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Evaluation and Treatment of Eye Complications of Vaccinia Vaccination

National Eye Institute (NEI) · 2004
ClinicalTrials.gov · Datasets · License: Public Domain · 2004
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immune-responsesmallpoxvaccine
This study will evaluate patients with eye complications related to vaccination against smallpox to learn more about these conditions. Vaccinia vaccination has been used for more than 100 years for preventing smallpox. A small number of people who receive the vaccination (less than 1 in 1,000) develop complications, sometimes in their eyes. This usually results from the accidental transfer of the infection from the vaccination site to the face or eyes, perhaps by touching the vaccination area and then the face or eyelids before washing the hands. The study will also examine whether an experimental treatment called NP-016 vaccinia immune globulin can reduce corneal scarring that is sometimes associated with serious vaccinia complications and can impair vision. Children and adults with keratitis, severe conjunctivitis, or blepharitis following exposure to vaccinia vaccination may be eligible for this study. Children must weigh at least 10 kg. Participants undergo the following tests and procedures at enrollment, with some tests repeated at scheduled study visits: 1. Medical history and physical examination 2. Infectious disease consultation 3. Complete eye evaluation including: * Fundus photography to examine the back of the eye - dilation of the pupils with eye drops to examine and photograph the back of the eye * Slit lamp biomicroscopy - evaluation of the front part of the eye with a slit lamp microscope * Eye pressure measurements * Eye swab to look for vaccinia virus or other causes of disease 4. Blood tests 5. Photographs and documentation of eye and skin lesions 6. Vaccinia diagnostic tests, such as skin or mucosa scrapings; blood, throat, or urine cultures; and tissue biopsies, if needed Patients begin treatment with standard medications for their eye disease, such as trifluridine (Viroptic® (Registered Trademark)) anti-viral eye drops. Patients whose condition becomes serious are offered additional treatment with intravenous (through a vein)
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