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The Future of Cataract Surgery

Paul c. Ajamian, od

Finally some recognition that co-management is “ok”!

The most important factor that determines if a patient is ready for cataract surgery in the eyes of CMS is:

A. Visual acuity

B. Glare testing

C. Lifestyle complaint

D. Density of cataract

Vision and Refraction

• Visual Acuity (D & N)

• Pinhole should be part of vision• Monocular diplopia or glare alleviated?

• Glare testing or BAT (medium setting), or “Ambient Light” (room lights on)

for any patient who is 20/40 or better

If that doesn’t work, try this………………….

Ocular Health

• Slit Lamp

• Dilated Fundus Exam

BEFORE YOU REFER: STOP AND THINK!

What can affect the results of cataract surgery and premium IOL’s?

• Surface disease/MGD

• Chalazia

• Pterygia

• Corneal dystrophies and degenerations

• Undetected pre-op retinal conditions

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You wouldn’t send this….. So why send this?

Could this be a problem?

RES15034SK

Clean Up Crew

Bumpy Corneas could mean Bumpy Post-Op Refraction

• 55 y/o F c/o months of monocular f.b. sensation, contact lens intolerance, tearing, and mild decrease in vision

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BEFORE AND AFTER:BCL in placeNSAID and antibiotic

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Where are We?

•Cataract Surgery is now refractive

•Patients deserve to know about the newest technologies

•Doctors of Optometry should be the authority, not just the referrer

The Changing Face of Cataract Surgery

• Large, rapidly growing demographic

• Educated, financially secure

• Increased life expectancy

• Longer working careers

• Demand high quality vision (reading, distance, night vision)

• New requirement for near vision (computers)

• Unwilling to compromise active lifestyles

The Baby Boomer Generation: 10,000/day reaching 65

LSX11513SK

Femtosecond Laser Assisted Cataract Surgery (FLACS)

Are you going to do the surgery with the laser??

The future of cataract surgery available now!

Do We Need FLACS?

• Cataract surgery already a “good” procedure?

• Only helps less experienced surgeons?

• Wait for technology to improve?

• Several lasers…wait to see which one is best?

• Laser too expensive to justify?

• Don’t believe the hype?

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OCT Guided Refractive Cataract Surgery

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LenSx®Alcon

• First commercially available FSL

• FDA approval for1. Anterior capsulotomy

2. Lens fragmentation

3. All corneal incisions (cataract surgery)4. Arcuate incisions for astigmatism

5. First U.S. procedure in Feb 20106. LASIK flaps

OptiMedica Catalys™/AMO

• FDA clearance December 20111. Anterior capsulotomy

2. Lens fragmentation3. Corneal incisions

4. Arcuate incisions for astigmatism

5. Fixed bed6. 1st U.S. procedure Feb 2012

Incisions

Reproducible Primary and Secondary Incisions

Computer programmed

incisions

• % depth

• Length & position

• Visualization of placement

Real time Corneal thickness

Customizable “planed”

incisions (up to 3)

Laser Arcuate Incision

• Square edge

• Uniform depth (no ripples)

• Precise, reproducible

– Arc shape

– Arc length

– Diameter

Steinert RF, Application of the Femtosecond Laser in Cataract Surgery for the Creation of Multi-Planar, Self-Sealing Incisions, ASCRS 2010, Boston

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Manual Arcuate Incisions• Manually executed by

“tracing” corneal marks with handheld diamond knife

• Inconsistent depth control

• Unpredictable effect due to imprecise wound architecture and depth

• No image-guided surgical planning or visualization

LSX11513SK

Laser Corneal Incisions- Astigmatism Management

• Precise incisions made in the O.R.

• Ability to titrate amount of correction

• May be opened intraoperatively

• May be opened postoperatively

Opening an Incision In-Office

Capsulotomy

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Laser Capsulotomy

Precise and reproducible

• Geometrically superior circle (vs. Manual

Capsulorhexis)

Automatic Centration and Size

• Based on limbus and (dilated / undilated) pupil

Capsular Edges

• Closest to manual capsulorhexis in terms of edge

uniformity*

* Bala C, Meades K. SEM of femtosecond laser capsulotomy edge: An inter-platform comparison. Accepted for publication in Journal of Cataract and Refractive Surgery

Why Is Capsulotomy Size

Important?

▪ Effective lens position (ELP) more predictable

▪ Refractive outcome more predictable

▪ Less frequent PCO

▪ Less chance for anterior capsule phimosis

Impact of ELP on IOL Predictability

If IOL is 0.5 mm posterior to the assumed plane, a 21 D lens will produce only 20 D of correction

If IOL is 0.5 mm anterior to the assumed plane, a 21 D lens will produce 22 D of correction

Hyperopic Myopic

1Norrby S, Sources of error in intraocular lens power calculation,J Cataract Refract Surg, 2008;34:368-376.

Fragmentation

Additional Lens Fragmentation for Versatility

Customizable Lens Fragmentation based on lens characteristics or surgeon preference

Cylinder Chop Hybrid Frag

Benefits of Lowering CDE(Cumulative Dispensed Energy)

• Less ultrasound energy (CDE)

• Short term

* decreased k edema 1 day post-op

* faster visual recovery

* decreases complications intra-op

• Long term

* decreased rate of endothelial cell loss

* pseudophakic bullous keratopathy less likely

LSX13070SK 42

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FLACS Video FLACS Video- Narrow Angle

FLACS Video-OR

How to Present to Patients?

• Laser makes more precise, accurate incisions

• 3D OCT Image guided surgery vs manual procedure

• Customized for the patient’s eye

• Less energy/less inflammation

• Manage low to moderate astigmatism

• Potentially safer

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Laser Cataract Surgery:Who is a candidate?

• Premium lens patients

• Astigmatism less than 1 diopter

• Guttata/Fuch’s /Mature/Traumatic cataracts

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Important to Explain

What’s covered

Cataract removal Monofocal lens resulting

in good distance vision if no astigmatism

Will need readers

What’s not covered

Astigmatism Tx with laserToric lensesMultifocal lensesAdditional testingInteroperative Aberrometry

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Laser Cataract Surgery:What Can You Expect Post-Op

• Subconjunctival heme (“ring around limbus”)

• Less AC reaction

• Decreased astigmatism

• Early “wow” factor

• BUT….due to arcuate incisions, there may be temporary corneal surface irregularities

• A new category has emerged in private pay cataract surgery

• Precision of femtosecond laser technology will drive innovation for future

• And to make outcomes even better…..

Femtosecond Laser in Summary

And to Make Something Good Even Better….The Cataract Refractive Suite

• Minimize opportunities for error

• Multiple technology integration1. A scan

2. Topography

3. Femtosecond cataract laser

4. Operating microscope

• Preoperative and intraoperative

• Better multifocal centration/toric alignment

• Improve outcomes

Cataract Refractive Suites• Verion (Alcon)

1. Only fully integrated system available (LenSx)2. Intraoperative aberrometry (Ora) soon

• Callisto (Zeiss)1. No FSL compatibility, (?Optimedica in future)2. No intraoperative aberrometry

• Cassini/TrueVision 3D1. Collaboration with LensAR2. Not commercially available

• Cirle 3-D/ Spectria1. Collaboration with Victus (B&L)2. Not commercially available

Identifying Sources of Variability in our Current Process

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Pre-Op Intra-Op Post-Op

Biometry

Transcription

Astigmatism Planning

Manual Marking

Cyclorotation

SIA

CapsulorhexisConstruction

IOL Positioning

Optimizing

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The Verion™ Image Guided System

Designed to help consistently achieve the

cataract refractive target.

VERION™ Image Guided System

GUIDE

VERION™ DIGITAL

MARKER

VERION™ REFERENCE

UNIT

VERION™ Image Guided SystemACQUIRE IMAGE VERION™ Image Guided System

TRANSFER TO PLANNER

Image Guided Technology OR Video- Toric Alignment

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Verion- Multifocal Centration The ORA System® with VerifEye®:

Intraoperative Aberrometry

• ORA® with VerifEye®

1. Part of Alcon® Cataract Refractive Suite

2. May be used independently

• Holos IntraOp™ Wavefront Aberrometer

1. Independent use only

2. Not compatible with FSL systems

The ORA System® with VerifEye®:

Intraoperative Aberrometry• Provides streaming refractive information to determine

power, cylindrical magnitude and axis, even for post-refractive-procedure eyes

• Accounts for anterior and posterior corneal astigmatism

• Reduces risk of residual postoperative astigmatism

The ORA™ System with VerifEye® Technology

• The ORA™ System uses wavefrontaberrometry data in the measurement and analysis of the refractive power of the eye (i.e. sphere, cylinder, and axis measurements)

• Real-time, intraoperative refractometer

• Measures anterior and posterior corneal astigmatism

• Minimizes post-op refractive surprises

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©2016 Novartis 05/16 US-ORA-16-E-1963

Real-time, streaming feedback and guidance

Streaming data to select proper IOL, position toric IOLs within 1° and decide if a toric is necessary

In your ocular On your monitor

©2016 Novartis 05/16 US-ORA-16-E-1963

Improved astigmatic outcomes with VerifEye®

*Results are statistically significant based on McNemar’s test (p=0.006).

1. Alcon data on file.2. Standard of Care: Conventional biometry measurement of the pre-op corneal astigmatism and toric calculator determination of IOL cylinder power.

This carefully controlled clinical study demonstrates that the ORA System® with VerifEye® provides for better astigmatic outcomes in cataract surgery.1

Percent of Patients Within ≤ 0.50 D of Intended Target at One Month; n = 111 patients, p = .006

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Custom Cataract Surgery w/Advanced Technology IOL’s

What’s New and What’s Coming?

RES15034SK

ReSTOR +2.5: Who is this lens for?

Aspheric MonofocalAcrySof® IQ IOL

Aspheric Apodized Diffractive Multifocal ReSTOR® +2.5 D IOL

Aspheric Apodized Diffractive Multifocal ReSTOR® +3 D IOL

The ReSTOR® +2.5 Patient• Patient w/ active lifestyle that wants good interm. and dist. Va• Not willing to compromise distance for a full range • Desires more opportunity for a range of vision vs monofocal• Desires spectacle independence at 21 inches and beyond• May need +1.00 reader for 16-20 inches

Optic Design Differences: ReSTOR® +2.5 vs. ReSTOR® +3.0

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Reduced the add power from 3.0D to 2.5D by:

• Reducing diffractive rings from 9 to 7 and increasing spacing

Altered the light distribution by:

• Increasing the distance energy of the center zone from 40% to 100%

• Reducing apodized diffractive area by 18%

• Increasing the outer distance area by 6%

Alcon Acrysof Restor

+2.50 add dominant eye

+3.00 add non-dominant eye

RESTOR TORIC: FINALLY APPROVED

• +3.0 add APPROVED (DECEMBER)

• +2.5 add APPROVED (MARCH 23)

• 1D-3.0D corneal astigmatism

Acrysof Toric- Extended Power Range

• SN6AT3- 1.03D corneal plane

• SN6AT4- 1.55D

• SN6AT5- 2.06D

• SN6AT6- 2.57D

• SN6AT7- 3.08D

• SN6AT8- 3.60D

• SN6AT9- 4.11D

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Bausch & Lomb Trulign Toric

• Only accommodative toric IOL approved in U.S.

• Good distance/intermediate

• Refractive surprises post-op

Tecnis Multifocal in +2.75/3.25 Technis Multifocal

ANDTecnis Toric

• Corneal astigmatism

1. ZCT150- 1.03D

2. ZCT225- 1.54D

3. ZCT300- 2.06D

4. ZCT400- 2.74D

Technis Symfony lens Technis Symfony lens-Approved July 15, 2016!

The first toric presbyopic lens: up to 2.75 cylinder

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Avoid this lens with:

• Myopes with large pupils

• Anyone who does a lot of night driving/activities at night

Problems with lens?

Play that Symphony!

OD’s Role IS Crucial in IOL Decision

• Be involved in decision making PREOP

• It all starts with patient goals and topography

• ?Monovision

• ?Eliminate distance Rx

• ?Eliminate Rx totally

Cassini Corneal Shape Analyzer

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120 60

50 30

10 330

240 300

N

Date of Birth May 20, 1944 OD Patient name STRICKLAND, MARY Patient id 86231

MAPS Anterior Axial / Sagittal

90

Ps

4

1

Clinic Capture date August 20, 2015 10:52 am

Physician -

56

55

54

53

52

51

50

49

48

472

T 0 180

-2

2

-4

270

-4 -2 0 2 4

Ts A s 46

45

44

43

42

0 41

40

39

38

37

36

35

34

33

32

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29

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American 27 Relative 0.50D 26

K-READINGS QUALITY FACTORSKeratometric SimK (n=1.337) Anterior SimK (n=1.376) Overall

Steep K 45.03 D (7.50 mm) @  19° Flat K 43.90 D (7.69 mm) @ 109° Astigm. 1.13 D

Steep K 50.16 D (7.50 mm) @  19° Flat K 48.91 D (7.69 mm) @ 109° Astigmatism 1.25 D

Corneal Coverage Axial Alignment

Posterior Lateral Alignment

Total Cornea Posterior SimK (n=1.336) SURFACE INDICESAstigmatism 1.69 D @  21° (Steep) Steep K -6.63 D (6.03 mm) @ 118°

Flat K -6.18 D (6.47 mm) @  28° Astigmatism -0.45 D

Q (Asphericity) -0.096 W2W/HVID 12.4 mm Pupil size 3.10 mm Pupil center 0.29 mm @ 183° Entered CCT 550 μm SRI 0.672 SAI 1.008

NOTES

CATARACT REPORT S/N ca1610 VERSION 2.1.1

Patients Want YOUR advice

• Easier conversion , better experience

• Embarrassing if they hear it for first time from surgeon

• Prepare them regarding out-of-pocket costs

Selecting The Right Surgeon

• Closest not always the best

• Very skilled/consistent results

• Communicates well with patient & OD

• Understands comanagement/history of supporting optometry/makes you look good

• Welcomes OR observation

• Organized/efficient practice

Post-Op Care

• Don’t abdicate it to someone else

• Post-Op management of premium IOL’s and LACS fairly straightforward

• Be positive on Day 1: its early, results won’t always be perfect

Why not do post op care?

• I’m not on Medicare

• “I’m not set up for it”

• Takes too much time for the $120 I get from Medicare

• Just not interested in doing this, let the surgeon do it even though he is an hour away!

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Once you drill it down….

• Medications are the real time drain on post-op care!

• Alternatives: CatarActiv3

• Designer Drugs Chattanooga 888-935-2930

• Trimoxi

Imprimis Dropless Therapy™

The modality of “Dropless” therapy involves the injection of an eye-compatible compound at the end of the cataract case as prophylaxis against inflammation and infection.

Currently, there are 2 combinations available only from Imprimis: • Tri-Moxi: triamcinolone acetonide and moxifloxacin hydrochloride• Tri-Moxi-Vanc: triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin

Imprimis Dropless Therapy™

The modality of “Dropless” therapy involves the injection of an eye-compatible compound at the end of the cataract case as prophylaxis against inflammation and infection.

Currently, there are 2 combinations available only from Imprimis:

• Tri-Moxi: triamcinolone acetonide and moxifloxacin hydrochloride

• Tri-Moxi-Vanc: triamcinolone acetonide, moxifloxacin hydrochloride and vancomycin

Cataract Patient Profile

80 years old

Arthritic hands + Scoliosis

Lives alone + Fixed income

Patient Surgery Scheduled

MD writes pre- and post-operative prescriptions for topical non-

steroidal, anti-inflammatory and off-label antibiotic drops

Day of Surgery

Patient shows up with QID generic drops

Cannot afford the prescribed QD and BID drops (~$400) or

pharmacy switched based on insurance plan requirements

2 Weeks Post-Operative

Difficulty administering drops

Confusion on drop regimen

Runs out and no refills available

Patient Experience

Calls office REPEATEDLY, confused and asking for help

MD questions efficacy of medications due to compliance

issues

Increased risk of endophthalmitis and inflammation

PATIENT JOURNEY: DROP THERAPY

Cataract Patient Profile

80 years old

Arthritic hands + Scoliosis

Lives alone + Fixed income

Patient Surgery Scheduled

No pre- or post- operative drops prescribed

Informed about Dropless therapy

Day of Surgery

Patient is given compound anti-inflammatory and anti-infective

medication, injected intravitreally at the end of the cataract case

intended to last the duration of the postoperative period*

1 Week Post-Operative

Eye looks quiet

No infection

No inflammation

1 Month Post-Operative

Patient happy with outcome

MD not concerned about compliance issues

Minimized risk of endophthalmitis

and inflammation

*Compounded by a pharmacist pursuant to a prescription to meet the needs of individual patients. May be customized. Some patients may need drops.

PATIENT JOURNEY: DROPLESSTHERAPY Dropless Therapy™ Patient Benefits

• Physically/mentally challenged patients

• Eliminate compliance challenges of drops

• Lift burden from family members/caregivers

• Put patients with “Eye Drop Phobia” at ease

• Avoid pharmacy issues: refills, generics

• Help patients in nursing facilities

• Aid patients without insurance, money or access to

sample drops

➢ Osteoarthritis

➢ Rheumatoid Arthritis

➢ Scoliosis

➢ Parkinson’s

➢ Kyphosis

➢ Alzheimer’s

➢ Dementia

➢ Drop Therapy with branded medications can cost over $400

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Tri-Moxi-Vanc Transzonular Injection

Just hanging around!

FOR COAG PATIENTS WITH CATARACTS……. The iStent Trabecular Micro-bypass• For patients with cataracts and glaucoma

iStent is:

• FDA approved therapy for the treatment of elevated IOP in adult patients with mild to moderate open angle glaucoma in conjunction with cataract surgery

• Improves aqueous outflow through the natural physiologic pathway

• Indicated for patients currently treated with ocular hypotensive medication

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iStent® Specifications

• iStent dimensions are customized for a natural fit within the 270 µm canal space

• Made of surgical-grade nonferromagnetic titanium

• Heparin-coated to promote self-priming

iStent is the smallest medical device known to be

implanted in the human body and weighs just 60 µg

Self-Trephining

Tip

Snorkel

0.3 mm

Lumen 120 µm

Express the Benefits of iStent to Your Patients• You play in an important role in the patient’s decision about the iStent‒

they trust you and want your guidance

Key Messages

• iStent is covered by Medicare and SOME private insurance companies

• The iStent is implanted at the same time of cataract surgery with an excellent overall safety profile

• Proven to reduce IOP and may reduce glaucoma medication usage

iStent® Insertion iStent® with Pigmented TM

iStent® Insertion w/ Heme iStent Postop Photos

• 1 day post op • 6 months post op

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A Little Stent with that Cataract? • 64 WM Brother in Law of a referring OD

• On Lumigan OU qhs for moderate glaucoma

• Uses it once a week according to “inside sources”

• Comes in for cataract evaluation. Moderate cupping IOP of 22 OU

• s/p IOL OS with iStent, IOP 1 day 16 IOP 1 week 14 IOP 1 month 13

• d/c Lumigan and IOP has remained in 12-14 range

COMPELLING CLINICAL RESULTS

Single iStent + Cataract Surgery Achieves IOP < 15 mm Hg Through 3 Years

36%

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Neuhann TH. Trabecular micro-bypass stent implantation during small-incision cataract surgery for open-angle glaucoma or ocular hypertension: Long-term results. J Cataract Refract Surg 2015; 41:2664–2671.

Lasting Outcomes Through 3 Years (T. Neuhann)

• Consecutive series of 62 eyes: decision to implant based on patient desire to reduce topical meds and intent to offer surgical treatment with favorable safety profile

• In consistent cohort of 39 eyes followed through 36 months, mean IOP was 14.9 mm Hg, a 36% reduction

• Over same period, mean number of topical meds declined from 1.9 to 0.3 or 86%

MIGS Study Group

• Prospective study,119 iStent® patients followed for 18 months

• Patients did not undergo cataract surgery (non-FDA approved)

• All patients on 1-3 glaucoma meds

• Compared IOP after 1, 2, and 3 iStents placed (without Phaco/IOL)

• IOP = 19.8, 20.1, and 20.4 respectively, before washout

• IOP = 25.0, 25.0, and 24.9 respectively, after washout

• IOP = 15.6, 13.9, and 12.3 respectively, 18 months post-op

Future MIGS Devices iStent inject®

• Two stents pre-loaded per injector

• US IDE Phase III Trial under way

Head(resides in Schlemm’s

Canal)

0.4 mmNeck(Trabecular Meshwork)

Flange(in AnteriorChamber)

0.3 mm dia

Caution: Investigational device limited by Federal (U.S.) law to investigational use only.

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iStent SUPRA®

Product Description

• Lumen Size: 0.165 mm

• Outer Diameter: 0.365 mm

• Length: 4 mm

• Length of Sleeve: 1.1 mm

US IDE Trial Under Way

Alcon CyPass Micro-StentApproved August 2, 2016

RES15034SK

Alcon CyPass Micro-Stent

• Alcon acquired Transcend Medical in February 2016

• Approved for mild to moderate glaucoma with cataract surgery

Xen Stent

• Crosslinked Porcine Gelatin Tube

• 6 mm long

• 45 micron lumen

Allergan

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Xen Stent Xen Stent

• De Gregorio (2017); 1 year results• Preoperative IOP 22.5 ± 3.7 mmHg 13.1 ± 2.4 mmHg

• Medication: 2.5 ± 0.9 0.4 ± 0.8 meds

• Galal et al. (2017); 1 year results• IOP dropped from 16 ± 4 mmHg 12 ± 3 mmHg at 1 year

• Medication: 1.9 ± 1 0.3 ± 0.49

• One case of extrusion; Two cases of choroidal detachments

Surgical Video (Xen)

Mitomycin C

Paracentesis

Viscoelastic

1.8 mm main

wound

Reimbursement Realities of MIGS

• Medicare YES

• Commercial insurance…VARIABLE but often NO

• Important to know if its covered before you promise it to patients

Take Home Points

• Work with leading surgeons who are on cutting edge of technology

• Go visit their office and ASC and see for yourself what patients will see

• Be involved in post op care: we earned it

• Compliance with glaucoma and post op meds a nightmare…now we have some answers!