Evidence map›Paper›PMID 29758184›Full record

Trial reportAmerican journal of ophthalmology2018

Therapeutic Penetrating Keratoplasty Button Cultures in The Mycotic Ulcer Treatment Trial II: A Randomized Trial Comparing Oral Voriconazole Versus Placebo.

Julie Cho, N Venkatesh Prajna, Prajna Lalitha, Revathi Rajaraman, Tiruvengada Krishnan, Yijie Brittany Lin, Kathryn J Ray, Thomas M Lietman, Jennifer Rose-Nussbaumer, Mycotic Ulcer Treatment Trial Group

Open access · greenAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in American journal of ophthalmology, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
0.6field-weighted citation impact, top 31% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 4 citations in OpenAlex.

  1. Article
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

10 authors at 2 institutions in 2 countries.

Julie ChoFrancis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
N Venkatesh PrajnaAravind Eye Care System, Madurai, Pondicherry, India.
Prajna LalithaAravind Eye Care System, Madurai, Pondicherry, India.
Revathi RajaramanAravind Eye Care System, Madurai, Pondicherry, India.
Tiruvengada KrishnanAravind Eye Care System, Madurai, Pondicherry, India.
Yijie Brittany LinFrancis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA.
Kathryn J RayFrancis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA.
Thomas M LietmanFrancis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA; Epidemiology and Biostatistics, University of California San Francisco, San Francisco, California, USA.
Jennifer Rose-NussbaumerFrancis I. Proctor Foundation, University of California San Francisco, San Francisco, California, USA; Department of Ophthalmology, University of California San Francisco, San Francisco, California, USA. Electronic address: jennifer.rose@ucsf.edu.
Mycotic Ulcer Treatment Trial Group
University of California, San Francisco · USAravind Eye Hospital · IN

Funding

Myocotic Ulcer Treatment TrialU10EY018573 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI LIETMAN, THOMAS M · 2009 to 2014
$3.7M
Predictions of Response to Treatment in Fungal KeratitisK23EY025025 · NEI · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI ROSE-NUSSBAUMER, JENNIFER · 2015 to 2019
$1.2M
NEI NIH HHS K23 EY025025NEI NIH HHS U10 EY018573
6 · The paper itself

Abstract

objectiveTo compare oral voriconazole vs placebo in addition to topical antifungals in the treatment of filamentous fungal keratitis.

designNon-prespecified, secondary case-control analysis from a multicenter, double-masked, randomized placebo-controlled clinical trial.

methodsStudy Participants: Patients with smear-positive filamentous fungal ulcers and visual acuity of 20/400 or worse who eventuated to therapeutic penetrating keratoplasty (TPK).

interventionStudy participants were randomized to oral voriconazole vs oral placebo; all received topical antifungal drops.

main outcome measuresTPK button culture positivity.

resultsA total of 95 of 194 (49.5%) study participants enrolled at Madurai, Coimbatore, or Pondicherry, India eventuated to TPK in an average of 20.9 days (standard deviation 15.2 days, range 2-71 days). TPK button cultures were available for 67 of 95 (71%) of the TPKs performed and were positive for filamentous fungus in 45 of 67 (67%) cases. For each 1-day increase in the time to TPK there was 0.94-fold decreased odds of fungal culture positivity (95% confidence interval [CI] 0.90-0.98, P = .005). Those randomized to oral voriconazole had 1.26-fold increased odds of TPK button culture positivity after controlling for time to TPK and baseline organism, but this was not statistically significant (95% CI 0.32-4.87; P = .74). Those who underwent TPK for lack of response to medical therapy were 10.64-fold more likely to be culture positive than if the indication for surgery was perforation and this was statistically significant (95% CI 2.16-51.70; P = .003).

conclusionsThere appears to be no benefit to adding oral voriconazole to topical antifungal agents in the treatment of severe filamentous fungal ulcers. Infection rather than inflammation appears to be the reason for the worsening clinical picture in many of these patients.

Indexed as

Keratoplasty, PenetratingAdministration, OralAdultAgedAntifungal AgentsBacteriological TechniquesCase-Control StudiesCombined Modality TherapyCorneaCorneal UlcerDose-Response Relationship, DrugDouble-Blind MethodEye Infections, FungalFemaleFollow-Up StudiesHumansAntifungal AgentsVoriconazole

Identifiers

PMID29758184
PMCPMC6584760
OpenAlexW2805242651

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

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.