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  • There have been several reports in the literature regarding corneal staining or ocular stress due to solution properties or interactions with materials. [advance]
  • 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]
  • 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).

Staining grid lecture Staining grid lecture Presentation Transcript

  • The Staining Grid: A Summary of OcularResponses to Lenses andSolutions 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 IndicateSome 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 AlconPOLYQUAD (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)
  • WarningSome 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 20052007 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 MessageNearly impossible to predict (and remember)which lens/solution combinations will causeunacceptable/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 MPSAcuvue 2 ProClearSoflens 66 Advance Oasys BiofinityPureVisionO2 Optix N&DLast Updated: H2O2 POLYQUAD BIGUANIDESJune 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 MPSAcuvue 2 ProClearSoflens 66 Advance Oasys BiofinityPureVisionO2 Optix N&DLast Updated: H2O2 POLYQUAD BIGUANIDESJune 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 MPSAcuvue 2 ProClearSoflens 66 Advance Oasys BiofinityPureVisionO2 Optix N&DLast Updated: H2O2 POLYQUAD BIGUANIDESJune 17, 2008
  • Staining Area Color Code MINIMAL – less than 10% Green MARGINAL – 10% to 20% Yellow EXCESSIVE – greater than 20% RedDisclaimerThe colors used in the corneal staining grid are intended only to differentiate theidentified data groupings and are not meant to suggest that the lens-solutioncombinations designated red or yellow indicate danger or caution or that suchcombinations 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 MPSAcuvue 2 ProClear 57% 61% 54% 53% 42%Soflens 66 73% 66% 62% 63% 56% Advance Oasys BiofinityPureVision 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 & PureVisionCoalescedStaining
  • Renu MultiPlus & PureVisionCoalescedStaining
  • 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 MPSAcuvue 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% BiofinityPureVision 73% 15% 21% 71% 76%O2 Optix 24% 41% 28% 28% 24% N&D 24% 36% 24% 26% 22%Last Updated: H2O2 POLYQUAD BIGUANIDESJune 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 MPSAcuvue 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 TestingPureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned PlannedO2 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 BIGUANIDESJune 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 MPSAcuvue 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 TestingPureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned PlannedO2 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 BIGUANIDESJune 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 MPSAcuvue 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 TestingPureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned PlannedO2 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 BIGUANIDESJune 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 MPSAcuvue 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 TestingPureVision 2% 1% 4% 7% 73% 15% 21% 71% 76% Planned PlannedO2 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 BIGUANIDESJune 17, 2008
  • Mechanism of StainingAmount 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 AdvantagesStaining 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 60Staining 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 ofsolution toxicity are three times more likely to experiencesuch an event (asymptomatic corneal infiltrates and infiltrativekeratitis) 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 70Comfort 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 60Staining 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 ApproachRecent 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 biocompatibleMinimize staining + = happy/healthy patientsmaximize comfort
  • Avoid the “RED” Combinations
  • THANK YOU!!!