Scleral Lenses

Panacea 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
 Welcome

OAA - 2012

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Ken Maller
 Welcome

A big thank you to

the organizers of
this meeting as this
particular topic isn’t
specifically related
to Orthokeratology.

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Ken Maller
 Introduction

Today’s Agenda
 Introduction.
 Definition.
 Manufacturing.
 Office Issues.
 Fitting Rationale.
 Cases.
 Conclusion.
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 Additional Questions/Answers/Discussion Session.
Ken Maller
 Introduction
My Role with Wave
I AM NOT PAID BY 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.
 2012  Developmental input.
Ken Maller
 Authored the 1st Certified Wave Designers program.
 Introduction
My Role with Wave
I AM STILL NOT PAID BY 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 fit all types of lenses;
 Soft, Corneal GP, Scleral GP, etc.
 My “lens of choice” is

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The one that works best!
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 Why?
 Full scleral
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 Definition

Q – Are these separations based on clinical considerations or

laboratory manufacturing issues?
From Contact Lens Spectrum 10/1/11
Scleral 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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 Definition

HVID becomes the reference point for this classification system.

From Future Contact Lens Spectrum

Peter Wilcox

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 Definition

SLS classification system is really a manufacturing classification

system.
Peter’s proposed classification system is really a clinical and
functional approach.
This dichotomy really needs to be resolved so that there is common
ground for proper communication amongst the manufacturers,
clinicians, and the public.

I find it interesting that corneal rigid lenses were never

distinguished based on size. Soft lenses are not distinguished by
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Ken Maller
diameter either.
 Manufacturing
Manufacture of Scleral Lenses is limited to approximately a dozen labs in the US
out of ~200 CLMA member labs. Only ~6% of CLMA labs can manufacture.

The available materials are currently limited to;

Manufacturer Materials
Paragon HDS 100
Lagado Tyro Onsi 56
Polymer Tech Boston XO Boston XO2
Contamac Optimum Extra
(Diagnostic Purposes) PMMA

There has been a 62 % increase year over year (source: Polymer Tech) in large
 2012 diameter Boston lens buttons - the materials currently dominating this category.
Ken Maller
 Office Issues

• Typically done with fitting

sets.

• Inability in-office to verify any

of the peripheral fitting curves.

• Inability to modify in-office as

tools are all made for smaller
corneal lenses.

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• Patient training.
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 over
a 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 for

practitioners when choosing the Scleral Lens modality for
normal 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.

 2012
Ken Maller  Full Day – 12 to 16+ hours per day/every day lenses are worn.
 Fitting Rationale

The Comfort Grid

Perceptions generally accepted and shared by practitioners.
Soft Lens Corneal GP Scleral GP Hybrid
Initial
Daily
Full Day
Short-Term
Long-Term

Patient comfort is obviously important but is it the only thing to consider?

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Ken Maller Additionally, is the above chart actually accurate?
 Fitting Rationale
Convenience
Economics of
Maintenance
“Hassle
Health
Factor”

Patient
Comfort Concern Over
Risks

Successful
Ease of
Vision Contact Obtaining
Lens Replacements
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Ken Maller
 Fitting Rationale

From the fitter’s

Vision
perspective, this is the
triad for the successful
contact lens patient.

Successful
Contact
Lens
Wearer

Health Comfort
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 Fitting Rationale

The Vision and Health Grid

Perceptions generally accepted and shared by practitioners.
Soft Lens Corneal GP Scleral GP Hybrid
Vision
Health

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.
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• Orthokeratology.
Ken Maller
 Fitting Rationale

Scleral Lens “adjunct achievements” + -

• Cornea isolated from the outside environment. X X
• Cornea isolated from the palpebral conjunctiva. X
• Poor tear film exchange. ? X
• Tear film nutrients withheld from cornea. X
• Metabolic waste build-up under lens.
(Cesspool Effect) X
• Concentration effect of products under
lens. (i.e. reason for unpreserved saline) X
• Keeps tears on the cornea by interfering
? ?
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with evaporation.
Ken Maller
 Fitting Rationale

Scleral Lens “adjunct achievements” + -

• Corneal oxygen available exclusively limited to
diffusion through lens material. Although Dk of
the current materials is fairly high, the lenses are X
very thick i.e. 0.4mm or >.

• When the lens settles into the conjunctiva there

is compression of the conjunctiva and the
underlying sclera as well. Direct compression X
of these tissues may have some unforeseen short
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and long term implications.
Ken Maller
 Fitting Rationale

Scleral Lens “adjunct achievements”

• Should there be concern over conjunctival tissue compression

for most of the day over the long term?

• Should there be concern over scleral tissue compression for

most of the day over the long term?

• Should there be concern over the corneal isolation effect?

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 Fitting Rationale

Scleral Lens “adjunct achievements”

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 Fitting Rationale

Scleral Lens “adjunct achievements”

Lens

Limbus

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 Fitting Rationale

Scleral Lens “adjunct achievements”

Lens

Even on this lens that

has a fair amount of
support from the
cornea, there is still
compression of the
scleral tissue outside the
limbus.
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Ken Maller
 Fitting Rationale

Scleral Lens “adjunct achievements”

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

Lens

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Compression
Ken Maller
 Fitting Rationale

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

Isolated
Conjunctival Scleral
Corneal
Compression Compression
Environment
Integrity of
Schlemm’s Toxicity
Canal Effects on
Epithelium,
• IOP Increased?
• Fragile Nerve
Keratocytes,
Goblet Cells? Compromised? Endothelium?

Unknown
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Ken Maller
 Case 1

Tight fitting SynergEyes lens. Patient not able, i.e. willing, to

discontinue his lenses and wear glasses long enough to get a great
topography. This is after one hour of not wearing his lenses.
The patient had issues with his SynergEyes lenses tearing and
wanted something that would still give him good vision and
comfort.

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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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 Case 1

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Compression Right Left
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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 Case 2
Normal Corneas.
OD -0.25 -3.75 x 005
OS -0.25 -3.25 x 005

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 Case 2

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Support ~8mm Right Left
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 but
has 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

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Support ~8mm Right Left
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+
 2012 OS -3.00 – 1.50 x 156 20/25-
Ken Maller
 Case 4

90D
15D

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 to
discomfort.

How many would proceed to fit this case with a Scleral

Lens design as a first-line treatment?
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Ken Maller
 Case 4 1 st 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 8
hours.
• A pair of soft lenses (Acuvue Oaysis 8.4/-0.50) mailed to
patient to attempt piggyback to help the redness and discomfort.
 2012 • Final Outcome – Failure due to discomfort and redness.
Ken Maller
 Case 4 2nd attempt

• Although patient record information was requested from

doctor’s office, nothing has been received.

• Final Outcome – Failure due to limited wear time, both eyes

getting 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 dozen
designs 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, question
about allergy and environment interfering with comfort,
question of neuropathic pain associated with the PKP.
• Final Outcome – Failure due to discomfort, redness, soreness
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Ken Maller
and aching.
 Case 4 4th attempt

How would you proceed now?

The patient left the country to pursue a non-US
FDA 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?
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Ken Maller
He is only 26 years old!
 General Introduction
Definition

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Ken Maller
 Case 4 5th attempt

• Final Lens designs after 2.5 weeks of care and 4 OD designs

and 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 corneal

GP lenses outperformed the Scleral designs in both health and
comfort.
• It is definitely possible for the corneal GP lens to be more
comfortable (even initially) than a scleral design. The problem
is that the more complex the corneal shape becomes, (such as
with irregular corneas), the more complex the corneal design
needs to be so it properly aligns.
• Let’s return to the comfort table.
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Ken Maller
 Conclusion

The Comfort Grid - Revisited

My perceptions based on personal experience.
Soft Lens Corneal GP Scleral GP Hybrid
Initial
Daily
Full Day
Short-Term
Long-Term
This has been true in my experience regardless of the complexities of the cornea.
 2012 Since I fit so many corneal designs, I have found that particularly on irregular
Ken Maller corneas, the vision “quality” tends to be better with corneal vs. Scleral design.
 Conclusion
When comparing the available treatment options (in our case,
contact lens options), it is important to compare “apples to apples.”

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

For the long term health

of our patient’s eyes, we
can’t afford to be like
AT&T in this cartoon.

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Ken Maller
 Thank You

Questions?

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Ken Maller