Scleral LensesPanacea or Pandora

Ken Maller, O.D., F.A.A.O., F.O.A.A.

5333 North Dixie Highway Suite #101

Fort Lauderdale, FL 33334

Consultation: www.noblur.com/consu.html

2012

Ken Maller

Welcome

OAA - 2012

2012

Ken Maller

Welcome

A big thank you tothe organizers ofthis meeting as thisparticular topic isn’tspecifically relatedto Orthokeratology.

2012

Ken Maller

Introduction

Today’s Agenda

Introduction. Definition. Manufacturing. Office Issues. Fitting Rationale. Cases. Conclusion. Additional Questions/Answers/Discussion Session.

2012

Ken Maller

IntroductionMy Role with Wave

Fitter. Contact lens only practice. Irregular corneas.

Previously National Clinical Support. Fellow Wave users that need help on a case by case basis.

Lectures. Formal instruction to bring Wave users up to speed.

Private Practitioner Consultation Services. In depth, case-by-case help, or one-on-one training.

Beta Tester. Developmental input.

Authored the 1st Certified Wave Designers program.

I AM NOT PAID BY WAVE!

2012

Ken Maller

IntroductionMy Role with Wave

I only receive payment from; My patients. Doctors interested in hearing what I have to say. Doctors interested in having me help them on a case. Doctors interested in having me do the case for them.

I AM STILL NOT PAID BY WAVE!

I fit all types of lenses; Soft, Corneal GP, Scleral GP, etc.

My “lens of choice” is

The one that works best!

2012

Ken Maller

Definition

Q - What is a scleral lens? (Why is it called scleral anyway?)

A – A lot more difficult to define than one might initially think.

This class of lens seems to have many sub-categories.

Corneoscleral

Mini-scleral

Semi-scleral

Full scleral

Why?

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Ken Maller

Definition

Q – Are these separations based on clinical considerations orlaboratory manufacturing issues?

From Contact Lens Spectrum 10/1/11Scleral Lens Education Society (SLS)

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Ken Maller

Definition

Another approach to scleral lens nomenclature.

From future Contact Lens Spectrum - Peter Wilcox

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Ken Maller

Definition

HVID becomes the reference point for this classification system.

From Future Contact Lens SpectrumPeter Wilcox

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Ken Maller

Definition

SLS classification system is really a manufacturing classificationsystem.

Peter’s proposed classification system is really a clinical andfunctional approach.

This dichotomy really needs to be resolved so that there is commonground for proper communication amongst the manufacturers,clinicians, and the public.

I find it interesting that corneal rigid lenses were neverdistinguished based on size. Soft lenses are not distinguished bydiameter either.

2012

Ken Maller

Manufacturing

Manufacture of Scleral Lenses is limited to approximately a dozen labs in the USout of ~200 CLMA member labs. Only ~6% of CLMA labs can manufacture.

The available materials are currently limited to;

Manufacturer MaterialsParagon HDS 100Lagado Tyro Onsi 56Polymer Tech Boston XO Boston XO2Contamac Optimum Extra(Diagnostic Purposes) PMMA

There has been a 62 % increase year over year (source: Polymer Tech) in largediameter Boston lens buttons - the materials currently dominating this category.

2012

Ken Maller

Office Issues

• Typically done with fittingsets.

• Inability in-office to verify anyof the peripheral fitting curves.

• Inability to modify in-office astools are all made for smallercorneal lenses.

• Patient training.

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Ken Maller

Fitting Rationale

• How many here fit scleral lenses?

• Who are the target audience for this modality?

• Why fit this modality instead of other available designs?

• Are there concerns when fitting this type of lens?

• Are there limitations with this type of lens?

• What would be the #1 reason to choose this lens modality overa corneal design gas permeable lens for normal corneas?

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Ken Maller

Fitting Rationale

Comfort for the patient seems to be the driving force forpractitioners when choosing the Scleral Lens modality fornormal corneas.Comfort actually needs to be defined;

Initial – Within two hours upon first exposure to the lens. Short-term – The first 2-3 weeks of wear upon first exposure to the lens. Long-term – Continued use of the modality over years even if the actual

lens product is replaced with another equivalent lens product.

Daily – 8 to 12 hours per day/every day lenses are worn. Full Day – 12 to 16+ hours per day/every day lenses are worn.

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Ken Maller

Fitting Rationale

The Comfort GridPerceptions generally accepted and shared by practitioners.

Soft Lens Corneal GP Scleral GP HybridInitialDailyFull DayShort-TermLong-Term

Patient comfort is obviously important but is it the only thing to consider?Additionally, is the above chart actually accurate?

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Ken Maller

Fitting Rationale

SuccessfulContact

LensWearer

Vision

Comfort

Health

EconomicsConvenience

ofMaintenance

“HassleFactor”

PatientConcern Over

Risks

Ease ofObtaining

Replacements

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Ken Maller

Fitting Rationale

SuccessfulContact

LensWearer

Vision

ComfortHealth

From the fitter’sperspective, this is thetriad for the successfulcontact lens patient.

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Ken Maller

Fitting Rationale

The Vision and Health GridPerceptions generally accepted and shared by practitioners.

Soft Lens Corneal GP Scleral GP HybridVisionHealth

Is this really the case for the Scleral GP contact lens?

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Ken Maller

Fitting Rationale

General Scleral Lens fitting goals;

• Full corneal and limbal coverage.• Supported in part or not at all by the cornea.• Vault the limbus.• Support on the conjunctiva.• Centration = Perfect.• Movement = None, to virtually imperceptible on the blink.• Vision – correction of myopia, hyperopia, astigmatism, irregular

optics, as well as possible multifocal correction.• Orthokeratology.

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”• Cornea isolated from the outside environment.• Cornea isolated from the palpebral conjunctiva.• Poor tear film exchange.

• Tear film nutrients withheld from cornea.• Metabolic waste build-up under lens.

(Cesspool Effect)• Concentration effect of products under

lens. (i.e. reason for unpreserved saline)• Keeps tears on the cornea by interfering

with evaporation.

+ -X X

X? X

X

X

X

? ?

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”• Corneal oxygen available exclusively limited to

diffusion through lens material. Although Dk ofthe current materials is fairly high, the lenses arevery thick i.e. 0.4mm or >.

• When the lens settles into the conjunctiva thereis compression of the conjunctiva and theunderlying sclera as well. Direct compressionof these tissues may have some unforeseen shortand long term implications.

+ -

X

X

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”

• Should there be concern over conjunctival tissue compressionfor most of the day over the long term?

• Should there be concern over scleral tissue compression formost of the day over the long term?

• Should there be concern over the corneal isolation effect?

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”

Lens

Limbus

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Ken Maller

Fitting Rationale

Scleral Lens “adjunct achievements”

Lens

Even on this lens thathas a fair amount ofsupport from thecornea, there is stillcompression of thescleral tissue outside thelimbus.

2012

Ken Maller

This lens that actually has “vault of the sclera” on one side stillcreates compression of the scleral tissue outside the limbus.

Fitting Rationale

Scleral Lens “adjunct achievements”

Lens

Compression

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Ken Maller

Fitting Rationale

Scleral Lens Long Term Use – 12 to 16 hours/day X years.

ConjunctivalCompression

Goblet Cells?

ScleralCompression

Integrity ofSchlemm’sCanal• IOP Increased?• Fragile Nerve

Compromised?

IsolatedCorneal

Environment

ToxicityEffects on

Epithelium,Keratocytes,

Endothelium?

UnknownImpact?

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Ken Maller

Case 1

Tight fitting SynergEyes lens. Patient not able, i.e. willing, todiscontinue his lenses and wear glasses long enough to get a greattopography. This is after one hour of not wearing his lenses.

The patient had issues with his SynergEyes lenses tearing andwanted something that would still give him good vision andcomfort.

2012

Ken Maller

Case 1

Normal Corneas. (Patient suffering with some residual “SynergItis”)

OD +1.50 – 3.25 x 030

OS +0.25 – 4.00 x 150

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Ken Maller

Case 1

Compression Right Left

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Ken Maller

Case 2

Patient is a previous wearer of Air Optix for astigmatism.

Reason for sclerals:

Cylinder in Rx went above parameters of Air Optix.

Comfort over corneal rgp.

Outcome: Good Comfort and VA of 20/20 OD, OS, OU.

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Ken Maller

Case 2

Normal Corneas.

OD -0.25 -3.75 x 005

OS -0.25 -3.25 x 005

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Ken MallerSupport ~8mm

Case 2

Right Left

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Ken Maller

Case 3

Patient was wearing SynergEyes.

Patient had difficulty taking the SynergEyes out.

Patient wanted easier handling lenses.

Good outcome on dispense , 20/30 OD, 20/20 OS, 20/20 OU buthas not returned for follow up since dispense in January.

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Ken Maller

Case 3

Normal Corneas.

OD -11.00 – 3.00 x 020

OS -2.50 – 1.50 x 145

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Ken Maller

Case 3

Support ~8mm Right Left

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Ken Maller

Case 4

• Keratoconus.

• Bilateral Penetrating Keratoplasty.

• Clear Grafts.

• Spec Rx OD -3.75 -3.50 x 057 20/30+ (6 Months Old)

(IZON) OS -3.25 – 3.00 x 180 20/30-

• Refraction OD -4.00 – 3.25 x 060 20/30+

OS -3.00 – 1.50 x 156 20/25-

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Ken Maller

Case 4

90D15D

75D

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Ken Maller

Case 4

• Irregular Corneas.

• OD very steep areas.

• OS particularly difficult due to the tilted graft.

• Cylinder oblique.

• History of multiple failures with Corneal GP designs due todiscomfort.

How many would proceed to fit this case with a ScleralLens design as a first-line treatment?

2012

Ken Maller

Case 4 1st attempt

• Final Lens designs after 7 weeks of care.

• 6.62/18.20/-9.75

• 6.89/18.20/-7.25

• OD 20/25, OS 20/20 Vision acceptable.

• Lenses feel dry, patient has redness, wear time maximum 8hours.

• A pair of soft lenses (Acuvue Oaysis 8.4/-0.50) mailed topatient to attempt piggyback to help the redness and discomfort.

• Final Outcome – Failure due to discomfort and redness.

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Ken Maller

Case 4 2nd attempt

• Although patient record information was requested fromdoctor’s office, nothing has been received.

• Final Outcome – Failure due to limited wear time, both eyesgetting red and sore, in particular the left one.

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Ken Maller

Case 4 3rd attempt

• Final Lens designs after 6 weeks of care and more than a dozendesigns on each eye.

• 7.38/18.5/-5.25

• 8.22/18.5/Plano

• OD 20/20, OS 20/15 Vision acceptable.

• Questionable comfort, wear time maximum 8 hours, questionabout allergy and environment interfering with comfort,question of neuropathic pain associated with the PKP.

• Final Outcome – Failure due to discomfort, redness, sorenessand aching.

2012

Ken Maller

Case 4 4th attempt

How would you proceed now?The patient left the country to pursue a non-USFDA approved specialty soft lens design.• Comfort was improved over the Sclerals so definitely improved

the wearability issues but the eye still did occasionally get red.• Vision improved over the spectacles but still was just about as

unacceptable as the spectacles.

NOW WHAT?He is only 26 years old!

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Ken Maller

General IntroductionDefinition

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Ken Maller

Case 4 5th attempt

• Final Lens designs after 2.5 weeks of care and 4 OD designsand 10 OS designs.

• 7.46 +- 0.13/11.2/-3.78 +- 1.14

• 7.47 +- 0.49/11.5/-3.62 +- 3.60

• OD 20/20, OS 20/20 Vision acceptable.

• Comfort excellent, wear time 12-15 hours, no redness/soreness.

• No interruption in wear schedule – every day, full day wear.

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Ken Maller

Case 4 5th attempt

• Here on this absolutely very difficult set of corneas, the cornealGP lenses outperformed the Scleral designs in both health andcomfort.

• It is definitely possible for the corneal GP lens to be morecomfortable (even initially) than a scleral design. The problemis that the more complex the corneal shape becomes, (such aswith irregular corneas), the more complex the corneal designneeds to be so it properly aligns.

• Let’s return to the comfort table.

2012

Ken Maller

Conclusion

The Comfort Grid - RevisitedMy perceptions based on personal experience.

Soft Lens Corneal GP Scleral GP HybridInitialDailyFull DayShort-TermLong-Term

This has been true in my experience regardless of the complexities of the cornea.

Since I fit so many corneal designs, I have found that particularly on irregularcorneas, the vision “quality” tends to be better with corneal vs. Scleral design.

2012

Ken Maller

Conclusion

When comparing the available treatment options (in our case,contact lens options), it is important to compare “apples to apples.”

Comfort is not a “given” with a Scleral Lens, just like discomfort isnot a “given” with a corneal GP lens design.

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Ken Maller

Conclusion

For the long term healthof our patient’s eyes, wecan’t afford to be likeAT&T in this cartoon.

2012

Ken Maller

Thank You

Questions?