The “Extended Range” of IOL Options LLUEI Fall 2017 Optometry Symposium

Michael Rauser, M.D. Chair and Associate Professor

Lens Implantation Options

• Cataract surgery is now considered part “refractive procedure”.

• Options exist to reduce or eliminate the need for glasses in many patients

Physician History •Completion of Medical History Form

– Assesses patient’s desire for eyeglass independence

– Prioritizes visual needs and desires •Activity of Daily Living difficulties

– Driving – Reading / sewing – Computer use – Unique occupational needs – Unique hobbies

•If myopic – reads without glasses?

Physician History • Diabetics

– Duration – H/O laser treatment or surgery

• Retinal Surgery – ? Post PPV – higher intraoperative PC tear rate

• Previous eye surgery – Esp. refractive - RK / PRK / LASIK – if yes- ?old

records available

• Eye trauma • Males - Prostate med hx ( Flomax, etc)

Physician History

• Contact lens use ( current or previous) – Single vision distance ( RGP or soft) – Monovision employed? Which eye near? – Bifocal contacts

Current IOL Choices • Monofocal IOL’s

– Provide one zone of focus • Distance or near can be chosen

– 100% covered by insurance • Lifestyle IOL’s- Designed to reduce need for eyeglasses after surgery “Cosmetic Upgrade” not covered by insurance ? Femtosecond upgrade ? Ora use

Cataract Surgery – Monofocal – IOL Choices

• Acrylic IOLs are the lens of choice in diabetics with significant retinopathy, or significant retinal pathology – High Myopes. Previous PPV, potential PPV in future

• AMO Tecnis • Alcon SN60WF ( blue-blocker) • Alcon SA60WF • Alcon SA60AT • Alcon MA60AC

– Least postop inflammation – Safe with silicone oil in vitreous

“Lifestyle” IOL Choices 1. Toric IOL’s - reduce astigmatism

1.Alcon 2.AMO 3.Staar 4.Bausch and Lomb

2. Multifocal Lenses – multiple focus zones • Restor IOL’s ( + Toric version)

– 3 “levels” of best near point of focus) • Tecnis Multifocal IOL’s ( + Toric version)

3. Symfony AMO extended focus IOL’s 4. Accommodative IOL’s

- Crystalens ( + Toric version)

Additional Testing for Lifestyle IOL patients – Corneal Topography

• Confirm amount and axis of astigmatism – R/ O irregular

astigmatism / Keratoconus

Pentacam Measures both

anterior and posterior corneal surface

Additional Testing for Lifestyle IOL Patients – Retina OCT

– R/O macular disease

• AMD • Epiretinal

membranes • Vitreomacular

traction • Diabetic Macular

Edema

Alcon Toric IOL

• In September of 2005 the FDA approved the use of the Alcon Toric Intraocular Lens

Alcon SN6AT Series- Toric IOL • Based on SN60WF

platform • > 1 – 4 diopter of Corneal

astigmatism • SN6AT3 - T9 • Potential visual acuity?

– No defined VA target – ? Better than 20/100?

• Desire for eyeglass independence in one zone ( distance or reading) – OK to target myopes at -2.5

to -3 with toric IOL’s • Least postop rotation =

best stability of toric IOLs

TECNIS® Toric IOL: Specifications

• Wavefront-designed anterior toric aspheric surface

• +5.0 D to +34.0 D in 0.5 D increments

Lens Model ZCT150 ZCT225 ZCT300 ZCT400

Cylinder Powers 1.50 D 2.25 D 3.00 D 4.00 D

Corneal Plane* 1.03 D 1.55 D 2.06 D 2.74 D

Corneal Astigmatism Correction Range (Preop Kcyl + SIA)

0.75–1.50 D

1.50–2.00 D

2.00–2.75 D

2.75–3.62 D

*Based on average pseudophakic human eye.

Represents diopter range of patients treated with each lens model in the IDE clinical study.

2013.07.12-CT7205

Restor Multifocal IOL

• Provides Distance, Intermediate, and Near vision correction without glasses

• Need normal macula and optic nerve function – No significant diabetic retinopathy, no macular

degeneration • Primary side effect – halo symptoms at

night ( due to rings on IOL) • Reading vision is light dependent

Restor IOL Ideal Candidate:

– Love to read ; minimal night driving ; enjoy computer use

– Strong desire to be eyeglasses independent

– Now 3 versions : • SN6AD3 – effective 3.0 Add (J1+) • SN6AD1** – effective 2.25 Add

(J1) – Better intermediate range

• SV25T0** – distance and intermediate IOL (J2-3)

** Toric option exists

– Reading is light dependent

31

Binocular Defocus Curve

Refraction (D)

IQ ReSTOR® IOL +3.0 D [N=117] IQ ReSTOR® IOL +4.0 D [N=114]

∞

20/25

20/32

20/40

20/50

20/63

20/80

20/100

20/20

+1.00 +0.50 0.00 -0.50 -1.00 -1.50 -2.00 -2.50 -3.00 -3.50 -4.00

Snel

len

Source: AcrySof® IQ ReSTOR® IOL Package Insert

RES15034SK

Now you can take distance vision one step further. The new AcrySof® IQ ReSTOR® +2.5 D IOL is designed to deliver sharp distance vision for your more active-lifestyle patients. Its new ACTIVEFOCUS™ design is an apodized diffractive optic with fewer steps, a central refractive zone for distance and increased negative asphericity.** Now you can offer an excellent balance of vision for your active lifestyle patients.

* Active lifestyle patients participate in activities that require intermediate and distance vision such as golf, tennis, theatre, and driving. **Compared to models SN6AD1, SN6AD3 and MN6AD1

18

RES15034SK

SV25T0 AcrySof IQ ReSTOR +2.5 D

SV = Sharp Vision 25 = +2.5 D add T = Toric 0 = Zero astigmatic correction

19

RES15034SK 20

Who is this lens for?

Aspheric Monofocal

AcrySof® IQ IOL Aspheric Apodized

Diffractive Multifocal ReSTOR® +2.5 D IOL

Aspheric Apodized Diffractive Multifocal

ReSTOR® +3 D IOL

The ReSTOR® +2.5 Patient •Patients with an active lifestyle that demands more intermediate

(53cm/21in) and distance (4m/13ft) vision* •Not willing to compromise distance for a full range

•Desires more opportunity for a range of vision versus monofocal •Desires increased spectacle independence at 21 inches and

beyond • Patient understands that +1.00 reader may be needed for 16-20

inches (40-50cm)

* Active lifestyle patients participate in activities that require intermediate and distance vision such as golf, tennis, theatre, and driving. **C d t d l SN6AD1 SN6AD3 d MN6AD1

RES15034SK 21

Who is this lens for?

Aspheric Monofocal

AcrySof® IQ IOL Aspheric Apodized

Diffractive Multifocal ReSTOR® +2.5 D IOL

Aspheric Apodized Diffractive Multifocal

ReSTOR® +3 D IOL

The +3.0 Patient • Broad range of vision

• Balance of activities at near, intermediate, & distant focal points

• Patient Seeks true performance at all distances from multifocal capabilities: desires full range of vision from 16 inches (40 cm) to distance with greatest

opportunity of spectacle independence at all distances

RES15034SK

Patients implanted with AcrySof® IQ ReSTOR® +2.5 D IOLs experienced 3.3% severe glare. Patients implanted with AcrySof® IQ Monofocal IOLs experienced 3.8% severe glare.

22

Visual Disturbances1

1. AcrySof® IQ ReSTOR® +2.5 Directions for use.

Tecnis® Multifocal IOL

• Pupil Independent1

• Balanced for near and far regardless of light conditions2

• Quality near image in low light3

1, 2, 3. Tecnis® Multifocal DFU

TECNIS® Multifocal IOL

TECNIS® Multifocal intraocular lenses are indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lenses are intended to be placed in the capsular bag.

2013.07.12-CT7205

Intermediate Vision

• TECNIS® Multifocal IOL provides intermediate vision:

• High-quality visual acuity at near and distance focal points allow better depth of focus and therefore better vision in the intermediate range*

• Clinical data support intermediate vision: – Spectacle independence of 89.7% at

intermediate distance as reported in the US clinical study1

1. TECNIS® Multifocal IOL [package insert] Abbott Medical Optics Inc. * vs. monofocal IOLs

Near Point

Intermediate

Energy for Distance Energy for Near

Distance Point

2013.07.12-CT7205

2013.07.12-CT7205

Symfony IOL – FDA Approved in Dec 2017

INTRODUCING: The first and only Extended Depth of Focus (EDOF) Presbyopia-Correcting IOL for

patients with and without Astigmatism

INDICATIONS: The TECNIS® Symfony Extended Range of Vision IOL, Model ZXR00, is indicated for primary implantation for the visual correction of aphakia, in adult patients with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model ZXR00 IOL is intended for capsular bag placement only.

INDICATIONS: The TECNIS® Symfony Toric Extended Range of Vision IOLs, Models ZXT150, ZXT225, ZXT300, and ZXT375, are indicated for primary implantation for the visual correction of aphakia and for reduction of residual refractive astigmatism in adult patients with greater than or equal to 1 diopter of preoperative corneal astigmatism, in whom a cataractous lens has been removed. The lens mitigates the effects of presbyopia by providing an extended depth of focus. Compared to an aspheric monofocal IOL, the lens provides improved intermediate and near visual acuity, while maintaining comparable distance visual acuity. The Model Series ZXT IOLs are intended for capsular bag placement only. See safety information on slides 28-33

PP2015CT0788

PP2016CT0928

US Clinical Trial: •Well Controlled Study

•Masked: Patients, Technicians, and Abbott •Randomized:

•50% (N=148) received TECNIS Symfony® IOL in both eyes •50% (N=150) received TECNIS® Monofocal IOL in both eyes •Continuous series of the first 148 cases at 14 sites •No enhancements of any kind permitted

•Examinations •6-Month Follow-up •FDA required Monocular and Distance-Corrected data for VA, Contrast Sensitivity, and Defocus •Abbott also reported Binocular and Uncorrected data for VA and patient-reported outcomes

TECNIS Symfony® IOL and TECNIS Symfony® Toric IOL have been studied in over 2,000 eyes in several studies throughout the world, including the US Clinical Trial.

STUDY DESIGN

PP2016CT0928 1. TECNIS® Symfony® IOL DFU

Proprietary Echelette Design Extends the depth of focus

Proprietary Achromatic Technology Corrects chromatic aberration for enhanced image contrast1

PROPRIETARY TECHNOLOGY

TECNIS Symfony® IOL Merges Two Complementary Enabling Technologies

28

PP2016CT0928

DIFFRACTIVE TECHNOLOGY

• Diffractive technology has been associated with multifocal IOLs, but it can be used in different ways

• Other industries use diffractive

lenses (cameras, telescopes, microscopes) to optimize optical performance under constrained conditions

29

PP2016CT0928

The proprietary echelette design introduces a novel pattern of light diffraction that elongates the focus of the eye1

•The echelette is the relief or profile of the lens (height differential) within each ring

• The height, spacing, and profile of the echelettes are optimized to create a diffractive pattern for an elongated focus

Elongated Focus

EXTENDED DEPTH OF FOCUS

1. TECNIS® Symfony® IOL DFU

30

PP2016CT0928

All corneas have a similar amount of chromatic aberration

Proprietary Achromatic Technology is optimized to counteract the chromatic aberration of the cornea

The net result is reduced chromatic aberration

ACTIVE CORRECTION OF CHROMATIC ABERRATION

Cornea Lens with Achromatic Technology

Cornea+ Lens with Achromatic Technology

31

PP2016CT0928

Long-Term Sustainability

Enhanced Functionality

Sharpest Vision

TECNIS SYMFONY® IOL

32

SHARPEST VISION

PP2016CT0928

TECNIS Symfony® IOL provides continuous, high-quality vision at all distances

TECNIS Symfony® IOL delivers: •Sustained mean visual acuity of 20/25 or better through 1.5 D of defocus •Increase of 1.0 D range of vision throughout the defocus curve compared to a monofocal

CONTINUOUS VISION

1. TECNIS® Symfony® IOL DFU

34

PP2016CT0928 1. TECNIS Symfony® NZ Study final data

CONTINUOUS VISION

TECNIS Symfony® Toric IOL delivers the same continuous range of vision as the TECNIS Symfony® IOL

35

PP2016CT0928

EXCELLENT VISION AT ALL DISTANCES

TECNIS Symfony® IOL delivers excellent uncorrected visual acuity at all distances1

1. TECNIS® Symfony® IOL DFU

36

Monocular Distance Corrected vision with TECNIS Symfony® IOL improved 2.4 lines for intermediate vision and 2.2 lines for near vision compared to the monofocal control.1

PP2016CT0928

• TECNIS material minimizes chromatic aberration

• In addition the ACCEL™ Achromatic Technology of TECNIS Symfony® IOL actively corrects the chromatic aberration of the eye1

• AcrySof® IQ ReSTOR® IOLs induce chromatic aberration of the eye1

1. DOF2015CT0018_Chromatic Aberration of the TECNIS Symfony IOL.

CHROMATIC ABERRATION CORRECTION

TECNIS Symfony® IOL actively corrects chromatic aberration1

37

PP2016CT0928

Significant loss in contrast sensitivity has been linked to increased incidence of crashes and increased risk of falls3,4

1. DOF2015CT0020_MTF of TECNIS Symfony IOL, and other lens models. 2. TECNIS® Symfony DFU 3. Owsley, McGwin. Vision Impairment and Driving. Survey of Ophthalmology. 43;6:535-550, 1999 4. Dhital, Pey and Stanford. Visual loss and falls: a review. Nature Eye. 24:1437-1446, 2010.

CONTRAST SENSITIVITY

TECNIS Symfony® IOL delivers contrast sensitivity with no clinically significant difference compared to a monofocal IOL

38

WARNING: The TECNIS® Symfony IOL may cause a reduction in contrast sensitivity under certain conditions, compared to an aspheric monofocal IOL. The physician should carefully weigh the potential risks and benefits for each patient, and should fully inform the patient of the potential for reduced contrast sensitivity before implanting the lens in patients. Special consideration of potential visual problems should be made before implanting the lens in patients with macular disease, amblyopia, corneal irregularities, or other ocular disease which may cause present or future reduction in acuity or contrast sensitivity. Patients implanted with the lens should be informed to exercise special caution when driving at night or in poor visibility conditions.

2

PP2016CT0928

STUDY DESIGN: Evaluate the clinical outcomes of far, intermediate and near visual acuities of patients implanted with the TECNIS Symfony® Toric IOL

• 6-month, prospective, bilateral, open-label clinical investigation, at 2 sites in New Zealand • TECNIS Symfony® Toric IOL n=39

POST-OP CYLINDER CORRECTION RESULTS:

Mean* SD 0.34D 0.32 D

of patients have ≤ 0.5 D 92%

92% of patients achieved ≤ 0.50 D of residual refractive cylinder1

1. DOF2016CT0025 TECNIS Symfony Toric Results

TECNIS Symfony® Toric IOL: SHARPEST VISION FOR PATIENTS WITH ASTIGMATISM

39 WARNING: Rotation of TECNIS® Symfony Toric IOLs away from their intended axis can reduce their astigmatic correction. Misalignment greater than 30° may increase postoperative refractive cylinder. If necessary, lens repositioning should occur as early as possible prior to lens encapsulation. *First Eye Data

ENHANCED FUNCTIONALITY

PP2016CT0928 1. DOF2016CT0025 TECNIS Symfony Toric Results, 2. SC2016OTH004 Preclinical Evaluation of Tolerance to Astigmatism with an ERV IOL

TOLERANCE TO ASTIGMATISM

TECNIS Symfony® IOLs delivers 20/20 vision even in the presence of astigmatism1, 2

41

Diopters of Cylinder Defocus

PP2016CT0928

TOLERANCE TO DECENTRATION

1. DOF2016CT0023 TECNIS Symfony® IOL Tolerance to decentration. 2. TECNIS Symfony® IOL DFU

TECNIS Symfony® IOL maintains image quality throughout 0.75 mm of decentration1

42 These calculations were performed with theoretical calculations.1 In the US Clinical Trial there was no report of decentration at 6 months.2

PP2016CT0928

LOW INCIDENCE OF HALO AND GLARE

1. TECNIS® Symfony® IOL DFU

Less than 3% of patients spontaneously reported incidence of severe night vision symptoms

43

WARNING: Some visual effects associated with the TECNIS® Symfony IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL.

PP2016CT0928

LOW INCIDENCE OF HALO AND GLARE

1. TECNIS Symfony® IOL DFU

TECNIS Symfony® IOL demonstrated a low incidence of halo and glare

44

WARNING: Some visual effects associated with the TECNIS Symfony® IOL may be expected due to the lens design that delivers elongation of focus. These may include a perception of halos, glare, or starbursts around lights under nighttime conditions. The experience of these phenomena will be bothersome or very bothersome in some people, particularly in low-illumination conditions. On rare occasions, these visual effects may be significant enough that the patient may request removal of the IOL.

PP2016CT0928

Less MTF loss provides better contrast under low-light conditions

1. TECNIS Symfony® IOL DFU 2. DOF2015CT0020_MTF of TECNIS Symfony IOL, and other lens models.

PUPIL INDEPENDENT LENS PERFORMANCE

TECNIS Symfony® IOL pupil independence enables optimal performance in all lighting conditions1,2

45

PP2016CT0928

*Although the questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence, data showed that the Symfony IOL

achieved the secondary effectiveness endpoint of reduced overall spectacle wear compared to the control monofocal IOL

1. TECNIS Symfony® IOL DFU

LOW SPECTACLE WEAR

85% of TECNIS Symfony® IOL patients wore glasses none or a little bit of the time*

46

LONG-TERM SUSTAINABILITY

PP2016CT0928

1. Data on File 150_Sensar not associated with glistenings – Literature analysis. Abbott Medical Optics, Inc., 2013. REF2014OTH0002 2. Christiansen G, et al. Glistenings in the AcrySof® intraocular lens: Pilot study. JCRS 2001; 27:728-733. REF2014MLT0005. 3. Colin J, et al. Incidence of glistenings with t.he latest generation of yellow-tinted hydrophobic acrylic intraocular lenses. JCRS 2012; 38:1140-1146. REF2014MLT0006. 4. Gunenc U, et al. Effects on visual function of glistenings and folding marks in AcrySof® intraocular lenses. JCRS 2001; 27:1611-1614. REF2014MLT0011. 5. Nagata M, et al. Clinical evaluation of the transparency of hydrophobic acrylic intraocular lens optics. JCRS 2010; 36:2056-2060. REF2015CT0080. 6. Bousquet M, PhD, Health Canada. Intraocular lenses and the development of glistenings. Canadian Adverse Reaction Newsletter 2013. REF2015CT0254. 7. Miyata A, Yaguchi S. Equilibrium water content and glistenings in acrylic intraocular lenses. JCRS 2004; 30:1768-1772. REF2014OTH0032. 8. van der Mooren, et al. Explanted multifocal intraocular lenses. JCRS 2015; 41:873-877. REF2015OTH0117. 9. Van der Mooren M, et al. Effects of glistenings in intraocular lenses. Biomedical Optics Express.11 July 2013:1294-1304. REF2014OTH0139.

LONG-TERM SUSTAINABILITY

48

PP2016CT0928

49

PATIENT SATISFACTION

TECNIS Symfony® IOL delivers high patient satisfaction

1.. DOF2016CT0024 Concerto Study Report, 2. DOF2015OTH0009 Symfony Harmony Observational Study

Symfony IOL Ideal Candidates:

- Strong desire for reading ability without glasses without significant compromise of night vision

- Don’t mind OTC readers for small print***

- Consider much wider age range vs multifocal IOL – “ working age population”

Symfony IOL Usage Tips!

Lens has some “ flexibility of focus” , allowing undercorrection of astigmatism

- IOL distance target : -0.25 sphere J2

Using Ora Intraoperative aberrometer to finalize IOL choice and IOL alignment ( toric)

Symfony IOL – My Experience

• 38 cases ( December 2016-present) • Excellent uncorrected distance vision • Excellent night vision quality

– Near vision – average J3 – Most patients need reading glasses for small

print

Additional Testing for Lifestyle IOL Patients – Retina OCT

– R/O macular disease

• AMD • Epiretinal

membranes • Vitreomacular

traction • Diabetic Macular

Edema

“Lifestyle” IOL Prices at Loma Linda

• Toric IOL- $1300 / eye • Multifocal, Symfony or

Crystalens - $2600 / eye

• “Refractive touch-up “ - $700 - Toric IOL pts

- No additional charge for Multifocal, Symfony or Crystalens pts

Time for Pearls! IOL Decision Making

Pearl #1 – Beware of Myopes! •If patient reads without glasses - best to keep myopic •IOL target similar to current Rx : •-3.25 - 3.50 target if refraction > - 3.50 •Myopic degeneration with cataract : best to keep highly myopic if reads without glasses

Pearl #2 – Maintain monovision! • If patient has h/o monovision due to refractive

surgery, contact lens wear, maintain monovision

• Cost effective • Patients have adapted • Near vision IOL target = J1=J1+ vision

Pearl #3 –Think About the Second Eye Before Operating on the 1st Eye

Example #1: Asymmetrical astigmatism •Monofocal - One eye •Toric – 2nd eye Need to discuss cost of Toric IOL for 2nd eye before proceeding with monofocal IOL left eye - goal is balanced vision at distance without glasses

Pearl #3 –Think About the Second Eye Before Operating on the 1st Eye

Example #2 : Unilateral cataract - +4.00 OU •1. Match refractive error of non-cataract eye •2. “Go for the gusto” - Reduce refractive error with lifestyle IOL - Second eye refractive lens exchange Key: need discuss 2nd eye plan BEFORE operating on 1st eye

Pearl # 4 – Mixing and Matching of IOL Types Is An Option

1. Monofocal and Multifocal – Usually when monofocal was used in 1st

eye several years ago – Provides near vision independence – not

as much as bilateral multifocal ( prolonged reading)

2. Mix Multifocals - Alcon Restor SN6AD1 – better

intermediate - Alcon Restor SN6AD3 – better reading

Pearl # 5 – Mini-monovision with Symfony IOL

- If reading vision for the 1st eye is underwhelming, target 2nd eye -0.25-0.50 for distance, will provide better near vision for patient.

Summary • IOL options for our patients continue to

expand • Important that your patients understand

these options and choose within the written consent process their preferred IOL

• Both the Surgeon and Optometrist play a key role in determining the appropriate IOL choice for our patients

Questions ?