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2012 scl care_system_hour2
1. ECC Care Systems
• Study package inserts!
• Abbott RevitaLens
• Alcon OPTI-FREE PureMoist
Soft Contact Lens Care
• Bausch + Lomb Biotrue
Systems and Compliance
• Bausch + Lomb Renu fresh
Eunice Myung Lee, O.D., FAAO
April 2012 • CIBA VISION (Alcon) Clear Care
CLS671 – Cornea & Contact Lenses II • CIBA VISION (Alcon) AQuify
ECC Care Systems – Pt ed MPS
• Purpose of each step • Preservatives
• Why is it important? • Unique products
• Neutralization of H2O2
MPS - Preservatives MPS - Preservatives
• Thimerosal (0.002%)
– Mercurial antibacterial • Benzalkonium Chloride (BAK)
– Effective against gram + bacteria – Cytotoxic to corneal epithelium
– May be in ocular medications
– CYTOTOXIC to corneal epithelium
• May lead to Type IV hypersensitivity
• Sorbic Acid = Potassium Sorbate
– Turns methafilcon lenses yellow
(CooperVision Hydrasoft)
– No longer used with SCLs, but may be in ocular
• Dymed & Polyquad
medications
– Newer
– Larger molecule size to decrease toxicity
2. MPS – Unique Products RevitaLens OcuTec MPDS
• New(est) kids on the block • Surfactant for lubrication
• Abbott RevitaLens • EDTA (chelant)
• Alcon OPTI-FREE PureMoist – Decreases deposit formation
• Bausch + Lomb Biotrue – Adds antimicrobial properties
OPTI-FREE PureMoist MPDS Biotrue MPS
• EDTA • Matches pH of tears
• Wetting agent – EOBO (HydraGlyde) • Natural lubricant (similar to tears)
• Keeps beneficial tear proteins alive
– Reduces hydrophobicity of SiHy lenses
– Reduces LIPID deposits
Other products Enzyme (Protein) Cleaners
• Rewetting drops
• Enzymatic cleaners
• Protein cleaners NO YES
Daily 2 wk 1 mo >1 mo
Disposable Repl Repl Repl
Heavy coater
GPC
3. FDA – Current Review Process FDA – Current Review Process
• Reviews Safety and Efficacy • Challenge Microorganisms
• Stand alone test – Staphylococcus aureus & epidermidis (gram +
cocci)
• Regimen test
– Serratia marcescens (gram – rod)
– Pseudomonas aeruginosa (gram – rod)
– Candida albicans (yeast)
– Fusarium solani (fungus)
FDA – What’s to come A Few Bad Years!
• Acanthamoeba trophozoites & cysts • Fall 2005 – CIBA VISION discontinues all lens
• New lens group care products
• New tests – “real world” scenarios • Summer 2006 – B&L recalls ReNu MoistureLoc
• Fall 2006 – AMO recalls Complete Moisture
• Aug 2010 – reaffirmed rub & rinse regimen Plus
• Winter 2006 – B&L recall of ReNu MultiPlus
Fusarium Keratitis Fusarium Keratitis
• Fungal • May be misdiagnosed as bacterial microbial
• Can’t penetrate intact cornea keratitis
• Symptoms • Filamentous, irregular borders; elevated, dirty
– Redness grey
– Blurred vision
– Tearing
– Excessive discharge
– Sensitivity to light
4. How Did It Happen? Biofilm
• Newer, larger molecules coated the lenses • “a microbial community”
• Some molecules released from SiHy lenses • Can aid in bacterial adhesion & colonization;
• Fungal keratitis – less than 1 in 1,000,000 per secretes substances that act as scaffold
year • May contain multiple species of organisms;
• Microbial keratitis – 4-21 per 10,000 in SCL can render resistance to biocidal properties of
wearers (higher in overnight lens use) lens care products
• Biofilm
Acanthamoeba Keratitis Lens Cases
• Tap water - water treatment facilities • Cleaning?
– EPA reduction of chlorine • Additional antimicrobials
– Distance from treatment facility • Replacement?
• Swimming, Hot tub • Reminder systems
• Trophozoite vs cysts
• 1 in 30,000 hydrogel wearers
Lens Cases - Cleaning Lens Cases - Antimicrobials
• Tap water? Saline? MPS? H2O2? – Impregnated with silver ions
• Rub? Soap? Dishwasher? • CIBA VISION PRO-GUARD case
– Significant reduction of challenge microorganisms
• Tissue wipe?
– Silver gradually released as case exposed to
• Air dry? Positioning? moisture
• Where? • Amcon Laboratories I-clean case
• Brien Holden Vision Institute
– Antimicrobial material to coat cases – in progress
5. Lens Cases - Replacement Lens Cases - Reminders
• Regularly. Monthly? Every 3 months? 6 • LensAlert (Watch Dog Group LC)
months? – # days replace lenses
– # days replace case
• With every bottle?
Compliance Handwashing
• “the extent to which a patient’s behavior • Correct process?
coincides with the clinical prescription” – – Soap & water
Sackett & Hayes 1976 – Antimicrobial hand sanitizers – contain alcohol
• Reported range of noncompliance with • Harris Interactive Poll (2005)
medical instructions of 8 to 92% – Compliance after public restroom usage
– 95% women, 75% men
• Failure to wash hands prior to lens handling –
1.49x increased risk MK (Dart, 2008)
Handwashing Help Hand Drying
• The Centers for Disease Control and • Paper towel –slight decrease in bacterial load
Prevention – Clean Hands Campaign – Lint free – good for CL care
• Wash hands with soap & water for 20 secs = • Hot air drying – increases bacterial load
time to sing “Happy Birthday” twice
• Warm water – better solvent than cold
6. Compliance – CL Patients Compliance – CL Patients
• PubMed search “compliance” + “contact • 26% of soft contact lens patients were fully
lenses” compliant with lens care and maintenance
– 163 refereed papers (Collins & Carney, 1986)
– Numerous non-peer reviewed • Virtually all non-compliant with at least 1
– First relevant reference – JF Morgan, 1979 required procedure (Turner et al, 1993)
– First relevant study – Collins & Carney, 1986 • 24% never cleaned lenses before disinfection,
5% used saline to “disinfect” (Ky et al, 1998)
Instructions AOA/AAO CL Sections Pt Ed
• 79% admitted non-compliance in some area of • Wash hands prior to lens handling
CL care (De Oliveira et al, 2003) • Rub lenses
• 0.3% compliant with 14 steps required • Don’t top off solutions
(Morgan, 2007) • Clean & regularly replace cases
• Full compliance very rare (Morgan et al, 2011) • D/C lens wear & immediately contact ECP if
• Improves by explaining benefits of compliant symptoms of pain, blurred vision, redness,
procedures (McMonnies, 2011) increased tearing/photophobia
Building Compliance Oh Great!!
• “Prescribe”, not recommend • “Patients are often lying when they say they
– Write on an Rx pad have regularly taken the prescribed medicine”
– Provide detailed written handout WITH soln name – Hippocrates, 400 BC
• Dispense complimentary starter kits
• Review advantages of product
• “If you deviate from this solution, you run the
risk of compromising comfortable, long-term
wear”
• COMMUNICATION! Consistent message.
7. Problems Care System Identification
• Generics • 48% brand name MPS
• Saline • 9% H2O2
• Rub vs. No-Rub • 3.5% generic
• Staining • 40% unsure
• Product confusion • Product pictures help
Other Issues
• Daily disposable wearers
• Part-time wearers
• Silicone Hydrogel
• Piggyback/hybrid lenses
• Swimming