Trust your eyes. Presbyopic treatment methods on the cornea. PresbyMAX Decision criteria and patient s acceptance

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Trust your eyes. Directory Presbyopic treatment methods on the cornea PresbyMAX The Principle PresbyMAX Expectations and Key Factors PresbyMAX Decision criteria and patient s acceptance PresbyMAX Upcoming Software Features 1

Introduction and Basics: Visual Acuity and Object Distance related to Age 120% Visual Acuity (%) 100% 80% 60% 40% Emmetrope 25yo Emmetrope 45yo Emmetrope 55yo The average distance (more than 1 m) visual acuity in emmetropes until 45 years of age is high, the senior population shows diminished performance. 20% 120% 0% 0 1 2 3 4 5 6 7 8 Object distance (m) 100% 80% The average (less than 1 m) visual acuity in emmetropes until 40 years of age is ok, the senior population shows diminished performance. Visual Acuity (%) 60% 40% 20% Emmetrope 25yo Emmetrope 45yo Emmetrope 55yo 0% 0,00 0,10 0,20 0,30 0,40 0,50 0,60 0,70 0,80 0,90 1,00 Object distance (m) Introduction and Basics: Monovision Advantage/Comfort Disadvantage/Discomfort Clear focus, i.e. sharp retinal image Anisometropia (more than 1 D) Highly accept in patients and physicians Loss in stereopsis Independent from pupil size intermediate N 2

Introduction and Basics: Bi-Focality Advantage/Comfort Clear foci; i.e. two sharp images on the retina Disadvantage/Discomfort Disturbing vision because of steps between zones Does typically not cover the whole distance range, especially not the intermediate part Pupil size critically dependent OR intermediate N Introduction and Basics: Q-value adjusted Advantage/Comfort Extended depth-of-focus The Q-value describes the shape between the cornea centre and periphery Disadvantage/Discomfort The Q-value is no predictor for visual performance Influenced by the change in radius of curvature (dioptric power); i.e. kind of unpredicted Unilateral (non-dominant eye) intermediate 3

Introduction and Basics: Multifocality Advantage/Comfort Covers the whole distance range due to different foci for distance, intermediate, Typically bilateral which keeps stereopsis Disadvantage/Discomfort Pupil size dependent Time of (neural) adaptation Possibly reduced contrast sensitivity OR intermediate N SCHWIND PresbyMAX vs. Competing Multifocal Technologies micro-monovision (ZEiSS) Aspheric (Nidek) PresbyMAX PresbyMAX µ-monovision Dominant Eye Non-dominant Eye intermediate 4

SCHWIND PresbyMAX vs. Competing Technologies Monovision AMO VISX CustomVue Presbyopia Technolas PV Supracor Nidek PAC Aspheric ZEiSS Laser Blended Vision Alcon Wavelight Q-value adjusted SCHWIND PresbyMAX SCHWIND PresbyMAX µ- monovision N N N N N N N N Far (>5m) Intermediate (70cm) Near (40cm) Alternative Presbyopic Solutions: IntraCOR Intrastromal presbyopia treatment using photodisruption with the Technolas femtosecond Five rings (1.8, 2.2, 2.6, 3.0 and 3.4 mm in diameter) are created Cutting design and stromal depth based on refractive error A shift towards myopia exists due to central corneal steepening (hyper-prolate shape) Advantage/Comfort Fast visual recovery Minimally invasive Disadvantage/Discomfort No refractive correction procedure, i.e. for emmetropes only No reverse application or re-treatment No tissue removal Difficulties in post-lasik patients exist Difficulties for LASIK post-intracor 5

Alternative Presbyopic Solutions: Corneal Inlay Intracorneal inlays have been designed to create a small aperture effect or central steepening. The implant is intended to be placed intra-stromally either under a corneal flap or into a corneal pocket. Placement of the CI will be centered over the pupil, typically in the non-dominant eye. I. The AcuFocus Kamra corneal inlay (US): Ø 3.8 mm, 10 µm thick, central opening of Ø 1.6 mm, thousands of small laser openings for good corneal nutrition transport II. Flexivue Micro-Lens (NL): clear circular implant of Ø 1.5 mm, 10 µm thick in the periphery, increase of 24 to 40 µm to the centre, out of hydrogel (hydrophilic polymer) III. PresbyLens (US): clear circular implant of Ø 2 mm like a tiny contact lens out of hydrogel Advantage/Comfort Easily removed or replaced Increased depth-of-focus without tissue removal Disadvantage/Discomfort No refractive correction procedure, i.e. for emmetropes only Really fast recovery PresbyMAX - Unique Treatment Range Before PresbyMAX With PresbyMAX Limited treatment range e.g. only hyperopic patients e.g. only patients with minor astigmatism e.g. no presbyopia treatment of emmetropic or myopic patients e.g. only in combination with standard treatments e.g. only in combination with wavefront guided treatments Presbyopia software that offers a broad treatment spectrum for different indications: Treatment of emmetropic, myopic, hyperopic, and astigmatic eyes Correction of these visual defects can be performed as Aberration-Free or Customized treatments Any treatment method possible: PRK, TransPRK, LASEK, LASIK and FemtoLASIK 6

PresbyMAX - The Principle extended depth-of-focus PresbyMAX multiaspheric cornea PresbyMAX pseudo--point foveola PresbyMAX pseudo--point Introduction and Basics: Visual Acuity Scales Distance Visual Acuity Scales Near Visual Acuity Scales logmar feet 20/ decimal -0.2 10 1.60-0.1 12.5 1.25 0.0 20 1.00 0.1 25 0.80 0.2 32 0.63 0.3 40 0.50 0.4 50 0.40 0.5 63 0.32 0.6 80 0.25 0.7 100 0.20 0.8 125 0.16 0.9 160 0.13 1.0 200 0.10 lograd (40 cm) Revised Jaeger (35 cm) Nieden (40 cm) -0.2 - - -0.1 - N1 0.0 J1: = 1.00 N2 0.1 J2: = 0.80 N3 0.2 J4: = 0.63 N4 0.3 J5: = 0.50 N5 0.4 J6: = 0.40 N6 0.5 J8: = 0.32 N7 0.6 J9: = 0.25 N8 0.7 J10: = 0.20 N9 0.8 J12: = 0.16 N10 0.9 J13: = 0.13 N11 1.0 J14: = 0.10 N12 7

PresbyMAX - Expectations Reading Acuity vs. Print Size» 0.8 lograd (J12; 20/125) 20 Pt @ 40 cm» 0.7 lograd (J10; 20/100) 18 Pt @ 40 cm» 0.5 lograd (J8; 20/63) 12 Pt @ 40 cm» 0.4 lograd (J6; 20/50) 10 Pt @ 40 cm normally suffices to clearly recognize newspaper print in well lit conditions» 0.2 lograd (J4; 20/30) 6 Pt @ 40 cm Pupil 3.0 mm 3.8 mm 4.5 mm 5.5 mm Far (6 m) Far Intermediate (1.5 m) Intermediate (70 cm) Near (40 cm) 8

Visual Acuity after PresbyMAX related to different Pupil Sizes Visual Acuity as a function of the object distance 100% 90% 80% 70% Visual Acuity (%) 60% 50% 40% PresbyMAX V2 +3D (6 mm) PresbyMAX V2 +3D (3,8 mm) PresbyMAX V2 +3D (2 mm) 30% 20% 10% 0% 0,000 0,101 0,20 2 0,30 30,40 0,50 4 0,60 5 0,70 6 0,80 0,90 7 1,00 8 Object distance (m) Visual Acuity after PresbyMAX related to different Additions Visual Acuity as a function of the object distance 120% 100% As a compromise between multifocality, distance and UCVAs, consider planning additions between 1.25 D to 2.50 D Visual Acuity (%) 80% 60% 40% Emmetrope (55 yo) PresbyMAX V2 +2D (50 yo) PresbyMAX V2 +3D (60 yo) 20% 0% 0,00 0 0,10 1 0,20 2 0,30 30,40 0,50 4 0,60 5 0,70 6 0,80 0,90 7 1,008 Object distance (m) 9

PresbyMAX - Expectations Uncorrected Visual Acuity over time 10 15 DUCVA (20/n) NUCVA (Jm) 1 DUCVA (20/n) 20 25 30 2 NUCVA (Jm) 35 40 0 1 2 3 4 5 6 7 8 9 10 11 12 Follow-up time (months) The postoperative progress behaves in all refraction types similar but the acceptance patient by patient may differ. 3 PresbyMAX - Key Factors for Success Patients with positive thinking preoperatively knowing that reduced distance vision postoperatively (DBCVA pre-op vs. UCVA post-op) may occur. Trial with multifocal contact lenses (centre for, periphery for distance) could be done prior to surgery or easier, even if no influence/effect in multifocality (SphAb) can be demonstrated, simulate a vision of 1 to 2 lines less than BSCVA and ask for the postoperative acceptance (e.g. simulate distance refraction 0.25 to 0.50 D less than BCVA to the patient; simulate refraction with addition +0.25 to +0.50 less than BCVA to the patient). Most satisfied patients are hyperopes, then high astigmatics, then high myopes, then emmetropes, then low myopes. 10

PresbyMAX - a possible Trial Contact Lens CibaVision AirOptix Aqua Multifocal aus AirOptix Kontaktlinsen Broschüre PresbyMAX - Key Factors for Success Exports are done for selected OZ» between 5.8 and 6.3 mm (~6.0 mm) in presbyopic myopia,» between 6.2 and 6.7 mm (~6.5 mm) in presbyopic hyperopia,» between 6.5 and 7.0 mm (~6.8 mm) in presbyopic astigmatism dominance Make sure the ablation map is large enough for the scotopic pupil size. Do both eyes simultaneously since otherwise the binocular vision will suffer from the multifocality on only 1 eye (anisometropia and aniseikonia). Perform treatments on the corneal vertex to reduce induction of coma aberrations disturbing vision at all distances. 11

PresbyMAX - The Principles Targets for the Central and Mid-Peripheral Areas Dominant Eye Non-dominant Eye PresbyMAX -0.5D -1.75D 0.0D -1.75D -0.5D with µ-monovision -0.125D -1.0D 0.75D -1.75D -0.875D PresbyMAX The Software Solution V4.4: Hyp.Astigmatism 12

PresbyMAX The Software Solution V4.4: Myo.Astigmatism PresbyMAX with µ-monovision The Software Solution V4.4: Hyp.Astigmatism 13

PresbyMAX - The Presbyopic Compensation SCHWIND PresbyMAX proposes a presbyopic compensation based on the age of the patient. Addition as a function of age 4,00 3,50 3,00 Addition (D) 2,50 2,00 1,50 Addition Model PresbyMAX 1,00 0,50 0,00 25 30 35 40 45 50 55 60 65 70 75 Age (years old) PresbyMAX - Guide SCHWIND Recommendation Document 14

Re-treatment Options PresbyMAX can be repeated if reading-spectacles demands renew. PresbyMAX can be repeated if reading quality (multifocality) is not sufficient but distance vision is satisfying. Aberration-Free treatment (with equal optical zone size to previous PresbyMAX procedure) can be performed on top for improved distance correction if reading quality (multifocality) is satisfying. PresbyMAX Reversal option with distance best corrected refraction included can be performed if the patient does not accept the PresbyMAX concept at all (too much compromise for the individual). Due to healing process and neuronal adaptation, a re-treatment procedure shall not be performed prior 6 months after surgery. PresbyMAX The Reversal Concept 15

PresbyMAX after Previous Refractive Surgery Previous Corneal Refractive Surgery (with the aim of emmetropic distance vision) Decision shall be equal to patients with virgin corneae. Futhermore, the SCHWIND decision tree for Aberration-Free, Corneal and Ocular Wavefront treatments might be considered Previous cataract surgery (natural lens exchange) Multifocal enhancement can be performed on the patient s cornea. Intraocular Surgery after PresbyMAX Aspheric IntraOcular Lenses: Properly calculated aspheric lenses (in the sense of aberration-neutral) after PresbyMAX provide the best quality of vision without compromising the already achieved pseudoaccommodation. (No decentration and tilting of the IOL and correct IOL power assumed) Spheric IntraOcular Lenses: Spheric Ienses induce positive spherical aberration and thus would remove in part or in total the already achieved pseudo-accommodation. Multifocal IntraOcular Lenses: Multifocal (refractive, diffractive, or accommodative) lenses induce negative spherical aberration and multiple foci and thus would enhance the already achieved pseudoaccommodation. But centration issues of the lenses become critical and may induce large amounts of coma from the misalignment between the PresbyMAX multifocal cornea and the multifocal IOL. 16

Thank you very much for your kind attention! Vielen Dank für Ihre Aufmerksamkeit! Muchas gracias por su amable atención! SCHWIND eye-tech-solutions fon: +49(0)6027 / 5 08-0 fax: +49(0)6027 / 5 08-208 email: apm@eye-tech.net internet: www.eye-tech-solutions.com SCHWIND eye-tech-solutions GmbH & Co. KG Mainparkstrasse 6-10 63801 Kleinostheim Germany 17