Evidence map›Paper›PMID 23710492›Full record

Trial reportJAMA ophthalmology2013

The mycotic ulcer treatment trial: a randomized trial comparing natamycin vs voriconazole.

N Venkatesh Prajna, Tiruvengada Krishnan, Jeena Mascarenhas, Revathi Rajaraman, Lalitha Prajna, Muthiah Srinivasan, Anita Raghavan, Catherine E Oldenburg, Kathryn J Ray, Michael E Zegans and 5 more

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
In one paragraph

Trial report in JAMA ophthalmology, 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00996736 (Mycotic Ulcer Treatment Trial), which is not on this map. Cited by 166 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
166citing papers in PubMed, 4 pooled it
11.5field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00996736 phase3completednot on this map

Mycotic Ulcer Treatment Trial

TypeinterventionalSponsorUniversity of California, San FranciscoRan2010 to 2012Enrolled323ConditionsCorneal Ulcer, Eye Infections, FungalArmsNatamycin, Voriconazole
3 · Its place in the literature

Who cites it

166 citing papers in PubMed, 4 syntheses or guidelines pooled it, 326 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Practice Guidelines for the Diagnosis and Management of Aspergillosis: 2016 Update by the Infectious Diseases Society of America.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2016
    Guideline
  4. Medical interventions for fungal keratitis.The Cochrane database of systematic reviews · 2015
    Pooled it
  5. Adjunctive povidone-iodine forAntimicrobial agents and chemotherapy · 2026
    Trial
  6. Continuous voriconazole lavage in managing moderate and severe fungal keratitis: a randomized controlled trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2023
    Trial
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106 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors at 1 institution in 1 country.

N Venkatesh PrajnaAravind Eye Care System, Madurai, India.
Tiruvengada Krishnan
Jeena Mascarenhas
Revathi Rajaraman
Lalitha Prajna
Muthiah Srinivasan
Anita Raghavan
Catherine E Oldenburg
Kathryn J Ray
Michael E Zegans
Stephen D McLeod
Travis C Porco
Nisha R Acharya
Thomas M Lietman
Mycotic Ulcer Treatment Trial Group
Aravind Eye Hospital · IN

Funding

Myocotic Ulcer Treatment TrialU10EY018573 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LIETMAN, THOMAS M · 2009 to 2014
$3.7M
Predicting and Improving Clinical Outcomes for Bacterial KeratitisK23EY017897 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ACHARYA, NISHA · 2007 to 2011
$1.1M
NEI NIH HHS K23 EY017897NEI NIH HHS U10 EY018573
6 · The paper itself

Abstract

objectiveTo compare topical natamycin vs voriconazole in the treatment of filamentous fungal keratitis.

methodsThis phase 3, double-masked, multicenter trial was designed to randomize 368 patients to voriconazole (1%) or natamycin (5%), applied topically every hour while awake until reepithelialization, then 4 times daily for at least 3 weeks. Eligibility included smear-positive filamentous fungal ulcer and visual acuity of 20/40 to 20/400.

main outcome measuresThe primary outcome was best spectacle-corrected visual acuity at 3 months; secondary outcomes included corneal perforation and/or therapeutic penetrating keratoplasty.

resultsA total of 940 patients were screened and 323 were enrolled. Causative organisms included Fusarium (128 patients [40%]), Aspergillus (54 patients [17%]), and other filamentous fungi (141 patients [43%]). Natamycintreated cases had significantly better 3-month best spectacle-corrected visual acuity than voriconazole-treated cases (regression coefficient=0.18 logMAR; 95% CI, 0.30 to 0.05; P=.006). Natamycin-treated cases were less likely to have perforation or require therapeutic penetrating keratoplasty (odds ratio=0.42; 95% CI, 0.22 to 0.80; P=.009). Fusarium cases fared better with natamycin than with voriconazole (regression coefficient=0.41 logMAR; 95% CI,0.61 to 0.20; P<.001; odds ratio for perforation=0.06; 95% CI, 0.01 to 0.28; P<.001), while non-Fusarium cases fared similarly (regression coefficient=0.02 logMAR; 95% CI, 0.17 to 0.13; P=.81; odds ratio for perforation=1.08; 95% CI, 0.48 to 2.43; P=.86).

conclusionsNatamycin treatment was associated with significantly better clinical and microbiological outcomes than voriconazole treatment for smear-positive filamentous fungal keratitis, with much of the difference attributable to improved results in Fusarium cases. APPLICATION TO CLINICAL PRACTICE: Voriconazole should not be used as monotherapy in filamentous keratitis.

trial registrationclinicaltrials.gov Identifier: NCT00996736

Indexed as

Administration, TopicalAdultAntifungal AgentsCorneal PerforationCorneal UlcerDouble-Blind MethodEye Infections, FungalFemaleFungiHumansKeratoplasty, PenetratingMaleMiddle AgedMycosesNatamycinOphthalmic SolutionsAntifungal AgentsNatamycinOphthalmic SolutionsPyrimidinesTriazolesVoriconazole

Identifiers

PMID23710492
PMCPMC3769211
OpenAlexW2001276323

What OpenQuestion holds

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Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.