Eyeworld

SEP 2011

EyeWorld is the official news magazine of the American Society of Cataract & Refractive Surgery.

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September 2011 by Enette Ngoei EyeWorld Contributing Editor ASCRS Cataract Clinical Committee publishes endophthalmitis white paper Cataract surgeons now have a definitive review of treatment and prevention of endophthalmitis S ince the idea was first put forth by Sonia Yoo, M.D., Bascom Palmer Eye Insti- tute, University of Miami, in April 2010, members of the ASCRS Cataract Clinical Com- mittee have been combing through all the available peer-reviewed litera- ture and publications on endoph- thalmitis. Their hard work has culminated in a definitive white paper on the treatment and preven- tion of endophthalmitis, published in the September issue of the Journal of Cataract and Refractive Surgery. The extensive review includes literature from the U.S., Europe, and Asia, according to Nick Mamalis, M.D., John A. Moran Eye Center, University of Utah, Salt Lake City. Dr. Yoo explained the impetus for the study. "I think we've all no- ticed that there's been a change in the spectrum of infection that we've seen in terms of the micro-organ- isms causing the infections. We've seen a shift over the last decade in the types of organisms that are caus- ing endophthalmitis. In particular, we've noticed at Bascom Palmer an increase in the incidence of methi- cillin-resistant organisms. We've seen that not only in endophthalmi- tis but also in corneal ulcers and post-refractive infections as well." The review summarizes the in- formation that's out there and tries to make sense of conflicting litera- ture, Dr. Yoo said. One example of that is the use of antibiotics, in particular, prophy- lactic topical antibiotics pre-op, she said. There's been a bit of a shift in the types of antibiotics that are used, when they are used, and for how long, she explained, and it seems like there still isn't solid evidence that the use of pre-op topical antibi- otics decreases the rate of post- cataract endophthalmitis. Based on the literature and surveys of practice patterns, the use of antibiotics after surgery has become the standard of care, but it's still controversial whether it actually decreases the risk of bacterial endophthalmitis, Dr. Yoo said. That's because the risk of en- dophthalmitis is so low that to do a controlled study will take many eyes, and it needs to be done in a very controlled setting, she ex- plained. Committee chair and driving force behind the monumental effort, Mark Packer, M.D., clinical associ- ate professor of ophthalmology, Casey Eye Institute, Oregon Health & Science University, Portland, said, "Obviously it's a high priority for surgeons to prevent infections; they're devastating and they can turn a wonderful result into a terri- ble result." CAUTION: Federal law restricts this device to sale by or on the order of a physician. INDICATION: The EX-PRESS ® Glaucoma Filtration Device is intended to reduce intraocular pressure in glaucoma patients where medical and conventional surgical treatments have failed. CLINICAL STUDY INFORMATION: A clinical study was performed with the EX-PRESS ® Glaucoma Filtration Device versions R-30 and R-50. The study was a prospective, open-label multi-center study of 113 open angle glaucoma patients with a follow-up period of one year. Results indicated an 80.4% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP reduction greater than 20% from baseline with or without medications. Results indicated a 75.9% overall success for the per-protocol cohort (R-30 and R-50, n=58) at one year, where overall success was defined as an IOP of less than 21 mmHg with or without medications. The mean IOP reduction at one year was 33.8%. The percentage reduction from baseline was greater than 28% for the R-30 version and greater than 40% for the R-50 version. The overall average number of glaucoma medications dropped significantly from 1.55 pre-operative to 0.52 medications at one-year postoperative. The clinical study was not designed to compare between the various versions of the EX-PRESS ® Glaucoma Filtration Device. The selection of the appropri- ate version is according to the doctor's discretion. The most commonly reported adverse events included the need for further filtering surgery, device explantation, bleb revision and iris touch. Reasons for device explantation included flat anterior chamber with hypotony, device exposure from erosion, and poor efficacy. Other adverse events such as, but not limited to, corneal and retinal complications, uveitis, and significant reduction in visual acuity, may occur as well. CONTRAINDICATIONS: The use of this device is contraindicated if one or more of the following conditions exist: Presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blephari- tis; pre-existing ocular or systemic pathol- ogy that, in the opinion of the surgeon, is likely to cause postoperative complica- tions following implantation of the device or patients diagnosed with angle closure glaucoma. WARNINGS/PRECAUTIONS: The surgeon should be familiar with the instructions for use. The integrity of the package should be examined prior to use and the device should not be used if the package is damaged and sterility is compromised. This device is for single use only. MRI of the head is permitted, however not recommended, in the first two weeks post implantation. ATTENTION: Reference the Directions for Use labeling for a complete listing of indications, warnings and precautions. © 2011 Novartis AG 7/11 EXP10587JAD 76011 EXP10587JAD_PI EW.indd 1 7/12/11 2:04 PM An example of endophthalmitis 2 days after uncomplicated phaco. A layered hypopyon and some corneal edema due to elevated IOP from the endophthalmitis are visible. The organism was MRSA Source: Sonia Yoo, M.D. When continued from page 45 ogy, and immunology, Eastern Vir- ginia Medical School, Norfolk, Va., said his clinic has been using intravitreal dexamethasone for decades as part of endophthalmitis treatment. "For one, it's short acting," Dr. Sheppard said. "Also, it's available preservative-free." The steroid helps because of the eye's reaction to infection, he said. "The eye is such a vascular structure that the host response tends to overwhelm the structural integrity of the eye," Dr. Sheppard said. "It's certainly incumbent upon the clinic to limit the damage either directly from the bacteria or from the immune system's collateral agents." Still, steroids can be harmful in certain endophthalmitis cases, Dr. Sheppard said. "When pseudomonas is involved, we know from keratitis models that steroids are deleterious," Dr. Sheppard said. "And of course with fungal endophthalmitis, steroids are deleterious." Still, Dr. Sheppard said it's hard to be conclusive about the impact of steroids in endophthalmitis cases. "When you're addressing steroid research even in a prospective man- ner, an infection as rare as post- cataract endophthalmitis will make it difficult to obtain significant num- bers," Dr. Sheppard said. EW Editors' note: Dr. Albrecht has no financial interests related to this study. Dr. Sheppard has no financial interests related to his comments. Contact information Albrecht: albrecht@telkomsa.net Sheppard: 757-622-2200, docshep@hotmail.com

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