RLE (Refractive Lens Exchange)- Bootcamp. Christopher Blanton, MD April 28,2018

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1 RLE (Refractive Lens Exchange)- Bootcamp Christopher Blanton, MD April 28,2018

2 Financial Disclosure Paid consultant: Johnson & Johnson, Inc.- Star S4/iFS IntraLase Medical Monitor Integra LifeSciences, Inc. One Legacy Organ and Tissue Bank

3 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

4 Goals To understand the considerations for RLE surgery patients- Candidacy/Lens options To properly select patients and describe the steps required to deliver outstanding preoperative and post-operative care

5 Demographics Comprehensive Report on the Global IOL Market. Market Scope 2. US Census Bureau, gallup.com/poll/166952/babyboomers.reluctant-retire.aspx 4. NextAvenue, nextavenue.org/hottest-trends-boomer-travel 5. AARP Getting to Know Americans Age 50+, AARP Planning Complete Streets for an Aging America, May 2009

6 Treatment of Astigmatism & Presbyopia in Cataract Surgery 1/3 of Patients have > 1.0D of astigmatism but only 1/4 of those patients % of Patients are receiving a Toric IOL receiving Toric IOL Every patient over the age of 50 is impacted by presbyopia 1, yet only 6.5% of patients receive a presbyopia-correcting IOL % of Patients receiving PC IOL 25% 6.5% PC IOL Monofocal IOL 8% 67% Patients > 1.0D Astigmatism Patients receiving Toric IOL 93.5% 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 Market Scope

7 Who Sees Cataract Patients First? 58,000 eye care professionals are licensed to perform comprehensive eye exams 1 18,000 Optometrists Ophthalmologists 16M (15%) 40,000 88M (85%) 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

8 Who/What makes a good candidate? Always review options- glasses, contact lenses or surgery Two most primary considerations Refractive error and Age

9 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

10 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

11 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

12 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.

13 Current IOL Options Monofocal IOLs Monofocal Toric IOLs Accommodating IOLs Accommodating Toric IOLs Multifocal IOLs Multifocal Toric IOLs The FDA recently approved a different class of lens: Extended Depth of Focus (EDOF) Presbyopia-Correcting IOL for patients with and without Astigmatism

14 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

15 Extended Depth of Focus 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 eye 1 15

16 Delivering Elongation of Focus Monofocal IOL Multifocal IOL EDOF IOL 1 Data on File._Data on File_Tecnis Symfony Green Light Bundle Bench Test DOF2014CT0005. Abbott Medical Optics Inc. 2014

17 What is Chromatic Aberration? 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 material 2,3 2. DOF2015OTH0004. Longitudinal Chromatic aberration of a monofocal TECNIS Achromat IOL. 3.Weeber et al. Differences in Chromatic Aberration of IOLs, ESCRS 2016.

18 The impact of chromatic aberration on image quality

19 Achromatic Technology A diffractive IOL with achromatic technology can correct chromatic aberration of the eye Cornea Typical IOL + = + = Cornea TECNIS Symfony Diffractive Technology

20 Discussion When is it time to discuss with a patient?

21 Protocols and Procedures Referral 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

22 Patient Education 1. 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

23 Patient Candidacy Lifestyle Considerations: " Occupational activities " Leisure activities " Nighttime activities " Spectacle use expectations Patients to Avoid: Previous refractive surgery Corneal disease Irregular astigmatism Patients with unrealistic expectations Surgical Considerations: " Ocular pathology " Preoperative refraction " Amount of astigmatism " Previous surgical history

24 Discussion When is it time to refer the patient?

25 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

26 Dry Eye Prevalence in Patients Scheduled for Cataract Surgery % of Patients Had Dry Eye Severity Score of Level 2 or Higher Percentage of Patients Level 0 Level 1 Level 2 Level 3 Level % 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 (Unpublished study.)

27 Hot Spots and Flat Spots Are Abnormal 27

28 Irregularly Shaped Or Smudgy Placido Disk Is Abnormal 28

29 Take A Closer Look If Average K Values Are Different 29

30 Post-Dry Eye Treatment: K Values Are Much More Similar 30

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

32 Patient Education Educate 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

33 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 likely have a greater range of vision PREPARE the patient not to expect vision to be perfect at Day 1

34 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

35 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

36 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

37 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

38 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

39 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

40 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

41 Thank You