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Corneal Infections from A-Z Disclosures (Acanthamoeba to Zoster) Allergan Pharmaceutical Advisory Panel Joseph P

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Corneal Infections from A-Z Disclosures (Acanthamoeba to Zoster) Allergan Pharmaceutical Advisory Panel Joseph P 8/28/16 Corneal Infections from A-Z Disclosures (Acanthamoeba to Zoster) Allergan Pharmaceutical Advisory Panel Joseph P. Shovlin, OD, FAAO AMO Global Medical Advisory Panel Scranton, PA -Acanthamoeba Outbreak Panel (ad hoc) Bausch & Lomb Scientific Advisory Panel -Global Steering Committee I. Risk Factors In Ulcerative Keratitis -Panel On Fusarium Keratitis (ad hoc) II. Differential Diagnosis of Infiltrative Keratitis Ciba Vision Post-Market Surveillance Study Group -Johns Hopkins Adjudication Committee (ad hoc) III. Treatment and Management of Ulcerative Keratitis Center for Disease Control & Prevention- Contact Lens Advisory Panel IV. Fungal and Protozoan Infection of the Johnson & Johnson Global Professional Advisory Panel Cornea Shire, Ophthalmic Advisory Panel Speaker’s Bureau: Vistakon, Ciba Vision, CooperVision, Bausch & Lomb, AMO, Alcon, V. The Herpes Family Genzyme, Shire 1 8/28/16 “Swine Flu”: H1N1 Infectious Keratitis Amoebic Herpes Keratitis Fungal Bacterial Keratitis Keratitis Keratitis 2 8/28/16 Case 7 -- corneal haze Stem Cell Deficiency Tear Film Defenses 3 8/28/16 Epidemiology: Relative Risk Risk Factors for Ulcerative Keratitis ¤ Population at risk: approximately 44 million in US and 120 million worldwide ¤Exogenous ¤ Overnight wear the overwhelming risk factor ¤Ocular Adnexal Dysfunction ¤ Relative risk of extended wear v. daily wear: 10- ¤Corneal Abnormalities 15:1 ¤Systemic Disease ¤ Overnight wear of disposable lenses equal risk ¤ Additional risks: aphakia, smoking, lens case, ¤Immunosuppressive Therapy minimal protective effect of hygiene Incidence Rates for Microbial Keratitis Microbial Keratitis Rates for Orthokeratology/Corneal Reshaping Any MK Severe MK ¤ Daily Wear GP 1.2 (1.1-1.5), 1.2 ¤ Incidence for microbial keratitis is estimated @ 7.7/10,000 ¤ Daily Wear DDCL 2.0 (1.7-2.4), .5 ¤ Children carry a higher rate @ 13.9/10,000 ¤ Overall, the infection rate is similar to overnight soft lens ¤ Occasional CW 2.2 (2.0-2.5), 1.8 use. ¤ CW soft 19.5 (14.6-29.5), 13.3 ¤ CDC MMWR Report: 37 GP cases of AK (2005-2011); nearly 25% Ortho-K wearers and 50% used tap water to store lenses overnight ¤ CW silicone 25.4 (21.2-31.5), 16.9 From: Stapelton F. et al, The incidence of contact lens related microbial keratitis in Australia, Ophthalmol, 2008. Bullimore M, Sinnott LT, and Jones-Jordan LA: The risk of microbial keratitis with overnight corneal reshaping lenses. Optom & Vis Sci. 2013; 90(9):937-944. The Incidence of Microbial Keratitis among Associated Publication: Wearers of a 30-Day Silicone Hydrogel Extended-Wear Contact Lens Oliver D. Schein, MD, MPH,1 John J. McNally, OD,2 Joanne Katz, ScD,3 Robin L. Chalmers, OD,4 James M. Tielsch, PhD,3 Eduardo Alfonso, MD,5 Mark Bullimore, MCOptom, PhD,6 Denis O’Day, MD,7 Joseph Shovlin, OD8 Purpose: To estimate the incidence of presumed microbial keratitis with and without loss of visual acuity among wearers of a silicone hydrogel contact lens (Lotrafilcon A, Night & Day, CIBA Vision, Inc., Duluth, GA), recently approved for up to 30 days of continuous wear. Design: Prospective cohort postmarket surveillance study. Participants: Contact lens wearers (recruited from 131 practices) who had been prescribed the lens for intended continuous wear of as many as 30 nights. Methods: The occurrence of a corneal infiltrate was ascertained through a combination of center report and direct contact with participants at 3 and 12 months. Whenever a corneal infiltrate was suspected, study and treatment medical records were systematically reviewed by an Endpoints Committee using a predetermined classification scheme for corneal infiltration. Cases of presumed microbial keratitis were determined based on the constellation of presenting signs and symptoms and clinical course. Main Outcome Measures: The incidence of presumed microbial keratitis with and without loss of visual acuity. Results: A total of 6245 participants were recruited between August 13, 2002 and July 2, 2003. Of these, 4999 subjects (80%) completed 12 months of follow-up, and these participants contributed a total of 5561 person years of lens wearing experience. Approximately 80% of participants routinely wore their lenses contin- uously for 3 or more weeks. The overall annual rate of presumed microbial keratitis was 18 per 10,000 (95% confidence interval (CI): 8.5–33.1). There were 2 cases of presumed microbial keratitis with loss of visual acuity, an annual rate of 3.6 per 10,000 (95% CI: 0.4–12.9), and an additional 8 cases without loss of visual acuity, an annual rate of 14.4 per 10 000 (95% CI: 6.1–28.4). The rate of presumed microbial keratitis was lower for users reporting typical wear of 3 or more weeks than for those wearing the lens for less than a 3-week continuous period (P ϭ 0.02). Conclusions: The incidence of loss of visual acuity due to microbial keratitis among users of the silicone hydrogel contact lens was low. The overall rate of presumed microbial keratitis with the wearing schedule of as many as 30 nights was similar to that previously reported for conventional extended-wear soft lenses worn for fewer consecutive nights. Ophthalmology 2005;112:2172–2179 © 2005 by the American Academy of Ophthal- December 2005 Publication mology. Ophthalmology In 1981, the United States Food and Drug Administration potential complication of contact lens extended wear is (FDA) approved the first of a series of soft contact lenses for ulcerative keratitis causing loss of vision. This condition is extended wear for as many as 30 days. The most serious presumed to be of microbial origin, although corneal cul- Journal of the American Academy of Ophthalmology Originally received: June 9, 2005. sity School of Medicine, Nashville, Tennessee. Accepted: September 8, 2005. Manuscript no. 2005-518. 8 Northeastern Eye Institute, Scranton, Pennsylvania. 1 Department of Ophthalmology, Johns Hopkins University School of Medicine, Baltimore, Maryland. This study was supported by a research grant from CIBA Vision Corpo- ration, Duluth, Georgia, to the Johns Hopkins University School of Med- 2 CIBA Vision Corporation, Duluth, Georgia. icine. Dr Chalmers is a paid consultant to CIBA Vision, and Dr McNally 3 Department of International Health, Johns Hopkins University Bloomberg is a full-time employee of CIBA Vision. Dr O’Day was supported in part School of Public Health, Baltimore, Maryland. by a challenge grant from Research to Prevent Blindness, New York, New 4 Clinical Trials Consultant, Atlanta, Georgia. York. None of the other authors has a consultative or proprietary interest in the product or company. 5 Bascom Palmer Eye Institute, University of Miami, Miami, Florida. 6 Correspondence to Oliver D. Schein, MD, 116 Wilmer Building, Johns Ohio State University College of Optometry, Columbus, Ohio. Hopkins Hospital, 600 N Wolfe Street, Baltimore, MD 21287-9019. E-mail: 7 Department of Ophthalmology and Visual Sciences, Vanderbilt Univer- [email protected]. 2172 © 2005 by the American Academy of Ophthalmology ISSN 0161-6420/05/$–see front matter Published by Elsevier Inc. doi:10.1016/j.ophtha.2005.09.014 4 8/28/16 Modifiable Risk Factors for MK Non-Modifiable Risk Factors ¤ Occasional CW Use: 1.87-3.96X ¤ Regular CW Use: 5.28X ¤ < 6 Months CL Use: 4.42X ¤ Smoking: 2.96X ¤ High Socioeconomic Class: 2.66X ¤ Poor Hygiene: 3.7X ¤ Hyperopia 1.77X ¤ Purchase Lens from Internet/Mail Order: 4.76X ¤ Age >50: .45X (protective) ¤ Not Always Washing Hands: 1.49X ¤ Male: 1.48X From: Stapelton F. et al, The incidence of contact lens related microbial keratitis in ¤ >2 Days Wear/Wk.: 3.46X Australia, Ophthalmol, 2008. From: Stapelton F. et al, The incidence of contact lens related microbial keratitis in Australia, Ophthalmol, 2008. Pathogenesis of Contact Lens Can We Prevent MK? Associated Microbial Keratitis ¤ Lens wear: 80X relative risk ¤Lack of basic knowledge on how the ocular ¤ Rate of infection has not changed over the past 20 years surface defends itself ¤ Longer wearing times, poor lens care hygiene are modifiable risks. ¤ Would it help if patients were more compliant? ¤ Daily disposable lens wear is associated with a reduction in ¤ Why is EW a risk factor? severity of infection and silicone hydrogel wear materials in disease duration. ¤ Does fluorescein staining predict risk of infection? ¤ Why Pseudomonas aeruginosa? ¤ Severe cases of infection tend to be associated with environmental organisms, a delay in seeking treatment and ¤ What is the relationship between infection and travel overseas. inflammation? ¤ Higher daytime temperatures carry a higher risk for severe Fleiszig SM and Evans DJ. Pathogenesis of contact lens associated microbial infection. keratitis. Optometry & Vision Science 2010;87(4):1-7. From: Stapelton F-BCLA Medal Address, 2015. Measures for Preventing Microbial Keratitis Lens Storage Cases and Risk for Infection ¤Minimize overnight wear ¤ Hall BJ and Jones L. Contact lens cases: The missing link in CL safety?. Eye & Contact Lens ¤Monitor contact lens induced changes: 2010;36(2): 1-5. surface temperature, epithelial compromise, tear film stagnation, and reduced oxygen ¤ Wu Y, Carndt N, Wilcox M and Stapleton F. Contact surface changes lens and lens storage case cleaning instructions: Whose advice should we follow?. Eye & Contact ¤Minimize lens care contamination: wash hands, remove lenses at pre-determined Lens 2010;36(2): 6-10. interval, small bottles of saline, lens case ¤ Wu Y, Zhu H, Harmis NY, et al. Profile and frequency replacement, antibiotic prophylaxis usually not recommended of microbial contamination of contact lens cases. Optometry & Vision Science 2010;87(3):152-158. 5 8/28/16 Common Organisms Encountered Bacterial Flora of the Normal Eye Staphylococcus epidermidis 75-90%* ¤ Northeast: Staph. species, Moraxella, Diphteroids (C. xerosis) 20-33% Pseudomonas aeruginosa, Streptococcus Staphylococcus Aureus 20-25%* pneumonia Streptococcus (S. viridan) 2-6% ¤ Southeast: Pseudomonas aeruginosa common Hemophilus influenza 3% or more ¤ Pseudomonas aeruginosa still a common Streptococcus pneumoniae 1-3%* organism in contact lens wear. Also Gram negative rods 1% or more* commonly found in burn patients, patients Pseudomonas aeruginosa 0-5%* with exposure keratopathy and those on ventaltory assistance.
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