

25

30

35

Mean

Sn

ell

en

Acu

ity

¤ Santhiago JCRS 11/10; # Bohorquez JCRS 11/10; § Pepose AJO 9/07; ¥ Hutz JRS 3/08; *Alfonso JCRS 5/09

Near 40cm Intermediate 80cm

20/25

20/21

20/23

20/32

20/27

20/18

20/28

20/17 20/17

(Letter Acuity (70cm )

20/26

Reading Speed

Reading Speed of at least 80 wpm:○ The lower limit for comfortable recreational

reading (Radner, Richter-Mueksch, Rubin, West)

Maximum reading speed beyond approximately 150 WPM is likely more a measure of brain function than optical acuity

.4 LogMAR (20/50)○ Reading speed at this print size commonly

reported because it is newspaper print size.

Comparison of Reading Speed at

40cm

using 0.4 LogMAR Print Size (20/50)

0

20

40

60

80

100

120

140

160

180

200

nanoFLEX ReSTOR D1 ** Synchrony # CrystaLens ¥ TetraFlex ¥

179

360184

70

90WP

M

** Santhiago JCRS 11/10; # Bohorquez JCRS 11/10; + Pepose AJO 9/07; ¥ Brown JCRS 10/09

How Often do You Wear Glasses?

0%

10%

20%

30%

40%

50%

60%

70%

80%

Never/Almost Never Sometimes

55%

18%

27%

% o

f P

ati

en

ts

73% Never or Almost Never

Patient Satisfaction with Near Vision

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Reading Newspapers

Computer Medicine Bottles

Shaving/Doing Make-up

Cooking/Sewing

3.43.6

2.5

4.0

3.5

MeanScore

No

Difficulty

Extreme

Difficulty

4= Very good / 3= good / 2 = poor / 1 = very poor

Patient Satisfaction with Distance Vision

0.0

0.5

1.0

1.5

2.0

2.5

3.0

3.5

4.0

4.5

Day Driving Night Driving Difficult Weather Driving

TV Out of home activities

4.0

3.4 3.5

4.03.9

MeanScore

4= Very good / 3= good / 2 = poor / 1 = very poor

No

Difficulty

Extreme

Difficulty

Stereopsis

Mean NC Far Stereo = 51 sec arc

Mean UC Far Stereo = 154 sec arc

Mean NC Near Stereo= 64 sec arc

Mean UC Near Stereo= 278 sec arc ○ Dropping 1 patient with abnormal near stereo with NC mean: 221

Visual Disturbance with Depth Perception Scale 0-4 (Severe to None) = 3.9

Stereopsis in other Pseudophakic Blended Vision Studies:

○ Zhang JCRS 3/11: Mean Near Stereopsis= 127

○ Finkelman JCRS 6/09 Mean Near Stereopsis=176

nanoFLEX Blended Vision

Patient Satisfaction

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Would recommend to family/friendsWould have blended vision again

100% 100%

% Patients Responding

Positively

Patient Satisfaction

nanoFLEX

Blended

Vision

ReStor D1 Investigator

Vision without

Eyeglasses – Very

Good

100% Lipstock

Would have Blended

Vision Again100% Lipstock

Would recommend BV

to Family/Friend100% Lipstock

Would have the

Procedure Again94%

Maxwell

JCRS 12/09

Extreme Difficulty

nanoFLEX ReStor D1 Crystalens

Night Vision 0% 2%* 2%***

Driving in

Difficult

Weather

0% 4%** -

* Maxwell JCRS 12/09

** Kohnen JCRS 12/09

*** FDA Crystalens Study

Conclusions Blended Vision (moderate monovision)

with STAAR Collamer Monofocal one piece IOL (nanoFlex) offers:

Excellent distance acuity

Good reading acuity

Excellent intermediate reading acuity

Comfortable reading speed for newspaper print size

High rate of spectacle independence

Extremely high patient satisfaction

nanoFLEX Blended Vision can be offered to patients with pre-op pathologies such as dry eye, ABMD and AMD – more importantly, unlike multifocal iols, if new ocular pathologies occur over time BCVA can always be obtained with eyeglasses

Pan-focal visual outcomes comparable to “premium IOLs”

Reduced Cost to Patient Great option for patients who can’t afford “premium IOL” presbyopic

corrections