INTENSITY| ADVANCED FULLRANGE OPTICS Technology and initial clinical experience

Prof. Ehud I. Assia

Director, Center for Applied Eye Research Department of Ophthalmology, Meir Medical Center, Kfar-Saba

Ein-Tal Eye Center, Tel Aviv, Tel- Aviv University, Tel-Aviv

ISRAEL

INTRODUCTION

• The is a part of the FullRange family of premium products.

• The lens is designed using a unique algorithm Gerchberg–Saxton algorithm along with Hanita merit function (GSH) to optimize diffractive optics.

• The GSH was implemented in the advanced Arizona eye model used in all Hanita Lenses premium lenses.

INTRODUCTION

• Optimization in the GSH was aimed to maximize light intensity utilization in order to get clear vision throughout the range of functional vision between 40 cm

to infinity.

INTRODUCTION

Intensity optimized GSH algorithm Technology/Design

5.2 mm Diffractive area

posterior surface: Aspheric –Diffractive Anterior surface: Spheric

Geometry

Zone pupil optimized lens Optic type

1.46 Refractive index

-0.13μ Spherical Aberration

25% Hydrophilic Acrylic Material

Natural Yellow Violet Filter Lens Color

LENS SPECIFICATION

Focus Addition

@ IOL plane Addition @ spectacle plane Distance [meter]

Far 0 ∞ ∞

Far Intensifier 0.9 D 0.75 D 1.33 m

Intermediate 1.5 D 1.25 D 0.80 m

Near intensifier 2 D 1.67 D 0.60 m

Near 3 D 2.50 D 0.40 m

Lens Foci

0,0%

5,0%

10,0%

15,0%

20,0%

25,0%

30,0%

35,0%

-1 -2 0 1 2

31,4%

3,2%

18,3% 19,9%

27,2%

Light Intensity Distribution

Infinity

133 cm

80 cm 60 cm

40 cm

0,0%

5,0%

10,0%

15,0%

20,0%

25,0%

30,0%

35,0%

-1 -2 0 1 2

31,4%

3,2%

18,3% 19,9%

27,2%

Light Intensity Distribution

Infinity

133 cm

80 cm 60 cm

40 cm

Mic

ron

mm

EYE PUPIL APERTURE OPTIMIZATION

• All zones are optimized by GSH

• Zone smooth shapes allow higher

efficiency in desired target intensity

• Multiple areas allow better

performance for different eye pupil

apertures

• Higher MTF at Far Vision for large

Eye Pupil

v

ZONE 1

ZONE 2

ZONE 3

DIFFERENCE BETWEEN ZONES

ZONE 1 ZONE 2 ZONE 3

The difference between zones will modify the intensity distribution at each foci

THROUGH FOCUS RESPONSE

Far Infinity

Far intensifier +0.90

Intermediate +1.50

Near intensifier +2.0

Near +3.0

Far

Intermediate

Near intensifier

Near

Far Intensifier

LOWEST ENERGY LOSS

86 86 88 92,5

14 14 12 7,5

0

20

40

60

80

100

FineVision AT Lisa tri PanOptix AFR

Energy utilization (%)

Lostenergy

40% decrease in lost light >> decreased visual disturbances

US AIRFORCE TARGET – 2 MM PUPIL

US AIRFORCE TARGET – 3 MM PUPIL

US AIRFORCE TARGET – 4.5 MM PUPIL

MF42

50 100 150 200 250 300

50

100

150

200

250

300

MF66

50 100 150 200 250 300

50

100

150

200

250

300

Trinova

50 100 150 200 250 300

50

100

150

200

250

300

AtLisaTri

50 100 150 200 250 300

50

100

150

200

250

300

Panoptix

50 100 150 200 250 300

50

100

150

200

250

300

SeelensMF

50 100 150 200 250 300

50

100

150

200

250

300

HALO ESTIMATION

MF42

50 100 150 200 250 300

50

100

150

200

250

300

MF66

50 100 150 200 250 300

50

100

150

200

250

300

Trinova

50 100 150 200 250 300

50

100

150

200

250

300

AtLisaTri

50 100 150 200 250 300

50

100

150

200

250

300

Panoptix

50 100 150 200 250 300

50

100

150

200

250

300

SeelensMF

50 100 150 200 250 300

50

100

150

200

250

300

MF42

50 100 150 200 250 300

50

100

150

200

250

300

MF66

50 100 150 200 250 300

50

100

150

200

250

300

Trinova

50 100 150 200 250 300

50

100

150

200

250

300

AtLisaTri

50 100 150 200 250 300

50

100

150

200

250

300

Panoptix

50 100 150 200 250 300

50

100

150

200

250

300

SeelensMF

50 100 150 200 250 300

50

100

150

200

250

300

• CLINICAL STUDY

OBJECTIVES

PRIMARY AIM:

To evaluate the monocular & binocular visual acuity for far, intermediate and

near distance after the INTENSITY implantation.

SECONDARY AIM:

To measure the defocus curve and patient satisfaction.

STUDY DESIGN

This study is a prospective, single arm, single center, open label study.

The aim of this study is to evaluate safety and performance of the INTENSITY IOL.

Population: Men and women diagnosed with cataract who require cataract surgery

procedure that meet the inclusion criteria.

INCLUSION CRITERIA

Age over 45 years and under 75 years.

Patients with bilateral age related cataracts, require bilateral cataract phacoemulsification combined Intraocular Lens implantation;

Patients with axial length of 22-24.5mm.

Normal corneas with less than 0.75D of regular corneal astigmatism.

Post-operative best corrected visual acuity projected to be 0.3 logMAR or lower.

Patient motivated for multifocal IOL after screening by surgeon.

Fundus visualization is possible.

Absence of retinal or optic nerve diseases

ENROLLMENT

0 2 4 6 8 10 12 14 16

Recruited

OP eye 1

OP eye 2

1 Week

1 Month

3 Months

# Patients

Study status

Parameter Average

SE [D] 0.26-

UDVA [LogMAR] 0.41

CDVA [LogMAR] 0.11

K1 [D] 44.14

K2 [D] 44.63

Cyl [D] 0.49-

AL [mm] 23.14

PRE OPERATIVE BIOMETRY &VA

movie

-0,5

-0,4

-0,3

-0,2

-0,1

0,0

1M SE

Spherical Equivalence 1 month post op

VISUAL ACUITY 1 MONTH POST-OP - UNCORRECTED

6/6.9

6/8.6

6/3.8

-0,30

-0,20

-0,10

0,00

0,10

0,20

0,30

UDVA UIVA UNVALogM

AR

Uncorrected: Distance – Intermediate - Near

VISUAL ACUITY 1 MONTH POST-OP - CORRECTED

6 / 6.1

6 / 8.3

6 / 4.2

-0,30

-0,20

-0,10

0,00

0,10

0,20

0,30

CDVA DCIVA DCNVALogM

AR

Corrected: Distance – Intermediate - Near

VISUAL ACUITY 1 MONTH POST-OP - CORRECTED BOTH EYES

6 / 5.9

6 / 7.5

6 / 3.9

-0,30

-0,20

-0,10

0,00

0,10

0,20

0,30

CDVA OU DCIVA-OU DCNVA OULogM

ar Corrected VA-OU: Distance – Intermediate - Near

DEFOCUS CURVE

Monocular: LogMAR Snell

Min VA range +0.5 to -3 0.12 6/7.9

Max VA range +0.5 to -3 0.1- 6/4.8

OU: LogMAR Snell

Min VA range +0.5 to -3 0.1 6/7.6

Max VA range +0.5 to -3 0.1- 6/4.8

2.40m 6.00m 1.20m 0.80 m 0.60 m 0.48 m 0.40m 0.34m 0.30m

-0,10

0,00

0,10

0,20

0,30

0,40

-4-3,5-3-2,5-2-1,5-1-0,500,51

Vis

ual

Acu

ity

[Lo

gMA

R)

Defocus [D]

Defocus curve Monocular N=8 OU N=4

CONTRAST SENSITIVITY

0

0,5

1

1,5

2

2,5

3 6 12 18

Log

CS

Spatial frequency [cpd]

Contrast sensitivity

Photopic Norm

Photopic

Mesopic

0 1 2 3 4

Reading small print (IFU, labels)

Reading Books, Newspapers

Reading the phone and large prints

Recognizing faces, people

Seeing steps

Reading traffic signs

capable to do fine handy work (kneating,…

Writing checks

Playing games - Domino/ Rumicube

Playing sports game

Cooking

Watching TV

Driving during the day

Driving during the night

Difficulty to do tasks; 3 months N=2

No difficulty

Slight Moderate Difficult Not able

Difficulty scale

3,7 4,0

Average difficulty to do tasks

Score per patient

pt- 4 pt-5

No Difficulty

Not able

No Difficulty

Not able

FUNCTION AND SATISFACTION

0 1 2 3

Blurry DISTANCE vision

Blurry NEAR vision

Halos

Glare

Diplopia (one eye)

Diplopia (Both eyes)

Difficulty seeing at night

Difficulty in depth perception

Difficulty in color perception

Scale of Visual phenomenon disturbance

Visual phenomenon Pt 5 pt 4

None Slight Moderate Severe

FUNCTION AND SATISFACTION

Glass dependency Use glasses for distance vision?

Never

Use glasses for Intermediate

vision?

Never

Use glasses for near vision

(Reading)? Never

FUNCTION AND SATISFACTION

Satisfaction Are you satisfied from the treatment in your

general feeling

Very

Satisfied

Would you go over the treatment again? Yes

FUNCTION AND SATISFACTION

• A promising new lens design that may truly provide a good depth of focus and spectacle freedom to presbyopic patients.

• Initial results show a remarkable defocus curve that, with exceptionally good near and intermediate vision, with visual acuity above 0.05 (6/6.7) throughout infinity to 40 cm.

• High Patients satisfaction.

• Still requires to evaluate a need to adjust the A-constant of the lens from the approximated constant with which the study initiated.

SUMMARY