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Natamycin and voriconazole in Fusarium and Aspergillus keratitis: subgroup analysis of a randomised controlled trial
  1. Venkatesh N Prajna1,
  2. Prajna S Lalitha1,
  3. Jeena Mascarenhas1,
  4. Tiruvengada Krishnan2,
  5. Muthiah Srinivasan1,
  6. C M Vaitilingam2,
  7. Catherine E Oldenburg3,
  8. Aileen Sy3,
  9. Jeremy David Keenan3,4,
  10. Travis C Porco3,5,
  11. Nisha R Acharya3,4,
  12. Thomas M Lietman3,4,5
  1. 1Department of Cornea and Refractive Surgery, Aravind Eye Care System, Madurai, Tamil Nadu, India
  2. 2Department of Cornea, Aravind Eye Care System, Pondicherry, India
  3. 3Francis I. Proctor Foundation, University of California, San Francisco, California, USA
  4. 4Department of Ophthalmology, University of California, San Francisco, California, USA
  5. 5Department of Epidemiology and Biostatistics, University of California, San Francisco, California, USA
  1. Correspondence to Dr Thomas M Lietman, F.I. Proctor Foundation, University of California, Room S309, 513 Parnassus Ave, UCSF, San Francisco, CA 94143-0412, USA; tom.lietman{at}ucsf.edu

https://doi.org/10.1136/bjophthalmol-2012-301825

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    Introduction

    Fusarium and Aspergillus species are aggressive corneal pathogens, and even with proper treatment, can lead to poor outcomes.1 Voriconazole is effective in vitro against Aspergillus species, but may not perform as well against Fusarium species.2 We undertook a clinical trial comparing topical voriconazole versus topical natamycin, with the overall results presented previously.3 Here, we perform a prespecified subgroup analyses of treatment within Fusarium cases, and separately, within Aspergillus cases, assessing the efficacy of voriconazole and natamycin.

    Methods

    Complete methods of the clinical trial have been reported elsewhere.3 In brief, eligible patients had a KOH-positive fungal smear with filamentous fungal elements, and were randomised to receive either topical voriconazole 1% (Pfizer, New York, NY, USA) or natamycin 5% (Alcon, Ft Worth, Texas, USA), and to repeat scraping or no rescraping. The primary outcome for the trial was best spectacle-corrected visual acuity (BSCVA) at 3 months from enrolment. Secondary outcomes included corneal perforation and/or therapeutic penetration keratoplasty (TPK) by treatment arm. Fungal cultures were performed for all patients enrolled in the trial. Fungal identification was performed using gross and microscopic characteristics. Ethical approval was obtained from the University of California, San Francisco and the Aravind Eye Care System.

    Analyses were performed in the subset of patients who were diagnosed with Fusarium or Aspergillus keratitis. Wilcoxon rank sum and Fisher's exact tests were used …

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    Footnotes

    • Contributors NVP designed study, collected data, drafted and approved the manuscript; PL designed the study, collected data, and critically revised and approved the manuscript; JM collected data and critically reviewed and approved the manuscript; TK designed the study, collected data, and critically reviewed and approved the manuscript; MS collected data and critically reviewed and approved the manuscript; CMV collected data and critically reviewed and approved the manuscript; CEO collected data, conducted analyses, drafted, reviewed, and approved the manuscript; AS conducted analyses, drafted, reviewed, and approved the manuscript; JDK designed study, assisted with analyses, critically reviewed and approved the manuscript; TCP designed study, conducted analyses, and critically reviewed and approved the manuscript; NRA designed study, collected data, obtained funding, and critically reviewed and approved the manuscript; TML designed study, obtained funding, oversaw entire study, and drafted, reviewed, and approved the manuscript.

    • Funding Alcon Inc donated natamycin, and Pfizer Inc donated voriconazole for the study. None of the authors have any financial disclosures related to this manuscript. Funding for this research was from That Man May See and the South Asia Research Fund. The Department of Ophthalmology at UCSF is supported by a core grant from the National Eye Institute, EY02162. Dr Acharya is supported by a National Eye Institute K23EY017897 grant and a Research to Prevent Blindness Career Development Award. Dr Lietman is supported by a National Eye Institute grant U10-EY015114 and a Research to Prevent Blindness award. Dr Porco is supported by That Man May See Foundation at UCSF. The sponsors did not have role in the design and conduct of the study; collection, management, analysis and interpretation of the data; and preparation, review or approval of the manuscript.

    • Competing interests None.

    • Ethics approval University of California, San Francisco Committee on Human Research; Aravind Eye Hospital Institutional Review Board.

    • Provenance and peer review Not commissioned; internally peer reviewed.