The document presents a staining grid that summarizes ocular responses and corneal staining levels associated with different contact lens and multipurpose solution combinations. The grid uses color coding to indicate minimal, marginal, and excessive staining levels based on staining area percentages. It provides staining results from multiple studies involving over 3,000 patient visits testing various lens materials and solutions. The grid is intended to help practitioners easily identify lens-solution combinations that are more likely to cause clinically insignificant or significant corneal staining.
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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.
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!
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.
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
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
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).