staining grid lecture

The Staining Grid: The Staining Grid: A Summary of Ocular A Summary of Ocular Responses to Lenses Responses to Lenses

and Solutions and Solutions CompatibilityCompatibility

Gary Andrasko, O.D., M.S.Columbus, Ohio

NowNow

Around 2000 silicone hydrogels Around 2000 silicone hydrogels introducedintroduced Better oxygen transmissionBetter oxygen transmission Less protein / more lipid depositsLess protein / more lipid deposits

Incompatibilities with some solution Incompatibilities with some solution preservativespreservatives

Previous Studies IndicatePrevious Studies Indicate

Some Multipurpose solutions, when Some Multipurpose solutions, when used with some lens material, used with some lens material, including newer Silicone Hydrogel including newer Silicone Hydrogel materials, some may induce materials, some may induce clinically significant…clinically significant…

Corneal Staining.Corneal Staining.

MPS PreservativesMPS PreservativesSolutionSolution PreservativePreservative ManufacturManufactur

ererOpti-Free Opti-Free ExpressExpress

Polyquaternium-1 Polyquaternium-1 (POLYQUAD & (POLYQUAD & ALDOX)ALDOX)

AlconAlcon

RepleniSHRepleniSH Polyquaternium-1 Polyquaternium-1 (POLYQUAD & (POLYQUAD & ALDOX)ALDOX)

AlconAlcon

ReNu MultiPlusReNu MultiPlus Polyaminopropyl Polyaminopropyl biguanide (DYMED)biguanide (DYMED)

B&LB&L

AQuifyAQuify PolyhexanidePolyhexanide

(PHMB)(PHMB)Ciba VisionCiba Vision

Complete Moist. Complete Moist. PlusPlus

Complete MPSComplete MPS

Polyhexamethylene Polyhexamethylene biguanide (PHMB)biguanide (PHMB)

AMOAMO

Walmart/TargetWalmart/Target

CVS/Walgreen CVS/Walgreen MPS (Renu MPS (Renu Multi- Plus)Multi- Plus)

Polyaminopropyl Polyaminopropyl biguanide (DYMED)biguanide (DYMED)

B&LB&L

PO

LY

QU

AD

BIG

UA

NID

ES

WarningWarning

Some lens/solution combinations Some lens/solution combinations especially when used with silicone especially when used with silicone hydrogel lenses cause toxic keratitis.hydrogel lenses cause toxic keratitis. DiscomfortDiscomfort RednessRedness Loss of intact epithelial barrier functionLoss of intact epithelial barrier function Discontinuation of lens wearDiscontinuation of lens wear

Which are the incompatible combinations?Which are the incompatible combinations?

Scientific evidence…Scientific evidence…

19971997 Jones L, Jones D, Houlford M.Jones L, Jones D, Houlford M. Clinical Comparison of Clinical Comparison of

Three polyhexanide-preserved disinfecting solutions.Three polyhexanide-preserved disinfecting solutions. Contact Lens Ant. Eye 1997;20(1)23-30.Contact Lens Ant. Eye 1997;20(1)23-30.

Caroline P, Campbell R.Caroline P, Campbell R. Multipurpose Non-Keratitis.Multipurpose Non-Keratitis. Spectrum March1997.Spectrum March1997.

2002-20032002-2003 Epstein A.B.Epstein A.B. SPK with Daily Wear of Silicone Hydrogel SPK with Daily Wear of Silicone Hydrogel

Lenses and MPS.Lenses and MPS. Contact Lens Spectrum. 2002;17(11): 30. Contact Lens Spectrum. 2002;17(11): 30. Jones L, MacDougall N, Sorbara LG.Jones L, MacDougall N, Sorbara LG. Asymptomatic Asymptomatic

Corneal Staining with the use of Balafilcon Silicone-Corneal Staining with the use of Balafilcon Silicone-hydrogel Contact Lenses Disinfected with Polyaminopropyl hydrogel Contact Lenses Disinfected with Polyaminopropyl Biguanide-preserved Care Regimen.Biguanide-preserved Care Regimen. Optom Vis Sci 2002, Optom Vis Sci 2002, Dec;79(12):753-61.Dec;79(12):753-61.

Young G, Pritchard N, Hunt C, Coleman S.Young G, Pritchard N, Hunt C, Coleman S. Subjective Subjective and Objective Measures of Corneal Staining Related to and Objective Measures of Corneal Staining Related to Multipurpose Care Systems.Multipurpose Care Systems. Contact Lens & Anterior Eye Contact Lens & Anterior Eye 26 (2003) 3-9.26 (2003) 3-9.

Even more scientific Even more scientific evidence…evidence…

Lebow KA, Schachet JL.Lebow KA, Schachet JL. Evaluation Evaluation of corneal staining and patient of corneal staining and patient preference with use of three multi-preference with use of three multi-purpose solutions and two brands of purpose solutions and two brands of soft contact lenses.soft contact lenses. Eye Contact Lens. Eye Contact Lens. 2003;29(4):213-20.2003;29(4):213-20.

20052005 Garofalo R, Dassanayake D, Carey Garofalo R, Dassanayake D, Carey

C, Stein J, Stone R, David R.C, Stein J, Stone R, David R. Corneal Staining and Subjective Corneal Staining and Subjective Symptoms with Multipurpose Symptoms with Multipurpose Solutions as a Function of Time.Solutions as a Function of Time. Eye Eye & Contact Lens 2005;31(4): 166-174& Contact Lens 2005;31(4): 166-174

Dassanayake N, Garofalo R et. al.Dassanayake N, Garofalo R et. al. Correlating Biocide Uptake and Correlating Biocide Uptake and Release Profiles with Corneal Staining Release Profiles with Corneal Staining and Subjective Symptoms.and Subjective Symptoms. ARVO 2005 ARVO 2005

20072007 Carnt N, Wilcox M, Evans V, Carnt N, Wilcox M, Evans V,

Naduvilath T, Tilia D, Papas E, Naduvilath T, Tilia D, Papas E, Sweeney D, Holden B.Sweeney D, Holden B. Corneal Corneal Staining: The IER Matrix Study. Staining: The IER Matrix Study. Contact Lens Spectrum Contact Lens Spectrum 2007;22(9):38.2007;22(9):38.

Multiple StudiesMultiple Studies

11 different solutions11 different solutions 9 different lens materials9 different lens materials Looked at comfort and stainingLooked at comfort and staining One masked observerOne masked observer Randomized order of solution testingRandomized order of solution testing N=30 for each combinationN=30 for each combination

Study ProceduresStudy Procedures

Successful hydrogel CL wearersSuccessful hydrogel CL wearers CL soaked in solution overnight-precycled CL soaked in solution overnight-precycled

casescases Baseline examBaseline exam CL insertedCL inserted 2 & 4 hour exam2 & 4 hour exam

Rated comfort and symptoms (100-point scale)Rated comfort and symptoms (100-point scale) Examined cornea for stainingExamined cornea for staining

NaFl with cobalt and Wratten (yellow) filterNaFl with cobalt and Wratten (yellow) filter

Staining ScalesStaining Scales

Staining TYPEStaining TYPE1.1. MicropunctateMicropunctate2.2. MacropunctateMacropunctate3.3. CoalescedCoalesced4.4. PatchPatch

Staining AREAStaining AREA Divided cornea Divided cornea

into 5 sectorsinto 5 sectors 0% to 100% in 0% to 100% in

10% 10% incrementsincrements

Corneal Staining Corneal Staining ExampleExample

Area

A (Central): 0%

B (Superior): 0%

C (Temporal): 10%

D (Nasal): 0%

E (Inferior): 0%

Total 10%

Total Avg. Corneal Staining Area = 2%

OD (10% / 5 = 2%)


Area

A (Central): 30%

B (Superior): 0%

C (Temporal): 10%

D (Nasal): 0%

E (Inferior): 10%

Total 50%

Total Avg. Corneal Staining Area = 10%OS (50% / 5 = 10%)


Area

A (Central): 0%

B (Superior): 70%

C (Temporal): 50%

D (Nasal): 40%

E (Inferior): 30%

Total 190%

Total Avg. Corneal Staining Area = 38%

(190% / 5 = 38%)

OD

Study ResultsStudy Results

Preformed nearly 3000 patients visitsPreformed nearly 3000 patients visits Majority of staining was Majority of staining was

micropunctatemicropunctate Heavier staining can be coalesced Heavier staining can be coalesced

Staining evident soon after lens Staining evident soon after lens insertioninsertion Peaks at 2 hrs.Peaks at 2 hrs.

Important MessageImportant Message

Nearly impossible to predict (and Nearly impossible to predict (and remember) which lens/solution remember) which lens/solution combinations will cause combinations will cause unacceptable/marginal staining.unacceptable/marginal staining.

Staining Grid!Staining Grid!

Staining GridStaining GridUnisol 4 Unisol 4 SalineSaline

Clear Clear CareCare

Optifree Optifree ExpressExpress

Optifree Optifree ReplenisReplenis

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Renu Renu MPlusMPlus

Complete Complete Easy RubEasy Rub AquifyAquify WalmaWalma

rt MPSrt MPSTarget Target MPSMPS

CVS CVS MPSMPS

WalgreWalgreen en

MPSMPS

Acuvue 2Acuvue 2

ProClearProClear

Soflens Soflens 6666

AdvanceAdvance

OasysOasys

BiofinityBiofinity

PureVisiPureVisionon

O2 OptixO2 Optix

N & DN & D

HH22OO22 POLYQUADPOLYQUAD BIGUANIDESBIGUANIDESLast Updated:Last Updated:

June 17, 2008June 17, 2008

Staining AreaStaining Area

Color CodeColor Code MINIMAL – less than 10%MINIMAL – less than 10%

GreenGreen MARGINAL – 10% to 20%MARGINAL – 10% to 20% YellowYellow EXCESSIVE – greater than 20%EXCESSIVE – greater than 20%

RedRedDisclaimerDisclaimer

The colors used in the corneal staining grid are intended The colors used in the corneal staining grid are intended only to differentiate the identified data groupings and are not only to differentiate the identified data groupings and are not meant to suggest that the lens-solution combinations meant to suggest that the lens-solution combinations designated red or yellow indicate danger or caution or that designated red or yellow indicate danger or caution or that such combinations are associated with an increased risk of such combinations are associated with an increased risk of corneal infection.corneal infection.


4%

Green Zone(about 60 dots)

Corneal Staining ExampleCorneal Staining Example

10%

Yellow Zone

(hundred of dots)


76%

Red Zone(thousands of

dots)





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CVS CVS MPSMPS

WalgreWalgreen en

MPSMPS

Acuvue 2Acuvue 2

ProClearProClear 57% 61% 54% 53% 42%

Soflens Soflens 6666 73% 66% 62% 63% 56%

AdvanceAdvance

OasysOasys

BiofinityBiofinity

PureVisiPureVisionon 73% 21% 71% 76%

O2 OptixO2 Optix 24% 41% 28% 28% 24%

N & DN & D 24% 36% 24% 26% 22%


June 17, 2008June 17, 2008

Renu MultiPlus & Renu MultiPlus & PureVisionPureVision

Coalesced Staining

Target MPS & PureVisionTarget MPS & PureVision

Target MPS & PureVisionTarget MPS & PureVision

Micropunctate Staining





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CVS CVS MPSMPS

WalgreWalgreen en

MPSMPS

Acuvue 2Acuvue 2

ProClearProClear 57% 12% 61% 54% 53% 42%

Soflens Soflens 6666 73% 17% 66% 62% 63% 56%

AdvanceAdvance 13% 12% 16% 13% 12% 12%

OasysOasys 12% 13% 10%

BiofinityBiofinity

PureVisiPureVisionon 73% 15% 21% 71% 76%

O2 OptixO2 Optix 24% 41% 28% 28% 24%

N & DN & D 24% 36% 24% 26% 22%


June 17, 2008June 17, 2008

Walmart MPS & AdvanceWalmart MPS & Advance

Macropunctate Staining

Target MPS & OasysTarget MPS & Oasys





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CVS CVS MPSMPS

WalgreWalgreen en

MPSMPS

Acuvue 2Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%

ProClearProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%

Soflens Soflens 6666 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%

AdvanceAdvance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%

OasysOasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%

BiofinityBiofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%

PureVisiPureVisionon 2% 1% 4% 7% 73% 15% 21% 71% 76%

No Testing Planned

No Testing Planned

O2 OptixO2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%

N & DN & D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%


June 17, 2008June 17, 2008

Private Label SolutionsBranded Solutions

OptiFree Replenish & O2 OptiFree Replenish & O2 OptixOptix

OptiFree Express & O2 OptiFree Express & O2 OptixOptix

Walmart MPS & AdvanceWalmart MPS & Advance





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CVS CVS MPSMPS

WalgreWalgreen en

MPSMPS

Acuvue 2Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1%

ProClearProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42%

Soflens Soflens 6666 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56%

AdvanceAdvance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12%

OasysOasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10%

BiofinityBiofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2%

PureVisiPureVisionon 2% 1% 4% 7% 73% 15% 21% 71% 76%

No Testing Planned

No Testing Planned

O2 OptixO2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24%

N & DN & D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22%


June 17, 2008June 17, 2008

Private Label SolutionsBranded Solutions

Mechanism of StainingMechanism of Staining

Amount of staining depends: Amount of staining depends: UptakeUptake – Amount of preservative absorbed – Amount of preservative absorbed

into the lens during overnight soakinto the lens during overnight soak ReleaseRelease - Amount & Rate that preservative - Amount & Rate that preservative

is released from the lens to the eye is released from the lens to the eye ToxicityToxicity - How irritating a specific - How irritating a specific

preservative is to corneal epithelial cellspreservative is to corneal epithelial cells

Keys to DiagnosisKeys to Diagnosis

Consult the Staining GridConsult the Staining Grid Use fluorescein w/ cobalt & Use fluorescein w/ cobalt &

yellow filteryellow filter Look early in wearing periodLook early in wearing period

- within 4 hours of insertion- within 4 hours of insertion

Listen to PatientListen to Patient - discomfort, dryness, red eyes - discomfort, dryness, red eyes

EARLY in dayEARLY in day

Wratten Filter Wratten Filter AdvantagesAdvantages

Staining is much easier to visualize using a Wratten Filter

So What???So What???

Four Important Questions…Four Important Questions…

1) Has anyone else found 1) Has anyone else found staining?staining?

2) How consistent is staining? 2) How consistent is staining?

3) What are consequences of 3) What are consequences of staining?staining?

4) How long does staining last?4) How long does staining last?

IER Matrix StudyIER Matrix Study

IER vs. Staining Grid IER vs. Staining Grid ResultsResults

0

10

20

30

40

50

60

70

0 5 10 15 20 25

IER Study - % Subj. With Staining

Stai

ning

Grid

- %

Sub

j. in

R

ed/Y

ello

w Z

ones

RR22 = 0.81 = 0.81

Shows that 2-hr staining observations Shows that 2-hr staining observations

predict long-term resultspredict long-term results

Staining Consistency Staining Consistency PureVision/Renu MultiPlus formulationPureVision/Renu MultiPlus formulation

0

10

20

30

40

50

60

70

80

90

100

% S

tain

ing

1 6 11 16 21 26 31 36 41 46 51 56 61 66 71 76 81 86

Patient #

1% in Green Zone98% in Red Zone 1% in Yellow Zone

Avg. = Avg. = 73%73%

What Does Staining What Does Staining Mean?Mean?

Consequences of corneal stainingConsequences of corneal staining Chronic in natureChronic in nature Disruption of epithelial barrier layerDisruption of epithelial barrier layer Increase risk of infiltratesIncrease risk of infiltrates Discomfort Discomfort (Staining NOT (Staining NOT

asymptomatic)asymptomatic)““Wearers who experience corneal disruption as a result of Wearers who experience corneal disruption as a result of solution toxicity are solution toxicity are three timesthree times more likely to experience more likely to experience such an event (asymptomatic corneal infiltrates and infiltrative such an event (asymptomatic corneal infiltrates and infiltrative keratitis) than those without staining.”keratitis) than those without staining.”

- - Carnt N, Jalbert I, Stretton S, Naduvilath T Papas E. Solution toxicity in soft contact lens Carnt N, Jalbert I, Stretton S, Naduvilath T Papas E. Solution toxicity in soft contact lens

daily wear is associated with corneal inflammation. Optom Vis Sci. 2007Apr;84(4):309-15daily wear is associated with corneal inflammation. Optom Vis Sci. 2007Apr;84(4):309-15 ..

Comfort Score vs. Staining Comfort Score vs. Staining (2 hrs.)(2 hrs.)

0

10

20

30

40

50

60

70

80

90

100

0 20 40 60 80

Staining Area (%)

Com

fort S

core

24-point loss of comfort!24-point loss of comfort!



1) Has anyone else found staining?1) Has anyone else found staining?




Daily Staining Cycle – PV Daily Staining Cycle – PV lenslens

0

10

20

30

40

50

60

70

80

0 hrs 2 hrs 4 hrs 6 hrs 8 hrs 10 hrs 12 hrs

Renu MP

Saline

Sta

inin

g A

rea

(%)

Time of Wear

7 hrs/day7 hrs/day

End of day observations End of day observations

will MISS signif. stainingwill MISS signif. staining

Closing ThoughtsClosing Thoughts

Consult the “Staining Grid”Consult the “Staining Grid” Examine patients 2-4 hours after insertionExamine patients 2-4 hours after insertion Recognize that solution is as important as Recognize that solution is as important as

the contact lensthe contact lens Emphasize to patients importance of Emphasize to patients importance of

continuingcontinuing to use solution which was to use solution which was prescribedprescribed

Staining affects health and decreases Staining affects health and decreases comfortcomfort

Refer to Refer to www.StainingGrid.com for updates for updates

Common Sense ApproachCommon Sense Approach

Recent events of 2006/2007, solution recalls, corneal Recent events of 2006/2007, solution recalls, corneal infections, etc. have taught us:infections, etc. have taught us:

We don’t have all the answers concerning MPSWe don’t have all the answers concerning MPS Cautious, conservative approach is bestCautious, conservative approach is best Minimize all RISK FACTORS (known and suspected)Minimize all RISK FACTORS (known and suspected)

corneal stainingcorneal staining For any lens material, at least 3 solutions are For any lens material, at least 3 solutions are

biocompatiblebiocompatible

Minimize stainingMinimize staining++ = happy/healthy patients = happy/healthy patients

maximize comfortmaximize comfort

Avoid the “Avoid the “REDRED” ” CombinationsCombinations

THANK YOU!!!THANK YOU!!!

staining grid lecture

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