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

Eric W Lindstedt, Carlien A Bennebroek, Dymph J van der Werf, Marc Veckeneer, Annette Ossewaarde-van Norel, Chris C Mayland Nielsen, Rene J Wubbels, Jaap T van Dissel, Jan C van Meurs

Research output: Contribution to journalArticleResearchpeer-review

Abstract

PURPOSE: 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.

PATIENTS AND 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.

CONCLUSION: 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.

Original languageEnglish
Pages (from-to)1631-7
Number of pages7
JournalGraefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie
Volume252
Issue number10
DOIs
Publication statusPublished - Oct 2014

Keywords

  • Aged
  • Aged, 80 and over
  • Bacteria/isolation & purification
  • Dexamethasone/adverse effects
  • Double-Blind Method
  • Endophthalmitis/drug therapy
  • Eye Enucleation
  • Eye Evisceration
  • Eye Infections, Bacterial/drug therapy
  • Female
  • Glucocorticoids/adverse effects
  • Humans
  • Intravitreal Injections
  • Male
  • Middle Aged
  • Phacoemulsification
  • Postoperative Complications
  • Prospective Studies
  • Visual Acuity/physiology
  • Vitreous Body/microbiology

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