Cataracts 20/20: The Optometrist’s Role in Pre

and Post-Op Care In The Era Of Specialty Lenses

Eric E. Schmidt, O.D., F.A.A.O.

Omni Eye Specialists

Wilmington, NC

schmidtyvision@msn.com

Cataract Management

• Visual Acuity 20/50 ?

• Glare and Lifestyle

• Is your patient young and wants refractive Cataract surgery

• Or is your patient health conscious and wants no risk

• What is Binocular vision

• How is their night vision and how often do they drive at night

The Future of Cataract Management by Optometry

• Know the Lens options

• Know the Patient

• Match Options to Patient

• Financial

• Medical

• Optical

The Future of Cataract Management by Optometry

• Earlier Referrals • Loftier Expectations • More Active Role In Pre-Operative Counseling • More active Role In Choosing Procedure • More Important Than Ever In Assuring Positive Outcomes • Changing Post-Op Role • Different “Co-management” Reimbursement Model

The Future of Cataract Management by Optometry

• Understand the fee structure of each modality

• Develop a personal fee structure

• There is no 20% rule In fact the majority of the examination and patient guidance is your responsibility and should be compensated

• There is very little difference in time and expertise to implant a SV, toric, or multifocal. In fact the majority of time spent is pre and Post surgery

Cataracts In The Year 2018

•Changing Paradigm

• Earlier Diagnosis

• Earlier Surgery

• Loftier Expectations

• Harder To Manage ??

Demographics

1. 2015 Comprehensive Report on the Global IOL Market. Market Scope 2. US Census Bureau, 2012 3. gallup.com/poll/166952/baby-

boomers.reluctant-retire.aspx 4. NextAvenue, nextavenue.org/hottest-trends-boomer-travel 5. AARP Getting to Know Americans Age

50+, 2014 6. AARP Planning Complete Streets for an Aging America, May 2009

Not All Cataracts Are Created Equal

• VA is no longer the only criteria for recommending surgery

• Glare

• Contrast Sensitivity

• Night Vision Difficulties

Not All Cataract Surgeries Are Created Equal

• What Does The Patient want (expect)?

• Spectacle independence?

• No specs for sports?

• No reading glasses?

• No responsibility?

Not All Cataract Surgeries Are Created Equal

• What Do The Doctors Want (Expect)?

• Surgeon vs Referring Doctor

• Setting Realistic Expectations Is The Key!!!!!

Cataract Surgery – Choosing The “Right One”

• So Many Choices – So Little Time

• Clear Cornea vs Femtosecond

• Astigmatic Keratotomy vs Toric IOL

• Single Vision vs Multifocal

• Multifocal vs Accomodating IOL

• What About Monovision????

• And What Is Extended Depth of Focus!!!???***

Why Use A Femtosecond Laser ?

• Precise Incision Control

• Managing Astigmatism

• More Precise Capsulorhexis

• More Predictable refractive outcome

• But Is It worth the Extra Cost????

Managing Astigmatism

• Limbal Relaxing Incision

• Astigmatic keratotomy (laser guided)

• Toric IOL

• The choice depends upon amount of pre-operative astigmatism

• (And the amount of money the patient chooses to spend!!!)

Treatment Astigmatism & Presbyopia in Cataract Surgery

Every patient over the age of 50 is impacted by presbyopia1, yet only 6.5% of patients receive a presbyopia-correcting IOL

67%

0%

8%

25%

33%

% of Patients receiving Toric IOL

■Patients > 1.0D Astigmatism

■Patients receiving Toric IOL

1/3 of Patients have > 1.0D of astigmatism but

only 1/4 of those patients are receiving a Toric

IOL

6.5%

93.5%

% of Patients receiving PC IOL

PC IOL

Monofocal IOL

Patients who do not have astigmatism and presbyopia treated at the time of cataract surgery must treat those conditions with glasses for the rest of their lives.

1. 2016 Market Scope

How Much Cylinder Can we Actually Correct?

Lens Model ZCT150 ZCT225 ZCT300 ZCT400 ZCT450 ZCT525 ZCT600

Cylinder Powers 1.50 D 2.25 D 3.00 D 4.00 D 4.50D 5.25D 6.00D

Corneal Plane* 1.03 D 1.54 D 2.06 D 2.74 D 3.08D 3.60D 4.11D

Corneal Astigmatism Correction Range (PreK Cyl + SIA)

0.75–1.50 D 1.50–2.00 D 2.00–2.75 D 2.75–3.62 D 3.00-3.50D 3.50-4.00D 4.00-4.75D

Astigmatism and Cataract Surgery

• Approximately 37.7% of the patient population has greater than 1D of astigmatism1

• Toric IOLs represent a potential market of approximately 268K procedures in 20141

• 7% market penetration forecasted for 20141

• Fastest growing segment of the premium IOL market the last several years2

1. Market Scope, 2013 Comprehensive Report on Global IOL Market. 2. Market Scope, 2014 Global IOL Report. Ophthalmic Market Perspectives. PP2015CT0370

16

Outstanding visual outcomes and patient satisfaction

Nearly 9 out of 10 patients achieved 20/32 or better uncorrected distance visual acuity

96.5%

3.5%

Yes No

Would you choose to have the TECNIS® Toric IOL again?

96.5% of patients would choose to have TECNIS® Toric IOL again

1. TECNIS Toric 1-Piece IOL [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc. PP2015CT0370

Tecnis® Toric ZCT150

IOL (n=101)

Control (n=93) 17

Postoperatively, 94.1% of patients implanted with the ZCT150 lens achieved ≤ 1.00 diopters of residual refractive cylinder. 72.3% achieved ≤ 0.50 diopters.*

72.3

94.1 99.1 100

49.5

70.3

93.4

100

0

20

40

60

80

100

≤ 0.50 ≤ 1.00 ≤ 1.50 ≤ 2.00

Pa

tien

ts (

%)

Diopters

Residual Refractive Cylinder1

TECNIS® Toric ZCT 150 IOL (N=101) Control (N=91)

* In the Randomized Control Arm of the study.

1. TECNIS Toric 1-Piece IOL [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc. PP2015CT0370

Warnings: The clinical study for the TECNIS® Toric 1-Piece IOL did not show evidence of effectiveness for the treatment of preoperative corneal astigmatism of less than one diopter.

18

Precise correction of astigmatism with excellent postop rotational stability

93

61 0

94

42 0

0

20

40

60

80

100

0-5 6-9 10-15 > 16

Impl

ante

d Ey

es (%

)

Measured Rotation (°)

1 month vs. 3 months 3 months vs. 6 months

1. TECNIS Toric 1-Piece IOL [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc. 2. Kim, Myung Hun, Korean J Ophthalmol 2010; 24(4):207-212

Mean Axis Change Between Baseline and Six Months1 Postop Rotational Stability1

* N=148 patients with photographic axis data at all visits through six months.

N = 148

PP2015CT0370

Why rotational stability matters: A loss of approximately 3.3% in cylindrical power occurs for every degree of rotation away from

the toric IOL’s intended axis.2 19

High spectacle independence

PP2015CT0370

80% of patients reported wearing glasses "none of the time" for far

1. TECNIS Toric 1-Piece IOL [package insert]. Santa Ana, Calif: Abbott Medical Optics Inc.

20

What About Presbyopia??

• Monofocal IOL w/ Readers

• Monovision

• Multifocal IOL

• Accomodating IOL

• Extended Depth of Focus IOL

• Again… The Choice Depends Upon The Expectations of The Patient

Treatment Astigmatism & Presbyopia in Cataract Surgery

Every patient over the age of 50 is impacted by presbyopia1, yet only 6.5% of patients receive a presbyopia-correcting IOL

67%

0%

8%

25%

33%

% of Patients receiving Toric IOL

■Patients > 1.0D Astigmatism

■Patients receiving Toric IOL

1/3 of Patients have > 1.0D of astigmatism but

only 1/4 of those patients are receiving a Toric

IOL

6.5%

93.5%

% of Patients receiving PC IOL

PC IOL

Monofocal IOL

Patients who do not have astigmatism and presbyopia treated at the time of cataract surgery must treat those conditions with glasses for the rest of their lives.

1. 2016 Market Scope

Clinical Data

23

Defocus Curve at 6 Months (bilateral subjects)

Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00. FOR INTERNAL USE ONLY PP2015CT0115

ReSTOR® IOL

24

• Alcon ReSTOR® IOL +3.0 defocus curve peaks at -2.50 (40 cm)

• Alcon ReSTOR® IOL +4.0 defocus curve peaks at -3.00 (33 cm)

https://www.myalcon.com/products/surgical/acrysof-iq-restor-iol/innovative-iols.shtml

Defocus Curve at 6 Months (bilateral subjects)

Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.

TECNIS® Multifocal IOL

• TECNIS® Multifocal IOL +3.25 IOL defocus curve peaks at -2.50 (40 cm)

• TECNIS® Multifocal IOL +4.0 IOL defocus curve peaks at -3.00 (33 cm)

FOR INTERNAL USE ONLY PP2015CT0115

Patient Reported Outcomes

25

85% of patients are able to function comfortably without glasses at ALL distances

87% of patients would elect to have the same IOL again

96% of patients reported an ability to function comfortably without glasses at intermediate and far distances.

94% of patients would elect to have the same IOL again

98% of patients reported an ability to function comfortably without glasses at intermediate and far distances.

97% of patients would elect to have the same IOL again

Data: DFU, TECNIS® Multifocal 1-Piece IOL, Models ZKB00 and ZLB00, and DFU, TECNIS Multifocal 1-Piece IOL, Model ZMB00.

The questionnaire was not determined to be a psychometrically valid assessment of the concept of spectacle independence.

FOR INTERNAL USE ONLY PP2015CT0115

Current IOL Options

• Monofocal IOLs

• Monofocal Toric IOLs

The FDA Approves a different class of lens:

The first and only

Extended Depth of Focus (EDOF)

Presbyopia-Correcting IOL

for patients with and without Astigmatism

• Accommodating IOLs

• Accommodating Toric IOLs

• Multifocal IOLs

• Multifocal Toric IOLs

Extended Depth of Focus

The TECNIS Symfony® IOL has unique optics, creating a different visual experience

27

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 to create a diffractive pattern for an elongated

focus

1. TECNIS® Symfony® IOL DFU

Monofocal IOL Multifocal IOL

TECNIS Symfony® IOL

Distinct Single Focus

Two Distinct Foci

Elongated Focus

1 Data on File. Tecnis Symfony Green Light Bundle Bench Test DOF2014CT005. Abbott Medical Optics Inc. 2014 PP2016CT1448

Extended Depth of Focus IOL

PP2016CT1738

• The power of the eye is wavelength

dependent. Colors that are out-of-focus

cause blur and reduce contrast.

• The phakic eye has approximately 1.38 D

of chromatic aberration between 450 and

700 nm1. Pseudophakic eyes have

between 1.45 and 2 D of chromatic

aberration, depending on the dispersion of

the IOL material2,3

2. DOF2015OTH0004. 2. Data on file. Longitudinal Chromatic aberration of a monofocal TECNIS Achromat IOL. 3.Weeber et al. Differences in Chromatic Aberration of IOLs, ESCRS 2016.

What is Chromatic Aberration?

The impact of chromatic aberration on image quality

Achromatic Technology

A diffractive IOL with achromatic technology can correct chromatic

aberration of the eye

Typical IOL

TECNIS Symfony®

Diffractive Technology

Cornea

+ =

Cornea

+ =

Achromatic Technology

Results in Contrast Enhancement

• Achromat technology for the correction of longitudinal chromatic aberration (LCA) causes contrast enhancement.

• Correction of corneal chromatic aberration results in a sharper focus of light. When combined with correction of spherical aberration, it increases retinal image quality, without negatively affecting depth of focus.1,2

• The benefits of chromatic aberration correction are pupil-size independent1

1. Weeber, H.A., & Piers, P.A. (2012). Theoretical Performance of Intraocular Lenses correcting both Spherical and Chromatic Aberration. J Refr Surg, 28 (1), 48-52.; 2. Artal, P., Manzanera, S., Piers, P., & Weeber, H. (2010). Visual effect of the combined correction of spherical and longitudinal chromatic aberrations. Opt Express, 18 (2), 1637-1648.

TECNIS Symfony® IOL actively corrects chromatic aberration1

0.0

0.5

1.0

1.5

2.0

2.5

TECNISSymfony

TECNIS 1P ReSTOR +2.5D ReSTOR +3D Thibos phakiceye model

Ch

rom

atic

ab

erra

tio

n

4

50

-70

0n

m (

dio

pte

r)

Aphakic

• The proprietary achromatic technology of

TECNIS Symfony® IOL not only reduces

chromatic aberration but actually corrects

chromatic aberration of the cornea.1

• Tecnis Symfony® IOL corrects chromatic

aberration to deliver a sharp image over the

entire range of vision2

1. DOF 2014CT0003 and DOF2015CT0023 . Chromatic aberration of the TECNIS® Symfony IOL

2. DOF2016CT0029. Chromatic Aberration of the Tecnis Symfony IOL over the range vision

Continuous Vision

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

1. TECNIS® Symfony® IOL DFU

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

1. TECNIS® Symfony® IOL DFU

Excellent Vision at All Distances1

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

1. TECNIS® Symfony® IOL DFU

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

Low Incidence of Halo and Glare

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.

*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

85% of TECNIS Symfony® IOL

patients wore glasses none or a

little bit of the time*

Low Spectacle Wear

TECNIS Symfony® IOL delivers high patient satisfaction

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

Patient Satisfaction

98% 94%

0%

20%

40%

60%

80%

100%

Harmony (N=146) Concerto (N=411)

Percent of patients who would recommend TECNIS Symfony® IOL to friends and family1,2

1. TECNIS® Symfony® IOL DFU

Patient Discussions

• Explain “Extended range of vision” to them

Expectation Setting Conversations

• There is no perfect lens

• Distance to computer vision, ability to read a menu

• Expect to need reading glasses for small print

• If they don’t use reading glasses it’s a bonus

• They will likely need prescription RX for some time of the day, for some specific tasks

• Day one expect slightly blurry vision,

• Vision will improve once second eye is done

• You may notice “starbursts” around light sources more noticeable at night

Preoperative considerations

Patient selection

Manage expectations

–Halos/starbursts

–Dependence on spectacles

– “No perfect lOL”

–Under-promise and over-deliver!

PP2016CT1738

So How Can The Referring Doctors Maximize Success For Their Patients?

The Future of Cataract Management by the Optometrist-

MANAGING THE OCULAR SURFACE

• Ocular Surface/Dry Eye Disease Work-up

– Meibomain Gland Dysfunction

• Lipiview

• Lipiflow

Future of Cataract Management by the Optometrist

• iTrace or Corneal Topography

– Pentacam

– General topography

irregular astigmatism, poor optical integrity of the cornea, accurate measurement of irregular astigmatism, map-dot fingerprint/ABMD/EBMD, Fuch’s Dystrophy

• Macular OCT

– ERM, AMD, edema, pseudohole/hole detection prior to surgery,

– Pre VS Post surgical changes

– Repeat during post op

Competitive advantage: The Future

• Comprehensive Optometric -Medical Care program

• One on one relationship with your PATIENTS

• Health and Wellness Philosophy of practice

Ocular Surface Wellness: The Opportunity

• Active maintenance of the Ocular Surface health supports patients’ long-term

– Vision quality – Healthy-looking eyes

– Ocular comfort – Successful Cataract surgery

– Cataract surgery can change the tear film dynamics and the ocular surface

46

Our Role in Optimizing Outcomes

When needed, pre-treat the ocular surface

Why prepare the ocular surface?

Better topography images/Improved Biometry (better K’s)

Potential for reduced risk of infection/less corneal staining

More comfortable patient

Faster healing

Outcomes

Dry Eye Prevalence in Patients Scheduled for Cataract

Surgery1

• 22.1% of patients had previously received a diagnosis of Dry Eye Disease

• 80.9% of patients had an ITF Dry Eye Level 2* or higher, based on the presence of signs and symptoms

* An ITF level of 2 indicates moderate Dry Eye. 1. Trattler et al. Clinical Study Report: Cataract and Dry Eye: Prospective Health Assessment of Cataract

Patients Ocular Surface Study. 2010. (Unpublished study.)

80% of Patients Had Dry Eye Severity Score of Level 2 or Higher

11.0% 8.1%

23.5%

54.4%

3.0%

0

20

40

60

80

100

Level 0 Level 1 Level 2 Level 3 Level 4

Perc

en

tag

e o

f

Pati

en

ts

Optimizing Vision

• Efforts to prevent or slow OS pathology help preserve vision

• Tear film irregularity can affect retinal image quality16

• DE patients experience

– Reduced contrast sensitivity17

– Fluctuating vision

– Impact on ease of daily activities (eg, reading,

computer, driving, TV)18

– Discomfort after Cataract Surgery

49

Optimizing Vision for

Ocular Surgery Candidates

• Refractive and cataract surgery patients have high expectations for postop comfort and vision

• Visual outcomes (and postop comfort) influenced by preop OS conditions25-29

• It is our responsibility to prepare our

patients for surgery

50

The Ocular Surface

Objective Testing Can Be Insightful

More variability in avg K and anterior corneal astigmatism was observed in the

hyperosmolar group, with significant resultant differences in IOL power

calculations*

*Epitropoulos AT, et. al. J Cataract Refract Surg. 2015 Aug;41(8):1672-7

Osmolarity > 322 altered post-op refraction result by .50-.62D

“Hot Spots” and “Flat Spots” Are Abnormal

52

Irregularly Shaped Or Smudgy Placido Disk Is Abnormal

53

Take A Closer Look If Average K Values Are Different

54

Post-Dry Eye Treatment: K Values Are Much More

Similar

55

Threats to Ocular Surface Wellness: Dry Eye and Blepharitis

• DE and blepharitis among the most common conditions eye physicians encounter43,44

– Using a very restrictive definition, DE affects nearly 5 million Americans aged 50 and older44

– Eye care practitioners may see blepharitis in ~40% of patients45

56

Threats to Ocular Surface Wellness: Dry Eye and Blepharitis

57

• Blepharitis comprises a number of inflammatory eyelid conditions and comorbidities46

– Dry eye

– Chalazion

– Hordeolum

– Conjunctivitis

– Keratopathy

• MGD (a form of blepharitis) may be the most common cause of evaporative

DE45,47,48

© 2014 Novartis

Threats to Ocular Surface Wellness: Medication Use

• Some common systemic meds increase risk of DE symptoms

– Antihistamines62-64

– Antianxiety medications63,64

– Antidepressants63,64

– Diuretics62,64

– Oral corticosteroids63

58

© 2014 Novartis

To Maintain and Restore Wellness Look for and Treat Problems

59

• Meibomian gland dysfunction

• Lagophthalmos

• Epithelial membrane basement dystrophy

• Conjunctivochalasis

• Aqueous-deficient dry eye

• Blink pattern deficiencies

• Keratitis

• Stem cell deficiency

• Tear film abnormalities

© 2014 Novartis

Make Use of New Ocular Surface Diagnostic Technology

• New tests add useful information

– Tear osmolarity – Tear MMP-9 level – Interferometry – Incomplete blink – Gland expression – Sjogren’s antibody testing – Topography – Meibography

• Enable detection of early-stage disease processes and

monitoring of the tear film 60

Discussion Questions How do you communicate to patients the value of a premium IOL?

What are the most common challenges you face with patient conversion and how do you address?

When speaking to patients what are the indicators you look for that give you confidence the patient is a good candidate?

PP2015CT0370

61

What Is The Proper Co-Management Arrangement?

• Post – Op visit – Day 1 or Week 1?

• Co-Management Codes – 66984-55

• Premium Services Upcharge -

Explain Neuroadaptation

EDOF is a DIFFERENT kind of lens

• The brain needs to get used to the extended depth of focus optics

− Help patient understand how EDOF technology works

• Emphasize that the goal is to achieve QUALITY of vision

• Explain that there’s always a trade-off

− “You may continue to need reading glasses on occasion, but you will have a greater range of vision”

• PREPARE the patient not to expect vision to be perfect at Day 1

Post-Op Considerations

• Similar to post-op care of “standard” cataract extraction

• Topical antibiotic, NSAID and steroid

• 1 Day, 1 Week, 3 Weeks, 3 Months

• The Biggest Challenge Is Managing Patient Expectations

• Reinforce Neuroadaptation

• Reinforce need for Prescription Eyeglasses

• Reinforce the Concept Of High Quality Vision

• What Is The Biggest Post-Operative Complication For These Patients?

Good Perioperative Management Relationships Are Built on Mutual Respect

• Communicate up front/define roles and expectations

• Select surgeons whose philosophies match your own

• Communicate your knowledge of the patient to the MD

• Visit the OR and schedule regular conversations

• Trade cell phone numbers; you need to be able to reach each other at any time

• Share all Pre-Op and Post-Op findings

More Discussion Questions

•Why aren’t these new technologies being embraced by OD’s?

•How do you handle the co-management fee and “upcharges”?

•What techniques can we employ to increase utilization of Premium IOLs?