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Study examines povidone-iodine solution for EKC
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An ongoing Web-based, open-label trial is designed to establish the efficacy of 5% povidone-iodine in treating adenovirus epidemic keratoconjunctivitis.
A group of clinicians spearheaded the Web-based study after an outbreak of epidemic keratoconjunctivitis (EKC) at their practice in New Jersey. The outbreak, which began in December 2006 and lasted for several months, involved more than 300 cases of EKC at three office sites. At the time of the EKC epidemic, prevention and supportive therapy were the only effective measures.
Starting in 2008, off-label Betadine (5% povidone-iodine ophthalmic solution, Alcon) was used to treat adenovirus-infected patients and staff, lead investigator Daniel B. Goldberg, MD, said. Betadine is approved as a prophylactic agent for the ocular surface before surgery.
“The epidemic that we saw hit us so fast that we actually had postop patients — cataract, refractive, corneal transplant and LASIK patients — that unfortunately got infected at the time,” Dr. Goldberg said. “The real danger of EKC was demonstrated to us right in front of our eyes.”
The use of Betadine irrigation for keratoconjunctivitis has been suggested in the literature for up to 30 years, but hard data on the efficacy of the treatment protocol are scarce, investigator Michael Y. Su, MD, said.
“This might be the first time in a long time that anybody’s tried to take a stab at some evidence-based medicine in regards to iodine in treatment of conjunctivitis,” Dr. Su said.
Enrollment of participating physicians began in June and is ongoing.
“We want to invite doctors around the world to sign up and help us establish the efficacy of Betadine in this application,” Dr. Goldberg said.
During the EKC outbreak, Drs. Su and Goldberg and colleagues used traditional prophylactic measures.
“At that time, as now, there was no recognized effective agent against adenovirus,” Dr. Goldberg said. “We were treating [patients] with supportive therapy. The most effective intervention that we were able to put in place was simply trying to prevent transmission of the virus in our office and from patient to patient.”
In fall 2008, the clinicians identified the presence of adenovirus and treated patients with 5% Betadine solution. The protocol proved successful and led Dr. Goldberg and colleagues to conceive the study. However, a larger patient sample is needed to obtain valid data on the treatment’s efficacy, he said.
“We’ve built up a series within the practice and have had excellent results with almost complete resolution of the infections,” Dr. Goldberg said. “But our numbers are small. In order to get a meaningful study that can demonstrate the efficacy, we realized that we needed to involve other doctors because we simply would never see enough unless we happened to be in the middle of another epidemic.”
Historically, treatment of EKC has involved artificial tears, cool compresses and antibiotics, but proven, effective therapies are lacking.
“Patients come in expecting a fix,” Dr. Su said. “When we tell them that’s not going to happen, they’ve got to wait it out, they’re kind of disappointed. A lot of doctors tend to prescribe things like fluoroquinolones, broad-spectrum antibiotics, when there isn’t really a role for that. The unintended consequences of that are fostering antibiotic resistance.”
Clinicians who wish to take part in the study may get further information, including protocol, informed consent and examination forms, at www.betadineforekc.com. Participating physicians can easily report clinical results through the Web site. Initial data collection is scheduled to end March 1, 2010.
For more information:
- Daniel B. Goldberg, MD, and Michael Y. Su, MD, can be reached at Atlantic Eye Physicians, 180 White Road, Little Silver, NJ 07757; (732) 219-9220; e-mails: dangold@att.net; msu76@verizon.net. Dr. Goldberg, Dr. Su and fellow study coordinator Lisa Ortenzio, OD, have no direct financial interest in the study.