A prospective multicentre randomized placebo-controlled superiority trial in patients with suspected bacterial endophthalmitis after cataract surgery on the adjuvant use of intravitreal dexamethasone to intravitreal antibiotics

Sonia Manning, Luana C Ugahary, Eric W Lindstedt, René J Wubbels, Jaap T van Dissel, Jan T G Jansen, Ivan Gan, Arnoud T van Goor, Carlien A Bennebroek, Dymph J van der Werf, Annette Ossewaarde-van Norel, Chris C Mayland Nielsen, Mauk Tilanus, Pieter R van den Biesen, Peter A Schellekens, Ellen La Heij, Koorosh Faridpooya, Koen van Overdam, Marc Veckeneer, Jan C van Meurs

Research output: Contribution to journalArticleResearchpeer-review

Abstract

PURPOSE: We aimed to determine whether intravitreal dexamethasone as an adjuvant to intravitreal antibiotics is beneficial in the treatment of suspected bacterial endophthalmitis after cataract surgery.

METHODS: Randomized, placebo-controlled superiority trial in three tertiary referral centres in the Netherlands. Patients with suspected bacterial endophthalmitis within 6 weeks after cataract surgery were eligible. A diagnostic vitreous biopsy was taken for culture, and patients received intravitreal injections of 400 μg dexamethasone (without preservatives) or placebo, in addition to 0.2 mg vancomycin and 0.05 mg gentamicin. The vancomycin and dexamethasone or placebo injections were repeated once at day 3 or 4. Primary outcome measure was best-corrected visual acuity (BCVA) at 1 year.

RESULTS: Between 1 November 2004 and 1 March 2014 (excluding two interruptions totalling 20 months), 324 eligible patients presented. A total of 167 patients (81 dexamethasone, 86 placebo) were available for the intention-to-treat analysis. Biopsies of 114 patients (68%) were culture-positive. Final BCVA did not differ between the dexamethasone and the placebo group (logMAR 0.31 ± 0.58 versus 0.27 ± 0.50; p = 0.90), nor did the number of patients with final vision of no light perception (LP, 7 versus 13). Pain, corneal oedema, the absence of a red fundus reflex on presentation, LP on presentation and culture of virulent pathogens from biopsy were statistically significantly associated with an unfavourable visual outcome.

CONCLUSION: Intravitreal dexamethasone without preservatives as an adjuvant to intravitreal antibiotics does not improve visual acuity (VA) in patients treated for suspected bacterial endophthalmitis after cataract surgery.

Original languageEnglish
Pages (from-to)348-355
Number of pages8
JournalActa Ophthalmologica
Volume96
Issue number4
DOIs
Publication statusPublished - Jun 2018

Keywords

  • Aged
  • Anti-Bacterial Agents/administration & dosage
  • Cataract Extraction/adverse effects
  • Dexamethasone/administration & dosage
  • Endophthalmitis/drug therapy
  • Eye Infections, Bacterial/etiology
  • Female
  • Follow-Up Studies
  • Gentamicins/administration & dosage
  • Glucocorticoids/administration & dosage
  • Humans
  • Intravitreal Injections
  • Male
  • Prospective Studies
  • Surgical Wound Infection/drug therapy
  • Treatment Outcome
  • Vancomycin/administration & dosage
  • Visual Acuity

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