RLE (Refractive Lens Exchange)- Bootcamp

Christopher Blanton, MD April 28,2018

Financial Disclosure

• Paid consultant:

• Johnson & Johnson, Inc.-

Star S4/iFS IntraLase Medical Monitor

• Integra LifeSciences, Inc.

• One Legacy Organ and Tissue Bank

RLE -definition• Also known as Clear Lens Extraction or Lens

Replacement Surgery• Replacing a clear natural lens with a synthetic

intraocular lens for the correction of refractive error and +/- presbyopia

Goals• To understand the considerations for RLE

surgery patients- Candidacy/Lens options• To properly select patients and describe the

steps required to deliver outstanding pre-operative and post-operative care

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

Treatment of 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 % of Patients

receiving Toric IOL

25%

8%67%

■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

% of Patients receiving PC IOL

93.5%

6.5%

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

Who Sees Cataract Patients First?

ODs perform an estimated 88 million comprehensive eye exams annually of the total of 104 million performed by all eye care professionals, or 85 percent of all comprehensive eye exams.2

2. http://reviewob.com/wp-content/uploads/2016/11/8-21-13stateofoptometryreport.pdf

OptometristsOphthalmologists

88M (85%)

16M (15%)18,000

40,000

58,000 eye care professionals are licensed to perform comprehensive eye exams1

1. https://www.aoa.org/Documents/news/state_of_optometry.pdf

Who/What makes a good candidate?• Always review options- glasses,

contact lenses or surgery• Two most primary considerations▪ Refractive error and▪ Age

Who/What makes a good candidate?Myopia Considerations

• The vast majority of myopes with clear lenses will be best treated with a corneal refractive procedure.

• Some high myopes will be better served with a phakic IOL.• Rarely, a high myope may be considered, but remember,

these are often the most challenging lens extraction patients because of abnormal anatomy and risk of retinal detachment

Who/What makes a good candidate?Mixed Astigmatism Considerations

• The vast majority of mixed astigmats with clear lenses will be best treated with a corneal refractive procedure.

• Why???-typically they have very low spherical equivalents

Who/What makes a good candidate?Hyperopia Considerations

• The vast majority of clear lens extractions are going to be done on HYPEROPES.

• Why???- the limitations of corneal refractive surgery in this group of patients

• Presbyopic Symptoms

Who/What makes a good candidate?Age Considerations

• Begin thinking of this procedure when patients reach their late 30’s.

• Why???- Presbyopia is right around the corner.• The more hyperopic they are, the more a younger patient makes

sense.• Upper age limit ~~60ish,but this is arbitrary- meaning that at

some point we are just going to be talking about cataract development.

Current IOL Options• Monofocal IOLs• Monofocal Toric IOLs

The FDA recently approved a different class of lens: Extended Depth of Focus (EDOF)

Presbyopia-Correcting IOLfor patients with and without Astigmatism

• Accommodating IOLs• Accommodating Toric IOLs

• Multifocal IOLs• Multifocal Toric IOLs

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

Extended Depth of Focus

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

the eye1

Delivering Elongation of Focus

Monofocal IOL

1 Data on File._Data on File_Tecnis Symfony Green Light Bundle Bench Test DOF2014CT0005. Abbott Medical Optics Inc. 2014

Multifocal IOL

EDOF IOL

• 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. 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

+ =

Discussion

When is it time to discuss with a patient?

Protocols and ProceduresReferral• Provide documentation and communicate

Pre-op• Discuss surgical options• Determine what testing will be performed in your office

Post-op• Schedule• Preferred Meds• Appropriate intervention

Patient Education1. Explain the conditions—cataract vs. clear lens, astigmatism and presbyopia

2. Discuss the options• Introduce condition-specific category options• Prepare the patient for the choice he’ll have to make when he visits the surgeon• Provide education materials for review at home

3. Set realistic expectations• Educate BEFORE surgery• Prepare the patient for the surgical consult

Patient CandidacyLifestyle Considerations:

● Occupational activities● Leisure activities● Nighttime activities● Spectacle use expectations

Surgical Considerations:● Ocular pathology● Preoperative refraction● Amount of astigmatism● Previous surgical history

Patients to Avoid: – Previous refractive surgery– Corneal disease– Irregular astigmatism– Patients with unrealistic expectations

Discussion

When is it time to refer the patient?

Our Role in Optimizing OutcomesWhen 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

0

25

50

75

100

Level 0 Level 1 Level 2 Level 3 Level 4

3

54.4

23.5

8.111

Perc

enta

ge o

f Pa

tient

s

“Hot Spots” and “Flat Spots” Are Abnormal

27

Irregularly Shaped Or Smudgy Placido Disk Is Abnormal

28

Take A Closer Look If Average K Values Are Different

29

Post-Dry Eye Treatment: K Values Are Much More Similar

30

Patient Education

Are we prepared to talk to patients about extended depth of focus?

Patient EducationEducate BEFORE surgery…• Clear, continuous vision from the computer on out• You may need +1.00D magnifiers for near• For the first few weeks, you’ll see lights around headlights• Vision won’t be perfect on day 1

Explain NeuroadaptationEDOF 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 likely have a greater range of vision”

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

Post-op Day 1• Review medications• IOP Check—concern if too high or too low• Check distance vision• Wound secure• Cornea clear/Edema• AC – 1-2+cells / formed• IOL centered• Provide patient instruction:

—Review restrictions – no swimming, no hot tubs, no gardening—Normal to be off balance

• Fax results to surgeon

Post-op Week 1• Review history/chief complaints and confirm meds• Check uncorrected vision at distance and near w/ good lighting• Refract- Push Plus• IOP• Slit lamp exam should be clear to < grade 2 cell• Check for infection or increased signs of inflammation• Fax results to surgeon

Neuroadaptation Reminders • REMIND patients that it is important to give the lens a little time to settle in

• Neuroadaptation time varies from patient to patient

If a patient believed he would be able to see perfectly at all distances, we failed to do our job of setting appropriate expectations … no matter how stellar the

outcomes

Post-op 1 Month• How is the patient functioning?• Check uncorrected vision at distance and near with good lighting• What is the final refraction• Check IOP• Slit lamp exam

—Clear cornea/edema—Look for surface disease—AC well formed with no cell—IOL well centered in pupil—Evaluate posterior capsule

● Fundus exam—Confirm that there is no CME—Check peripheral retina

● Fax results to the surgeon

Post-op 3 Months• Main purpose of exam: Assess presence of posterior capsular

opacification• Treat any visual fluctuation resulting from ocular surface disease—

optimize outcomes

And don’t forget…

Fax your results to the surgeon

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

Be Part of the Legacy• Strive for outstanding versus satisfactory• You have an opportunity to give patients better vision.• Consider life expectancy when considering an IOL; will your patient be

missing out on many years, or decades, of quality vision?• IOLs leave a lasting legacy; work with a surgeon who uses technology

that can help deliver excellent outcomes• Optometrists are rewarded with satisfied patients who will be loyal for

life

Thank You