AIR OPTIX AQUA

By : Alcon Vision Care

The Importance of Oxygen &
Technology Silicone Hydrogel
for Contact Lenses
Oxygen

2008-096-16166
Why does the Cornea need Oxygen?
Energy derived from metabolic processes is used in
vegetative functions, such as:
- Cellular division
- Synthesis of proteins, lipids, etc.
- Construction and maintenance of junctional attachments
- Cellular chemical balance (pH and osmotic)
- Programmed cell maturation
- Repair

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 Supply of Nutrients to the Cornea
Aqueous
Glucose
Amino acids
Vitamins Tears Aqueou
s humor
Minerals
Various Sources
Oxygen

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Sources of Corneal Oxygen (without Contact Lens)

Open eye
- Atmosphere
- Tear film
Closed eye
- Limbus
- Palpebral conjunctiva
- The aqueous
- One-third the level of open eye condition!

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Oxygen availability
Open eyes

155mmHg

Closed eyes

55mmHg

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Gaseous Concentrations in the Atmospheric

Gas Partial Pressure* Concentration

(mmHg) (%)
Oxygen 155 21
Nitrogen 600 78
CO2 <10 1
Water vapor <10 0.04

* at sea level

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Oxygen availability
Oxygen
partial
Oxygen Atmospheric
pressure
% pressure

20.9% 657mmHg 134mmHg

20.9% 760mmHg 155mmHg

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 Effect of Altitude
8700 m Mt. Everest
21% O2
53 mmHg

2250 m Mexico City

21% O2
Denver 122 mmHg
21% O2
1500 m 137
Sea Level mmHg
21% O2
0m 155 mmHg

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Requirements for Corneal Health

Tears

Immune System

Oxygen

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Effect of Insufficient Oxygen
Supply on the Cornea

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The Cornea
Epithelium

Bowmans layer

Stroma

Descemets membrane

Endothelium

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 Compromised Function/tissues

Anoxia

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis /
thinning

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts

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 Compromised Function/tissues

Over-
Dark pupil illuminated
iris

Inclusion
displaying Inclusion
unrevers displaying
ed reversed
Illumination Illumination
(probably a (probably
fluid a
vacuole) microcyst)

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis /
thinning
Microcysts
Vacuoles

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts
Vacuoles
Edema / swelling

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts
Vacuoles
Edema / swelling
pH drop

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts
Vacuoles
Edema / swelling
pH drop
Keratocyte death /
thinning

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 Compromised Function/tissues
Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts
Vacuoles Striae
Edema / swelling
pH drop
Keratocyte death / thinning

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis / thinning
Microcysts Striae

Vacuoles Folds
Edema / swelling
pH drop
Keratocyte death / thinning

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
Slowed mitosis /
thinning
Striae Folds
Microcysts
Limbal redness
Vacuoles& Neovascularisation

Edema / swelling
pH drop
Keratocyte death /
thinning

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Vascularization

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 Compromised Function/tissues

Anoxia
- Suboptimal m etabolism
Slowed mitosis
hinging
/t
Microcysts
Striae
Vacuoles
Folds
Edema / swelling
Limbal redness &
pH drop Neovascularisation
Keratocyte death Blebs
/ thinning

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Blebs

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 Compromised Function/tissues
Anoxia
- Suboptimal metabolism
sis / thinning
Slowed mito
Microcysts Striae

Vacuoles Folds

Edema / sw elling Limbal &

pH drop redness on
Keratocyte d Neovascularisati

eath Blebs
Polymegethism
Pleomorphism

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism

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 Compromised Function/tissues

Anoxia
- Suboptimal metabolism
- Reduced barrier function

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 Compromised Function/tissues
Anoxia
- Suboptimal metabolism
- Reduced barrier function
Epithelial thinning
Reduced intercellular attachment
Reduced adhesion to bowmans layer

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 Compromised Function/tissues
Anoxia
Physical damage
- Abrasion

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 Compromised Function/tissues
Anoxia
Physical damage
- Abrasion
- Superior arcuate epithelial lesions (SEALS)

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 Compromised Function/tissues

Anoxia
Physical damage

contribute to the occurrence of an infection

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 Effects of insufficient oxygen supply - Summary
Epithelium Stroma Endothelium
Edema Edema Edema
Microcysts Striae and Folds Blebs
Slower mitosis Acidosis Polymegethism
Thinning Keratocyte Death Pleomorphism
Hypoaesthesia Thinning Impaired Hydration Control
Reduced Oxygen Uptake
Vascularization Corneal exhaustion
Compromised Junctional
Integrity
Infectious Keratitis

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 A Contact Lenses is a Potential Barrier for
Corneal Oxygen Supply

Goal: Need lenses, that let pass sufficient amounts of oxygen

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 Effects of Contact Lens induced Hypoxia
12 - 24% of wearers drop out of
contact lens wear every year
Discomfort most prominent reason
Also reported:
- Stinging and burning*
- Dryness during the day*
- End-of-Day dryness*
- Red eyes*
Is discomfort related to hypoxia?
ALSO: Higher risk for infections,
inflammations, ulcers
*Fonn et al: 1993, 1995

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Sources of Corneal Oxygen (with Contact Lenses)

Tear pump
- Important factor for rigid, pas permeable lenses
- Not relevant for soft contact lenses
Through the contact lens
(requires: Oxygen transmissibility of the lens
material, the actual lens)
-Especially important for soft contact lenses, as
tear
pump not relevant

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Sources of Corneal Oxygen (with Contact Lenses)

Oxygen transmissibility of the contact lens

Goal:
Fulfill at least critical need, better over deliver.
This need will (again) depend on open or
closed eye condition, the wearing environment
and the individual eye as such.
Least / no difference to eye health when
compared to no lens wear.

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 Long-term Corneal Health with Silicone-Hydrogel Lenses
Absence of chronic tissue changes
Epithelial permeability
Bacterial adherence
- Lin, Polse, et al
- Ren, Cavanagh et al
Microcysts
- Sweeney and others ~ Cell size & viability
- Stapleton et al

Acidosis Limbal injection

- Lin, Polse - Papas and others

Corneal edema Myopic shift

- Fonn et al and others - Dumbleton et al

Endothelial polymegathism
- Tighe et al, Guillon et al

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Limbal Redness

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GHOSTING and empty vessels
Longterm low DK - DW/EW

Nine Months FND 30NEW

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Safe and Successful Contact Lens Wear
Oxygen availability
Adequate movement
Coating and deposit control
Optical (and visual) performance
Minimal physical pressure
Ocular compatibility
Surface wettability
Microbe-free

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The real critical oxygen requirement
for contact lens wear is 20.9%
(Efron and Brennan, Contax 1987)

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 Overnight Corneal Edema
When no lens edema = 2%
When Dk/t = 87 then edema = 4.0%
When Dk/t = 107 then edema = 3.5%
When Dk/t = 125 then edema = 3.2%
When Dk/t = 175 then edema = 2.5%

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Range of Overnight Oedema Responses to Low Dk/t

Holden & Mertz, 1984

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 High Levels of Oxygen Under
the Contact Lens
To maintain non lens wear corneal function

To minimise average corneal swelling

To maintain white limbal area

To eliminate hypoxia

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 Dk/t Demand
Indicator #1 Limbal Redness
Papas
- Estimate of the peripheral
Dk/t required to eliminate
limbal redness on average
is 125 units for DW
Maldonado-Codina et al
- Detected significant
differences in DW limbal
redness between lenses
with 26 and 86 units

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Central Dk/t or Average Dk/t?
Holden-Mertz criteria of:
-24 x 10-9 units to avoid end-of-first day edema
-87 x 10-9 units to avoid 4.0% overnight edema
(125 X 10-9 units to avoid 3.2% overnight edema)

BASED ON AVERAGE Dk/t MEASUREMENTS

ACROSS THE OPTIC ZONE
Harvitt and Bonanno mathematical model:
125 units for overnight wear

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 CORNEAL SWELLING vs
OXYGEN TRANSMISSIBILITY (Dk/t)
Holden and Mertz, 1984

15
14 y = 63.812x-0.621
13
12
11 Dk/t for 4.0% = 87
10
9
8 Dk/t for 3.5% = 107
7 Dk/t for 3.2% = 125
6
5
4
3
2
1
0
0 50 100 150
Dk/L (x10-9)
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 Hydrogel Patient Cycle

Current HEMA
Lenses

2008 CIBA VISION Corporation 2008-07-0763

 Ideal Patient Cycle

Keep It
Going and
Growing!

2008 CIBA VISION Corporation 2008-07-0763

 What is AIR OPTIXall about?

BREATHABLE LENS
5X more oxygen

Improve
Ocular Health

See
Feel
Whiter, Brighter,
End-of-day
Healthy-looking Eyes
Comfort
AIR OPTIX AQUA
Oxygen
Range of Overnight Oedema Responses to Low
Dk/t

Holden & Mertz, 1984

 Average Environment?
8700m Mt.
Everest
21% O2
53 mmHg
2250m
21% less Mexico
City
21% O2
Denver
1500m 11% less 122
21% O2
mmHg
137
mmHg
0m Sea Level
21% O2
155
mmHg

Oxygen varies with altitude

Conclusion

For healthy, comfortable contact

lens wear, the cornea requires
LOTS of oxygen!

but how much is enough?

87
 Overnight Corneal Edema
When no lens edema = 3.2%
When Dk/t = 87 then edema = 4.0%
When Dk/t = 107 then edema = 3.5%
When Dk/t = 125 then edema = 3.2%
When Dk/t = 175 then edema = 2.5%
 Critical Oxygen Levels to
Avoid Corneal Edema for
Daily and Extended Wear
Contact Lenses
Holden BA, Mertz GW
Invest Ophthalmol Vis Sci 1984;25:1161-7.
How much Oxygen?
CORNEAL SWELLING vs
OXYGEN TRANSMISSIBILITY (Dk/t)

Holden and Mertz, 1984

Dk/t for 4.0% = 87

Dk/t for 3.5% = 107
Dk/t for 3.2% = 125
Limbal Redness in Daily Wear Low Dk/t
Precursor to neovascularisation

Low Dk/t
lenses
High Dk/t patient Benefits

High Dk/t promotes long-term corneal health:

Reduces Epithelial permeability (Lin, Polse, et al)1
Reduces Microcysts (Sweeney)2
Reduces Acidosis (Lin, Polse, et al)1
Reduces Corneal oedema (Fonn, et al)3
Reduces Bacterial adherence (Ren, Cavanaugh)4
Reduces Endothelial polymegathism (Tighe, et al)5
Reduces Limbal injection (Papas)6
Reduces Myopic shift (Dumbleton)7

1-7 Data on file

 Still the Highest Oxygen
Delivers the highest oxygen transmissibility of any
available soft contact lensfor white, healthy-
looking eyes1
AIR OPTIX NIGHT & DAY AQUA Brand A
Biofinity AIR OPTIX AQUA
Dk/t The higher the Dk/t of a
contact lens, the closer
the lens comes to fulfilling
the oxygen needs of the
corneaespecially the
Dk=140 Dk=128 Dk=110 peripheral cornea2
ACUVUE
BrandOASYS
B PureVision
Brand C ACUVUE ADVANCE
Brand D NIGHT & DAY shows no
significant difference in
overnight corneal swelling
compared to no lens at
all3
Dk=103 Dk=91 Dk=60

1. CIBA VISION data on file, 2008. 2. Alvod L, Hall J, Keyes D, et al. Corneal oxygen distribution with contact lens wear. Cornea. 2007; 26 (6):654-64. 3. Mueller N, Caroline P, Smythe J, et al.
A comparison of overnight swelling response with two high Dk silicone hydrogels. Optom & Vis Sci. 2001:78(12S):199.

ACUVUE is a registered trademark and OASYS is a trademark of Johnson & Johnson Vision Care, Inc. Biofinity is a registered trademark of CooperVision, Inc.
PureVision is a registered trademark of Bausch & Lomb, Inc.
Surface
 Brand B Brand C
Brand A
 Patented Surface Treatment
Contributes to Healthy Lens Wear

Brand A Brand B Brand C Brand D Brand E

Lens Material
 Water Content

Brand A Brand B Brand C Brand D

Benefits of a low water content
Silicone hydrogels left to air dry

AIR OPTIXTM
:00 15:00
Elapsed Time in Minutes

47% H20 33% H20 24% H20

Dk/t 86 Dk/t 138 Dk/t 175

Photos taken after these lenses have been allowed to sit in air
for 15 minutes. The benefit of a low water content can be
clearly seen in the difference in lens dehydration in AIR OPTIX
and NIGHT&DAY.
The lower the water content the less in air dehydration.
Lens Design
 Advantages of Aspheric design

AIR OPTIX
Product specifications

Material: lotrafilcon B
Water content: 33%
Handling tint: light blue
Powers: -0.25 to -8.00, 0.25D steps
-8.50 to -10.00, 0.50D
steps
Package: +0.25
6 lensto +6.00,
pack 0.25D steps
/ 3 lens
Replacement schedule: pack
4 weeks
Diameter (mm): 14.2
Base curve (mm): 8.6
Center thickness (mm): 0.08@ -3.00D
Dk/t: 138@ -3.00D
Wearing schedule: daily wear or up to 6 nights extended wear for 4
Fitting: weeks no refit required for existing wearers of
O2OPTIXTM

2008-03-0296
a Novartis company