Endophthalmitis Clinical Trial
Official title:
Concentrating on Antisepsis: 5% vs. 10% Povidone-Iodine Prior to Intravitreal Injection
This is a randomized controlled single blind prospective study evaluating the efficacy of ocular surface sterilization between three different povidone-iodine preparation techniques prior to intravitreal injection. The primary end point is significant different between median colony-forming units pre- and post-sterilization and injection.
Introduction: An estimated 5.9 - 7.9 million intravitreal injections (IVI) were given in
2016. While the incidence of post-injection endophthalmitis is exceedingly low, it is a
feared complication of the procedure. 96% of culture-positive post-injection endophthalmitis
cases are caused by conjunctival commensals, emphasizing the importance of ocular surface
sterilization prior to IVI. The most recently published guidelines for IVI state that
"Povidone-Iodine (5-10%) should be the last agent applied to the intended injection site
before the injection," a recommendation that is universally followed. However, there is no
standard of care regarding the concentration of PI nor the field of sterilization (e.g,
cleaning the eyelids and lashes), and technique varies widely in clinical practice. The
literature reveals no direct comparison of 5% vs 10% PI in the context of intravitreal
injection.
Methods: Single-center randomized prospective trial enrolling patients into three protocols:
5% P-I applied to ocular surface from bottle, 10% P-I swabstick applied to ocular surface,
and 10% P-I swabstick applied to lids, lashes, and ocular surface. Pre-procedure cultures
will be obtained from the ocular surface, and a second culture will be taken following
antisepsis, injection, and irrigation. Standard microbiologic techniques will be used to
collect, culture, identify, and quantify ocular surface bacteria counts. Kruskal Wallis test
will be used to assess significant difference between median bacterial loads at baseline and
post-cleaning, as well as median reduction from baseline. Chi-squared test will be used to
assess significant difference between reduction in number of patients with specific bacteria.
Following injection, a patient survey will be administered to compare patients' subjective
symptoms of ocular surface irritation during the PI preparation phase of the procedure.
Conclusions: The investigators anticipate that no significant difference exists in decrease
of median CFUs between the three protocols, and that lower concentration of P-I provides a
more comfortable patient experience.
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