Multifocal Progressive Diffractive Lens to Improve Light Distribuition and Avoid Light Loss: Two Years Clinical Results

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$Multifocal Progressive Diffractive Lens to Improve Light Distribuition and Avoid Light Loss: Two Years$

1 Multifocal Progressive Diffractive Lens to Improve Light Distribuition and Avoid Light Loss: Two Years Clinical Results Matteo Piovella MD & Barbara Kusa MD CMA, Centro di Microchirurgia Ambulatoriale Monza (Milan) Italy

2 Financial Disclosure Dr Piovella has the following Financial interest or relationship to disclose as consultant: Abbott Medical Optics BVI Beaver Visitec International Slack INC as lectures fees: Aaren Scientific Carl Zeiss Medictec Ocular Therapeutic Soleko

3 In-focus Image Quality Characterization Image Contrast Measure of Contrast Image Dimension

In-focus Image QualityCharacterization How to combine different image dimensions and corresponding contrasts into a single characteristic?

4 In-focus Image QualityCharacterization How to combine different image dimensions and corresponding contrasts into a single characteristic? Modulation Transfer Function (MTF) = modulations at the image plane as a function of spatial frequency MTF is Quantitative Measure of the Ability of Optical System to Reproduce Contrast of Original Object by its Image

5 Testing for Through Focus MTF Translating Stage of the MTF test system is used to find Best Focus position and measure Through Focus image quality called Through Focus Response (TFR) Testing

6 Quality of Vision Effect of Contrast Reduction

$Pupil Size and % Light Distribution Refractive MIOL Technology However, differences can be shown with respect to: - pupil dependent performance -$

7 Pupil Size and % Light Distribution Refractive MIOL Technology However, differences can be shown with respect to: - pupil dependent performance - usage of transmitted light - adequate light distribution for intermediate vision Sources: IOL data are from the FDA submission for the optic profile.

8 % Light Distribution and Pupil Size All multifocal IOLs provide adequate performance for Far and Near distances at nominal 3 mm pupil and differencescan be shown towards the limits of the pupil range: 2 mm and 5 mm

$Pupil Size and % Light Distribution Refractive MIOL$ for Far and Near distances at nominal 3 mm pupil and

$range: 2 mm and 5 mm Refractive IOLs and % Light$ Distribution Pupil Size 3 mm Sources: IOL data are from the

9 Pupil Size and % Light Distribution Refractive MIOL Technology All multifocal IOLs provide adequate performance for Far and Near distances at nominal 3 mm pupil and differences can be shown towards the limits of the pupil range: 2 mm and 5 mm Refractive IOLs and % Light Distribution Pupil Size 2 mm Refractive IOLs and % Light Distribution Pupil Size 3 mm Sources: IOL data are from the FDA submission for the optic profile. Ligh Refractive IOLs and % Light Distribution Pupil Size 5 mm

10 Weak points of most popular Multifocal IOLs Diffractive MIOLs : Diffraction Grooves (Blaze hight) Creates Different Diffraction Efficiency and Light Loss Reduction of Contrast Sensitivity (up to 30%) Post-operative 0.50 Diopter SE generates loss of one line of Visual Acuity Multifocal IOLs corneal astigmatism tolerance : 0.75 D Healos, Glare and Ghost Images are Difficult to Manage in Suspicious Patients Poor Intermediate Distance Vision Perfect Target : Plano Postoperative Result

$Diffractive MIOL : ReSTOR (Alcon) Diffraction Efficiency : % Light Distribution and Light Loss Light Loss" graph is absolute light energy; Far and Near graphs are relative values.$

11 Diffractive MIOL : ReSTOR (Alcon) Diffraction Efficiency : % Light Distribution and Light Loss Light Loss" graph is absolute light energy; Far and Near graphs are relative values. Advantages Distance Dominant Diffractive Optics allow for Far and Near vision Apodized diffractive design to reduce halos Disadvantages May not have sufficient Near at large pupils No provision for intermediate focus Substantial percent of light is outside range of vision for small to medium pupils Light Loss

$Diffractive MIOL - AcriLisa (Zeiss) Diffraction Efficiency: % Light Distribution and Light Loss Advantages$ $Refractive phase sub-zones allow to increase light use for imaging vs balze sharp diffractive MIOL$

12 Diffractive MIOL - AcriLisa (Zeiss) Diffraction Efficiency: % Light Distribution and Light Loss Advantages Distance Dominant Diffractive Optics allow for Distance and Near vision for full range of pupils Refractive phase sub-zones allow to increase light use for imaging vs balze sharp diffractive MIOL Disadvantages No provision for intermediate vision Significant percent of light is still outside range of vision Light Loss

$Diffractive MIOL - TECNIS (AMO - Abbo*) Diffraction Efficiency: % Light$ for Distance and Near vision for full range of pupils No provision for

13 Diffractive MIOL - TECNIS (AMO - Abbo*) Diffraction Efficiency: % Light Distribution and Light Loss Advantages Disadvantages Diffractive Optics allow for Distance and Near vision for full range of pupils No provision for intermediate vision Substantial percent of light is outside range of vision -- Light Loss

14 Three Year Tecnis MIOLs Manifest Refraction Spherical Equivalent - 32 Eyes Outcomes for targeted refraction D I O P T E R S

15 EYEVISPOD Mix and Match Uncorrected Near Vision Visual Acuity Tecnis ReZoom Tecnis ReZoom Tecnis ReZoom 5.03± ± ± ± ± ± ± ± ± 0.95

16 EYEVISPOD Mix and Match Uncorrected Intermediate Visual Acuity Intermediate (70 cm) Binocular Visual Acuity intermediate vision is efficient in 94% of the cases

17 Tecnis MIOL Uncorrected Near Vision Visual Acuity Monocular vs Binocular Tecnis Tecnis Tecnis 3.41 ± ± ± ± ± ± 0.51

$OptiVis MIOL (Aaren Scientific, Inc) Posterior multifocal surface consists of 3 zones: Zone 1 of Progressive Refractive powers for Far and Intermediate within central 1.$

18 OptiVis MIOL (Aaren Scientific, Inc) Posterior multifocal surface consists of 3 zones: Zone 1 of Progressive Refractive powers for Far and Intermediate within central 1.5 mm diameter Apodized Diffractive Zone 2 for Far with 2.5 D Effective Add for Near within 1.5 to 3.8 mm diameter Peripheral Refractive Zone 3 is shaped for bi-sign aspherization

$Base Surface of the Diffractive Zone 2 is to expand Depth of Focus at Far to intermediate A Refraction zone has$

19 Central Progressive power zone Zone 1 Power profile starts with Intermediate power at the center of the lens Power profile shape is to extand focus range from Far to intermediate distances Negative surface slop of Zone 1 and part of Base Surface of the Diffractive Zone 2 is to expand Depth of Focus at Far to intermediate A Refraction zone has advantage of utilizing 100% of light for retinal image thus reducing the overall light loss as compare with any other diffraction optic

20 Apodization Surfice Area Initial Diffractive groove is to direct light to Near focus Groove heights reduce towards Zone 2 periphery in order to direct more light to Far Light Loss is smaller with more unequal Far to Near light split OptiVis apodization allocates the smallest surface area for equal Far to Near light split where light loss is the largest Apodization Form - Instance light split at each surface diameter, not within a diameter as reported by light distribution light loss is largest

$Apodization Zone 2 Initial Diffractive groove is to direct light to Near focus Zone 2 groove$ with more unequal Far to Near light split OptiVis apodization allocates the smallest surface

with more unequal Far to Near light split OptiVis apodization allocates the smallest surface

21 Apodization Zone 2 Initial Diffractive groove is to direct light to Near focus Zone 2 groove heights reduce towards periphery in order to direct more light to Far Light Loss is smaller with more unequal Far to Near light split OptiVis apodization allocates the smallest surface area for equal Far to Near light split where light loss is the largest light loss is largest

22 Bi-Sign Asphericity Other Aspherics are designed to compensate for a selected level of Corneal spherical aberration. This leads to a significant reduction of image contrast at large pupils with Cornea of different Asphericity and Lens decentration or tilt Balanced Aberrations at Large Pupil Bi-sign asphericity is that at 3 mm diameter it has Eye aberration similar to with spherical IOL but the opposite sign. As the pupil increases, the aberration of opposite sign to the central lens area kicks in to balance out a total Eye aberrations at large pupil Bi-sign asphericity balances out aberration at large pupil within the lens itself for any corneal asphericity thus reducing a reliance on specific corneal shape. The resulted improvement in image contrast at large pupils is maintained for different corneal Asphericities and even with Lens decentration or tilt

23 % Distribution of Light Rays With Accommodative IOLs there is no loss of light, so quality of vision is not compromised. 1 Pupil Synchrony ReSTOR TECNIS MF Near 2 mm 100% 40% 41% 5 mm 100% 84% 41% Distance 2 mm 100% 40% 41% 5 mm 100% 10% 41% Intermediate 2 mm 100% 0% 0% 5 mm 100% 0% 0% LIGHT LOSS 2 mm 0% 20% 18% 5 mm 0% 6% 18% Reference: 1. Stahl J. The importance of quality of vision. Ophthalmol Manage. 2011;(suppl):8-9.

$OptiVis MIOL (Aaren Scientific, Inc) Diffraction Efficiency: % Light Distribution and Light Loss Advantages: 1. Intermediate focus in addition to Far and Near foci 2.$

24 OptiVis MIOL (Aaren Scientific, Inc) Diffraction Efficiency: % Light Distribution and Light Loss Advantages: 1. Intermediate focus in addition to Far and Near foci 2. Improved Apodization to minimize light loss 3. Reduction in both, light loss and fraction of light to Near focus at large pupil this is to reduce nighttime dysphotopsia 4. Bi-sign Aspherization to improve retinal image contrast at large pupil for different corneal asphericities and even lens decentration and tilt

25 Second Generation Multifocal Diffractive IOL What is the Difference? OptiVis Central Area is 2.1 sq. mm. ReStor and Acri.Lisa Central Area is 1.3 sq. mm. ReStor and Acri.Lisa Central Areas is the First Diffraction Groove that works together with the other diffraction grooves OptiVis Central Area acts as a stand alone refractive zone of Progressive power range which complements the lens diffraction grooves to provide Intermediate foci Other differences - optimized Apodization to reduce light outside the range of vision and improved Aspherization to minimize effect of lens tilt and decentration

26 Materials and Methods OptiVis implanted in 80 eyes of 41 patients (38 Bilateral implantation) Mean age: ± 6.25 years. Follow-up: 2 year (13 eyes) Follow-up: ± days Uncorrected VA (UCVA), Near (UCNVA) and Distance (DCNVA) Best corrected distance VA (BCDVA) Distance Intermediate VA, uncorrected (UNIVA) and distance corrected Near VA

$Manifest Refraction: Spherical Equivalent 80$

27 Manifest Refraction: Spherical Equivalent 80 Eyes Outcome for targeted refraction D I O P T E R S

Monocular Far Visual Acuity: 80 Eyes Far Vision Outcome 1.

99 1 0.99 0.95 0.93 0.7 0.7 0.6 0.5 0.6 0.5 0.42 0.4 0.3 0.23 0.

1 0 Preop 1 Week PO 1 Month PO 3 Months PO 6 Months PO 1 Year

28 Monocular Far Visual Acuity: 80 Eyes Far Vision Outcome UCVA BCVA Preop 1 Week PO 1 Month PO 3 Months PO 6 Months PO 1 Year PO 2 Years PO 0 Preop 1 Week PO. 1 Month PO. 3 Months PO. 6 Months PO. 1 Year PO 2 Years PO

29 Two years Binocular Near* Vision Visual Acuity 41 Patients 80 Eyes MEAN ETDRS 20/# MEAN JAEGER BEST VISION MEAN DISTANCE UCNVA PHOTOPIC cm DCNVA PHOTOPIC cm Two years Binocular Intermediate* Vision at 70 cm 41 Patients 80 Eyes MEAN ETDRS 20/# MEAN JAEGER DISTANCE UNCORRECTED INTERMEDIATE VISION cm DISTANCE CORRECTED INTERMEDIATE VISION cm * Used same ETDRS Logarithmic Visual Acuity Chart 2

30 Testing Near Vision at 40 cm with ETDRS Logarithmic Visual Acuity Chart 2 20/40

Near Vision Acuity Conversion Chart: EDTRS vs Jaeger 20/20 JAGER 20/400 19 20/230 18 20/250

31 Near Vision Acuity Conversion Chart: EDTRS vs Jaeger 20/20 JAGER 20/ / / / / / / / / / / / /25 2

33 Weak points of most popular Multifocal IOLs Diffractive MIOLs : Diffraction Grooves (Blaze hight) Creates Different Diffraction Efficiency and Light Loss Reduction of Contrast Sensitivity (up to 30%) Post-operative 0.50 Diopter SE generates loss of one line of Visual Acuity Multifocal IOLs corneal astigmatism tolerance : 0.75 D Healos, Glare and Ghost Images are Difficult to Manage in Suspicious Patients Poor Intermediate Distance Vision Perfect Target : Plano Postoperative Result

34 Diffractive MIOL - TECNIS (AMO - Abbo*) Contrast Sensitivity Daytime, Nighttime and Nighttime with glare Post-op 1 D Cylinder : Corrected vs Not Corrected Without Cylinder Correction With Cylinder Correction

35 Acri.LISAtoric Sphere Equivalent (22 Eyes) D I O P T ER S

36 Monofocal Technology Snellen Visual Acuity as Func=on of Pupil Size and Defocus (Courtesy of Jack Holladay and Val Portney)

37 Diffrac=ve Technology Snellen Visual Acuity as Func=on of Pupil Size and Defocus (Courtesy of Jack Holladay and Val Portney) Pupil size D i o p t e r s TDL 20/09 20/06 20/04 20/04 20/03 20/ /10 20/09 20/10 20/10 20/11 20/ /12 20/15 20/19 20/24 20/28 20/ /19 20/24 20/33 20/44 20/52 20/ /36 20/49 20/68 20/95 20/121 20/130 TDL indicates Theoretical Diffraction Limits

38 Diffrac=ve Technology Snellen Visual Acuity as Func=on of Pupil Size and Defocus In terms of toric vs. spherical it is two times difference, for instance, the effect of 1 D cylinder error on VA is about 0.5 D spherical refractive error. In terms of multifocal lenses, VA sensitivity to refractive error depends on a multifocal design. For instance, refractive technology was close to monofocal for the width of the Distance Peak but in Diffractive MultifocalTechnology width of the Distance Peak was about half the monofocal width, and the effect of refractive error was about twice more sensitive than monofocal In case of OptiVis, the lens was designed with increased width of Distance Peak as compared with conventional diffractive multifocal.

39 BIOMETRY USING IOL MASTER OPTIVIS FORMULA RELETED CONSTANT Nominal Haigis HofferQ Holl.1 SRK/T SRK II A=118.1 a0=0.77 a1=0.40 a2=0.10 pacd = 4.98 sf=1.20 A=118.0 A=118.1

40 BIOMETRY WITH IOL MASTER: PERSONAL EXPERIENCE Eye Axial Lenght FORMULA <22.5 HOFFER Q SRK-T/HAIGIS HOLLADAY >26.0 SRK-T / HAIGIS / HOFFER Q

41 GETTING PLANO POST-OPERATIVE RESULTS REFRACTIVE TARGET PLANO / MULTIFOCAL IOLs CORNEAL ASTIGMATISM TOLERANCE 0.75 D

42 Quality of Vision Contrast Sensitivity and Control Values Control values for CS are derived from Hohberger paper B. Hohberger et al. Measuring contrast sensitivity in normal subjects with OPTEC 6500: influence of age and glare Graefes Arch Clin Exp Ophthalmol, 2007; 245: healthy phakic subjects for the following age groups: <30; 30-39;40-49;50-59; 60 Functional Image Analyzer OPTEC 6500P Daytime (85 cd/m 2 ), Nighttime (3 cd/m 2 )and Nighttime with Glare(3 cd/m 2 ) Monocular testing Paper demonstrated strong age dependence of C S with age

43 ReZoom Contrast Sensitivity Daytime, Nighttime and Nighttime with glare

44 Optivis contrast sensitivity Daytime, Nighttime and Nighttime with glare

$Diffractive$ IOLs and

45 Diffractive Multifocal IOLs and Contrast Sensitivity Acri.LISA Acri.LISA Toric Tecnis Optivis

46 Synchrony contrast sensitivity Daytime, Nighttime and Nighttime with glare

47 Diffractive Multifocal IOLs High PCO Sensitivity : % of Yag Laser Capsulotomy at 2 Years Post-op 80 Eyes with Optivis Multifocal implants: Yag laser capsulotomy 29 eyes (36.25%)

48 Conclusions OptiVis multifocal design has a Provision for intermediate foci and clinically demonstrated excellent Intermediate vision in addition to Far and Near Contrast Sensitivity scores were comparable or exceeded the Average CS of Healthy eyes, age > 60 years, in Daytime condition and a small reduction at 12 and 18 c/ deg at Nighttime condition for some patients Reference to optical/visual symptoms was prompted only by the Physician s Questionnaire and no severe symptoms were reported

49 Conclusions New multifocal IOLs generation represents a new concept in multifocal IOL optics, combining benefits of both diffractive bifocal and progressive refractive designs by providing near, far, and intermediate vision in a single IOL.

50 Thank you for your attention

Quality of Vision With Multifocal Progressive Diffractive Lens: Two-Year Follow-up

$Quality of Vision With Multifocal Progressive Diffractive Lens: Two-Year Follow-up$ Quality of Vision With Multifocal Progressive Diffractive Lens: Two-Year Follow-up Antonio Mocellin, MD & Matteo Piovella, MD CMA, Centro di Microchirurgia Ambulatoriale Monza (Milan) Italy Dr Piovella