Why I Have Decided to Implant Trifocal IOLs Technology in My Own Eyes

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Georgiana Woods
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Why I Have Decided to Implant Trifocal IOLs Technology in My Own Eyes Dr Piovella Has the Following Possible Financial Interests or Relationships to disclose.

1 Why I Have Decided to Implant Trifocal IOLs Technology in My Own Eyes Dr Piovella Has the Following Possible Financial Interests or Relationships to disclose. As Consultant: Acufocus Carl Zeiss Meditec Johnson & Johnson TearLab As Lectures Fees: *Matteo Piovella, MD & **Barbara Kusa, MD *President of Italian Ophthalmological Society SOI *Medical Director ** Centro di Microchirurgia Ambulatoriale - CMA Monza - Milan Italy BVI Beaver Visitec International Ocular Therapeutix TearScience Dr. Kusa Does Not Have Any Financial Interests or Relationships to Disclose.

2 The Marvellous Journey of Cataract Surgery Has Always Been Based on Progress and Surgical Evolution Nobody Has the Opportunity to Block the Progress of Science From The Very Beginning Cataract Surgery Has Provided for the Removal of Lens Which Progressively Loses Transparency Today Refractive Cataract Surgery Is the Most Common and Efficient Way to Correct Refractive Defects, Myopia, Hyperopia, Astigmatism and to Overcome Presbyopia Limitations The Good News is That You Have the Opportunity to Adopt These Extraordinary Updates Without Having to Overturn Your Surgical Skills It Is However Necessary To Revolutionize the Organization of the Surgical Center by Taking Advantage of the Possibility of Introducing the Use of the Most Advanced Technologies The Most Challenging Thing is to Succeed in Moving from an Organizational System Based on High Numbers at Low Cost Embracing High Tech Refractive Cataract Surgery : This is The Change Cost Efficiency is a Non Medical Indication Acting Normally in Contries Members of The Third World Community No Patient Has Ever Thanked Me for Spending Less and Not Giving Him the Best Care M Piovella 2010

Corresponding Contrasts Into a Single Characteristic?

3 Today It Is Necessary to Provide a Good Quality of Vision After Cataract Surgery Loss of Contrast Sensitivity Penalizes All People After 60 Years of Age In-focus Image Quality - Characterization 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 (IOLs) to Reproduce Contrast of Original Object by Its Image

MTF Quality of Vision Drops Down From 100% to 0% with Only 8 Degree Axis Rotation Misalignment with a Toric IOLs Implant to Correct 2 D Astigmatism MTF (50 lp/mm)

90 0.80 0.70 0.60 0.50 0.40 0.30 0.20 0.10 0.00 0 2 4 6 8 10 12 14 16 18 20 ROTATION (DEGREES) 0.0D 0.5D 1.0D 2.

4 MTF Quality of Vision Drops Down From 100% to 0% with Only 8 Degree Axis Rotation Misalignment with a Toric IOLs Implant to Correct 2 D Astigmatism MTF (50 lp/mm) Sensitivity vs Toric IOL Rotation Errors The Importance of Callisto Markerless Digital System MTF WITH CORNEA CYLINDER CORRECTED ACE, 550 nm, 5MM MTF@50lp/mm ROTATION (DEGREES) 0.0D 0.5D 1.0D 2.0D 2 D Cylinder Correction Toric IOL Pupil Size 5 mm E (20/40) sensitivity to IOL rotation errors of 0, 5, 10, 15, 20 degrees 5.0 mm Multifocal Toric Optic is More Sensitive to Cylinder Misalignment then Monofocal Toric Optic

$Residual Postop Astigmatism is Responsible for the Biggest Complains Concerning Low Quality of Vision Low-Order Aberrations Due to Post-operative Refraction Residues Significantly Penalize Quality of$

5 Residual Postop Astigmatism is Responsible for the Biggest Complains Concerning Low Quality of Vision Low-Order Aberrations Due to Post-operative Refraction Residues Significantly Penalize Quality of Vision and They Multiply Exponentially the Effects of High-Order Aberrations Such as Coma and Trefoil Corneal Astigmatism Management : Toric IOLs When 0.75 Diopters of Astigmatism is Detected with Most Advanced Technology This Means Implanting Multifocal Toric Intraocular Lenses in 50% of Patients Undergoing Cataract Surgery The Use of IOL Master 700 and the Callisto System is Mandatory The Postop Refractive Gold Range to Achieve Good Quality of Vision is 0.50 Diopters The Use of Latest-Generation Autorefractometer Allows a Perfect Identification of the Residual Refractive Defects The Most Widely Used EDOF IOLs Do not Allow Precise Identification of the Postoperative Residual Refractive Defect by the Latest Generation Autorefratometers. Moreover, Postoperative Refractive Stability is Normally not Determined Before 30 days Postoperatively Zeiss Trifocal Lenses Allow Precise Identification of Postoperative Residual Refractive Defect in Real Time. Normally Maintain a Stable Refraction Two Days After Surgery

AT LISA Tri Toric Materials and Methods 40.

$Refractive Result Within 0.$ patients Mean Age 66.83 ± 11.64 Mean Preoperative UCVA 20/68 ± 39.24 Mean Time Follow Up 4 years ± 3.

6 AT LISA Tri Toric Materials and Methods 40.85% of Toric IOLs Implanted Provides Only One Diopter of Astigmatism Correction to Match the Postoperative Refractive Result Within 0.50 D Normally 50% of Cataract Patients Need Toric IOLs Implants AT LISA tri toric implanted in 142 eyes of 86 patients Mean Age ± Mean Preoperative UCVA 20/68 ± Mean Time Follow Up 4 years ± 3.6 Months Mean Preoperative Sphere Equivalent ± 3.78 Mean Preoperative Corneal astigmatism 1.45 ± 0.53 Mean Preoperative Refractive Astigmatism 0.95 ± 0.84 Toric IOLs Diopters Correction Range : 89.44% within 2 Diopters of Corneal Astigmatism ,85 48, ,56 1,00 D 1,5 D - 2,00 D > 2,00 D

$The History of Modern Multifocal IOLs 15 Years Developments Restor + 4 Sferical Bifocal IOL Alcon 2004 Restore + 4 Asferic Bifocal IOL Alcon 2005 ReZoom Refractive MIOL AMO ABBOTT 2004 TECNIS Bifocal$

7 The History of Modern Multifocal IOLs 15 Years Developments Restor + 4 Sferical Bifocal IOL Alcon 2004 Restore + 4 Asferic Bifocal IOL Alcon 2005 ReZoom Refractive MIOL AMO ABBOTT 2004 TECNIS Bifocal IOL AMO ABBOTT 2006 Restor +3 Bifocal IOL Alcon 2007 Acri Lisa Bifocal IOL Zeiss 2009 Acri Lisa Toric Bifocal IOL Zeiss 2010 Oculentis 2011 AT Lisa Trifocal IOL Zeiss 2012 Restor 2.5 Bifocal IOL Alcon 2013 AT Lisa Trifocal Toric IOL Zeiss 2013 CMA European Victori Study Coordinator Centre (Centre 01) Mini Well SIFI 2014 Synfony Extended Depth of Focus IOL AMO ABBOTT 2014 Panoptix IOL Alcon 2015 IC8 Pinhole IOL Acufocus 2015 Panoptix Toric IOL 2016 AT Lara Extended Depth of Focus IOL Zeiss 2017 AT Lara Toric Extended Depth of Focus IOL Zeiss 2018

$Technology Submitted and Approved for Distance, Intermediate and Near Vision Less Sensitive to Small Post Operative Refractive Errors Then Bifocal IOLs Best Technology for Clear Near Vision M.$ Piovella MD, S. Colonval MD A. Kapp MD, J. Reiter MD, F. Van Cauwenberge MD J.

Piovella MD, S. Colonval MD A. Kapp MD, J. Reiter MD, F. Van Cauwenberge MD J.

8 Trifocal, Extended Depth Of Focus (EDOF)and Pinhole IOLs Have Replaced Bifocal Multifocal Technology in Countries Where Are Available Depending the Different IOLs Technologies Trifocal IOLs IOLs Technology Submitted and Approved for Distance, Intermediate and Near Vision Less Sensitive to Small Post Operative Refractive Errors Then Bifocal IOLs Best Technology for Clear Near Vision M. Piovella MD, S. Colonval MD A. Kapp MD, J. Reiter MD, F. Van Cauwenberge MD J. Alfonso MD Patient outcomes following implantation with a trifocal toric IOL: twelve-month prospective multicentre study Nature, Eye, May 2018 Extended Depth Of Focus IOLs IOLs Technology Submitted and Approved Only for Distance and Intermediate Vision Less Sensitive to Small Post Operative Refractive Errors Due to Far Extended Depth of Focus Normally Need Glasses (+ 1 Diopter) for Comfortable Near Vision Pinhole IOLs IC8 Acufocus Pinhole Effect : No Need of Toric Correction Up to 2 Diopters Far Quality of Vision Based on Dominant Eye and Best Monofocal IOL No Far Monovision : Distance Vision at Least 20/25 with IC8 Implants Best IOLs After RK or in Presence of Aberrating Corneas H.Burkhard Dick, MD,PhD, Matteo Piovella, MD, John Vukich, MD, Srividhya Vilupuru, OD,PhD, Ling Lin, PhD Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery. J Cataract Refract Surg ;43: doi: /j.jcrs

After Bilateral Trifocal IOLs Implantation On July,3/4, 2014,The Quality of My Vision Has Improved Considerably I Have not Experienced Difficulties in Using a Surgical Microscope I Have not

$50 cyl axis 165 Left Eye AT LISA tri toric + 9.50 D +1.50 Toric D axis 71 Refractive Results Right Eye BCFVA 20/12.$

9 After Bilateral Trifocal IOLs Implantation On July,3/4, 2014,The Quality of My Vision Has Improved Considerably I Have not Experienced Difficulties in Using a Surgical Microscope I Have not Experienced Penalization in Dealing with Complex Surgical Maneuvers or Driving at Night My Near Vision Is Excellent My Personal Bilateral Cataract Surgery Management : Cataract Surgical Plan : Surgeon : Burkhard Dick Bochum - Germany J&J Catalys Femto Assisted Cataract Surgery Right Eye BCFV 20/25-8 sph Right Eye AT LISA tri D Left Eye BCFV 20/25-8 sph cyl axis 165 Left Eye AT LISA tri toric D Toric D axis 71 Refractive Results Right Eye BCFVA 20/12.5-0,50 Cyl 40 Left Eye BCFVA 20/16-0,25 Sph - 1,00 Cyl Cataract Live Surgery Demonstration Nov, SOI National Meeting Uncorrected Far Intermediate and Near Vision Results

10 Why I Decided to Implant Zeiss AT LISA tri and Toric IOLs in My Own Eyes I started to Implant Modern Multifocal IOLs Routinely in 2006 I Started Adopting Zeiss Bifocal IOLs Despite my Resistances in Adopting Plate Instead of Traditional C Haptic Because in 2010 It Was the Only IOL to Provide Toric Correction Zeiss AT LISA tri Was My First and Standard Choice for Presbyopia Correction Since Its Introduction in 2012 My Center Was the Monitor Centre for Multicenter Victory Study on Zeiss AT LISA tri Toric I Personally Measured Postoperative Refraction of All Patients Using the Most Advanced Technology to Detect The Gold Range ± 0.50 Diopters

700 130 Eyes (65 BILATERAL IMPLANT) WITH TRIFOCAL IOL 10,8 3,1 116 Eyes (58 BILATERAL IMPLANT)

11 Advanced Biometry is a Real Key Point Right Range : Sphere Equivalent Within - ±0.50 Sph IOL Master 700 Callisto System Advanced Technologies Adoption CALLISTO EYE IOL MASTER Eyes (65 BILATERAL IMPLANT) WITH TRIFOCAL IOL 10,8 3,1 116 Eyes (58 BILATERAL IMPLANT) WITH TORIC TRIFOCAL IOL 5,2 8,6 2 Eye In 1 Eye Out Both Eyes Out 2 Eye In 1 Eye Out Both Eyes Out 86,2 86,2

IMPLANT) WITH TRIFOCAL TECHNOLOGY 4,1 9,8 IOL MASTER 700 86,2 2 Eye In 1 Eye Out Both Eyes Out 96% OF

12 Advanced Biometry Outcome is a Key Point Right Range : Sphere Equivalent Within - ±0.50 Sph Avoid the Eye Cyclotorsion Effect Adopting IOL Master 700 and Callisto System 246 Eyes (123 BILATERAL IMPLANT) WITH TRIFOCAL TECHNOLOGY 4,1 9,8 IOL MASTER ,2 2 Eye In 1 Eye Out Both Eyes Out 96% OF PATIENTS IN THE RIGHT RANGE (Almost One Eye in the Right Range) 1.98 % OF ALL PATIENTS ADOPT GLASSES SOMETIMES FOR NEAR VISION CALLISTO EYE

$Clinical Indications, Patient and Eye Selection and Surgical Center Organization to Adopt Safely and Successfully Advanced Technology IOLs in Refractive Cataract Surgery : The Italian$ With Blocked Meibomian Glands Apply Treatments to Unblock the Excretory Ducts of Glands 3. Advanced Biometry: IOL Master 700 or Equivalent Technologies 4.

With Blocked Meibomian Glands Apply Treatments to Unblock the Excretory Ducts of Glands 3. Advanced Biometry: IOL Master 700 or Equivalent Technologies 4.

13 Clinical Indications, Patient and Eye Selection and Surgical Center Organization to Adopt Safely and Successfully Advanced Technology IOLs in Refractive Cataract Surgery : The Italian Ophthalmological Society (SOI) Report 1. Dry Eye and Meibomian Glands Disfunction(MGD) Management to Provide Healthy Cornea Surface 2. With Blocked Meibomian Glands Apply Treatments to Unblock the Excretory Ducts of Glands 3. Advanced Biometry: IOL Master 700 or Equivalent Technologies 4. Advanced Biometry Exam Performed Two Times Before and After MGD Management 5. Adopting Different Formulas and New IOLs Calculators Depending Axial Lenght or Previous Laser Vision Correction 6. Continuous Update of Costants 7. Callisto Markerless System or Equivalent Tecnologies to Overcome Eye Cyclotorsion : Avoid Toric IOLs Manual Alignment 8. Corneal Astigmatism Management : Apply Toric IOLs When 0.75 Diopter of Astigmatism is Detected 9. Target Postoperative Refraction : ±0.50 D or Emmetropia 10. Automated Mechanical Capsulotomy More Precise Then Capsulorhexis : It Reduces the Complications Rate of Refractive Cataracts 11. The Importance of an Indication Based Mainly on the Selection of the Eye and not on the Evaluation of the Habits or Requests of Patients 12. Preoperative Normal Convergence,Stereopsis and Near Vision 13. A New Surgical Center Organization 14. Professional Refraction Management

AT LISA Tri and Tri Toric Materials and Methods AT

Age 67.35 ± 10.28 Mean Preoperative BCVA 20/43 ± 38.

0 months ± 3 months Mean Preoperative Sphere

14 AT LISA Tri and Tri Toric Materials and Methods AT LISA trifocal technology implanted in 294 eyes Mean Age ± Mean Preoperative BCVA 20/43 ± Mean Time Follow Up 44.0 months ± 3 months Mean Preoperative Sphere Equivalent ± 1.98 AT LISA TRIFOCAL 839 MP IOL AT LISA TORIC TRIFOCAL 939 MP IOL

AT LISA Trifocal Technology Uncorrected Binocular VA Results : Distance Intermediate and Near Vision 142 patients (284 eyes) Uncorrected Binocular Distance Vision 20/20 Uncorrected Binocular

Month 3 Months UCDVA 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 41,30 Preop 21,20 21,83 20,05 21,00 20,60 22,00 21,90 20,00

15 AT LISA Trifocal Technology Uncorrected Binocular VA Results : Distance Intermediate and Near Vision 142 patients (284 eyes) Uncorrected Binocular Distance Vision 20/20 Uncorrected Binocular Intermediate Vision 20/20 Uncorrected Binocular Near Vision 20/24 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 67,00 Preop 20,48 21,03 20,10 20,05 20,00 19,99 20,80 20,10 1 Month 3 Months UCDVA 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 41,30 Preop 21,20 21,83 20,05 21,00 20,60 22,00 21,90 20,00 1 Month 3 Months UCIVA 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 58,00 Preop 25,00 23,90 25,10 25,00 24,10 25,00 26,00 24,00 1 Month 3 Months UCNVA 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years

AT LISA Toric Trifocal Technology Uncorrected Binocular VA Results : Distance Intermediate and Near Vision 58 patients (116 eyes) Uncorrected

180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 72,10 Preop 21,20 21,99 20,46 20,05 20,00 19,80 20,10 20,00 1 Month 3 Months 6

21,20 21,00 20,80 22,00 22,00 20,41 1 Month 3 Months 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00

16 AT LISA Toric Trifocal Technology Uncorrected Binocular VA Results : Distance Intermediate and Near Vision 58 patients (116 eyes) Uncorrected Binocular Distance Vision 20/20 Uncorrected Binocular Intermediate Vision 20/20 Uncorrected Binocular Near Vision 20/24 UCDVA UCIVA UCNVA 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 72,10 Preop 21,20 21,99 20,46 20,05 20,00 19,80 20,10 20,00 1 Month 3 Months 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 41,30 Preop 21,20 21,83 21,20 21,00 20,80 22,00 22,00 20,41 1 Month 3 Months 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years 200,00 180,00 160,00 140,00 120,00 100,00 80,00 60,00 40,00 20,00 0,00 45,00 Preop 25,00 24,99 24,00 24,10 23,82 25,00 24,70 24,00 1 Month 3 Months 6 Months 1 Year 2 Years 3 Years 4 Years 5 Years

17 70 % of Our Cataract Patients Were Implanted with Trifocal IOLs Since % of Our Patients Were Implanted with Trifocal IOLs in Year % of Our Patients Were Implanted with Trifocal IOLs in Year % of Our Patients Were Implanted with Presbyopic IOLs in Year %(2015) - 44%(2016) - 51%(2017) of These Groups Were Implanted with Trifocal Toric IOLs Personalized Advanced Biometry Was Applied in All Patients

Communication and Path of The Patient 1 3 5 2 4 FIRST CONTACT SECRETARY TECHNICAL STAFF EYE DOCTOR FOLLOW UP Phone Email Person Website Check

18 Communication and Path of The Patient FIRST CONTACT SECRETARY TECHNICAL STAFF EYE DOCTOR FOLLOW UP Phone Person Website Check in Demographic General informations Diagnostic Information (dilation) Medical Examination Raccomendations Maintenance contact with The Patient

19 Thank you for your attention

Options for Presbyopia. Choice of Lenses

Options for Presbyopia. Choice of Lenses Options for Presbyopia Multifocal IOL Multifocal IOL s MIX AND MATCH GERMAN CATARACT & REFRACTIVE MEETING Heidleberg 2008 John Chang, MD Director of Guy Hugh Chan Refractive Surgery Centre Hong Kong Sanatorium