EDOF-IOLs: Are they all the same?

Gerd.Auffarth@med.uni-heidelberg.de www.ivcrc.com www.djapplelab.com EDOF-IOLs: Are they all the same? G. U. Auffarth International Vision Correction Research Centre (IVCRC), The David J. Apple International Laboratory for Ocular Pathology Department of Ophthalmology, Ruprecht-Karls-University of Heidelberg Chairman: G. U. Auffarth, MD, PhD, FEBO

IVCRC / DJ Apple Laboratory: Financial Disclosure 2017/2018 Acufocus 1 Alcon/Novartis 1,2,3,4 Alimera 1,2 Allergan 2,3,4 AMO/Johnson&Johnson 1,2,3,4 Bausch+Lomb 2,3 Carl Zeiss Meditec 1,2,3 Contamac 1 Glaukos 1,2,3 Hoya 1,2,3 HumanOptics 1,3 Kowa 1,2,3 LENSAR 1 Oculentis 1,2,3 Oculus 1,2,3 Ophtec 1 Physiol 1 Polytech 2,3 Powervision 1 Presbia 2,3,4 Rayner 1,2,3 RxSight 4 SIFI 1,2,3 Ursapharm 1,2,3 1 = Research Grants; 2 = Travel Expenses; 3 = Lecture Fees; 4 = Consulting

What are we measuring in EDOF? Near /Intermediate Visual Acuity? Defocus curve (subjectively)? Only Intermediate Visual Acuity? Through Focus Scan/ Defocus curve (Objectively)?

EDOF/EROV IOLs IOLs with mit verbesserter enhanced depth Tiefenschärfe of focus Tecnis Symfony EROV IOL (AMO, USA) Tecnis Symfony EROV IOL (Abbott, USA) Gesamt Ø 13.00 mm Optik Total Ø diameter 6.013.00 mm mm Design Optic diameter 1-stückig 6.00 mm Optik Design asphärisch, 1-piece achromatisch, Optic diffraktiv, aspherical, Echelette achromatic, Design Optikmaterial diffractive, hydrophobes Echelette design Acrylat Optic material hydrophobic acrylic Mini Well Ready (SIFI, Italy) Italien) Gesamt Total diameter Ø 10.75 10.75 mm mm Optik Ø 6,0 mm Optic diameter 6.00 mm Design 1-stückig Design 1-piece Optik Bkonvex, progressive, multifokal, Optic asphärisch biconvex progressive Optikmaterial hydrophiles multifocalacrylat aspherical Copolymer Optic material hydrophilic acrylic

EDOF/EROV IOLs IOLs with mit verbesserter enhanced depth Tiefenschärfe of focus Tecnis IC-8 Small Symfony Aperture EROV IOL (Acufocus, IOL (AMO, USA) USA) Gesamt Total diameter Ø 13.00 12.50 mm mm Optik OpticØ diameter 6.06.00 mm mm Design 1-stückig 1-piece Optik Optic asphärisch, Small aperture achromatisch, dimensions diffraktiv, 1.36 mm Echelette aperture Design Optikmaterial hydrophobes 3.23 mm total Acrylat diameter Optic material hydrophobic acrylic Mini LS 313 Well MF15 Ready Lentis (SIFI, Comfort Italien) (Oculentis, Germany) Gesamt Total diameter Ø 10.75 11.00 mm mm Optik Ø 6,0 mm Optic diameter 6.00 mm Design 1-stückig Design 1-piece Optik Bkonvex, progressive, multifokal, Optic asphärisch asymmetrical, sector Optikmaterial hydrophiles shaped refractive Acrylat Copolymer +1.5 Dpt. near addition Optic material hydrophilic acrylic

Visualising Optical Pathway of EDOF IOLs* *Data on file and Copyright: The David J Apple International Laboratory for Ocular Pathology, Dept. of Ophthalmology, University of Heidelberg, Germany PP2016CT1473

Visualising Optical Pathway of EDOF IOLs* *Data on file and Copyright: The David J Apple International Laboratory for Ocular Pathology, Dept. of Ophthalmology, University of Heidelberg, Germany

Visualising Optical Pathway of EDOF IOLs* Miniwell Ready Symfony ZXR00 Lentis 313 MF15 AT Lara 829 MP *Data on file and Copyright: The David J Apple International Laboratory for Ocular Pathology, Dept. of Ophthalmology, University of Heidelberg, Germany

EDOF-Concept Echelette design feature Achromatic technology + Symfony Mini Well

Extended Range of Vision IOL: Tecnis Symfony Prospective Cases series Aim: Analysis of functional outcome after bilateral implantation of the Tecnis Symfony Methods: 40 Centres worlswide 411 Eyes in 2 Groups: Micro-Monovision vs. Non-Monovision Clinical evaluation: Pre-OP and 4-8 weeks Post- OP Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sept;42(9):1268-1275

Extended Range of Vision IOL: Tecnis Symfony Mean UDVA: 0.95 in both groups, 0.94 in Micro-Monovision, 0.95 in Non-Monovision (p=0.485) Mean UIVA: 0.82 in both groups, 0.88 in Micro-Monovision, 0.79 in Non-Monovision (p=0.003) Mean UNVA: 0.69 in both Groups, 0.74 in Micro-Monovision, 0.67 in Non-Monovision (p=0.011) Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sept;42(9):1268-1275

Extended Range of Vision IOL: Tecnis Symfony Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sept;42(9):1268-1275

Extended Range of Vision IOL: Tecnis Symfony Halos: No to Mild 90.3% in both groups, 87.0% in Micro-Monovision, 91.6% in Non-Monovision Glare:No to Mild 93.0% in both groups, 96.0% in Micro-Monovision, 91.9% in Non-Monovision Starbust:No to Mild 97.3% in both groups, 96.4% in Micro-Monovision, 97.6% in Non-Monovision Cochener B; Concerto Study Group. Clinical outcomes of a new extended range of vision intraocular lens: International Multicenter Concerto Study. J Cataract Refract Surg. 2016 Sept;42(9):1268-1275

SIFI Mini Well Ready

Optical Concept SIFI Mini Well Ready +W (μm) -W (μm)

Defocus: SIFI Mini Well Ready MiniWell EDOF IOL Multifokale (diffraktive) IOL Monofokale IOL

Visual Acuity: Mini Well EDOF IOL* Prospective non-randomized clinical study, EC approval 27 eyes of 14 patients Preoperative SE: Median 0.50 D (range: -7.75 to 4.88 D) *Data on file: International Vision Correction Research Centre (IVCRC), : Presented ESCRS 2016

Enhanced Depth of Focus IOLs Performance: Intermediate Vision and Reading ability Evaluation with Salzburg Reading Desk (SRD)

Methods: Salzburg Reading Desk (SRD) Objective Evaluation of Reading Performance

SRD: Symfony / MiniWell EDOF IOL* Symfony Median uncorrected binocular (n=13) Near (40cm) Preferred Near Intermediate (80cm) Preferred Intermediate Visual Acuity (logmar) 0.10 0.13 0.11 0.11 Distance (cm) 40.30 39.50 79.20 62.80 Mini Well Letter Size (log-scaled) 1.25 1.25 1.25 1.00 Median distance-corrected binocular (n=13) Near (40cm) Preferred Near Intermediate (80cm) Preferred Intermediate Visual Acuity (logmar) 0.21 0.19 0.10 0.12 Distance (cm) 40.30 38.90 79.40 60.00 Letter Size (log-scaled) 1.50 1.50 1.25 1.00 *Data on file: International Vision Correction Research Centre (IVCRC), :Presented ESCRS 2016

Enhanced Depth of Focus IOLs Performance: Defocus curves

Results: Defocus Curve* Mini Well EDOF IOL 2.25 Dpt 3.0 Dpt 1.8 Dpt 2.7 Dpt Symfony EDOF IOL *Data on file: International Vision Correction Research Centre (IVCRC),

Enhanced Depth of Focus IOLs Side effects: Halo & Glare

Halo & Glare Simulator* Screenshot of patient s exam with Halo & Glare Simulator (Eyeland Design Network, Vreden, Germany) *Data on file: International Vision Correction Research Centre (IVCRC), : Presented ESCRS 2016

Results: Perception Halo Type of Halos* 100% 90% 80% Halo Type 70% 60% 50% 40% Starburst Halo None 30% 20% 10% 0% Miniwell Z7560CZ n=14 Symfony ZXR00 n=7 Panop x TFNT00 n=10 Aspira MC 6125 AS n=12 EDOF EDOF TRIFOCAL MONOFOCAL *Data on file: International Vision Correction Research Centre (IVCRC), : Presented ESCRS 2016

Results: Representation of Mean Values* *Data on file: International Vision Correction Research Centre (IVCRC), : Presented ESCRS 2016

Results: Representation of Maximum Values* *Data on file: International Vision Correction Research Centre (IVCRC), : Presented ESCRS 2016

IC-8 Extended Depth of Focus IOL Optic Design Single piece hydrophobic acrylic 6.00 mm optic diameter 12.50 mm overall diameter Mask PVDF & nano-particles of carbon 1.36 mm aperture 3.23 mm total diameter 3200 microperforations 5 microns thick A-constant: 120.5 Diopter Range: +20.0 D to +27.5 D (Equivalent to +18.0 D with a typical lens due to A-constant) Injector System 3.5 mm incision for capsular bag insertion, non-folding, single use 28

AcuFocus IC-8 IOL +2.0 D +1.0 D 0.0 D -1.0 D 21.0 D -2.0 D 11979-2 ISO Standard Bench testing by The Pilot Group 29

AcuFocus IC-8 IOL: Prospective Multicentre Trial* Results: The study comprised 105 patients. At 6 months, the UDVA, UIVA, and UNVA in eyes with the small-aperture IOL were 20/23, 20/24, and 20/30, respectively. Ninety-nine percent, 95%, and 79% of patients achieved 20/32 or better binocular UDVA, UIVA, and UNVA, respectively. *Dick HB, Piovella M, Vukich J, Vilupuru S, Lin L.Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery. J Cataract Refract Surg. 2017 Jul;43(7):956-968

AcuFocus IC-8 IOL: Prospective Multicentre Trial* *Dick HB, Piovella M, Vukich J, Vilupuru S, Lin L.Prospective multicenter trial of a small-aperture intraocular lens in cataract surgery. J Cataract Refract Surg. 2017 Jul;43(7):956-968

Case: Male, 72 years old Diagnosis: OD/OS Hyperopia, Cataract OS: Pterygium, irregular Astigmatism Pre-OP Prescription: OD +3,25-0,75 076= 0,50 OS +3,75-0,75 123= 0,32 Patient wish for spectable independence

Case: Male, 72 years old OD/OS: FLACS (LensX) with implantation of: OD: Oculentis Mplus 20 OS: Acufocus IC-8

Case: Male, 72 years old

Case: Male, 72 years old Post-OP OD (1w) OS (1w) BIN UDVA 0,8 0,63++ 0,8-1,0 Refraction -0,50 sph -0,50-1,0 165 BCDVA 0,8 0,8 1,0 UNVA 0,63 0,5 0,63 Post-OP OD (1-2m) OS (1-2m) BIN UDVA 0,8 0,8 1,0 Refraction 0,25-0,5 160-0,25-1,0 140 BCDVA 1,0 1,0 1,25 UNVA 0,63 0,8 0,8

Lentis Comfort LS-313 MF15, Oculentis) Segmental refractive MIOL with Near Add of +1.50 D LS-313 MF15 Optic Design Material Near addition Optic size Overall length Available Diopters Aspherical surface posterior, sectorshaped nearvision segment anterior Optic and haptics with square edges, posterior 360 continuous barrier effect Copolymer consisting of acrylates with hydrophobic surface, UV absorbing +1.5 D 6.0 mm 11.0 mm -10.0 D to -1.0 D (1.0 D increments) ±0.0 D to +36.0 D (0.5 D increments)

Prospective clinical Study LS-313MF15 Visus UDVA [logmar] CDVA [logmar] UNVA [logmar] DCNVA [logmar] CNVA [logmar] Nah add [D] UIVA [logmar] DCIVA [logmar] CIVA [logmar] Präoperative Postoperative Median 0.41 0.25 - - - - - - - Min 1.30 0.60 - - - - - - - Max 0.04 0.06 - - - - - - - Median -0.01-0.07 0.43 0.45 0.03 2 0.16 0.18 0.05 Min 0.16 0.10 0.68 0.64 0.20 1.25 0.34 0.40 0.20 Max -0.14-0.22 0.16 0.16-0.12 3 0.04 0.02-0.10 Salzburg Reading Desk (uncorrected) Salzburg Reading Desk (diostance corrected) Subj. Near Intermediate 80 cm Subj Near Intermediat e 80 cm Near 40 cm Subj. Intermediate Near 40 cm Subj. Intermediate

Refractiv-segmental-multifokal (Low Add) Nahaddition + 1,5 Dpt. Defocus curve Oculentis MF15

Summary: EDOF IOLs Clinical results show excellent postoperative visual acuity both for distance and intermediate vision as well as good near visual acuity. High degree of Patient satisfaction. Very low incidence of optical phenomena (halos, glare) especially for Mini Well EDOF IOL reported. Refractive tolerance to sub 1.0 Dpt astigmatism or spherical ametropia with the Tecnis Symfony IOL and IC-8 IOL

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