title: A prospective multicenter randomized placebo-controlled trial of dexamethasone as an adjuvant in the treatment of postoperative bacterial endophthalmitis: interim safety analysis of the study drug and analysis of overall treatment results.
abstract: OBJECTIVE
  In an ongoing prospective multicenter randomised placebo-controlled trial we study the adjuvant use of intravitreal dexamethasone in the treatment of patients with suspected bacterial endophthalmitis after phacoemulsification. In accordance with the study protocol, a mid-inclusion interim analysis of the safety of the study drug was performed.
  
  
  METHODS
  Patients with suspected endophthalmitis after phacoemulsification were asked to participate in this study. A diagnostic vitreous biopsy was taken and the patients received intravitreal injections of 400 micrograms dexamethasone or a placebo, plus 0.2 mg vancomycin and 0.05 mg gentamicin. Injections were repeated after 3 or 4 days. The safety analysis included: the number of eyes with an evisceration; no light perception; or a visual acuity of less than 5/200. Treatment outcome was evaluated in terms of: the percentage of patients with a visual acuity of 20/40 or more and 20/100 or more.
  
  
  RESULTS
  The interim analysis included 81 patients with at least 1 year follow-up. Sixty-three patients (65 %) were culture-positive. Safety analysis: 7 eyes were eviscerated (3 dexamethasone, 4 placebo); 4 eyes had no light perception (2 dexamethasone, 2 placebo); and 4 eyes had less than 5/200 vision (3 dexamethasone, 1 placebo). Treatment outcome: 70 % of patients had a visual acuity of at least 20/40.
  
  
  CONCLUSIONS
  The safety analysis does not warrant premature discontinuation of the study. So far, the overall outcome of our treatment regimen, consisting of merely a diagnostic biopsy instead of a vitrectomy and an optimized antibiotic dosing, compares favourably to published literature.
authors.affiliation: The Rotterdam Eye Hospital, Schiedamsevest 180, 3011 BH, Rotterdam, The Netherlands.
authors.forename: Eric W
authors.initials: EW
authors.lastname: Lindstedt
authors.forename: Carlien A
authors.initials: CA
authors.lastname: Bennebroek
authors.forename: Dymph J
authors.initials: DJ
authors.lastname: van der Werf
authors.forename: Marc
authors.initials: M
authors.lastname: Veckeneer
authors.forename: Annette Ossewaarde-van
authors.initials: AO
authors.lastname: Norel
authors.forename: Chris C Mayland
authors.initials: CC
authors.lastname: Nielsen
authors.forename: Rene J
authors.initials: RJ
authors.lastname: Wubbels
authors.forename: Jaap T
authors.initials: JT
authors.lastname: van Dissel
authors.forename: Jan C
authors.initials: JC
authors.lastname: van Meurs
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D001419:Bacteria / Q000302:isolation & purification; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D009877:Endophthalmitis / Q000188:drug therapy* / Q000382:microbiology; D015353:Eye Enucleation; D017234:Eye Evisceration; D015818:Eye Infections, Bacterial / Q000188:drug therapy* / Q000382:microbiology; D005260:Female; D005938:Glucocorticoids / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D058449:Intravitreal Injections; D008297:Male; D008875:Middle Aged; D018918:Phacoemulsification; D011183:Postoperative Complications; D011446:Prospective Studies; D014792:Visual Acuity / Q000502:physiology; D014822:Vitreous Body / Q000382:microbiology
chemical_list: D005938:Glucocorticoids; D003907:Dexamethasone
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