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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

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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.

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Acknowledgments

Clinical Research Unit, Rotterdam Ophthalmolmic Institute, Schiedamsevest 160, Rotterdam, the Netherlands.

SWOO-Flieringa Foundation (Research FOundation Rotterdam Eye Hospital).

SNOO (Foundation of Dutch Ophthalmological Research).

Conflict of interest statement

None of the authors and members of the study group have any actual or potential conflict of interest.

Author information

Authors and Affiliations

  1. The Rotterdam Eye Hospital, Schiedamsevest 180, 3011 BH, Rotterdam, The Netherlands

    Eric W. Lindstedt, Marc Veckeneer & Jan C. van Meurs

  2. University Medical Center Utrecht, Utrecht, Netherlands

    Carlien A. Bennebroek, Dymph J. van der Werf & Annette Ossewaarde-van Norel

  3. Radboud University Nijmegen Medical Centre, Nijmegen, Netherlands

    Chris C. Mayland Nielsen

  4. Rotterdam Ophthalmologic Institute, Rotterdam, Netherlands

    Rene J. Wubbels

  5. Leiden University Medical Center, Leiden, Netherlands

    Jaap T. van Dissel

  6. Erasmus Medical Center Rotterdam, Schiedamsevest 180, 3011 BH, Rotterdam, The Netherlands

    Jan C. van Meurs

Authors
  1. Eric W. Lindstedt
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  2. Carlien A. Bennebroek
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  3. Dymph J. van der Werf
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  4. Marc Veckeneer
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  5. Annette Ossewaarde-van Norel
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  6. Chris C. Mayland Nielsen
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  7. Rene J. Wubbels
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  8. Jaap T. van Dissel
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  9. Jan C. van Meurs
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Corresponding author

Correspondence to Jan C. van Meurs.

Appendix: the Endophthalmitis Dexamathasone Study Group

Appendix: the Endophthalmitis Dexamathasone Study Group

Ivan Gan, MD, the Rotterdam Eye Hospital, the Netherlands,

Luana C. Ugahary, MD, the Rotterdam Eye Hospital, the Netherlands

Jan Jansen, Pharmacist, the Rotterdam Eye Hospital, the Netherlands

Tjaco Ossewaarde, MD, Microbiology Dpt., Maasstad Hospital, Rotterdam

Koen van Overdam, MD, the Rotterdam Eye Hospital, the Netherlands

Koorosh Farid Pooya, MD, the Rotterdam Eye Hospital, the Netherlands

Tom van Goor, MD, the Rotterdam Eye Hospital, the Netherlands

Peter Schellekens, MD, University Medical Center Utrecht, the Netherlands

Pieter van den Biesen, MD, University Medical Center Utrecht, the Netherlands

Benjamin Pijl, MD, University Medical Center Nijmegen, the Netherlands

Jacqueline Moor, MD, University Medical Center Nijmegen, the Netherlands

Mauk Tilanus, MD, University Medical Center Nijmegen, the Netherlands

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Lindstedt, E.W., Bennebroek, C.A., van der Werf, D.J. et al. 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. Graefes Arch Clin Exp Ophthalmol 252, 1631–1637 (2014). https://doi.org/10.1007/s00417-014-2770-8

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  • DOI: https://doi.org/10.1007/s00417-014-2770-8

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