O N E O F T H E R E F R A C T I V E E R R O R P R O T O C O L S

Myopia Protocol(s)

Richard L. Anderson, OD, FOAA Myopia Protocol Committee Head, OAA

Disclosure

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No corporate sponsors. Owner of: OrthoKDoctors.com MyopiaPrevention.org

www.MyopiaPrevention.org/myopiaprotocol.pdf OAA Scottsdale RLA

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1 . F O R M E D A M Y O P I A P R O T O C O L C O M M I T T E E W I T H T H E K N O W L E D G E T H A T R E F R A C T I V E C O N T R O L I S O U R F U T U R E .

2 . T A S K E D T H E C O M M I T T E E W I T H C R E A T I N G A M O D E R N D A Y P R O T O C O L .

3 . N O R E S T R I C T I O N S – “ T A K E I T W H E R E V E R I T N E E D S T O G O . ”

What is the OAA doing?

Thomas Aller Jeffrey Cooper Jerry Legerton Earl Smith Jeff Walline Christine Wildsoet

Currently on the committee:

OAA Scottsdale RLA

History of Myopia Protocols

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“The most commonly used methods of myopia control are plus lenses at near and rigid contact lenses.”

http://www.aoa.org/documents/CPG-15.pdf

Optometric Clinical Practice Guideline American Optometric Association 1997.

Optometric Clinical Practice Guideline American Optometric Association 2002.

http://www.aoa.org/documents/CPG-2.pdf

“Early detection and preventive care can help avoid, or minimize, the consequences of disorders such as amblyopia and strabismus.” (No mention of myopia control)

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“Because of lack of efficacy and associated risks, orthokeratology is not recommended for prevention of myopia progression in children.”

Refractive Errors & Refractive Surgery Preferred Practice Guidelines 9/2007

http://one.aao.org/CE/PracticeGuidelines/PPP_Content.aspx?cid=e6930284-2c41-48d5-afd2-631dec586286

OAA Scottsdale RLA

1) Not adequate for what is possible

2) Do not incorporate prevention and control of refractive errors.

Problems with prior protocols

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I. Scientifically defensible at specified strengths of evidence. II. Useful for the practitioner.

A myopia protocol must be what?

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I. Scientifically defensible at specified strengths of evidence.

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Meta-analysis of multiple randomized controlled clinical trials. ... … … …

Case reports or opinions of recognized experts

High

Low

II: Useful to the practitioner

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Is it useful? Example: “All young myopes should be evaluated by an orthokeratologist.” Is it useful to tell ALL the optometrists around you to send you ALL their myopes? Or expect over half of optometry to become orthokeratologists? Example: “Children meeting specific criteria should be given information on orthok as part of a comprehensive program of myopia prevention and control.” Is this proper treatment of an emerging myope?

Why does this matter?

OAA Scottsdale RLA

We are about to tell vision practitioners that the way they have treated the most common diagnosis in their practice for over a hundred years is WRONG. “Myopia just isn't the evil that folks think it is.” JK “You guys are just fishing in the dark and basically using junk science.” FV “As a -6.00 myope myself…What’s so bad about myopia?” JG Or “…malpractice is her method of care” (for letting myopes progress) PP

What doesn’t work or works poorly

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I. Spectacles *Often used as the standard for progression *Undercorrection makes myopia worse *Current designs of flat base curves theoretically bad for control

What doesn’t work or works poorly

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I. Spectacles II. Progressive Addition Lenses (PALs)

* May help a subset of patients with near eso and lag of accommodation. Or not. Gwiazda (2004) vs Gwiazda (2011) * No help for everyone else

What doesn’t work or works poorly

OAA Scottsdale RLA

I. Spectacles II. Progressive Addition Lenses (PALs) III. Bifocals * Don’t seem to work. Some discussion of customizing the add based on lag and phoria (Cheng 2011)

What doesn’t work or works poorly

OAA Scottsdale RLA

I. Spectacles II. Progressive Addition Lenses (PALs) III. Bifocals IV. RGPs (standard) * Works most the first year, then not.

What doesn’t work or works poorly

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I. Spectacles II. Progressive Addition Lenses (PALs) III. Bifocals IV. RGPs (standard) V. Soft Lenses * Nope

What doesn’t work or works poorly

OAA Scottsdale RLA

I. Spectacles II. Progressive Addition Lenses (PALs) III. Bifocals IV. RGPs (standard) V. Soft Lenses VI. Lots of stuff we’ll probably never prove –

good or bad. Can’t easily do many studies. * Over-plus at all distances * Pinhole glasses, etc.

What sorta works

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Radial Refractive Gradients Power varies along the radial of a lens, from pupil center to edge, 360°

* Center-distance soft contact lenses

Most common “standard” lens: CooperVision Proclear Multifocal D

Asia: CooperVision MiSight - 37% reduction??

Many patents – some with lenses in trials

At least one report of 87% reduction (Aller)

What sorta works

OAA Scottsdale RLA

Radial Refractive Gradients Power varies along the radial of a lens, from pupil center to edge, 360°

* Center-distance soft contact lenses

* Spectacles

Asia: Zeiss – MyoVision 30% reduction??

What sorta works

OAA Scottsdale RLA

Radial Refractive Gradients Power varies along the radial of a lens, from pupil center to edge, 360°

* Center-distance soft contact lenses

* Spectacles

* Orthokeratology

You came to the right place to hear about this one!

Studies to date not as exciting (50%? Reduction) as case reports

What sorta works

OAA Scottsdale RLA

Radial Refractive Gradients Power varies along the radial of a lens, from pupil center to edge, 360°

* Center-distance soft contact lenses

* Spectacles

* Orthokeratology

Outdoor time

Different studies show different levels of effect.

Mechanism unknown. Could be peripheral focus effects, dopamine…

What works

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Atropine Lots of studies

Not due to cycloplegia or mydriasis

1% works great, many side effects

.01% works almost as well while preserving pupil and accommodative functions (Chia 2011)

What might work

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Diet – Low carb? The arguments look good but no studies. Light – Dark cycles Interesting animal studies.

Now What?

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Your Personal Myopia Control Protocol

* How aggressive should you be?

* Remember “Scientifically defensible at specified

strengths of evidence.”

* What should it include?

Your Personal Myopia Protocol

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* Age of Patient Younger onset = higher myopia Later onset = faster initial rate of change

Your Personal Myopia Protocol

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* Age of Patient * Family History More myopes in family = bad

Your Personal Myopia Protocol

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* Age of Patient * Family History * Social History Indoor, sedentary, high carb intake, poor visual hygeine, etc.

Your Personal Myopia Protocol

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* Age of Patient * Family History * Social History * Amount of myopia +.50? Plano? -.50? -1.00? -5.00?

Your Personal Myopia Protocol

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* Age of Patient * Family History * Social History * Amount of myopia * Ocular Health Can’t wear contacts?

Your Personal Myopia Protocol

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* Age of Patient * Family History * Social History * Amount of myopia * Ocular Health * Cost Any care beyond “vision plan” refused?

Your Personal Myopia Protocol

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* Age of Patient * Family History * Social History * Amount of myopia * Ocular Health * Cost * Availability If best alternative is OrthoK, what if nearest orthokeratologist is 150 miles away? If atropine is best alternative, what if state license prohibits its use?

The Future

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What is the goal?

* Stop all myopia at -1.00 or better? Stop at +.50?

* Permanence? We don’t know yet.

* Safety? Encouraging orthok in areas without specialists is risky.

* Cost? Becomes a factor for many patients.

* Keep it an optometric procedure?

Think

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Imaginary Scenario:

* Drug company modifies atropine molecule slightly so they can patent it. * They do clinical trials at .01% and find it is better than atropine by 5%. * They advertise to the public: “Don’t let your child go blurry – call your doctor about MyoClear drops.” * Pediatricians add MyoClear drops to their routinely prescribed medications along with vaccines, fluoride tablets, etc. * Myopia falls by 80%. They never come to your practice.

Not your protocol

OAA Scottsdale RLA

Goal is slowing or stopping further progression into myopia Yearly cycloplegic exams starting at age 4 specific to myopia progression

Ocular health, cycloplegic refraction, near phoria, lag of accommodation Expected mean spherical equivalent +.50 D. SD= approximately .6 D. (Gwiazda 1993) A-scan if available Counseling about need for 2-3 hours of outdoor time daily. Counseling about need for proper nutrition; reduction of carbohydrates/grains/sugar may be beneficial.. Discussion of risk factors due to any parental myopia

If patient reaches -.25 and age = ? Or less controversial as to whether to begin treatment.

counseling about need for 2-3 hours of outdoor time daily. counseling for why lenses are needed when vision is clear

Not your protocol

OAA Scottsdale RLA

devices for creating more peripheral myopia are desired: RRG (Radial Refractive Gradient) spectacles when available instead Rx is for full time wear decrease exam interval to every six months until stable for two years

If the juvenile patient has moved into myopia (-.50 or worse) WITH cycloplegia Myopia has already been progressing for 1-2 years Review parental risk factors; modify outdoor time, diet The younger the patient, the further myopia is expected to progress The older the patient, the faster the myopia is expected to progress

Not your protocol

OAA Scottsdale RLA

Most aggressive creation of peripheral myopia possible, in order: Orthokeratology Bifocal contact lenses (center far; CIBA Vision and CooperVision are in Asia) RRG spectacles when available (currently in Asia) Bifocal or PALs spectacles (not reading glasses) Single vision lenses as last resort; remove for near tasks?

If progressing with peripheral myopia control: Add .01% Atropine HS Adult onset myopia

Not as well studied Creation of peripheral myopia is still assumed to be desirable Same prescription devices as for juvenile onset myopia

Not your protocol

OAA Scottsdale RLA

Degenerative myopia of steadily increasing power with pathological changes such as glaucoma, choroidal atrophy, breaks in Bruch's membrane, subretinal neovascular membranes, subretinal neovascularization, retinal breaks and detachments are most likely due to additional mechanisms not well understood yet. No studies have been done to see if control of peripheral hyperopia prevents progression into degenerative myopia but the assumption is that it may help. Treatment of these more severe, sight threatening conditions is beyond the scope of this protocol and needs to be pursued considering the latest available treatment options.

T H A N K Y O U !

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Your Work is Just Beginning