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The Staining Grid:
 A Summary of Ocular
Responses to Lenses and
Solutions Compatibility

    Gary Andrasko, O.D., M.S.
         Columbus, Ohio
Now
   Around 2000 silicone hydrogels introduced
     Better oxygen transmission
     Less protein / more lipid deposits

   Incompatibilities with some solution
    preservatives
Previous Studies Indicate
Some Multipurpose solutions, when used with
 some lens material, including newer Silicone
 Hydrogel materials, some may induce clinically
 significant…

       Corneal Staining.
MPS Preservatives
                 Solution             Preservative            Manufacturer
             Opti-Free Express    Polyquaternium-1                Alcon
POLYQUAD




                                  (POLYQUAD &
                                  ALDOX)
             RepleniSH            Polyquaternium-1                Alcon
                                  (POLYQUAD &
                                  ALDOX)
             ReNu MultiPlus       Polyaminopropyl biguanide        B&L
                                  (DYMED)
BIGUANIDES




             AQuify               Polyhexanide                  Ciba Vision
                                  (PHMB)
             Complete Moist. Plus Polyhexamethylene               AMO
             Complete MPS         biguanide (PHMB)
             Walmart/Target       Polyaminopropyl biguanide        B&L
             CVS/Walgreen MPS     (DYMED)
             (Renu Multi- Plus)
Warning
Some lens/solution combinations especially when
  used with silicone hydrogel lenses cause toxic
  keratitis.
     Discomfort
     Redness
     Loss of intact epithelial barrier function
     Discontinuation of lens wear


 Which are the incompatible combinations?
Scientific evidence…
1997
 Jones L, Jones D, Houlford M. Clinical Comparison of Three polyhexanide-
   preserved disinfecting solutions. Contact Lens Ant. Eye 1997;20(1)23-30.
 Caroline P, Campbell R. Multipurpose Non-Keratitis. Spectrum March1997.

2002-2003
 Epstein A.B. SPK with Daily Wear of Silicone Hydrogel Lenses and MPS.
   Contact Lens Spectrum. 2002;17(11): 30.
 Jones L, MacDougall N, Sorbara LG. Asymptomatic Corneal Staining with
   the use of Balafilcon Silicone-hydrogel Contact Lenses Disinfected with
   Polyaminopropyl Biguanide-preserved Care Regimen. Optom Vis Sci 2002,
   Dec;79(12):753-61.
 Young G, Pritchard N, Hunt C, Coleman S. Subjective and Objective
   Measures of Corneal Staining Related to Multipurpose Care Systems. Contact
   Lens & Anterior Eye 26 (2003) 3-9.
Even more scientific evidence…
      Lebow KA, Schachet JL. Evaluation of corneal
       staining and patient preference with use of three
       multi-purpose solutions and two brands of soft
       contact lenses. Eye Contact Lens. 2003;29(4):213-
       20.
2005
      Garofalo R, Dassanayake D, Carey C, Stein J,
       Stone R, David R. Corneal Staining and
       Subjective Symptoms with Multipurpose Solutions
       as a Function of Time. Eye & Contact Lens
       2005;31(4): 166-174
      Dassanayake N, Garofalo R et. al. Correlating
       Biocide Uptake and Release Profiles with Corneal
       Staining and Subjective Symptoms. ARVO 2005
2007
      Carnt N, Wilcox M, Evans V, Naduvilath T,
       Tilia D, Papas E, Sweeney D, Holden B.
       Corneal Staining: The IER Matrix Study. Contact
       Lens Spectrum 2007;22(9):38.
Multiple Studies

   11 different solutions
   9 different lens materials
   Looked at comfort and staining
   One masked observer
   Randomized order of solution testing
   N=30 for each combination
Study Procedures
   Successful hydrogel CL wearers
   CL soaked in solution overnight-precycled cases
   Baseline exam
   CL inserted
   2 & 4 hour exam
     Rated comfort and symptoms (100-point scale)
     Examined cornea for staining
           NaFl with cobalt and Wratten (yellow) filter
Staining Scales
    Staining TYPE
    1.   Micropunctate
    2.   Macropunctate
    3.   Coalesced
    4.   Patch

    Staining AREA
        Divided cornea
         into 5 sectors
        0% to 100% in
         10% increments
Corneal Staining Example

                                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%)
Corneal Staining Example

                                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%)
Corneal Staining Example

                              Area
              A (Central):    0%
              B (Superior):   70%
              C (Temporal):   50%
              D (Nasal):      40%
              E (Inferior):   30%
              Total           190%

              Total Avg. Corneal
              Staining Area = 38%
  OD              (190% / 5 = 38%)
Study Results

   Preformed nearly 3000 patients visits
   Majority of staining was micropunctate
       Heavier staining can be coalesced
   Staining evident soon after lens insertion
       Peaks at 2 hrs.
Important Message

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


           Staining Grid!
Staining Grid
                Unisol 4   Clear   Optifree Optifree Renu    Complete            Walmart Target   CVS Walgreen
                                                                        Aquify
                 Saline    Care    Express Replenish MPlus   Easy Rub             MPS     MPS     MPS  MPS

Acuvue 2

 ProClear

Soflens 66

 Advance

  Oasys

 Biofinity

PureVision

O2 Optix

 N&D

Last Updated:              H2O2    POLYQUAD                              BIGUANIDES
June 17, 2008
Staining Grid
                Unisol 4   Clear   Optifree Optifree Renu    Complete            Walmart Target   CVS Walgreen
                                                                        Aquify
                 Saline    Care    Express Replenish MPlus   Easy Rub             MPS     MPS     MPS  MPS

Acuvue 2

 ProClear

Soflens 66

 Advance

  Oasys

 Biofinity

PureVision

O2 Optix

 N&D

Last Updated:              H2O2    POLYQUAD                              BIGUANIDES
June 17, 2008
Staining Grid
                Unisol 4   Clear   Optifree Optifree Renu    Complete            Walmart Target   CVS Walgreen
                                                                        Aquify
                 Saline    Care    Express Replenish MPlus   Easy Rub             MPS     MPS     MPS  MPS

Acuvue 2

 ProClear

Soflens 66

 Advance

  Oasys

 Biofinity

PureVision

O2 Optix

 N&D

Last Updated:              H2O2    POLYQUAD                              BIGUANIDES
June 17, 2008
Staining Area

                                                 Color Code
 MINIMAL – less than 10%     Green
 MARGINAL – 10% to 20%       Yellow
 EXCESSIVE – greater than 20% Red



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



                       4%
                 Green Zone
                 (about 60 dots)
Corneal Staining Example



                       10%
                  Yellow Zone
                  (hundred of dots)
Corneal Staining Example



                        76%
                     Red Zone
                  (thousands of dots)
Staining Grid
                Unisol 4   Clear   Optifree Optifree Renu    Complete            Walmart Target   CVS Walgreen
                                                                        Aquify
                 Saline    Care    Express Replenish MPlus   Easy Rub             MPS     MPS     MPS  MPS


Acuvue 2

 ProClear                                            57%                          61%    54%      53%   42%
Soflens 66                                           73%                          66%    62%      63%   56%
 Advance

  Oasys

 Biofinity

PureVision                                           73%                21%       71%    76%
O2 Optix                                             24%                          41%    28%      28%   24%

 N&D                                                 24%                          36%    24%      26%   22%
Last Updated:
June 17, 2008
                           H2O2    POLYQUAD                              BIGUANIDES
Renu MultiPlus & PureVision


Coalesced
Staining
Renu MultiPlus & PureVision




Coalesced
Staining
Target MPS & PureVision
Target MPS & PureVision




                     Micropunctate
                     Staining
Staining Grid
                Unisol 4   Clear   Optifree Optifree Renu    Complete            Walmart Target   CVS Walgreen
                                                                        Aquify
                 Saline    Care    Express Replenish MPlus   Easy Rub             MPS     MPS     MPS  MPS

Acuvue 2

 ProClear                                            57%                12%       61%    54%      53%   42%
Soflens 66                                           73%      17%                 66%    62%      63%   56%
 Advance                                             13%      12%                 16%     13%     12%   12%
  Oasys                                                                           12%             13%   10%
 Biofinity

PureVision                                           73%      15%       21%       71%    76%
O2 Optix                                             24%                          41%    28%      28%   24%

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

Last Updated:              H2O2    POLYQUAD                              BIGUANIDES
June 17, 2008
Walmart MPS & Advance



                 Macropunctate
                 Staining
Target MPS & Oasys
Staining Grid
                                           Branded Solutions                           Private Label Solutions
                Unisol 4   Clear   Optifree Optifree Renu      Complete            Walmart Target    CVS Walgreen
                                                                          Aquify
                 Saline    Care    Express Replenish MPlus     Easy Rub             MPS     MPS      MPS  MPS

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

 ProClear         1%       1%       1%       2%      57%         6%       12%       61%    54%       53%          42%
Soflens 66        1%       1%       1%       1%      73%        17%        8%       66%    62%       63%          56%
 Advance          1%       1%       1%       1%      13%        12%        2%       16%     13%      12%          12%
  Oasys          2%        1%       3%       5%       9%         4%        3%       12%     8%       13%          10%
 Biofinity       2%        2%       3%       2%       4%         2%        2%       4%      3%        3%           2%
                                                                                                    No Testing   No Testing
PureVision       2%        1%       4%       7%      73%        15%       21%       71%    76%       Planned      Planned


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

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

Last Updated:
                           H2O2    POLYQUAD                                BIGUANIDES
June 17, 2008
OptiFree Replenish & O2 Optix
OptiFree Express & O2 Optix
Walmart MPS & Advance
Staining Grid
                                           Branded Solutions                           Private Label Solutions
                Unisol 4   Clear   Optifree Optifree Renu      Complete            Walmart Target    CVS Walgreen
                                                                          Aquify
                 Saline    Care    Express Replenish MPlus     Easy Rub             MPS     MPS      MPS  MPS

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

 ProClear         1%       1%       1%       2%      57%         6%       12%       61%    54%       53%          42%
Soflens 66        1%       1%       1%       1%      73%        17%        8%       66%    62%       63%          56%
 Advance          1%       1%       1%       1%      13%        12%        2%       16%     13%      12%          12%
  Oasys          2%        1%       3%       5%       9%         4%        3%       12%     8%       13%          10%
 Biofinity       2%        2%       3%       2%       4%         2%        2%       4%      3%        3%           2%
                                                                                                    No Testing   No Testing
PureVision       2%        1%       4%       7%      73%        15%       21%       71%    76%       Planned      Planned


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

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

Last Updated:
                           H2O2    POLYQUAD                                BIGUANIDES
June 17, 2008
Staining Grid
                                           Branded Solutions                           Private Label Solutions
                Unisol 4   Clear   Optifree Optifree Renu      Complete            Walmart Target    CVS Walgreen
                                                                          Aquify
                 Saline    Care    Express Replenish MPlus     Easy Rub             MPS     MPS      MPS  MPS

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

 ProClear         1%       1%       1%       2%      57%         6%       12%       61%    54%       53%          42%
Soflens 66        1%       1%       1%       1%      73%        17%        8%       66%    62%       63%          56%
 Advance          1%       1%       1%       1%      13%        12%        2%       16%     13%      12%          12%
  Oasys          2%        1%       3%       5%       9%         4%        3%       12%     8%       13%          10%
 Biofinity       2%        2%       3%       2%       4%         2%        2%       4%      3%        3%           2%
                                                                                                    No Testing   No Testing
PureVision       2%        1%       4%       7%      73%        15%       21%       71%    76%       Planned      Planned


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

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

Last Updated:
                           H2O2    POLYQUAD                                BIGUANIDES
June 17, 2008
Staining Grid
                                           Branded Solutions                           Private Label Solutions
                Unisol 4   Clear   Optifree Optifree Renu      Complete            Walmart Target    CVS Walgreen
                                                                          Aquify
                 Saline    Care    Express Replenish MPlus     Easy Rub             MPS     MPS      MPS  MPS

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

 ProClear         1%       1%       1%       2%      57%         6%       12%       61%    54%       53%          42%
Soflens 66        1%       1%       1%       1%      73%        17%        8%       66%    62%       63%          56%
 Advance          1%       1%       1%       1%      13%        12%        2%       16%     13%      12%          12%
  Oasys          2%        1%       3%       5%       9%         4%        3%       12%     8%       13%          10%
 Biofinity       2%        2%       3%       2%       4%         2%        2%       4%      3%        3%           2%
                                                                                                    No Testing   No Testing
PureVision       2%        1%       4%       7%      73%        15%       21%       71%    76%       Planned      Planned


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

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

Last Updated:
                           H2O2    POLYQUAD                                BIGUANIDES
June 17, 2008
Mechanism of Staining

Amount of staining depends:
   Uptake – Amount of preservative absorbed into the
    lens during overnight soak
   Release - Amount & Rate that preservative is
    released from the lens to the eye
   Toxicity - How irritating a specific preservative is to
    corneal epithelial cells
Keys to Diagnosis
 Consult the Staining Grid
 Use fluorescein w/ cobalt & yellow filter

 Look early in wearing period
      - within 4 hours of insertion
   Listen to Patient
       - discomfort, dryness, red eyes EARLY in day
Wratten Filter Advantages




Staining is much easier to visualize using a Wratten Filter
So What???
   Four Important Questions…

1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?
IER Matrix Study
IER vs. Staining Grid Results
                             70

                             60
Staining Grid - % Subj. in


                                      Shows that 2-hr staining observations
    Red/Yellow Zones


                             50            predict long-term results
                             40

                             30

                             20

                             10
                                                                    R2 = 0.81
                             0
                                  0         5        10        15       20      25
                                           IER Study - % Subj. With Staining
So What???
   Four Important Questions…

1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?
Staining Consistency
                   PureVision/Renu MultiPlus formulation
             100
             90
             80                                                                     Avg. =
             70                                                                     73%
% Staining




             60
             50
             40
             30
             20
              10
              0
                   1   6   11   16   21    26   31   36    41   46   51   56   61   66   71   76   81   86

                                                          Patient #

    98% in Red Zone                       1% in Yellow Zone                         1% in Green Zone
So What???
   Four Important Questions…

1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?
What Does Staining Mean?
 Consequences of corneal staining
  Chronic in nature

  Disruption of epithelial barrier layer

  Increase risk of infiltrates

  Discomfort (Staining NOT asymptomatic)
“Wearers who experience corneal disruption as a result of
solution toxicity are three times more likely to experience
such an event (asymptomatic corneal infiltrates and infiltrative
keratitis) than those without staining.”
       - 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):309-15 .
Comfort Score vs. Staining (2 hrs.)
                100
                 90                          24-point loss of comfort!
                 80
                70
Comfort Score




                60
                50
                40
                30
                20
                10
                 0
                      0   20          40           60          80
                               Staining Area (%)
So What???
   Four Important Questions…

1) Has anyone else found staining?
2) How consistent is staining?
3) What are consequences of staining?
4) How long does staining last?
Daily Staining Cycle – PV lens
                    80
                                                                    Renu MP
                    70
                                                                    Saline
                    60
Staining Area (%)




                    50
                    40                             End of day observations
                    30                             will MISS signif. staining
                    20
                                 7 hrs/day
                    10
                     0
                         0 hrs   2 hrs   4 hrs   6 hrs   8 hrs   10 hrs 12 hrs

                                     Time of Wear
Closing Thoughts
   Consult the “Staining Grid”
   Examine patients 2-4 hours after insertion
   Recognize that solution is as important as the
    contact lens
   Emphasize to patients importance of continuing
    to use solution which was prescribed
   Staining affects health and decreases comfort
   Refer to www.StainingGrid.com for updates
Common Sense Approach
Recent events of 2006/2007, solution recalls, corneal infections, etc.
  have taught us:
 We don’t have all the answers concerning MPS

 Cautious, conservative approach is best

 Minimize all RISK FACTORS (known and suspected)

    corneal staining

 For any lens material, at least 3 solutions are biocompatible


Minimize staining
      +                 = happy/healthy patients
maximize comfort
Avoid the “RED” Combinations
THANK YOU!!!

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Staining grid lecture

  • 1. The Staining Grid: A Summary of Ocular Responses to Lenses and Solutions Compatibility Gary Andrasko, O.D., M.S. Columbus, Ohio
  • 2. Now  Around 2000 silicone hydrogels introduced  Better oxygen transmission  Less protein / more lipid deposits  Incompatibilities with some solution preservatives
  • 3. Previous Studies Indicate Some Multipurpose solutions, when used with some lens material, including newer Silicone Hydrogel materials, some may induce clinically significant… Corneal Staining.
  • 4. MPS Preservatives Solution Preservative Manufacturer Opti-Free Express Polyquaternium-1 Alcon POLYQUAD (POLYQUAD & ALDOX) RepleniSH Polyquaternium-1 Alcon (POLYQUAD & ALDOX) ReNu MultiPlus Polyaminopropyl biguanide B&L (DYMED) BIGUANIDES AQuify Polyhexanide Ciba Vision (PHMB) Complete Moist. Plus Polyhexamethylene AMO Complete MPS biguanide (PHMB) Walmart/Target Polyaminopropyl biguanide B&L CVS/Walgreen MPS (DYMED) (Renu Multi- Plus)
  • 5. Warning Some lens/solution combinations especially when used with silicone hydrogel lenses cause toxic keratitis.  Discomfort  Redness  Loss of intact epithelial barrier function  Discontinuation of lens wear Which are the incompatible combinations?
  • 6. Scientific evidence… 1997  Jones L, Jones D, Houlford M. Clinical Comparison of Three polyhexanide- preserved disinfecting solutions. Contact Lens Ant. Eye 1997;20(1)23-30.  Caroline P, Campbell R. Multipurpose Non-Keratitis. Spectrum March1997. 2002-2003  Epstein A.B. SPK with Daily Wear of Silicone Hydrogel Lenses and MPS. Contact Lens Spectrum. 2002;17(11): 30.  Jones L, MacDougall N, Sorbara LG. Asymptomatic Corneal Staining with the use of Balafilcon Silicone-hydrogel Contact Lenses Disinfected with Polyaminopropyl Biguanide-preserved Care Regimen. Optom Vis Sci 2002, Dec;79(12):753-61.  Young G, Pritchard N, Hunt C, Coleman S. Subjective and Objective Measures of Corneal Staining Related to Multipurpose Care Systems. Contact Lens & Anterior Eye 26 (2003) 3-9.
  • 7. Even more scientific evidence…  Lebow KA, Schachet JL. Evaluation of corneal staining and patient preference with use of three multi-purpose solutions and two brands of soft contact lenses. Eye Contact Lens. 2003;29(4):213- 20. 2005  Garofalo R, Dassanayake D, Carey C, Stein J, Stone R, David R. Corneal Staining and Subjective Symptoms with Multipurpose Solutions as a Function of Time. Eye & Contact Lens 2005;31(4): 166-174  Dassanayake N, Garofalo R et. al. Correlating Biocide Uptake and Release Profiles with Corneal Staining and Subjective Symptoms. ARVO 2005 2007  Carnt N, Wilcox M, Evans V, Naduvilath T, Tilia D, Papas E, Sweeney D, Holden B. Corneal Staining: The IER Matrix Study. Contact Lens Spectrum 2007;22(9):38.
  • 8. Multiple Studies  11 different solutions  9 different lens materials  Looked at comfort and staining  One masked observer  Randomized order of solution testing  N=30 for each combination
  • 9. Study Procedures  Successful hydrogel CL wearers  CL soaked in solution overnight-precycled cases  Baseline exam  CL inserted  2 & 4 hour exam  Rated comfort and symptoms (100-point scale)  Examined cornea for staining  NaFl with cobalt and Wratten (yellow) filter
  • 10. Staining Scales  Staining TYPE 1. Micropunctate 2. Macropunctate 3. Coalesced 4. Patch  Staining AREA  Divided cornea into 5 sectors  0% to 100% in 10% increments
  • 11. Corneal Staining Example 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%)
  • 12. Corneal Staining Example 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%)
  • 13. Corneal Staining Example Area A (Central): 0% B (Superior): 70% C (Temporal): 50% D (Nasal): 40% E (Inferior): 30% Total 190% Total Avg. Corneal Staining Area = 38% OD (190% / 5 = 38%)
  • 14. Study Results  Preformed nearly 3000 patients visits  Majority of staining was micropunctate  Heavier staining can be coalesced  Staining evident soon after lens insertion  Peaks at 2 hrs.
  • 15. Important Message Nearly impossible to predict (and remember) which lens/solution combinations will cause unacceptable/marginal staining. Staining Grid!
  • 16. Staining Grid Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 ProClear Soflens 66 Advance Oasys Biofinity PureVision O2 Optix N&D Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 17. Staining Grid Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 ProClear Soflens 66 Advance Oasys Biofinity PureVision O2 Optix N&D Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 18. Staining Grid Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 ProClear Soflens 66 Advance Oasys Biofinity PureVision O2 Optix N&D Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 19. Staining Area Color Code  MINIMAL – less than 10% Green  MARGINAL – 10% to 20% Yellow  EXCESSIVE – greater than 20% Red Disclaimer The colors used in the corneal staining grid are intended only to differentiate the identified data groupings and are not meant to suggest that the lens-solution combinations designated red or yellow indicate danger or caution or that such combinations are associated with an increased risk of corneal infection.
  • 20. Corneal Staining Example 4% Green Zone (about 60 dots)
  • 21. Corneal Staining Example 10% Yellow Zone (hundred of dots)
  • 22. Corneal Staining Example 76% Red Zone (thousands of dots)
  • 23. Staining Grid Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 ProClear 57% 61% 54% 53% 42% Soflens 66 73% 66% 62% 63% 56% Advance Oasys Biofinity PureVision 73% 21% 71% 76% O2 Optix 24% 41% 28% 28% 24% N&D 24% 36% 24% 26% 22% Last Updated: June 17, 2008 H2O2 POLYQUAD BIGUANIDES
  • 24. Renu MultiPlus & PureVision Coalesced Staining
  • 25. Renu MultiPlus & PureVision Coalesced Staining
  • 26. Target MPS & PureVision
  • 27. Target MPS & PureVision Micropunctate Staining
  • 28. Staining Grid Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 ProClear 57% 12% 61% 54% 53% 42% Soflens 66 73% 17% 66% 62% 63% 56% Advance 13% 12% 16% 13% 12% 12% Oasys 12% 13% 10% Biofinity PureVision 73% 15% 21% 71% 76% O2 Optix 24% 41% 28% 28% 24% N&D 24% 36% 24% 26% 22% Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 29. Walmart MPS & Advance Macropunctate Staining
  • 30. Target MPS & Oasys
  • 31. Staining Grid Branded Solutions Private Label Solutions Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1% ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42% Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56% Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12% Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10% Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2% No Testing No Testing PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24% N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22% Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 33. OptiFree Express & O2 Optix
  • 34. Walmart MPS & Advance
  • 35. Staining Grid Branded Solutions Private Label Solutions Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1% ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42% Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56% Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12% Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10% Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2% No Testing No Testing PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24% N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22% Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 36. Staining Grid Branded Solutions Private Label Solutions Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1% ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42% Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56% Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12% Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10% Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2% No Testing No Testing PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24% N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22% Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 37. Staining Grid Branded Solutions Private Label Solutions Unisol 4 Clear Optifree Optifree Renu Complete Walmart Target CVS Walgreen Aquify Saline Care Express Replenish MPlus Easy Rub MPS MPS MPS MPS Acuvue 2 1% 1% 2% 5% 1% 1% 1% 1% 1% 1% 1% ProClear 1% 1% 1% 2% 57% 6% 12% 61% 54% 53% 42% Soflens 66 1% 1% 1% 1% 73% 17% 8% 66% 62% 63% 56% Advance 1% 1% 1% 1% 13% 12% 2% 16% 13% 12% 12% Oasys 2% 1% 3% 5% 9% 4% 3% 12% 8% 13% 10% Biofinity 2% 2% 3% 2% 4% 2% 2% 4% 3% 3% 2% No Testing No Testing PureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned Planned O2 Optix 2% 1% 2% 5% 24% 3% 3% 41% 28% 28% 24% N&D 2% 1% 2% 3% 24% 1% 3% 36% 24% 26% 22% Last Updated: H2O2 POLYQUAD BIGUANIDES June 17, 2008
  • 38. Mechanism of Staining Amount of staining depends:  Uptake – Amount of preservative absorbed into the lens during overnight soak  Release - Amount & Rate that preservative is released from the lens to the eye  Toxicity - How irritating a specific preservative is to corneal epithelial cells
  • 39. Keys to Diagnosis  Consult the Staining Grid  Use fluorescein w/ cobalt & yellow filter  Look early in wearing period - within 4 hours of insertion  Listen to Patient - discomfort, dryness, red eyes EARLY in day
  • 40. Wratten Filter Advantages Staining is much easier to visualize using a Wratten Filter
  • 41. So What??? Four Important Questions… 1) Has anyone else found staining? 2) How consistent is staining? 3) What are consequences of staining? 4) How long does staining last?
  • 43. IER vs. Staining Grid Results 70 60 Staining Grid - % Subj. in Shows that 2-hr staining observations Red/Yellow Zones 50 predict long-term results 40 30 20 10 R2 = 0.81 0 0 5 10 15 20 25 IER Study - % Subj. With Staining
  • 44. So What??? Four Important Questions… 1) Has anyone else found staining? 2) How consistent is staining? 3) What are consequences of staining? 4) How long does staining last?
  • 45. Staining Consistency PureVision/Renu MultiPlus formulation 100 90 80 Avg. = 70 73% % Staining 60 50 40 30 20 10 0 1 6 11 16 21 26 31 36 41 46 51 56 61 66 71 76 81 86 Patient # 98% in Red Zone 1% in Yellow Zone 1% in Green Zone
  • 46. So What??? Four Important Questions… 1) Has anyone else found staining? 2) How consistent is staining? 3) What are consequences of staining? 4) How long does staining last?
  • 47. What Does Staining Mean? Consequences of corneal staining  Chronic in nature  Disruption of epithelial barrier layer  Increase risk of infiltrates  Discomfort (Staining NOT asymptomatic) “Wearers who experience corneal disruption as a result of solution toxicity are three times more likely to experience such an event (asymptomatic corneal infiltrates and infiltrative keratitis) than those without staining.” - 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):309-15 .
  • 48. Comfort Score vs. Staining (2 hrs.) 100 90 24-point loss of comfort! 80 70 Comfort Score 60 50 40 30 20 10 0 0 20 40 60 80 Staining Area (%)
  • 49. So What??? Four Important Questions… 1) Has anyone else found staining? 2) How consistent is staining? 3) What are consequences of staining? 4) How long does staining last?
  • 50. Daily Staining Cycle – PV lens 80 Renu MP 70 Saline 60 Staining Area (%) 50 40 End of day observations 30 will MISS signif. staining 20 7 hrs/day 10 0 0 hrs 2 hrs 4 hrs 6 hrs 8 hrs 10 hrs 12 hrs Time of Wear
  • 51. Closing Thoughts  Consult the “Staining Grid”  Examine patients 2-4 hours after insertion  Recognize that solution is as important as the contact lens  Emphasize to patients importance of continuing to use solution which was prescribed  Staining affects health and decreases comfort  Refer to www.StainingGrid.com for updates
  • 52. Common Sense Approach Recent events of 2006/2007, solution recalls, corneal infections, etc. have taught us:  We don’t have all the answers concerning MPS  Cautious, conservative approach is best  Minimize all RISK FACTORS (known and suspected)  corneal staining  For any lens material, at least 3 solutions are biocompatible Minimize staining + = happy/healthy patients maximize comfort
  • 53. Avoid the “RED” Combinations

Editor's Notes

  • #7: There have been several reports in the literature regarding corneal staining or ocular stress due to solution properties or interactions with materials. [advance]
  • #22: This example demonstrates the method used to determine average corneal staining area. The calculation is straightforward. The total is added and then divided by the 5 sectors to derive an average. CHUCK NOTE: Photo is missing [Advance]
  • #48: Now that we know that significant corneal staining can occur with some lens/solution combinations, what are the consequences of this staining? (dissolve in “Chronic in nature”) First, it is important to keep in mind that staining induced by toxic keratitis is chronic in nature. In other words, it is likely to occur every time a patients uses a particular lens/solution combination. (dissolve in “Disruption of epithelial barrier layer”) Corneal staining is always a concern for the optometrist as it represents a disruption in the epithelial barrier layer of the cornea. This layer is important in protecting the deeper layers of the cornea from microorganism invasion. (dissolve in “Increase risk of infiltrates”) In a retrospective record review of over 600 patients Pappas and his group found a three-fold increase in the risk of corneal infiltrative events, that is asymptomatic corneal infiltrates and infiltrative keratitis, when chronic solution toxicity exists. (dissolve in “Discomfort”) Andrasko, in his Staining Grid study, found a definite trend in decreased lens wearing comfort as staining increases past a moderate level. This trend is shown in the figure plotting Staining Area vs. subjective comfort ratings with 2 lens brands. (show next slide).