Orthokeragology Workshop Concepts, Procedures and Management

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Doctors of Optometry | Course Notes

W2 – 2 CE Orthokeragology Workshop Concepts, Procedures and Management Supported with an unrestricted education grant by Precision Technology

Monday, February 19, 2018 10:15 am – 12:15 pm Plaza A – 2nd Fl

Presenter: Randy Kojima Randy Kojima is the Clinical Research and Development Director for Precision Technology based in Vancouver, Canada. He also serves as Research Scientist and Clinical Instructor at the Pacific University College of Optometry in Forest Grove, Oregon. Additionally, he is a clinical advisor to Medmont Instruments in Melbourne, Australia.

Randy has published numerous articles and submitted posters on various contact lens related topics as well as been a contributing author in a number of text book chapters. He lectures globally and enjoys sharing insights, methods and research with eye care colleagues from around the world.

Randy is a Fellow of the American Academy of Optometry, the British Contact Lens Association, the Scleral Lens Education Society and the International Academy of Orthokeratology.

Course Description

This workshop focuses on orthokeratology treatment and how it fits into practice today. Practitioners will understand its application for myopia control in children as well as its use in adult population. The various pre-fit procedures and analysis will be discussed along with the initial lens determination and evaluation. Then heavy emphasis will be placed on the post wear analysis which includes the slit lamp exam, acuity and corneal topography response. The follow-up, ongoing care and problem solving will also be reviewed. Attendees will also have the opportunity in the course to evaluate cases both pre-fit and post wear.

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Doctors of Optometry | Course Notes

NOTES:

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Orthokeratology Workshop

Randy KojimaFAAO, FBCLA, FSLS, FIAO

Disclosures for:Randy Kojima, FAAO, FBCLA, FSLS, FIAO

• Director, Technical Affairs• Precision Technology

• Clinical Affairs Consultant• Medmont, Australia

• Contact Lens Designer• KATT Design Group

• Speaker/Consultant: • Paragon Vision Sciences, Bausch and Lomb,

Contamac, Various GP Laboratories

Early Attempts to Reduce Corneal CurvatureAncient Chinese used sandbags on

eyes at night to flatten cornealcurvature

Early Attempts to Reduce Corneal CurvatureDr. J. Bell – 1850 Developed an eye cup

with spring mounted plunger to pound thecornea flat through the closed eye

Early Attempts to Reduce Corneal Curvature

Kalt (1888) – Used glass scleral lenses“to flatten the corneal apex in keratoconus”

The Beginnings of Orthokeratology

Jessen (1962) “Ortho Focus”

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Clinical Studies:A Brief History (PMMA)

• Jesson (1962) • Neilson and Grant (1964)• Ziff (1968)• May and Grant (1971)• Nolan (1972)• Freeman (1974) • Kerns (1976 - 1978)• May and Grant (1977) • Freeman (1978)• Polse et al - the Berkeley

Study (1983)• Tabb and Coon (1982 - 1984)

Challenges

• Decentration• Comfort• Rx limitations

Early studies showed…

• Modest reduction in myopia (approx. 1.00 – 1.50Dp)

• Individual variability, poor predictability

• Induction of astigmatism due to poor lens centration

• The procedure was safe

• Regression to baseline over weeks to months after ceasing lens wear.

Reverse Geometry OrthokLens Designs

Jesson (1964) Hypothesis of the Ideal Lens “It would be necessary to grind a concave surface with a flatter portion in its centre and steep portion peripherally. The center portion would act to flatten the corneal apex. The intermediate portion would act to centre the lens.”

Fontana (1972)First to use a reverse geometry lens design for orthokeratology

BC 1.00 D. flatter than “K” Lens periphery fitted on “K”

Posterior OZ 6.0 mm

Center Mid-Periphery

Three Curve Reverse Geometry Lens Design

Stoyan and Wlodyga (1989)

ThreeCurveLens

Design

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Four Curve Reverse Geometry Lens Design

Reim and El Hage (1990’s)

FourCurveLens

Design

Advantages of Reverse Geometry Lens Designs

Include:• Improved lens centration

• Rapid corneal flattening effects• Relatively large optic zone created• Good retention of effect (all day)

Rebirth ofOrthokeratology 2000

• Reverse geometry lens designs• High Dk RGP lens materials• Instruments for detailed topographic analysis• Improved fitting techniques• Overnight reshaping modality• Greater understanding as to how OK works

Overnight FDA Approval for Corneal Refractive Therapy

January 2002 FDA panel approval forovernight corneal reshaping with the

Paragon CRT Lens

Pre-Treatment

Reverse Geometry Lens

Post Treatment

20/400 20/20

Lens Designs for Corneal Reshaping• BE Free System• BE Retainer Design• BOSLOW• Contex OK-E System • Corneal Refractive Therapy

• DreimLens• Emerald Design• Forge Design• NightForm• Controlled Kerato-Reformation• R&R Design• NightMove• Vipok• Fargo Design• OrthoFocus• Orthotool• Wave System• Reversible Corneal Therapy• Free Dimension / e Lens• Alignment Series / Falcon

Reverse Geometry

Lens Construction

Optical Zone RC AC IC PC

6 microns 64 12 0 33 138

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Tear Layer Profile of the reverse geometry orthok lens

Squeeze Film Force Model

• Tear Layer Clearance

• -0.50 to -1.00 14.3um• -2.00 5.3• -3.00 3.9• -4.00 3.3

• Squeeze Film Force increases exponentially as the clearance decreases

COMPRESSION

TENSION

Epithelium = 50 microns

Q

Epithelial Changes

Alharbi, Swarbrick – 2003Max. of 20um of apical

“thinning”

Choo - 2005Central cellular compressionPeripheral thickening

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Post OK Elevation (-6.00Dp change)

-21 microns

+20 microns +20 microns

Pre OKCornea

Treatment Zones

If the maximum displacement is 20um, any additional flattening of the apical curvature must occur over a smaller area (Munnerlyn’s Formula)

Treatment Zones& Rx Change

Rx -0.50 +7.0mm-1.00 6.8-2.00 6.4-3.00 5.2-4.00 4.7-5.00 4.2-6.00 3.7

How long does a patient need to sleep in lenses to

create a topographical effect?

How quickly does the eye show a response to OK?

A) 15-60 Min.B) > 1 hourC) ≥ 3 hoursD) ≥ 5 hoursE) ≥ 7 hours

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Pre-fitting: Simulated In Office Fit13 minutes of wear

Don’t rush to conclusions…Orthokeratology full effect is 7-10 days

Alharbi, Swarbrick, 2004

Is Orthokeratology Safe?

Watt and Swarbrick, 2008U. Of New South Wales – ROK Group129 reported cases from 2001 - 2008

MK Incidence

• UNSW-Vision CRC: Stapleton, Keay, Edwards, et al. (’03-’04)

• Incidence per 10,000• 19.5 ON wear *• 10 Occasional ON *• 2 Daily Disposable *• 1.7 Daily Wear *• 1.2 RGP

• * Includes all soft material types

• UK case Control Study: Radford, Minassion, Dart et. Al. (’03-’05)

• Relative Risk (Daily Disp1.0 – reference)

• 5.3x ON wear *• 1.9x Occasional ON *• 1.6x Daily Wear*• 0.16x RGP

• * Includes all soft material types

FDA Post Marketing StudyMark Bullimore MCOptom, PhD, FAAO

Ohio State University

2010 Global Specialty Lens Symposium

Las Vegas NV

• 1316 patients 639 adults (49%) 677 children (51%)

• 2 events of microbial keratitis (neither case resulted in a loss of visual acuity)

“The risk of MK with overnight corneal reshaping is similar to that with other overnight contact lens

modalities”

Is Orthokeratology Safe?

• Koffler et al, Eye & Contact Lens (2016)• 3 ophthalmology practices• 260 eyes• Conclusion: “Orthokeratology is a safe,

effective method to correct myopia. Only 1.4% of patients were unresponsive to the correction”

• Liu et al, Eye & Contact Lens (2016)• 170 publications (58 English, 112 Chinese)• Years: 1980 - 2015• Conclusions: “There is sufficient evidence to

suggest that OrthoK is a safe option for myopia correction and retardation. Long-term success of OrthoK treatment requires a combination of proper lens fitting, rigorous compliance to lens care regimen, good adherence to routine follow-ups, and timely treatment of complications.”

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Myopia Control and OrthokCho, Hong Kong Poly (2004)

Vitreous Chamber ElongationAfter 24 Months

Incidence (1999-2009)• 17% Poland• 35% Spain• 50% US• 50% UK• 60% Japan• 74% Singapore• 78% China• 80% Hong Kong

Prevalence of Myopia East Asia

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Greater than 80% in Hong Kong, Taiwan & Singapore

5 to 7% in rural, uneducated groups (Morgan 2006)

5% in grandparents in Hong Kong (Lam 1994)

Suggest environmental factors rather than genetic factors are responsible for influx

of myopia.

Increased Prevalence of Myopia in the US Between 1971-1972 and 1999 -2004

Susan Vitale PhD, Robert Sperduto MD, Frederick Ferris MDArchives of Ophthalmology Vol. 127 No. 12 December 2009

Ages 12 -54

1971-1972 1999-2004

25.0% 41.6%

Myopic Myopic

In 30 years a 62% increase in myopia

Myopia Incidence Worldwide

• Sankaridurg, 2015• Brien Holden Vision Institute• Estimated myopia changes• 2000 to 2050

• 2000 = 22%• High myopia 2%

• 2050 = 49% (4.9B)• High myopia: 9.7%

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Dr. Monica Jong, 2015Brien Holden Vision Institute

70% of today’s myopia is environmentally driven 30% is genetic.

What are the environmental factors???

Myopia Progression in Kids

• Average -0.50 per year• Fulk et al, 2000• Gwiazda et al, 2003• Walline et al 2004• Walline et al, 2008

• 8 year old with -1.00 progressing linearly would become -5.00 by age 16

High Myopia – Why Worry?

• Premature cataracts

• Glaucoma• Retinal detachment• Macular degeneration

Disease Incidence in Children

• Cancer• <0.4 % (ACCO 2015)

• Cardiovascular disease• <0.9% (AHA 2013)

• Learning disabilities (ADHD)• 8% (CDC 2013)

• Allergies• 9% (CDC 2013)

• Asthma• 14% (CDC 2013)

• Obsesity• 17% (CDC 2013)

• Myopia• 40% (Vitale, 2009)

Should we be concerned about this 6 year old?

• Mother• Od: -6.25• Os: -6.75

• Father• Od: -8.00• Os: -8.00

1985, Ashton1995, Mutti2002, Mutti2007, Kurtz

Genetic predisposition:

1 myopic parent = 2 x 2 myopic parents = 5 x

Monitor?

• Ocular growth produces a myopic shift towards emmetropization

• 6 year olds have an incidence of myopia of 2%

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Risk FactorsCompiled by

Kate Johnson, BAppSc(Optom)HonsGCOT, FBCLA, FIACLE, FCCLSA, FAAO

Brisbane, AustraliaPresented at BCLA 2015

Younan et al 2002; Ogawa & Tanaka 1988: Vongphanit et al 2002; Flitcroft 2012

Benefits of Reducing High Myopia

• Noel Brennan, CL & Anterior Eye 2012

• Danger of high myopia (>5 D) • Increased risk of choroidal

neovascularization• retinal detachment• glaucoma• cataract

• Myopia Reduction of:• 33% reduces high myopia frequency by 73%• 50% “ “ “ “ “ 90%

Hyperopic Defocus

Myopic Defocus

Undercorrection for Myopia Control

Under Full % ChangeCorrection Correction Annual RE Progression

Chung 0.50 0.39 -16%AdlerMillodot 0.50 0.42 -22%

The undercorrectedgroups showed

INCREASED myopia and axial length.

Hyperopic Peripheral Defocus with Standard Glasses

• Tabernero et al. Vision Research, 2009

• Lin, Holden et al, OVS, January 2010

• Single vision glasses produce increased hyperopic defocus

Effect of Single Vision Soft Contact Lenses on Peripheral Refraction

• Under, full, over-correction in 34 myopic adults

• All had myopic foveal and peripheral defocus without correction

• All forms of correction resulted in hyperopic defocus of the peripheral refraction

Kang et al, OVS, 2012

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Alignment Fitting GP’s andMyopia Control

GP Control % ChangeCorrection Correction Annual Axial

GrowthKatz, 2003 0.42 0.40 -5%

Walline, 2004 0.27 0.25 -8%

What happens when we correct with spherical glasses, soft

contacts or GP lenses?• Spectacle Lenses

• Tabernero et al. Vision Research, 2009

• Lin, Holden et al, OVS, January 2010

• Soft Lenses• Kang et al, OVS, 2012• Berntsen et al, OVS, 2013

• GP Lenses• Katz et al, AJO, 2003• Walline et al, AO, 2004

Myopia Control Studies

• Under-correction 0%• Glasses – PALs 18%• Glasses – Myopia control 30%• Soft Multifocal <50%• Orthokeratology 51%• Atropine 75%

What is the best choice for kids?

Shape Factor (E2)

Shape Factor: 0.34

Change in Corneal Power

44.12Dp

Δ-1.00Dp

43.12Dp

Corneal Power After OrthoK

40.75Dp

43.75Dp

Δ3.00Dp

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Correcting Myopia in Children Change in Shape Factor and Corneal Power

Shape Factor:-0.04 E2

Shape Factor: 0.34 E2

Soft Multifocal LensesTarget >+3.00 Add

Soft Multifocalsin Myopia Control

• Image courtesy of Bickle & Nichols, CLS, August, 2014

Approximately 50% Control

Anterior surface of GP Multifocal –Aspheric front surface

Central: 42.87Peripheral: 44.62Δ1.75 Dp

42.87Dp

44.62Dp44.50Dp

GPs to Induce Peripheral Myopic DefocusPaune et al, Optometry & Vision Science (2015)

• N = 52• One eye fit with two designs

• Standard GP• Novel Gp

• Results• Standard: 100% had hyper peri defocus• Novel GP: 60% had myopic peri defocus

>1Dp

Conclusions: “Custom-designed RGP contact lenses can generate a significant degree of relative peripheral myopia in myopic patients regardless of their baseline spherical equivalent refractive error”

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Myopia Control Options?Advantages/Disadvantages

OrthokeratologySoft Multifocal GP Multifocal

Delivering Myopia Control Optics:Which is Better?

• Turnbull et al, 2016• Patients chose treatment:

• Orthokeratology 49.1%• Multifocal SCL 28.1%• Atropine 2.6%• No Treatment 19.3%

• “Both orthok and dual focus SCLs are effective strategies for targeting myopia progression in the clinic. We saw no significant difference in the efficacy of the two methods in this regard, and so we believe there are very few barriers for any contact lens practitioner to be actively promoting myopia control treatment to at-risk patients

Orthokeratology

Multifocal SCL’s

Soft Multifocals VsSingle Vision Spectacles

• Pomeda et al, 2017• N=74, 41 in MF, 33 in SV• 8-12 years old• Myopia -0.75 to -4.00• Evaluated at 12 and 24 months• Quality of life scores higher in

MF group• Near vision was significantly

better in the SV group at both 12 and 24 months (P < 0.001)

Adolescent vision with soft multifocal lenses

• Kang et al, 2017• N = 24• Cooper ProClear MF• Adds: +1.50 and +3.00• High and Low Contrast

reduced initially• Low contrast VA continued to

be affected after 2 weeks• “the study determined that

clinicians should educate patients about these effects on vision”

Myopia Control: A ReviewWalline, Eye Contact Lens. 2015

What not to do:

• Under correction• SV GPs or SCLs• Outdoor time *• Bifocal and multifocal spectacles *

What to do:

• Soft multifocal lenses

• Orthokeratology• Atropine

Push Plus into the eye!ImageShell

ImageShell

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Standard 6mm OZ designs were constructed for Adults 6mm OZ

Standard OrthokDesign

Optical Zone RC AC IC PC

6mm Optical Zone

6mm

OK Myopia Control Studies

• Cho, 2005 47%• Walline, 2009 43%• Kakita, 2011 36%• Walline, 2009 58%• Despositis, 2009 80%• Hiraoka, 2012 42%• Chen, 2013 52%

Average: 51%

Chow 5 Year OK Axial Length Study

• Traditional 5 Curve OK Lens Design N = 165• Aspheric 6 Curve OK Lens Design N = 129• Historical Control CLEERE Study 2007

Traditional 5 Curve Design Aspheric 6 Curve OK Design

.0

.2

.4

.6

.8

1.0

1.2

1.4

1.6

1.8

-1 -2 -3 -4 -5 -6+

Fiv

e Y

ea

r A

xia

l L

en

gth

Ch

an

ge

Fro

m B

ase

line

(m

m)

Baseline Spherical Equivalent (D Rounded)

Lens Design and Myopia ControlOrthokeratology forAdults Versus Kids

5.0 oz6.0 oz

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Dedicated Myopia Control DesignBE Free MC

6.0mm Oz

5.0mm Oz

3.01Dp Bulls-eyeAxial Map

1DpPower

Change

3.03Dp Bulls-eyeAxial Map

2DpPower

Change

3.05Dp Bulls-eyeAxial Map

3.00DpPower

Change

Variable Optical Zones Variable RMS Error

1Dp PowerShift

2Dp PowerShift

3Dp PowerShift

How do you begin?

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OK Design Options

• Empirical• Lowest start-up costs• Least predictive

• Fitting Set• Moderate start-up costs• More predictive, more

visits?

• Inventory• Highest start-up costs• Predictive, most efficient

Ideal Candidates

• Low Rx• <4.00Dp Myopia• <1.00Dp Astigmatism

• Topography• Sphere• Apical astigmatism (<1.50dp)

Moderate Candidates

• Moderate Rx• 4.00-6.00Dp Myopia• 1.25-1.75Dp Cylinder

• Topography• Limbus to Limbus astigmatism (1.50-2.00Dp cyl)

• Against the rule (>1.00Dp)

DifficultCandidates

• High Rx• >6.00Dp Myopia• ≥2.00Dp Cylinder

• Topography• Displaced apex• Corneal cylinder >2.00Dp

Optimizing Capture Tear Film Reflection

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Tear Film Reflection Capture Considerations

Lid and Lashes Ring DistortionTear Film Break-up/ scarring

Optimal Capture:Normal Eye

Lid and Lash Limitations

Placido capture on the visual axis and with modified fixation in the direction of the 4 principle axis

Analysis of shape on the 5 different fixations

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Composite Eye:100% Corneal Coverage Comparison of Systems

>8.0mmLarge Cone

Topographer

>10.5mmMedmontCapture

>12mmMedmont

Composite Eye

Where will an orthoklens center on this eye?

Displaced Eye- decentered outcome

Where will an orthoklens center on this eye?

Symmetric eye- centered outcome

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Which eyeis tougher to fit?

Apical Astigmatism

Sagittal Depth

Flat: 1427Steep: 1444

Δ 17µm

Limbus to Limbus Astigmatism

Sagittal Depth

Flat: 1464Steep: 1551

Δ 87µmDifference87 microns

Difference17 microns

Limbus to Limbus

AstigmatismApical

Astigmatism

*

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Clinical Pearl:Consider a toric design:

Sag differential =>30 microns (8mm)

*

Orthokeratology onApical Astigmatism

Orthokeratology onLimbus to Limbus Astigmatism Comparison of Effect

Apical Astigmatism Limbus to Limbus

Symmetric Vs. Toricon an astigmatic eye

Symmetric Toric

The Perfect FluoresceinPattern, but…

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Fluorescein is visibleat 20 microns

Carney, LG (1972) Young, G (1998) Young, G (1998)

20 Microns

What are we looking

for?

Pre-fitting Evaluation:What if you aren’t sure?

Procedures:Application & Removal

• Clean, dry hand• Solutions

• GP conditioner• MPS• Artificial tears (Gel)

• Apply just prior to sleep

ScheduleOvernight Wear

Post Treatment AM Evaluation: Slit Lamp

• Lenses on• Allows you to observe

adherence• Allows you to see the effects

immediately post removal• Patient less comfortable

• Lenses off• Patient is more comfortable• Can’t observe fitting signs as

easily

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Post Treatment AM Evaluation: Slit Lamp

• Lenses on• Check for adherence• Lens position?

• Lenses off/Remove lenses

• Check for staining• Visual acuity

The power of the acuity chart

• Start with the pre-fit acuity level

• Work down the chart line by line

1 Day AM Post Removal Staining in Orthokeratology

2004, Walline: 58%2008, Lipson: 32%2012, Cho: 23%

Day 2 No Staining Topographical Outcomes

Central IslandBulls-eye

Frowney FaceSmiley Face

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What is the outcome of orthokeratology?

What is the outcome of orthokeratology?

What is the outcome of orthokeratology?

1 Night Effect 3 Night Effect

Subtractive Maps in Orthok

1) Pre-fit Topography

2) Post-fit Topography

3) Subtractive Map

3 Nights Effect:Axial Subtractive Map

3 Nights Effect:Tangential Subtractive Map

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How do we read Axial Subtractive Maps?

How do we read Tangential Subtractive Maps?

Axial Subtractive Map Tangential Subtractive Map

Bulls-eye Response• Correct sagittal depth• Correct alignment zone• Centered treatment zone• Myopic reduction

Axial Subtractive Map

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Tangential Subtractive Map Central Island Response• Excessive sagittal depth?• Tight alignment zone?• Inappropriate lens diameter?• Inferior treatment zone and/or central

steepening• Poor vision/ induced astigmatism

Axial Subtractive Map Tangential Subtractive Map

Smiley Face Response

• Inadequate sagittal depth?• Loose alignment zone?• Superior treatment zone

Axial Subtractive Map

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Tangential Subtractive Map Frowny Face Response• Sagittal depth appropriate• Tight alignment zone• Inappropriate lens diameter?• Inferior treatment zone• Aberrations?

Visual Response:First Morning

• Unpredictable

• Lack of retention

• May require additional power

Soft Lens Dispensing

• Expect to lose -0.50 to -1.00Dp on the first day post wear

• Provide lenses in 0.50Dp increments

• Example:• Pre-treatment Rx: -4.00• 1 night post wear: -2.00• Provide: -2.50, -2.00, -1.50, -

1.00

1 Night Effect 1 Month Effect

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Don’t Rush to Topographic Conclusions

1 Night 1 Month

Partial OK• Charm et al, HK

Polytech• N=52, 8-11 years, >-

5.00• OK target -4.00Dp• OK group after 2

years -0.13Dp increase

• Control group after 2 years -1.00Dp

• Axial growth 63% lower in OK group

Treatment Schedule• 1 night in the custom

• same evaluation as the 1 night trial• Retainers on

• 7-14 days• AM appointment• Visit without lenses on

• 1 month• PM appointment• Check retention and the end of the day vision• Review weekly schedule – reduced wear?

• 6 months• Check for deposits and warpage

Therapy Fees

•Assume 7 visits (2-3 hours)

•1 Pair (back-up pair optional)

Orthok Fees

• Fitting Software: $0 - 1200• Topographer $8,000 – 50,000 ($15K aver)

• Lens Fees• Symmetric Unwarranted: $65 - 95• Toric Unwarranted $85 - 105

• Symmetric Warranted (3 lenses) $175• Toric Warranted (3 lenses) $220

• Treatment Fees to the Patient• Range: $1000 – 5000• Typical: $1500 – 2500

Lens Packages

• Cost per patient:• Unwarranted (4 lenses) $300/ $380• Warranted (6 lenses) $350/ $440

• Treatment Fees (Warranted):• Easy: $1500 $1150/ 1060• Moderate $2000 $1650/ 1560• Difficult: $2500 $2150/ 2060

• Annual considerations• 2 patients per month (24) @ $2000: $39,600 (sym)

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Fee Schedule

• Orthok Candidacy: $100-300• Start treatment: 1/3 payment• 1st dispensing visit: 1/3 payment• 1 month 1/3 payment

How many patients does it take to pay for the tools?

• $2000 Fee• $350 Warranted pair

•9-10 patients pays for the system (2-3 pays for the lease)

• Choose low Rx’s to start (<-2.00Dp)

• A record of 100% success speaks volumes

• First 10 patients (case study) reduced fees?

• Send ecstatic patients into the community

Initial Practice Tips Practitioner tools

• Orthokeratology Academy of America

• www.orthokacademy.com

• http://www.myopiaprofile.com/

• www.myopiaprevention.org

Orthok Conferencesand Education

• Certification - Requirement

• Global Specialty Lens Symposium

• January, Las Vegas

• Vision by Design• April, Different annual location

You have plenty of support throughout the orthokprocess

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Thank-you!

Randy KojimaFAAO, FBCLA, FSLS, FIAO