prof. ehud i. assia - hanita france
TRANSCRIPT
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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
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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.
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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.
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INTRODUCTION
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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
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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
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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
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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
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Mic
ron
mm
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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
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DIFFERENCE BETWEEN ZONES
ZONE 1 ZONE 2 ZONE 3
The difference between zones will modify the intensity distribution at each foci
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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
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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
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US AIRFORCE TARGET – 2 MM PUPIL
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US AIRFORCE TARGET – 3 MM PUPIL
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US AIRFORCE TARGET – 4.5 MM PUPIL
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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
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• CLINICAL STUDY
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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.
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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.
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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
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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
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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
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movie
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-0,5
-0,4
-0,3
-0,2
-0,1
0,0
1M SE
Spherical Equivalence 1 month post op
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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
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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
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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
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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
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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
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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
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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
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Glass dependency Use glasses for distance vision?
Never
Use glasses for Intermediate
vision?
Never
Use glasses for near vision
(Reading)? Never
FUNCTION AND SATISFACTION
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Satisfaction Are you satisfied from the treatment in your
general feeling
Very
Satisfied
Would you go over the treatment again? Yes
FUNCTION AND SATISFACTION
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• 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
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