Can the dexamethasone intravitreal implant Ozurdex be safely administered in an out-of-operating room setting?

Abstract

Purpose: To describe a standardized protocol of the dexamethasone intravitreal (DEX) implant Ozurdex (Allergan, Dublin, Ireland) performed in a controlled environment surgical cabin (CESC). Methods: Retrospective and observational study conducted on patients who underwent a DEX implant between May 2011 and June 2019, in a third level University Hospital. The controlled environment surgical cabin (ArcSterile, Imex, Valencia, Spain) used in this study was the MB 20 (2 m width, 1.60 m depth, and 2 m height) with an uninterrupted power system (ARSSAI1) to keep the cabin working for 20 min. The cabin was used in the open mode. A standardized protocol of intravitreal injections in controlled environment surgical cabin was designed. Results: From May 2011 to February 2015, a total of 454 DEX implants were performed in the operating room, whereas from March 2015 to June 2019, 1054 DEX devices were implanted using the CESC. The mean number of DEX implants/per week was significantly lower in the operating room than in the CESC [2.3 (2.1 to 2.5) versus 3.8 (3.6 to 4.1), mean difference 1.5 (1.2 to 1.8), p < 0.0001]. The incidence of endophthalmitis was similar in the two populations, 0/454 (0.0%; 95% CI 0.0 to 0.81%) and 0/1054 (0.0%; 95% CI 0.0 to 0.35%) in the operating room and in the CESC, respectively. Conclusions: The CESC may be a good alternative to the conventional operating room for the administration of the intravitreal DEX implant.

Keywords: ArcSterile; Dexamethasone implant; controlled environment surgical cabin; retina; safety.

Figure 1.

Number of eyes treated with the intravitreal dexamethasone implant Ozurdex. Abbreviations. CESC: controlled environment surgical cabin; OR: operating room. First: Years 2011 and 2015 for the OR and CESC, respectively. Second: Years 2012 and 2016 for the OR and CESC, respectively. Third: Years 2013 and 2017 for the OR and CESC, respectively. Fourth: Years 2014 and 2018 for the OR and CESC, respectively. Fifth: Years 2015 and 2019 for the OR and CESC, respectively. *From 10 May 2011 in the OR and from 4 March 2015 in the CESC. **Until 19 February 2015 in the OR and till 25 June 2019 in the CESC.