NOV 2013

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

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48 EW FEATURE Corneal crosslinking November 2013 Crosslinking continued from page 46 "The CXLUSA group employs a UV light source that is currently approved in the U.S. for a different indication, and its physicians are using the light source in an off-label manner," Dr. Donnenfeld said. In the CXLUSA studies, crosslinking is performed by loading the epithelium with the riboflavin drops (which can be done by a technician) in the epi-on technique, Dr. Trattler (an investigator for the CXLUSA group) said. During the epioff studies, a surgeon needs to be involved in removing the epithelium. In Europe, a specially formulated riboflavin is used; in the U.S., physicians can purchase commercial riboflavin outside the U.S. or have a compounding pharmacy prepare it, Dr. Donnenfeld said. "There are many differences in the riboflavin including concentration, vehicle and formulations that disrupt the epithelium to enhance transepithelial penetration. The riboflavin is used topically so it can be used in multiple dosages or individual vials for each patient depending on the physician preference," and study protocol, he said. In general, however, riboflavin is dripped onto the cornea and then Coming soon … the December issue of Ophthalmology Business Confronting problem employees A stepwise approach to dealing with problem behavior at work Personal health records PHRs give patients a close-up view of medical history, presenting opportunities for both patients and ophthalmologists. Attract and retain top talent Attracting, qualifying, hiring, training, and keeping top talent is one of the most challenging endeavors an ophthalmologist takes on. This article contains key principles to help you stay a leader in your market. Read more at Give your ASC an annual check-up Your center can benefit from an annual internal evaluation of clinical and financial factors by the staff member responsible for the center's day-to-day operations, typically the clinical director. Physician burnout Physician burnout is common in today's tense healthcare environment. This article details how to recognize the symptoms and recharge. Check out these articles and more in the December issue of Ophthalmology Business. digital.ophthalmologybusiness.org. exposed to the ultraviolet light; it is this exposure that causes the riboflavin to fluoresce which, in turn, leads to the formation of bonds between collagen molecules, according to the description on the Avedro website. The role of the ophthalmic tech Dr. Donnenfeld (involved in the U.S. studies) has his technicians deliver the drops every two minutes for 30-90 minutes depending on the patient, and he debrides the epithelium and checks for adequate penetration of the riboflavin into the corneal stroma, he said. "The ophthalmologist checks the pachymetry and begins the treatment with UV light," he said. "The technician makes certain the light is well centered. The ophthalmologist removes the speculum and the technician applies the bandage contact lens," Dr. Donnenfeld explained. The trial protocol will dictate how long the drops are applied (anywhere from 10 to 30 minutes for epioff procedures, 20 to 90 minutes for epi-on procedures, Dr. Trattler said). Riboflavin drops are dispensed with a single-use injector. Because it's an external drop, the riboflavin itself does not present much of a safety issue (and so the issues earlier this summer with various compounding pharmacies are somewhat mitigated). "In the epi-on procedure, the drops are extremely safe," he said. "In the Avedro epi-off procedure, it's an FDA-sponsored study and so the group is using its own proprietary formulation." Ongoing clinical trials within the US Setting up a clinical trial involves working with the FDA to set up an IND as well as an Institutional Review Board (IRB) to approve the wording of the informed consent. Under these governing bodies, surgeons can develop a clinical trial to treat patients with crosslinking. EW Editors' note: Both physicians are investigators for corneal crosslinking studies. Contact information Donnenfeld: 516-766-2519, ericdonnenfeld@gmail.com Trattler: wtrattler@gmail.com

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