Myopia control vbd

Myopia ControlAttempted Methods, Randomized Clinical Trials

What They Tell Us and How to Implement a Myopia Control Specialty

Alan N. Glazier, OD, FAAO

Rockville, MD

Financial Disclosures

• EyeCarePro• Jobson• CEingIsBelieving Virtual Conferences• TearScience• Freedom Meditech• Europa• EyePosts• VisionCareInventing.com• ODs on facebook• MyopiaInstitute.com

Building a Myopia Control Specialty –Parents WILL Ask!!!

. . You Need to Know the Answer AND Provide the Service

Myopia - Prevalence

• Varies By Country

• Reaches as High as 70-90% in Asian Countries

• Epidemiologic Evidence Prevalence is Increasing

Myopia – Cost to Society

• Prevalence 1-3% of the Population

• US Treatment Costs $250M per Year

• As Prevalence Increases, Incidence of Pathologic Myopia Increases

Methods of Myopia Control

• Hyperopic Peripheral Defocus


Creating Hyperopic Defocus Around Macular Region of Posterior Pole Has Shown Positive Results in

Reducing the Rates of Myopic Creep

Managing Peripheral Refraction; Hyperopic Peripheral Defocus

– OrthoK Lenses

• Flattening of Central Cornea, Peripheral Cornea Largely Unchanged.

• Change in Corneal Spherical Aberration

• Foveal Vision Corrected to Approx Emmetropia While Peripheral Retina Remains Relatively Myopic.

– Retardation of Myopia Progression Produced by OrthoK Lenses Provides Support for Peripheral Hyperopic Defocus Theory.

– (Courtesty of Mark Bullimore; http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/)

Thank You Mark Bullimore

Hyperopic Peripheral Defocus

• Berkeley Orthokeratology Study

• 80 Subjects

• Larger Effect for Patients Randomized for OrthoK Than Not

• Reduction Did Not Persist After (Pose KA, 1983)

Long Term Ortho-K Research in Children (LORIC) (Cho et al. and Walline et al.)

• 2-year Pilot Studies

• Controls (soft lenses and spectacles)

• OrthoK Slowed Axial Elongation by 46% and 56%, respectively.

Retardation of Myopia in Orthokeratology(ROMIO) (Cho and Cheung 2012)

• Findings of LORIC Subsequently validated in 2 year Randomized Clincial Trial

• Concluded Subjects Wearing OrthoK Lenses Had Slower Increase in Axial Elongation Compared to Subjects Wearing Single-Vision Glasses

– 20% of 7-8 Year-Old OrthoK Patients Progressed at Greater Than 1.00D/Year

–63% of the Control Group Did So.

– Rates Slowed Down Significantly by Ages 9-10 When Only 13% of the Controls and 9% of the OrthoK Patients Progressed

Stabilization of Myopia Through Accelerated Reshaping Technologies (SMART)

(Eiden et al)

• 200 Children Age 8-14; OrthoK Compared to Standard Soft

• Interim Results – OrthoK Wearers Experienced Minimal Change in Myopia 3 Years Out

• Soft lens Wearers Worsened

Corneal Reshaping and Yearly Observation of Nearsightedness (CRAYON)

(Walline et al, 2009)

• Determine Whether Corneal Reshaping Devices Slow Eye Growth

• 40 Subjects 6-11 Years Old

• -.75 to -4.00 D Myopia

• Age Matched to SCL Wearer

• Results Confirm Slowed Eye Growth in Corneal Reshaping Lenses

Conclusion: OrthoK

STABILIZING EFFECT FOR ORTHOK:

NO WAY TO PREDICT HOW MUCH EFFECT PER SUBJECT, ALTHOUGH IT CAN HAVE AN EFFECT

(Thanks to Mark Bullimore; http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/)

Multifocal Soft (Aller et al, 2008)

• Twin Study; 12 Year Old Females• Randomly Assigned BF and SV for One Year –

Double Masked• Second Year Both Wore BF• Both Esophoric; Both Myopic• Child Wearing SV in First Year Showed Significant

Myopic Creep (-1.19D) / Child in Bifocal Soft Showed No Progression

• Switch of SV Child to Bifocal in 2nd Year Arrested Progression

Multifocal Soft (Walline et al.)

• Daily Wear Distance-Center Multifocal Soft Lenses Slowed Progression by 50% (2 year study)

• Reduction in Axial Elongation Only 29%Compared to Control Group

(Thanks to Mark Bullimore; http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/)

Multifocal Soft (Anstice et al, 2011)

• Randomized, Paired-Eye Controlled Investigator Masked Trial With Cross-Over

• 40 Children Ages 11-14

• Center Distance Peripheral W +2.00 D Defocus

• Both Myopia Progression and Eye Elongation Reduced Significantly

Conclusion: Multifocal Soft

• Effective at Slowing Myopic Creep and Managing Axial Elongation in Center Distance Multifocal Lenses With Minimum +2.00 Adds

Spectacle Lens Designs Inducing Peripheral Hyperopic Defocus

• Novel Spectacle Lens Designs Intending to Reduce Peripheral Hyperopic Defocus Sans Corneal Molding.

Spectacle Lens Designs InducingPeripheral Hyperopic Defocus (Sankaridurg et al.,

2010)

• Chinese children randomized to wearing either one of three novel spectacle lens designs or conventional, single-vision spectacle lenses

• Study Ran 1 year (Age 6-16)

• Conclusion: No statistically significant reduction in myopia progression observed with the novel designs

• HOWEVER: For Children under 12 years with a parental history of myopia, progression was 30% lower than with control spectacles.

(Courtesy of Mark Bullimore; http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/)

Spectacle Lens Designs For Obtaining Peripheral Hyperopic Defocus

(Brien Holden Institute/Vision CRC)

• Vision Cooperative Research Centre (Vision CRC)

• Announced That Myopia Can be Controlled With New Technology Based on Research Conducted By Vision CRC Partners

• Zeiss Myovision Lenses



• Gas Permeable Contact Lens Wear

Possible Mechanism: RGP

• Improved Retinal Image

• Flattened Cornea

Gas Permeable Lenses:Singapore Study

(Katz, 2003)

• Randomized Trial of RGP Contact Lenses

• Children 6-12 Years

• Myopia -1.00 to -4.00

• 393 Children Followed

• RGP Lenses Did Not Slow Progression of Myopia

Gas Permeable Lenses - OSU(Walline: Arch Ophthalmol 2004; 122: 1760-1766)

• Randomized Trial of the Effects of Rigid Contact Lenses on Myopia Progression

• Showed RGP Wearers Myopia Progressed Less Than That of SCL Wearers

Gas Permeable Lenses(Katz J et al, 2003)

• Randomized Trial of Rigid Gas Permeable Contact lenses to Reduce Progression of Children’s Myopia

• 428 Singaporean Children

• 6-12 Years of Age

• Did Not Slow Rate of Progression

Gas Permeable LensesContact Lens and Myopia Progression Study (CLAMP)

(Walline et al, 2001-2004)

• Addresses Limitations of Other Studies

• Evaluated Myopia Progresion Over a Three-Year Period

• 116 Children; 8 to 11 Year Olds

• Children Given Two Months to Adapt to Wearing the Rigid Contact Lenses Before Study Officially Began

• Axial Growth for Two Treatment Groups Statistically Insignificant

Initiative to Encourage Vision Empowerment Study (ACHIEVE)

(Walline et al, 2008)

• Studied if Soft Lenses CAUSE Increase in Myopia Greater Than No Lenses or Glasses

• Found They DO NOT Cause a Statistically Significant Increase in Myopia

• ….Although They Do NOTHING to Slow Down or Control Axial Elongation

Conclusion: RGP Lenses

• RGPs Do Not Slow Progression

• Soft Spherical Lenses Do Nothing to Arrest Progression But Don’t Increase Rate of Progression




• Bifocal and Multifocal Ophthalmics

Multifocal Spectacle Lenses

• Number of Investigators (Betz, 1949, Gamble, 1949, Miles,

1957, Miles, 1962, Parker ?) Suggested Accommodative Response May Play Role in Progressive Myopia

Multifocal Spectacle Lenses(Shih et al, 2000)

• Non-Significant Reduction of Progression in 227 Myopic Children Aged 6-12 Years

Multifocal Spectacle Lenses(Cheng D)

• Myopic Chinese Canadian children randomly assigned one of three treatments: • Single-vision lenses

• Executive bifocals

• Executive bifocals with base-in prism in the near segment of each lens

• 3 years

• Results: 39% and 51% for bifocals with and without prism, respectively,

• Axial elongation similar for each of the two bifocal treatment groups.

Multifocal Spectacle Lenses(Cheng D et al 2010, 2014)

• Larger the near portion, the greater the treatment effect.

• PAL’s Worse: Execs and 35mm Segs Best

Again, Thanks Mark Bullimore . . And

Thanks Facebook

Mark Bullimore

Multifocal Spectacle Lenses (Parsinnen O, 1989)

• 240 Myopic Schoolchildren - Finland Randomized:(a) Minus Lenses - Full Correction – Continuous Use

(b) Minus Lenses - Full Correction - Distance Use Only

(c) Bifocal Lenses

Found No Signficant Differences in Rate of Myopia Progression Between Groups After 3 Years

Multifocal Spectacle Lenses (Fulk et al., 2000)

• Hypothesis: Bifocals Slow Myopia Progression in Children With Near-Point Esophoria

• Randomized

• Seemed to Slow Myopia Progression to Slight, Statistically Significant Degree

Multifocal Spectacle Lenses(Edwards MH et al 2002; Gwiazda J et al 2003)

• Hong Kong Progressive Lens Myopia Control Study (Edwards)

• Progressive addition spectacle lenses (PALs) produce a statistically significant and clinically relevant 11–13% slowing of myopia progression based on 2 and 3 year randomized clinical trials

Multifocal Spectacle LensesCorrection of Myopia Evaluation Trial (COMET)

(Gwiazda et al. 2011)

• Randomized Trial PAL’s Vs. Single Vision

• Ongoing

• Double-Masked

• 469 Myopic Children, Aged 6-11

• PALs Compared to SVLs Slowed Progression of Myopia Children by Small, Statisitically Significant Amounts Only During First Year.

• Treatment Effect Remained Similar for Next 2 Years

Multifocal Spectacle Lenses(Fulk GA et al 2001; Bernstein DA et al 2012)

• Other clinical trials of PALs and flat-top bifocals in hypothetically high-risk groups have found similarly modest treatment effects





• Vision Training

Vision Training

• Bates – Overaction of EOM’s Leads to Changes in Accommodation

• Trachtman – Ciliary Muscle Action Responsible for Refractive Error Change Susceptible to Biofeedback Training

Vision Training

• Behavioral Training for Myopia Long Term Maintenance of Improved Acuity,

• Collins, FI., Ricci, J.A. and Burkett, J.A. 1981 Behavioral Research and Therapy 19 (3), 265-268

Vision Training

• Myopia Reduction training With a Computer Based Behavioral Technique; A Preliminary Report

• Leber, Leray and Thomas A Wilson, 1993, Journal of Behavioral Optometry, 4:87-92

Vision Training

• The Baltimore Myopia Study 40 Years Later,• Trachtman, J., and Giambalvo, V., 1991, Behavioral

Optometry, 2, 47-50

Vision Training

• No Randomized Trials and No Conclusive Evidence for Any Theory of Myopia Control Via Vision Training





• Vision Training

• Pharmacologic

Pharmacological

• Used extensively in Asian countries, but there has been general resistance to its widespread adoption in the West given its side effects of cycloplegia and photophobia.

Thanks Again to . . . .http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/

Atropine(Chia A et al, 2012; Cooper A et al, 2013 )

• A recent clinical trial has demonstrated that the lower concentrations of 0.1% and 0.01% can slow progression by 68% and 59%, respectively.

• At a concentration of 0.01% accommodation is relatively unaffected and symptoms absent making this an attractive option that is gaining traction in the US.

Atropine(Chua WH et al., 2006; Bedrossian 2006)

• Large Scale Studies on the Effect of Atropine of Varying Strength in Stabilizing and in Some Case Reducing Myopia - Randomized, Double-Masked

– Topical Atropine Effective in Slowing Progression and Controlling Axial Elongation in Low and Moderate Myopia

• Studied the Effect of Atropine on Myopia. In his Study Control Eyes Showed Significant Increases in Myopia Compared to Treated Eyes

Atropine(Shih YF, 2000; Shih et al 1999; Yen MY 1989)

• Range of Concentrations of Atropine EyedropsTested in Three Randomized Clinical Trials

• Schoolchildren in Taiwan

• Rate of Progression of Myopia in Atropine Group Significantly Lower Compared to Control Group

Atropine

• Shih YF, et al, Study Entitled “An Intervention Trial on Efficacy of Atropine and Multi-focal Glasses in Controlling Myopic Progression – (acta Ophthalmol Scand., 2001 Jun; 79(3):233-6)

• Syniuta LA, Isenberg SJ, Binoc Vis Strabismus Q., 2001;16(3)203-8

• Chiang MF, et al (Binocul Vis Strab Q. 2001;16(3):209-15) report the Largest Known Series of Patients Treated Simultaneously With Bifocals and Topical Atropine

Atropine

• Kennedy et al Ran Another Study in Progression of Myopia– (Trans Am Ophthalmol Soc., 1995;93:755-800)

• Brodstein et al, “The Treatemnt of Myopia With Atropine an Bifocals., A Long Term Prospective Study”– (Ophthalmology 1984, Nov;91(11):1373-9)

• Atropine Reduces Experimental Myopia and Eye Enlargement Via a NonaccommodativeMechanism– (Invest Ophth Vis Sci Jan; 34(1): 205-15)

• Gimbel HV, “The Control of Myopia With Atropine (Can J Ophthalmol 1973 Oct 8(4): 527-32 Studied the Safety and Efficacy of Topical 1% Atropine Eye Ointment in Retarding Myopic Progression in Children With Moderate to Severe Myopia

• Jpn Journ. Ophthalmol 2007; 51;27-33 “Safety and Efficacy of Topical 1% Atropine Eye Ointment in Retarding Myopic Progression in Children With Moderate to Severe Myopia

Pirenzipine

• Selective M1 Subtype Muscarinic Receptor Antagonist

• Randomized Clinical Trials Currently in Progress

• Siatkowski et al 2004 Multicenter, Double Masked Placebo Controlled

• Children 8-12 Years

• Effective and Safe – 50% reduction compared to controls

Dopamine

• In Rabbits, Injections of Dopamine Prevented the Myopic Shift and Vitreous Chamber and Axial Elongation Typically Associated With Form Deprivation Myopia– (Gao Q et al 2006)

• In Guinea Pigs, Systemic L-Dopa Shown to Inhibit the Myopic Shift Associated with FDM and Has Compensated to the Drop in Retinal Dopamine Levels (Mao Jet al 2010)

Dopamine

• Theory: Dopamine Antagonist

• Study Suggests That Dopamine Participates in Visually Guided Eye Growth Regulation (Pendrak K et al, 1997)

• L-dopa Treatment in children with Amblyopia Showed an Improvement in Visual Acuity. (Lequire LE et al, 2002)

Ocular Hypotensives

• Suggested Theory; Myopia May be Due to Passive Stretching of Sclera Due to Increased Intraocular Pressure From Increase in Vitreous Chamber Volume

• Timolol .25% vs Spectacles in Denmark

• No Significant Difference After 2 Years (Jensen H, 1991)

Ocular Hypotensives

• Adrenaline and Pilocarpine Have Also Been Studied, but Not in Randomized Controlled Study

• Lack of Evidence for Support of Hypothesis and Side Effects Significant

Conclusion: Pharmacologic

• Atropine is probably most effective treatment to slow myopia progression

• Pirenzipine Seems to Have an Effect

• Mechanism of action is retinal or scleral and not accommodative





• Vision Training

• Pharmacologic (Atropine and Pirenzipine)

• Nutrition and Environment

Nutrition and Environment

• Hypothesis: Time Spent Outdoors Reduces Likelihood Children Will Develop Myopia

• Possibly Because Light Levels Are Much Higher Outdoors Than Indoors.

Nutrition and Environment

• Effects of High Ambient Lighting on Vision-Induced Myopia in Monkeys Were Determined

• Daubs JG, et al Reported Incidence of Reported blindness Due to Malignant Myopia Found to be Inversely Related To Distance to Seacoast

• Correlated the Distance to Reduction in Sunshine, Fluoride, Calcium and Selenium. Made Comparison to Risk Factors for Dental Carries

• Suggests Further Study of These Factors in Progression of Malignant Myopia

Nutrition and EnvironmentAvon Longitudinal study of Parents and Children (ALSPAC)

aka Children-Of-The-90s Study

• 7000 Children in Great Britain

• Found Those Who Spent Little Time Outdoors Daily at 8-9 Years of Age Were 40% More Likely to Develop Myopia By Age 15 Than Those Who Spent 3 Hours a Day or More Outdoors in the Summer and More Than 1 Hour Daily in The Winter. (Invest Ophthalmol Vis Sci, 2012:53

2856-2865

• Epidemiologic Evidence Indicates That Time Outdoors Reduces the Risk of Myoipa, Suggesting a Link Possibly for Vitamin D http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3109057/

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3109057/

Nutrition and Environment(Politzer M et al, 1977)

Experiences in the Medical Treatment of Progressive Myopia

• Studied the Effect of Anthocyanosides and Vitamin E on Refraction, Visual Acuity and Eye Fundus.

• Non-Randomized

• Concluded Form of Vitamin E They Used (Difrarel E) Achieves Therapeutically Valuable Results in the Treatment of Progressive Myopia.

Nutrition and Environment(Edwards MH et al)

• Studied Association Between Diet and Myopia for the First Time for a Group of Children Who Weren’t Myopic to Start and Became Myopic and With a Group Who Did Not Become Myopic.

• Non-Randomized

• Children Who Developed Myopia Had Generally Lower Intake of Many of the Food Components Than Children Who Did Not Become Myopic

Nutrition and Environment(Lane et al)

• Reported Highly Significant Chromium/Vanadium Ratio Depression Indexed in Nape Hair of MyopesAssociated with Depressed Dose of CiliaryMuscle Insulin Receptors

• Also Claims Foods Rich in Chromium and Vanadium including Chocolate, Kelp, Mushrooms, Most US chow-Fed Poultry, and Seafood Larger Than Herring Play a Role in the Progression of Myopia in People Predisposed to Myopia

Behavior

Behavior

• Dubious History

• SeeClearly Method and the Bates Method and recent attempts to control myopia by vision training have failed.

Near Work and Myopia(Multi DO et al, 2002; Saw SM et al 2002)

• Well-designed large-scale studies failed to find compelling association between the amount of near work undertaken by a child and the incidence or progression of myopia.

• (Mark Bullimore;

http://onlinelibrary.wiley.com/enhanced/doi/10.1111/opo.12130/)

Myopia and the Outdoors(Multi DO et al, 2002; Rose KA 2008)

• Strong evidence that more time spent outdoors lowers the risk of developing myopia.

Myopia and the Outdoors(Wu PC et al 2013; Jones-Jordan LA et al 2012)

• Studies Found Time spent outdoors in childhood is not associated with rates of myopia progression

• nor does it appear to be related to myopiastabilization. (Scheiman et al, 2014)





• Vision Training

• Pharmacologic


• Undercorrection

Undercorrection

• 2006 Randomized Study – Children Between 6 and 15 (48 children)– 18 Months– 23 Participants Fully Corrected/25 Undercorrected by

+.50. Statistically Insignificant Results.

Although Slight Progression (0.17D) in UndercorrectedChildren Not Only Ineffective, May Actually INCREASE Progression (Adler et al, 2006)

Intentional Undercorrection Can Put Students at Disadvantage, Affect Sports and Safety





• Vision Training

• Pharmacologic


• Undercorrection

• Traditional Chinese Interventional Treatments

Traditional Chinese Interventional Treatments

• Facial “Qi Qong” Exercises Created in 1950’s in China

• Involves Massaging Various Acupuncture Points Around the Eyes

• Two Non-Randomized Trials

Inconclusive

Semen Impatiens

• Different Parts of Plants Used for Remedies for Skin Maladies

• Evaluated and Significant Treatment Effects Claimed

Summary of Data

• Evaluation of Randomized Controlled Trials Determined the Most Likely Effective Treatment to Slow Myopia Progression Thus Far is Anti-Muscarinic Topical Medication





• Vision Training

• Pharmacologic


• Undercorrection

• Traditional Chinese Interventional Treatments

All Unsubstantiated and Exaggerated Claims

• Vitamins

• Scleral Surgery

• Biofeedback

• Ocular Hypotensives

• Ocular Relaxation Techniques

• Acupuncture

How to Talk to Parents

• Chickens and Ping Pong Balls

• Long Hair and Reading

• Screen Working Distance

• Obtuse vs Acute

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