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
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