Myopia control vbd

Myopia Control
Attempted 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
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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/)

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 Inducing
Peripheral 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 Lenses
Contact 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

(Shih et al, 2000)
• Non-Significant Reduction of Progression in
227 Myopic Children Aged 6-12 Years

(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.

(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

(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

(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

(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

Correction 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

(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 Eyedrops
Tested 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 Nonaccommodative
Mechanism
– (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.

• 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

Avon 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/P
MC3109057/

(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.

(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

(Lane et al)
• Reported Highly Significant Chromium/Vanadium
Ratio Depression Indexed in Nape Hair of Myopes
Associated with Depressed Dose of Ciliary
Muscle 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
• 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 Undercorrected
Children 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

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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