Updated: March 7, 2007. Understanding Corneal Staining and Responding to Andrasko Material and data...
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Transcript of Updated: March 7, 2007. Understanding Corneal Staining and Responding to Andrasko Material and data...
Updated: March 7, 2007
Understanding Corneal Staining and Responding to Andrasko
Material and data provided by Lynn Lasswell, OD, Stan Huth, MA,
Denise Tran, BS, Cheryl Skotnitsky, OD, PhD
What is staining?
• Staining with a topical dye is a clinical procedure used to observe the integrity and vitality of the epithelial cells of the ocular surface
• Fluorescein, Rose Bengal and lissamine green dyes are used in different staining procedures
Corneal staining with fluorescein dye
• Orange fluorescein dye absorbs blue light and emits green light.• Stains corneal defects upon application by diffusing between cells and adjacent intercellular spaces and penetrating into the underlying stroma. Stains whenever there is disruption of cell-cell junctions. Intensity of the stain increases with cell degeneration or death due to membrane & junction damage.•Can stain healthy cells.•Staining is not blocked by tear components such as albumen and mucin. •Detects epithelial defects and assists in the diagnosis of erosions, corneal abrasion and keratitis.•Very useful in detecting permeability of the epithelium and endothelium.
Molecular structure, with 2 negative charges
Topical application of fluorescein: the orange
dye is released from commercially available sterile paper strips by wetting the strips with sterile saline and then
touching the conjunctiva
Assessment of the “Red Eye” September 20, 2006http://eyelearn.med.utoronto.ca/Lectures04-05/RedEye/12Abrasion.htm> Sept 20, 2006
Punctate (point-like) fluorescein staining of cornea epithelium arising from solution toxicity
What amount of staining is considered acceptable?
• Corneal fluorescein staining occurs occasionally in virtually everyone, including contact lens and non-contact lens wearers.
• Trace punctate or pinpoint fluorescein staining can occur in healthy, normal individuals as a result of a normal cornea expressing epithelial turnover of dying surface cells undergoing replacement with new cells arising from below.
Dundas M. Walker A. Woods RL. Clinical grading of corneal staining of non-contact lens wearers. Opthalmic Physiol Opt 2001; 21:30-5
Accepted Staining Methodologies
• Efron
• CCLRU (Sydney, Australia)
• CCLR (University of Waterloo, Canada)
Efron Staining Scale
Efron Staining Scale
5 cornea sectors
5 point scale
Efron staining scale
5 Point ScaleGrade 0: Not significant
Grade 1: Not Significant
Grade 2: Requires monitoring
Grade 3:Therapeutic Intervention
Grade 4:Treatment
CCLRU
Cornea and Contact Lens Research Unit (CCLRU)
School of Optometry and Vision Science, The University of New South Wales,
Sydney, Australia
CCLRU standard for corneal staining with fluorescein
TYPE
DEPTH
EXTENT
Punctate (point-like) fluorescein staining types are determined for each cornea
zone
0: none
1: micropunctate2:
macropunctate
3: coalesced
macropunctate
4: patch (≥ 1mm)
Punctate (point-like) fluorescein staining of cornea
epithelium: CCLRU types
•Type 2: Macropunctate
•30% of central zone
•Type 4: Patch
•30% of nasal zone
CCLRU Example
Zone 1 0 0 10%
Zone 2 1 2 20%
Zone 3 2 4 30%
Zone 4 2 2 20%
Zone 5 3 3 30%
Zone Type Depth Extent
Clinical Significance determined by zone with greatest staining:
Type is greater than Grade 2 (macropunctate)
and/or
Depth is greater than Grade 1 (superficial epithelial involvement)
and/or
Extent is greater than Grade 1 (1-15% surface involvement)
CCLR
Lyndon Jones,
University of Waterloo
CCLR (University of Waterloo)
• CCLRU expanded by Dr. Jones, University of Waterloo
• Changed 0-4 staining type to 0-100 type– 25=micropunctate– 50=macropunctate– 75=coalesced macropunctate– 100= patches
• Continues to use 5 zones
• Multiplies staining type by percentage area of zone
• Result ranges from 0-10,000 per zone, 0-50,000 global
CCLR Example
Zone 1: 50 (macro) x 20= 1000
Zone 2: 0
Zone 3: 50 (macro) x 20= 1000
Zone 4: 25 (micro) x 10= 250
Zone 5: 50 (macro) x 30= 150 1000
0
1000
250
+ 1500
3750 Global Score
3750/5= 750 Average Sector Score
Global Score < 6000 or
Average Sector score < 1200
is clinically insignificant
4T=25
%=10
1T=50
%=20
5T=50
%=30
T=0
%=02
3T=50
%=20
3
Andrasko corneal staining grid
• Andrasko study
• Staining method
• Results
<http://www.staininggrid.com/gridmain.aspx> Sept. 21, 2006
Andrasko et al., “Ocular Response Observed with Silicone Hydrogel Lenses and Multi-purpose Solution Combinations” June 2006 Poster
Andrasko Study Design
•A series of randomized, double-masked, crossover studies consisting of 9-14 subjects each were run.•Subjects with staining at baseline were excluded from the study.•Prior to wear, the contact lenses were soaked for 12 hrs in the solution tested.•Subject’s cornea was examined with fluorescein, cobalt filter and a yellow filter at baseline (after 15 minutes of lens wear), and after 2 hours and 4 hours of lens wear.•Len/solution comfort was evaluated with a 100 point scale at baseline and after 2 hours and 4 hours of lens wear.
“Nearly all corneal staining was micropunctate”- Andrasko Poster
Staining Grid chart depicts only average percent staining across all zones.
Lenses and Solutions Studied
Contact Lens •AcuVue 2
•Proclear
•Acuvue Advance
•AcuVue Oasys
•PureVision
•O2 Optix
•Focus Night and Day
•BioFinity
Solution •Unisol
•Clear Care
•Opti-Free Express
•Opti-Free Replenish
•Renu MoistureLoc
•Renu Multi-Plus
•Walmart MPS (Renu MP)
•Target MPS (Renu MP)
•Complete MoisturePlus
•AQuify
Corneal staining was examined according to the following scale. The cornea was divided into five zones and staining was evaluated according to type (0-4) and area (0-100%) for each zone.
Andrasko Staining Method
Average corneal staining results with each lens type at baseline, after 2 hrs, and after
4 hours of lens wear.For the most part, baseline to the 2 hr point showed the greatest increase in
staining area Nearly all corneal staining was micropunctate,
type 1.
Andrasko comfort vs. staining results
• The only comfort data reported was for PureVision™
• Found a moderate, inverse correlation between comfort and staining at 4 hours of lens wear across all combinations of MPS and contact lenses. (i.e, high staining, low comfort)
• The plot below is of PureVision ™ lens only. It shows the average comfort rating at each visit, with the staining area % noted in parentheses.
Lens and Solution Combinations
Percentage of Average Corneal Staining Area at 2 Hours
Unisol1 4 Saline Clear Care4 Opti-free
Express1Opti-free
Replenish1Renu
Moistureloc3Renu
Multiplus3Walmart
MPS Target MPS Complete Moisture Plus2 Aquify4
Acuvue5 2 1% 1% 2% 5% 25% 1% 1% 1% 2% 1%
Acuvue Advance5 1% 1% 1% 1% No Further
Tesing13% 16% 13% 20% 2%
Acuvue Oasys5 2% Testing Ongoing 3% 5% 10% 9% 12% Testing
Ongoing 5% 1%
Purevision3 2% Testing Ongoing 6% 7% 6% 73% 71% Testing
Ongoing 48% 21%
O2 Optix4 2% Testing Ongoing 2% 5% 7% 24% 41% Testing
Ongoing 18% 7%
Focus Night & Day4 2% Testing
Ongoing 4% 3% 6% 24% 36% Testing Ongoing 16% 3%
Updated: September 19, 2006 H2O2 POLYQUAD Biguanides
Andrasko Staining GridLens and Solution Combinations
Percentage of Average Corneal Staining Area at 2 Hours
under 10% 10% to 20% over 20%Note: the CCLRU acceptance standard for % area is up to 15% when only micropunctate type 1 staining is present
http://www.siliconehydrogels.org/grading_scales/DATA/back_page.htm
Lens and Solution Combinations
Percentage of Average Corneal Staining Area at 2 Hours
Unisol1 4 Saline Clear Care4 Opti-free
Express1Opti-free
Replenish1Renu
Moistureloc3Renu
Multiplus3Walmart
MPS Target MPS Complete Moisture Plus2 Aquify4
Acuvue5 2 1% 1% 2% 5% 25% 1% 1% 1% 2% 1%
Acuvue Advance5 1% 1% 1% 1% No Further
Tesing13% 16% 13% 20% 2%
Acuvue Oasys5 2% Testing Ongoing 3% 5% 10% 9% 12% Testing
Ongoing 5% 1%
Purevision3 2% Testing Ongoing 6% 7% 6% 73% 71% Testing
Ongoing 48% 21%
O2 Optix4 2% Testing Ongoing 2% 5% 7% 24% 41% Testing
Ongoing 18% 7%
Focus Night & Day4 2% Testing
Ongoing 4% 3% 6% 24% 36% Testing Ongoing 16% 3%
Updated: September 19, 2006 H2O2 POLYQUAD Biguanides
Andrasko Staining GridLens and Solution Combinations
Percentage of Average Corneal Staining Area at 2 Hours
under 10% 10% to 20%
over 20%
Same Products!
Summary response to Andrasko
• Only Type 1 micropunctate staining was found: this is common, even among non-lens wearers
• Subjective estimates of % surface area are unreliable- staining results for the same solution varied by 17% in Andrasko (ReNu Multiplus = 24% and Walmart MPS = 41%; yet they are the same solution!)
• The standard of acceptance for Type 1 micropunctate staining is ≤ 15% of the surface area for any sector, not 10% per Andrasko (Table II and ref. 15 in Snyder article)
• Andrasko mixed studies to provide results (e.g., O2 Optix: OFX= 2%, CMP = 4.5% and Aquify = 7% in same study/ population. Andrasko reported 18% for CMP instead, taken from another study.
• Our own SH compatibility studies, including staining, show CMP produces no significant staining with SH lenses, except PV
Studies
An 8% incidence of moderate-to-severe staining among contact lens wearers is
not uncommon and can arise from factors other than the care system
• Nichols KK, Mitchell GL, Simon KM, Chivers DA, Edrington TB. Corneal staining in hydrogel lens wearers. Optom Vis Sci 2002;79:20-30.
• PURPOSE: The purpose of this study was to determine the factors that contribute to corneal staining in hydrogel lens wearers by examining the following variables: type of lens worn, wearing time and lens replacement schedule, lens care system, and topical and systemic medication use.
• METHODS: 500 full-time, successful hydrogel contact lens wearers were evaluated for corneal fluorescein staining.
• 0-4 staining scale used, summed scores for each of 5 corneal zones
• Moderate (Grade 3) to severe (Grade 4) = cumulative score ≥ Grade 3 with at least one quadrant score ≥ 2.
Nichols staining study results
• RESULTS: Corneal fluorescein staining was present in at least one eye in 55.7% of the hydrogel lens wearers examined in this study, and 8.0% had moderate-to-severe staining.
• CONCLUSIONS: Staining occurs to some extent in many hydrogel contact lens patients, and is influenced by many factors. Moderate-to-severe staining, which may be more clinically significant, is associated with noncompliance with care systems, a conventional replacement schedule (not planned replacement or disposable lenses), and higher plus or minus lens powers (>3 diopters).
Comfort
Relationship of staining to comfort
For Your Understanding:
Corneal staining associated with hydrogel contact lens wear may or may not be associated with patient symptoms
Relationship of staining to comfort
Study Design:• At least 40 subjects in each cell• Subjects wore one of a range contact lenses for up to 3
months with disposal as per label• Silicone hydrogel lenses and multi-purpose solutions studied
ACUVUE ™ ADVANCE™ ACUVUE ™ OASYS™PureVision™
O2 Optix™ Focus ™ Night & Day™
• Examined solution toxicity, defined as diffuse punctate staining
• Subjects rated comfort on a scale of 1-10 (1=poor, 10=excellent)
AOSEPT ClearCare ™AQuify ™ReNu with MoistureLoc ™OPTIFREE EXPRESS ™OPTI-FREE RepleniSH ™
Tilia et al., Institute for Eye Research, AustraliaPapas et al. “Solution Toxicity in Soft Contact Lens Daily Wear is Asociated with Corneal Inflammation” Poster
Relationship of staining to comfort
Subjects were asked to rate their experience with their lenses on a scale of 1 to 10, where 1= poor and 10= excellent.
Controls Toxic Staining Group
Subjects experiencing solution toxic staining report lower than average comfort ratings than those who do not: upon insertion of the lens (7.9±2.0 vs 8.4±1.6, p=0.02) and at the end of the day (6.7±2.1 vs 7.2±2.1, p=0.04 ).
Tilia et al., Institute for Eye Research, AustraliaPapas et al. “Solution Toxicity in Soft Contact Lens Daily Wear is Asociated with Corneal Inflammation” Poster
Chart 1
Bausch & Lomb EyeMatters newsletter, Vol. 9-September 2006Bausch & Lomb EyeMatters newsletter, Vol. 9-September 2006Recognizing the Clinical Realities of Corneal StainingRecognizing the Clinical Realities of Corneal Staining
Corneal Staining Summary
• 3 major staining methodologies– Regional preference
• High degree of subjectivity• Great variability between practitioners• Need to drive wedge between Andrasko results and
accepted staining methods– Call results into question
• Nearly all staining was micropunctate• Multiple studies and patient populations were used• Identical products had vastly different results• No statistical significance identified
– Transition to AMO data• Neutral Red Retention• 5 studies in EVA on compatibility
• Get back on message– Tear quality– Maintains corneal integrity– 2 Demulcents– Eliminates microbial contamination from lens
• Highly effective
Trademarks
• The AMO logo, Blink-N-Clean, COMPLETE, the COMPLETE logo, COMPLETE MoisturePLUS and ULTRACARE are registered trademarks and Blink Contacts is a trademark of Advanced Medical Optics Inc.
• OPTI-FREE, EXPRESS and REPLENISH are registered trademarks of Alcon, Inc.
• RENU, MULTI-PLUS and MOISTURELOC are registered trademarks of Bausch & Lomb, Inc.
• ACUVUE, ACUVUE 2, and ADVANCE are registered trademarks and ACUVUE Oasys is a trademark of Johnson & Johnson Corporation.
• AQUIFY and NIGHT & DAY are registered trademarks and O2OPTIX is a trademark of Novartis AG Corporation.
• CLEAR CARE is a registered trademark of CIBA Vision.
• REFRESH and REFRESH Contacts are registered trademarks of Allergan, Inc.