Our ophthalmology led comprehensive eye care practice saw over 300 cases of a severe strain of EKC 2 years ago. We are still following patients with steroid-dependent SEIs, some of whom were post-op cataract and refractive patients and who were unfortunate enough to be seen post-op before we realized we were in the midst of an onslaught and before we instituted preventive measures.
After reviewing the literature we learned about the use of 5% Betadine irrigation to treat EKC. There are sporadic reports dating back over 30 years, but more rigorous confirmation of the efficacy of treatment is needed.
Ophthalmologists have become experienced with 5% Betadine irrigation as a pre-operative antiseptic, and 5% Betadine is now available as an FDA approved product which can be used 'off-label' to treat EKC. This agent has minimal toxicity when used properly and followed by saline irrigation. In vitro, povidone iodine is effective against adenovirus as well as many other infectious agents. Prior trial with 1.5% Betadine to treat adenovirus conjunctivitis in children was inconclusive, and this study will test the use of 5% solution to treat EKC in adults.
Further, the availability of an in-office immunoassay test can confirm the presence of adenovirus infection prior to treatment which will yield more powerful data. For humanitarian reasons, where cost or availability of RPS testing is problematic, we will collect data from patients with clinical diagnosis of EKC who are treated per protocol.
Our purpose is to confirm the effectiveness of our protocol using 5% Betadine irrigation for treatment of acute EKC and to
expand the awareness amongst eye care professionals of this inexpensive treatment for EKC—a common, worldwide, highly
contagious and often severe form of conjunctivits with the potential for long term visual sequelae due to corneal
Betadine for EKC Coordinating Committee
• Daniel B. Goldberg, MD
Clinical Associate Professor of Ophthalmology
Drexel College of Medicine
• Michael Su, MD
• Lisa Ortenzio OD
All committee members are associated with Atlantic Eye Physicians, in Long Branch, Little Silver, and Holmdel New
Jersey. We are an ophthalmology led comprehensive eye care practice. At present, there are no commercial sponsors, and no financial interest. This project is undertaken in the interest of public health, and support may be provided in the future by a grant from a charitable trust.
This protocol is open to ophthalmologists and optometrists, US and international, who agree to follow the protocol and report
clinical results thru our website.
“Off-Label” Use of Marketed Biologics
This protocol involves the off-label use of 5% povidone-iodine ophthalmic solution(Betadine 5% Sterile Ophthalmic Solution
manufactured by Alcon). Betadine 5% is FDA approved for “pre-operative prep and irrigation of the ocular surface,” and is
routinely used for pre-operative antisepsis prior to ophthalmic surgery. Betadine 5% is contraindicated for individuals known
to be sensitive to iodine.” Instructions for use require “flushing eye thoroughly with sterile saline solution after each use.”
As per the US Food and Drug Administration (http://www.fda.gov/oc/ohrt/irbs/offlabel.html): Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product’s use and effects.
Use of a marketed product in this manner when the intent is the “practice of medicine” does not require the the submission of Investigational New Drug Application(IND), Investigational Device Exemption(IDE), or review by an Institutional Review Board(IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight. Pregnant and breastfeeding women are excluded from the study.
Use of FDA-Approved Diagnostic Test
Also used in this protocol is a rapid, in-office, immunodiagnostic test for detecting the presence of adenovirus antigens. The RPS AdenoDetector meets the criteria established within the October 2006 Preferred Practice Pattern on Conjunctivitis for the American Academy of Ophthalmology, and is FDA approved and CLIA waived for use as an aid in the rapid differential diagnosis of acute adenoviral conjunctivitis.
The test is covered under CPT Code 87809—Infectious agent antigen detection by immunoassay with direct optical observation: Adenovirus. Medicare reimbursement is approximately $17 and cost of test from RPS is $13. For further information, visit: www.rps-tests.com.